PA0179/002/013 PA0179/002/013 0.9 % w/v Sodium Chloride Injection BP B. Braun Medical Limited 08/04/1987 HM Marketed AU Solution for injection V07AB Well-established use application (Article 10a of Directive No 2001/83/EC) Intramuscular use Intravenous use Subcutaneous use Sodium chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1968/018/001 PA1968/018/001 0.9% Sodium Chloride Intravenous Infusion Solution Laboratoire Aguettant 31/05/1999 HM Not marketed AU Solution for infusion B05BB B05BB01 Not Currently Available Intravenous use Sodium chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0736/044/001 PA0736/044/001 1% w/v Lidocaine Hydrochloride Injection BP B. Braun Melsungen AG 22/04/1992 HM Marketed AU Solution for injection N01BB N01BB02 Not Currently Available Epidural use Intradermal use Intramuscular use Intravenous use Perineural use Submucosal use Lidocaine Hydrochloride Monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1383/001-002 EU/1/19/1383/001-002 10 mg/ml Solution for infusion UCB Pharma S.A. 26/08/2019 HM Unknown AU Solution for infusion N03AX18 Informed consent application (Article 10c of Directive No 2001/83/EC) Lacosamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1422/016-017 EU/1/20/1422/016-017 100 units/mL Tempo Pen solution for injection in pre-filled pen Eli Lilly Nederland B.V. 25/04/2022 HM Unknown AU Solution for injection in pre-filled pen A10AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Insulin lispro Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0736/044/002 PA0736/044/002 2% w/v Lidocaine Hydrochloride Injection BP B. Braun Melsungen AG 22/04/1992 HM Marketed AU Solution for injection N01BB N01BB02 Not Currently Available Epidural use Intradermal use Intramuscular use Intravenous use Perineural use Submucosal use Lidocaine Hydrochloride Monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1422/013-015 EU/1/20/1422/013-015 200 units/mL KwikPen solution for injection in pre-filled pen Eli Lilly Nederland B.V. 24/03/2020 HM Unknown AU Solution for injection in pre-filled pen A10AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Insulin lispro Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1968/019/001 PA1968/019/001 5% Glucose Intravenous Infusion Solution Laboratoire Aguettant 31/05/1999 HM Not marketed AU Solution for infusion B05BB B05BB02 Not Currently Available Intravenous use Glucose Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0179/006/001 PA0179/006/001 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP B. Braun Medical Limited 01/04/1983 HM Marketed AU Solution for infusion B05XA B05XA02 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium bicarbonate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only TR2309/021/001 TR2309/021/001 A.Vogel Uva-ursi & Echinacea Cystitis oral drops A.Vogel Ireland Limited 26/06/2020 HM Marketed AU Oral drops, solution Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0577/193/001 PA0577/193/001 Abacavir/Lamivudine Mylan 600 mg/300 mg film-coated tablets McDermott Laboratories Ltd., T/A Gerard Laboratories 07/10/2016 HM Not marketed AU Film-coated tablet J05AR J05AR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abacavir Lamivudine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/056/001 PA23266/056/001 Abacavir/Lamivudine Viatris 600 mg/300 mg Film-coated Tablets Viatris Limited 10/11/2017 HM Marketed AU Film-coated tablet J05AR J05AR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abacavir sulfate Lamivudine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) EU/1/14/944/001-004 EU/1/14/944/001-004 ABASAGLAR 100 units/mL solution for injection in a cartridge Eli Lilly Nederland B.V. 09/09/2014 HM Unknown AU Solution for injection in cartridge A10AE A10AE04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Insulin glargine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/944/005-008 EU/1/14/944/005-008 ABASAGLAR 100 units/mL solution for injection in a pre-filled pen Eli Lilly Nederland B.V. 09/09/2014 HM Unknown AU Solution for injection in pre-filled pen A10AE A10AE04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Insulin glargine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1539/001 EU/1/21/1539/001 Abecma 260 - 500 x 106 cells dispersion for infusion Bristol-Myers Squibb Pharmaceuticals uc 18/08/2021 HM Unknown AU Dispersion for infusion L01 Known active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Idecabtagene Vicleucel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23163/004/001 PA23163/004/001 Abendur 2.5 mg tablets Ascot Laboratories (Ireland) Limited 16/01/2026 HM Unknown AU Tablet C03AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bendroflumethiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23163/004/002 PA23163/004/002 Abendur 5 mg tablets Ascot Laboratories (Ireland) Limited 16/01/2026 HM Unknown AU Tablet C03AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bendroflumethiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1515/001-005 EU/1/20/1515/001-005 Abevmy 25 mg/mL concentrate for solution for infusion Biosimilar Collaborations Ireland Limited 21/04/2021 HM Unknown AU Concentrate for solution for infusion L01XC07 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Bevacizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1186/001/001 PA1186/001/001 Abidec Multivitamin Oral Drops Solution Chefaro Ireland DAC 01/09/2000 HM Marketed AU Oral drops, solution A11BA Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ergocalciferol Thiamine hydrochloride Riboflavin sodium phosphate Pyridoxine hydrochloride Nicotinamide Ascorbic acid Vitamin a palmitate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/04/276/033-035 EU/1/04/276/033-035 IC0092-047-019 Abilify 1 mg/mL oral solution Otsuka Pharmaceutical Netherlands B.V. HM Unknown AU Oral solution N05AX N05AX12 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/276/024-026 EU/1/04/276/024-026 IC0092-002-056 Abilify 10 mg orodispersible tablets Otsuka Pharmaceutical Netherlands B.V. 20/06/2005 HM Unknown AU Orodispersible tablet N05AX N05AX12 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/276/006-010 EU/1/04/276/006-010 IC0092-002-056 Abilify 10 mg tablets Otsuka Pharmaceutical Netherlands B.V. HM Unknown AU Tablet N05AX12 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/276/027-029 EU/1/04/276/027-029 IC0092-032-056 Abilify 15 mg orodispersible tablets Otsuka Pharmaceutical Netherlands B.V. HM Unknown AU Orodispersible tablet N05AX12 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/276/011-015 EU/1/04/276/011-015 IC0092-032-056 Abilify 15 mg tablets Otsuka Pharmaceutical Netherlands B.V. HM Unknown AU Tablet N05AX12 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/276/030-032 EU/1/04/276/030-032 IC0092-033-056 Abilify 30 mg orodispersible tablets Otsuka Pharmaceutical Netherlands B.V. HM Unknown AU Orodispersible tablet N05AX12 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/276/016-020 EU/1/04/276/016-020 IC0092-033-056 Abilify 30 mg tablets Otsuka Pharmaceutical Netherlands B.V. HM Unknown AU Tablet N05AX12 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/276/001-005 EU/1/04/276/001-005 IC0092-001-002 Abilify 5 mg tablets Otsuka Pharmaceutical Netherlands B.V. HM Unknown AU Tablet N05AX N05AX12 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/276/036 EU/1/04/276/036 Abilify 7.5 mg/mL solution for injection Otsuka Pharmaceutical Netherlands B.V. HM Unknown AU Solution for injection N05AX N05AX12 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/882/001,003 EU/1/13/882/001,003 Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Otsuka Pharmaceutical Netherlands B.V. HM Unknown AU Powder and solvent for prolonged-release suspension for injection N05AX N05AX12 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/882/002,004 EU/1/13/882/002,004 Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Otsuka Pharmaceutical Netherlands B.V. 30/01/2014 HM Unknown AU Powder and solvent for prolonged-release suspension for injection N05AX N05AX12 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/882/009 EU/1/13/882/009 Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe Otsuka Pharmaceutical Netherlands B.V. 25/03/2024 HM Unknown AU Prolonged-release suspension for injection in pre-filled syringe N05AX12 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Aripiprazole Monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/882/010 EU/1/13/882/010 Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe Otsuka Pharmaceutical Netherlands B.V. 25/03/2024 HM Unknown AU Prolonged-release suspension for injection in pre-filled syringe N05AX12 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Aripiprazole Monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/304/002 PA0711/304/002 IC0123-117-003 Abiraterone 500 mg film-coated tablets Rowex Limited, 18/06/2021 HM Not marketed AU Film-coated tablet L02BX03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1512/001 EU/1/20/1512/001 IC0123-130-014 Abiraterone Accord 250 mg tablets Accord Healthcare S.L.U. 26/04/2021 HM Unknown AU Tablet L02BX03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1512/002-003 EU/1/20/1512/002-003 IC0123-117-003 Abiraterone Accord 500 mg film-coated tablets Accord Healthcare S.L.U. 26/04/2021 HM Unknown AU Film-coated tablet L02BX03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1983/008/001 PA1983/008/001 IC0123-130-014 Abiraterone Aristo 250 mg tablets Aristo Pharma GmbH 07/05/2021 HM Not marketed AU Tablet L02BX03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1983/008/002 PA1983/008/002 IC0123-117-003 Abiraterone Aristo 500 mg film-coated tablets Aristo Pharma GmbH 07/05/2021 HM Marketed AU Film-coated tablet L02BX03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA25251/001/001 PA25251/001/001 IC0123-130-014 Abiraterone AshCure 250 mg film-coated tablets AshCure Pharma B.V. 16/01/2026 HM Not marketed AU Film-coated tablet L02BX03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA25251/001/002 PA25251/001/002 IC0123-117-003 Abiraterone AshCure 500 mg film-coated tablets AshCure Pharma B.V. 16/01/2026 HM Not marketed AU Film-coated tablet L02BX03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0126/336/001 PA0126/336/001 IC0123-117-003 Abiraterone Clonmel 500 mg film-coated tablets Clonmel Healthcare Ltd 13/08/2021 HM Marketed AU Film-coated tablet L02BX03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1553/001-003 EU/1/21/1553/001-003 IC0123-117-003 Abiraterone Krka 500 mg film-coated tablets KRKA, d.d., Novo mesto 24/06/2021 HM Unknown AU Film-coated tablet L02BX03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1571/009-012 EU/1/21/1571/009-012 Abiraterone Mylan 1000 mg film-coated tablets Mylan Pharmaceuticals Limited 20/08/2021 HM Unknown AU Film-coated tablet L02BX03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1571/001-008 EU/1/21/1571/001-008 IC0123-117-003 Abiraterone Mylan 500 mg film-coated tablets Mylan Pharmaceuticals Limited 20/08/2021 HM Unknown AU Film-coated tablet L02BX03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0074/092/001 PA0074/092/001 IC0123-117-003 Abiraterone Rowa 500 mg Film-coated tablets Rowa Pharmaceuticals Limited, 22/07/2022 HM Marketed AU Film-coated tablet L02BX03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/103/001 PA1986/103/001 IC0123-117-003 Abiraterone Teva 500 mg film-coated tablets Teva B.V. 24/06/2022 HM Marketed AU Film-coated tablet L02BX03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/428/001 EU/1/07/428/001 Abraxane 5 mg/ml powder for dispersion for infusion Bristol-Myers Squibb Pharma EEIG 11/01/2008 HM Unknown AU Powder for concentrate for dispersion for infusion L01CD L01CD01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Paclitaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/23/1752/007-009 EU/1/23/1752/007-009 Abrysvo powder and solvent for solution for injection Pfizer Europe MA EEIG 23/08/2023 HM Unknown AU Powder and solvent for solution for injection J07BX05 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Respiratory syncytial virus, subgroup A, stabilized prefusion F protein 847A Respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. EU/1/23/1752/001-006 EU/1/23/1752/001-006 Abrysvo powder and solvent for solution for injection Respiratory syncytial virus vaccine (bivalent, recombinant) Pfizer Europe MA EEIG 23/08/2023 HM Unknown AU Powder and solvent for solution for injection J07BX05 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Respiratory syncytial virus, subgroup A, stabilized prefusion F protein 847A Respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/412/1-2 EU/1/07/412/1-2 Abseamed 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Medice Arzneimittel Putter GmbH & Co. K.G 28/08/2007 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/412/15-16 EU/1/07/412/15-16 Abseamed 10 000 IU/1 mL solution for injection in a pre-filled syringe Medice Arzneimittel Putter GmbH & Co. K.G 28/08/2007 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/412/3-4 EU/1/07/412/3-4 Abseamed 2 000 IU/1 mL solution for injection in a pre-filled syringe Medice Arzneimittel Putter GmbH & Co. K.G 28/08/2007 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/412/021-22 EU/1/07/412/021-22 Abseamed 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Medice Arzneimittel Putter GmbH & Co. K.G HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Subcutaneous use Epoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/07/412/5-6 EU/1/07/412/5-6 Abseamed 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Medice Arzneimittel Putter GmbH & Co. K.G 28/08/2007 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/412/023-24 EU/1/07/412/023-24 Abseamed 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Medice Arzneimittel Putter GmbH & Co. K.G 26/11/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Subcutaneous use Epoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/412/7-8 EU/1/07/412/7-8 Abseamed 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Medice Arzneimittel Putter GmbH & Co. K.G 28/08/2007 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/412/025-26 EU/1/07/412/025-26 Abseamed 40 000 IU/1 mL solution for injection in a pre-filled syringe Medice Arzneimittel Putter GmbH & Co. K.G 26/11/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Subcutaneous use Epoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/412/9-10 EU/1/07/412/9-10 Abseamed 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Medice Arzneimittel Putter GmbH & Co. K.G 28/08/2007 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/412/11-12 EU/1/07/412/11-12 Abseamed 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Medice Arzneimittel Putter GmbH & Co. K.G 28/08/2007 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/412/13-14 EU/1/07/412/13-14 Abseamed 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Medice Arzneimittel Putter GmbH & Co. K.G 28/08/2007 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA2242/019/001 PA2242/019/001 Abstral 100 microgram sublingual tablets Grunenthal Pharma Limited. 22/05/2009 HM Marketed AU Sublingual tablet N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Sublingual use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA2242/019/002 PA2242/019/002 Abstral 200 microgram sublingual tablets Grunenthal Pharma Limited. 22/05/2009 HM Marketed AU Sublingual tablet N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Sublingual use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA2242/019/003 PA2242/019/003 Abstral 300 microgram sublingual tablets Grunenthal Pharma Limited. 22/05/2009 HM Marketed AU Sublingual tablet N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Sublingual use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA2242/019/004 PA2242/019/004 Abstral 400 microgram sublingual tablets Grunenthal Pharma Limited. 22/05/2009 HM Marketed AU Sublingual tablet N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Sublingual use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA2242/019/005 PA2242/019/005 Abstral 600 microgram sublingual tablets Grunenthal Pharma Limited. 22/05/2009 HM Marketed AU Sublingual tablet N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Sublingual use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA2242/019/006 PA2242/019/006 Abstral 800 microgram sublingual tablets Grunenthal Pharma Limited. 22/05/2009 HM Marketed AU Sublingual tablet N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Sublingual use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1255/010/001 PA1255/010/001 ACARIZAX 12 SQ-HDM sublingual lyophilisate ALK-Abello A/S 29/11/2019 HM Marketed AU Sublingual lyophilisate V01AA03 Full application (Article 8(3) of Directive No 2001/83/EC) Sublingual use Dermatophagoides Farinae Extract Dermatophagoides Pteronyssinus Extract Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/14/946/001-002 EU/1/14/946/001-002 Accofil 30 MU/0.5 ml solution for injection/infusion in pre-filled syringe Accord Healthcare S.L.U. HM Unknown AU Solution for injection in pre-filled syringe L03AA L03AA02 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Filgrastim Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/14/943/003-004 EU/1/14/943/003-004 Accofil 48 MU/0.5 ml solution for injection/infusion in pre-filled syringe Accord Healthcare S.L.U. 18/09/2014 HM Unknown AU Solution for injection in pre-filled syringe L03AA L03AA02 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Filgrastim Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2021/002/001 PA2021/002/001 Accusol 35 Potassium 2 mmol/lSolution for haemofiltration, haemodialysis and haemodiafiltration Nikkiso Belgium bvba 28/04/2006 HM Marketed AU Solution for haemodialysis/haemofiltration B05ZB Well-established use application (Article 10a of Directive No 2001/83/EC) Haemodialysis Intraarterial use Sodium chloride Calcium chloride Magnesium chloride Sodium bicarbonate Potassium chloride Glucose anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2021/002/002 PA2021/002/002 Accusol 35 Potassium 4 mmol/lSolution for haemofiltration, haemodialysis and haemodiafiltration Nikkiso Belgium bvba 28/04/2006 HM Marketed AU Solution for haemodialysis/haemofiltration B05ZB Well-established use application (Article 10a of Directive No 2001/83/EC) Haemodialysis Intraarterial use Sodium chloride Calcium chloride Magnesium chloride Sodium bicarbonate Potassium chloride Glucose anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2021/001/001 PA2021/001/001 Accusol 35 Solution for haemofiltration, haemodialysis and haemodiafiltration Nikkiso Belgium bvba 28/04/2006 HM Marketed AU Solution for haemodialysis/haemofiltration B05ZB Well-established use application (Article 10a of Directive No 2001/83/EC) Haemodialysis Intraarterial use Sodium chloride Calcium chloride Magnesium chloride Sodium bicarbonate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0568/018/004 PA0568/018/004 Acerycal 10mg/10mg tablets Les Laboratoires Servier 13/06/2008 HM Marketed AU Tablet C09BB Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Perindopril arginine Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/018/002 PA0568/018/002 Acerycal 5mg/10mg tablets Les Laboratoires Servier 13/06/2008 HM Marketed AU Tablet C09BB Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Perindopril arginine Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/018/003 PA0568/018/003 Acerycal 10mg/5mg tablets Les Laboratoires Servier 13/06/2008 HM Marketed AU Tablet C09BB Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Perindopril arginine Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/018/001 PA0568/018/001 Acerycal 5mg/5mg tablets Les Laboratoires Servier 13/06/2008 HM Marketed AU Tablet C09BB Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Perindopril arginine Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23163/003/001 PA23163/003/001 Acetylcysteine Essential-Healthcare 600 mg effervescent tablets Ascot Laboratories (Ireland) Limited 29/03/2018 HM Not marketed AU Effervescent tablet R05CB R05CB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Acetylcysteine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/017/001 PA0711/017/001 Acic 5% Cream Rowex Ltd 02/05/2003 HM Not marketed AU Cream D06BB D06BB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Topical Aciclovir Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only 2 g tube: Retail sale through pharmacies only in pack sizes not exceeding 2g. 2 g and 5 g tube: Prescription only medicine. 2 g tube: to the professions. 2 g and 5 g tube: to the professions as a prescription only item. PA0711/017/006 PA0711/017/006 Acic Cold Sore 5% w/w Cream Rowex Ltd 23/11/2012 HM Marketed AU Cream D06BB D06BB03 Informed consent application (Article 10c of Directive No 2001/83/EC) Cutaneous use Aciclovir Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public Product not subject to medical prescription if compliant with the following restrictions: maximum strength: 5%, maximum pack size: 2.0 g, limited indication: cold sores. PA22697/001/001 PA22697/001/001 Aciclovir 200 mg/5ml Oral Suspension Syri Pharma Limited t/a Thame Laboratories 26/05/2016 HM Marketed AU Oral suspension J05AB J05AB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/043/001 PA1122/043/001 Aciclovir 250 mg powder for solution for infusion Noridem Enterprises Limited 24/01/2025 HM Not marketed AU Powder for solution for infusion J05AB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Aciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/215/001 PA0822/215/001 Aciclovir 25mg/ml concentrate for solution for infusion Pfizer Healthcare Ireland Unlimited Company 22/01/1999 HM Marketed AU Concentrate for solution for infusion J05AB J05AB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Aciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/041/001 PA2299/041/001 Aciclovir 25mg/ml Concentrate for solution for infusion Baxter Holding B.V. 27/03/2013 HM Not marketed AU Concentrate for solution for infusion J05AB J05AB01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Aciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22697/001/002 PA22697/001/002 Aciclovir 400 mg/5ml Oral Suspension Syri Pharma Limited t/a Thame Laboratories 26/05/2016 HM Not marketed AU Oral suspension J05AB J05AB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/043/002 PA1122/043/002 Aciclovir 500 mg powder for solution for infusion Noridem Enterprises Limited 24/01/2025 HM Not marketed AU Powder for solution for infusion J05AB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Aciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22584/001/001 PA22584/001/001 Aciclovir Agepha 30 mg/g eye ointment AGEPHA Pharma s.r.o. 19/08/2019 HM Marketed AU Eye ointment S01AD03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Ocular use Aciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1852/003/001 PA1852/003/001 Aciclovir Azevedos 250 mg Powder for solution for infusion Laboratórios Azevedos - Indústria Farmacêutica S.A 06/10/2017 HM Marketed AU Powder for solution for infusion J05AB J05AB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Aciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/075/001 PA0281/075/001 Acidex Oral Suspension, Sodium Alginate 500mg, Sodium Bicarbonate 267mg, Calcium Carbonate 160mg/10ml Pinewood Laboratories Limited 26/06/1998 HM Marketed AU Oral suspension B05CB B05CB04 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium alginate Sodium bicarbonate Calcium carbonate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/05/308/001 EU/1/05/308/001 Aclasta 5 mg solution for infusion Sandoz Pharmaceuticals d.d. HM Unknown AU Solution for infusion M05BA M05BA08 Known active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Zoledronic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA22743/001/001 PA22743/001/001 Acnecide 5% w/w Gel Galderma International 17/04/1984 HM Marketed AU Gel D10AE D10AE01 Well-established use application (Article 10a of Directive No 2001/83/EC) Topical use Benzoyl Peroxide Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA22743/001/002 PA22743/001/002 Acnecide Wash 5 % w/w Gel Galderma International 31/10/1997 HM Marketed AU Gel D10AE D10AE01 Well-established use application (Article 10a of Directive No 2001/83/EC) Cutaneous use Topical use Benzoyl Peroxide Product not subject to medical prescription Supply through pharmacies only Advertising to the general public HOR1149/001/001 HOR1149/001/001 Aconite A. Nelson & Company Limited 11/03/2011 HM Not marketed AU Not assigned Not Currently Available Oral use Aconitum napellus Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA2113/002/002 PA2113/002/002 ACTAIR 100 IR & 300 IR sublingual tablets Stallergenes 08/10/2021 HM Marketed AU Sublingual tablet V01AA03 Hybrid application - change in withdrawal period (Article 19(1)(a) of Regulation (EU) 2019/6) Sublingual use Dermatophagoides Pteronyssinus Extract Dermatophagoides Farinae Extract Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2113/002/001 PA2113/002/001 ACTAIR 100 IR sublingual tablets Stallergenes 08/10/2021 HM Marketed AU Sublingual tablet V01AA03 Hybrid application - change in withdrawal period (Article 19(1)(a) of Regulation (EU) 2019/6) Sublingual use Dermatophagoides Pteronyssinus Extract Dermatophagoides Farinae Extract Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2113/002/003 PA2113/002/003 ACTAIR 300 IR sublingual tablets Stallergenes 08/10/2021 HM Marketed AU Sublingual tablet V01AA03 Hybrid application - change in withdrawal period (Article 19(1)(a) of Regulation (EU) 2019/6) Sublingual use Dermatophagoides Pteronyssinus Extract Dermatophagoides Farinae Extract Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/817/001-013 EU/1/13/817/001-013 IC0050-099-039 Actelsar HCT 40 mg/12.5 mg tablets Actavis Group hf HM Unknown AU Tablet C09DA C09DA07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Hydrochlorothiazide Telmisartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/817/014-028 EU/1/13/817/014-028 IC0050-081-039 Actelsar HCT 80 mg/12.5 mg tablets Actavis Group hf 13/03/2013 HM Unknown AU Tablet C09DA C09DA07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Hydrochlorothiazide Telmisartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/817/029-041 EU/1/13/817/029-041 IC0050-100-039 Actelsar HCT 80 mg/25 mg tablets Actavis Group hf 13/03/2013 HM Unknown AU Tablet C09DA C09DA07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Hydrochlorothiazide Telmisartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23490/029/001 PA23490/029/001 ACTIFED 30 mg/1.25 mg per 5 ml Syrup JNTL Consumer Health I (Ireland) Limited 01/04/1978 HM Not marketed AU Syrup R01BA R01BA02 Not Currently Available Oral use PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Sale through pharmacies only in packs containing not more than 100ml per pack. Packs containing more than 720mg pseudoephedrine are subject to medical prescription. PA23490/029/002 PA23490/029/002 Actifed 60mg/2.5mg Tablets JNTL Consumer Health I (Ireland) Limited 01/04/1978 HM Marketed AU Tablet R01BA R01BA02 Not Currently Available Oral use PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only Sale through pharmacies only in packs containing not more than 12 units per pack. Packs containing more than 720mg pseudoephedrine are subject to medical prescription. PA0775/011/001 PA0775/011/001 Actilyse 10 mg powder and solvent for solution for injection and infusion Boehringer Ingelheim International GmbH 08/09/1994 HM Marketed AU Powder and solvent for solution for injection/infusion B01AD B01AD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Alteplase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0775/011/002 PA0775/011/002 Actilyse 20 mg powder and solvent for solution for injection and infusion Boehringer Ingelheim International GmbH 19/06/1989 HM Marketed AU Powder and solvent for solution for injection/infusion B01AD B01AD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Alteplase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0775/011/003 PA0775/011/003 Actilyse 50 mg powder and solvent for solution for injection and infusion Boehringer Ingelheim International GmbH 19/06/1989 HM Marketed AU Powder and solvent for solution for injection/infusion B01AD B01AD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Alteplase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0775/011/004 PA0775/011/004 Actilyse Cathflo 2 mg powder for solution for injection and infusion Boehringer Ingelheim International GmbH 09/04/2010 HM Marketed AU Powder and solvent for solution for injection/infusion B01AD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Alteplase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0678/061/002 PA0678/061/002 Actiprofen 200 mg tablets Haleon Ireland Limited 24/03/1992 HM Marketed AU Film-coated tablet M01AE M01AE01 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only Subject to the following restriction: maximum strength 200 mg, maximum pack size 50, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children over 12 years. PA1113/036/001 PA1113/036/001 Actiq 200 micrograms compressed lozenge with integral oromucosal applicator Phoenix Labs Unlimited Company 23/01/2002 HM Marketed AU Compressed lozenge N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Oromucosal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1113/036/002 PA1113/036/002 Actiq 400 micrograms compressed lozenge with integral oromucosal applicator Phoenix Labs Unlimited Company 23/01/2002 HM Marketed AU Compressed lozenge N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Oromucosal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PPA0465/407/002 PPA0465/407/002 Actiq 400 micrograms compressed lozenge with integral oromucosal applicator PCO Manufacturing Ltd. 15/05/2015 HM Unknown AU Compressed lozenge N02AB03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oromucosal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1113/036/003 PA1113/036/003 Actiq 600 micrograms compressed lozenge with integral oromucosal applicator Phoenix Labs Unlimited Company 23/01/2002 HM Marketed AU Compressed lozenge N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Oromucosal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0218/052/001 PA0218/052/001 Activelle 1 mg/0.5 mg film-coated tablets Novo Nordisk A/S 28/08/1998 HM Marketed AU Film-coated tablet G03FA G03FA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Estradiol Norethisterone acetate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/150/002 EU/1/00/150/002 Actos CHEPLAPHARM Arzneimittel GmbH 13/10/2000 HM Unknown AU Tablet A10BG03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pioglitazone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/150/005 EU/1/00/150/005 Actos CHEPLAPHARM Arzneimittel GmbH 13/10/2000 HM Unknown AU Tablet A10BG03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pioglitazone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/150/011 EU/1/00/150/011 Actos Takeda Pharma A/S 16/09/2003 HM Unknown AU Tablet A10BG03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pioglitazone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/150/001 EU/1/00/150/001 Actos 15 mg tablets CHEPLAPHARM Arzneimittel GmbH 13/10/2000 HM Unknown AU Tablet A10BG03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pioglitazone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/150/003 EU/1/00/150/003 Actos 15 mg tablets CHEPLAPHARM Arzneimittel GmbH 13/10/2000 HM Unknown AU Tablet A10BG03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pioglitazone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/150/004 EU/1/00/150/004 Actos 30 mg tablets CHEPLAPHARM Arzneimittel GmbH 13/10/2000 HM Unknown AU Tablet A10BG03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pioglitazone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/150/006 EU/1/00/150/006 Actos 30 mg tablets CHEPLAPHARM Arzneimittel GmbH 13/10/2000 HM Unknown AU Tablet A10BG03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pioglitazone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/229/001-035 EU/1/02/229/001-035 Actraphane Novo Nordisk A/S 07/10/2002 HM Unknown AU Solution for injection A10AD A10AD01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Insulin human Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/229/036-037 EU/1/02/229/036-037 Actraphane 30 40 IU/ml Suspension for injection Novo Nordisk A/S 13/08/2003 HM Unknown AU Suspension for injection A10AD A10AD01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Insulin human Insulin human Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/230/001-015 EU/1/02/230/001-015 Actrapid Novo Nordisk A/S 07/10/2002 HM Unknown AU Solution for injection A10AB A10AB01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Insulin human Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/230/016-017 EU/1/02/230/016-017 Actrapid Novo Nordisk A/S 13/08/2003 HM Unknown AU Solution for injection A10AB A10AB01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Insulin human Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1824/015/001 PA1824/015/001 Acular 0.5% w/v Eye Drops, solution AbbVie Limited 14/06/1995 HM Marketed AU Eye drops, solution S01BC S01BC05 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Ketorolac trometamol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/200/001 PPA1463/200/001 Acular 0.5% w/v Eye Drops, solution IMED Healthcare Ltd. 13/01/2023 HM Marketed AU Eye drops, solution S01BC S01BC05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Ocular use Ketorolac trometamol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/287/001 PPA0465/287/001 ACULAR 0.5% w/v Eye drops, solution PCO Manufacturing Ltd. 20/07/2012 HM Unknown AU Eye drops, solution S01BC S01BC05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Ocular use Ketorolac trometamol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1983/001 EU/1/25/1983/001 Acvybra 60 mg solution for injection in pre-filled syringe Reddy Holding GmbH 17/11/2025 HM Unknown AU Solution for injection in pre-filled syringe M05BX04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Denosumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23450/003/001 PA23450/003/001 Adaluzis 500mg Powder for concentrate for solution for infusion Advanz Pharma Limited 29/09/2017 HM Not marketed AU Powder for concentrate for solution for infusion J01DI J01DI01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Ceftobiprole medocaril sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/823/001 EU/1/13/823/001 ADASUVE 4.5 mg inhalation powder, pre-dispensed Ferrer Internacional, S.A HM Unknown AU Inhalation powder, pre-dispensed N05AH N05AH01 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Loxapine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/13/823/002 EU/1/13/823/002 ADASUVE 9.1 mg inhalation powder, pre-dispensed Ferrer Internacional, S.A HM Unknown AU Inhalation powder, pre-dispensed N05AH N05AH01 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Loxapine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/794/001 EU/1/12/794/001 ADCETRIS 50 mg powder for concentrate for solution for infusion Takeda Pharma A/S 25/10/2012 HM Unknown AU Powder for concentrate for solution for infusion L01FX05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Brentuximab vedotin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/08/476/001-004 EU/1/08/476/001-004 Adcirca (previously Tadalafil Lilly) Eli Lilly Nederland B.V. 01/10/2008 HM Unknown AU Film-coated tablet G04BE G04BE08 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Tadalafil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/476/005-06 EU/1/08/476/005-06 Adcirca 20 mg film-coated tablets Eli Lilly Nederland B.V. 15/12/2022 HM Unknown AU Film-coated tablet G04BE08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tadalafil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2059/024/001 PA2059/024/001 Addiphos concentrate for solution for infusion Fresenius Kabi Deutschland GmbH 01/04/1983 HM Marketed AU Concentrate for solution for infusion B05XA B05XA30 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Potassium dihydrogen phosphate Potassium hydroxide Disodium phosphate dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/023/002 PA2059/023/002 Additrace N concentrate for solution for infusion Fresenius Kabi Deutschland GmbH 27/03/2015 HM Marketed AU Concentrate for solution for infusion B05XA B05XA31 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Chromic chloride hexahydrate Copper chloride dihydrate Ferric chloride hexahydrate Manganese chloride tetrahydrate Potassium iodide Sodium fluoride Sodium molybdate dihydrate Sodium selenite anhydrous Zinc chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/907/021 EU/1/13/907/021 Adempas 0.15 mg/mL granules for oral suspension Bayer AG 23/06/2025 HM Unknown AU Granules for oral suspension C02KX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Riociguat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/13/907/001-003 EU/1/13/907/001-003 Adempas 0.5 mg film-coated tablets Bayer AG HM Unknown AU Film-coated tablet C02KX C02KX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Riociguat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription. (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/13/907/004-006 EU/1/13/907/004-006 Adempas 1 mg film-coated tablets Bayer AG 27/03/2014 HM Unknown AU Film-coated tablet C02KX C02KX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Riociguat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription. (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/13/907/007-009 EU/1/13/907/007-009 Adempas 1.5 mg film-coated tablets Bayer AG 27/03/2014 HM Unknown AU Film-coated tablet C02KX C02KX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Riociguat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription. (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/13/907/010-012 EU/1/13/907/010-012 Adempas 2 mg film-coated tablets Bayer AG 27/03/2014 HM Unknown AU Film-coated tablet C02KX C02KX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Riociguat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription. (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/13/907/013-015 EU/1/13/907/013-015 Adempas 2.5 mg film-coated tablets Bayer AG 27/03/2014 HM Unknown AU Film-coated tablet C02KX C02KX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Riociguat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription. (See Annex I: Summary of Product Characteristics, section 4.2) PA0540/139/001 PA0540/139/001 Adenocor 3 mg/ml solution for injection Sanofi-Aventis Ireland Limited T/A SANOFI 16/06/1994 HM Marketed AU Solution for injection C01EB C01EB10 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Adenosine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/004/001 PA2059/004/001 Adenosine 3 mg/ml solution for injection in pre-filled syringe Fresenius Kabi Deutschland GmbH 28/08/2015 HM Marketed AU Solution for injection in pre-filled syringe C01EB C01EB10 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Adenosine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/447/001-002 EU/1/08/447/001-002 Adenuric 80 mg film-coated tablets Menarini International Operations Luxembourg S.A. 21/04/2008 HM Unknown AU Film-coated tablet M04AA M04AA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Febuxostat Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/447/003-004 EU/1/08/447/003-004 Adenuric120 mg film-coated tablets Menarini International Operations Luxembourg S.A. HM Unknown AU Film-coated tablet M04AA M04AA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Febuxostat Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1688/001/002 PA1688/001/002 Adizem-SR 120 mg Prolonged Release Capsules Mundipharma Pharmaceuticals Limited 20/04/1995 HM Marketed AU Prolonged-release capsule, hard C08DB C08DB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Diltiazem hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1688/001/003 PA1688/001/003 Adizem-SR 180 mg Prolonged Release Capsules Mundipharma Pharmaceuticals Limited 20/04/1995 HM Marketed AU Prolonged-release capsule, hard C08DB C08DB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Diltiazem hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1688/001/001 PA1688/001/001 Adizem-SR 90 mg Prolonged Release Capsules Mundipharma Pharmaceuticals Limited 20/04/1995 HM Marketed AU Prolonged-release capsule, hard C08DB C08DB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Diltiazem hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1688/001/004 PA1688/001/004 ADIZEM-XL 120mg prolonged release capsules Mundipharma Pharmaceuticals Limited 16/12/1994 HM Marketed AU Prolonged-release capsule, hard C08DB C08DB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Diltiazem hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1688/001/005 PA1688/001/005 ADIZEM-XL 180mg prolonged release capsules Mundipharma Pharmaceuticals Limited 16/12/1994 HM Marketed AU Prolonged-release capsule, hard C08DB C08DB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Diltiazem hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1688/001/006 PA1688/001/006 ADIZEM-XL 240 mg prolonged release capsules Mundipharma Pharmaceuticals Limited 16/12/1994 HM Marketed AU Prolonged-release capsule, hard C08DB C08DB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Diltiazem hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1688/001/007 PA1688/001/007 ADIZEM-XL 300 mg prolonged release capsules Mundipharma Pharmaceuticals Limited 16/12/1994 HM Marketed AU Prolonged-release capsule, hard C08DB C08DB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Diltiazem hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/578/001 EU/1/09/578/001 Adjupanrix suspension and emulsion for emulsion for injection. Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals S.A. 05/11/2009 HM Unknown AU Emulsion and suspension for emulsion for injection J07BB J07BB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Purified antigen fractions of inactivated split virions a/vietnam/1194/2004 nibrg-14 (h5n1) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1968/002/001 PA1968/002/001 Adrenaline (Epinephrine) 1 mg/10 ml (1:10,000) Solution for Injection in Pre-Filled Syringe Laboratoire Aguettant 11/03/2016 HM Marketed AU Solution for injection in pre-filled syringe C01CA C01CA24 Well-established use application (Article 10a of Directive No 2001/83/EC) Intramuscular use Intravenous use Adrenaline tartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0073/035/001 PA0073/035/001 Adrenaline (Epinephrine) 1:1,000 Solution for Injection Mercury Pharmaceuticals (Ireland) Ltd 01/04/1979 HM Marketed AU Solution for injection C01CA C01CA24 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Subcutaneous use Adrenaline (epinephrine) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/364/001-004 EU/1/06/364/001-004 IC0052-102-002 Adrovance 70 mg/2800 IU tablets N.V. Organon 04/01/2007 HM Unknown AU Tablet M05BB03 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Vitamin d3 Alendronic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/364/006-008 EU/1/06/364/006-008 IC0052-103-002 Adrovance 70 mg/5600 IU tablets N.V. Organon 02/10/2007 HM Unknown AU Tablet M05BB03 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Vitamin d3 Alendronic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1554/001-003 EU/1/21/1554/001-003 Adtralza 150 mg solution for injection in pre-filled syringe LEO Pharma A/S 17/06/2021 HM Unknown AU Solution for injection in pre-filled syringe D11AH07 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Tralokinumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1554/004-005 EU/1/21/1554/004-005 Adtralza 300 mg solution for injection in pre-filled pen LEO Pharma A/S 17/06/2021 HM Unknown AU Solution for injection in pre-filled pen D11AH07 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Tralokinumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/387/001-002 EU/1/07/387/001-002 Advagraf 0.5 mg prolonged-release hard capsules Astellas Pharma Europe BV 23/04/2007 HM Unknown AU Prolonged-release capsule, hard L04AA L04AA05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tacrolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/387/1-2 EU/1/07/387/1-2 Advagraf 0.5 mg prolonged-release hard capsules Astellas Pharma Europe BV 23/04/2007 HM Unknown AU Prolonged-release capsule, hard L04AD L04AD02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tacrolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/07/387/003-006 EU/1/07/387/003-006 Advagraf 1 mg prolonged-release hard capsules Astellas Pharma Europe BV HM Unknown AU Prolonged-release capsule, hard L04AA L04AA05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tacrolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/387/3-6 EU/1/07/387/3-6 Advagraf 1 mg prolonged-release hard capsules Astellas Pharma Europe BV 23/04/2007 HM Unknown AU Prolonged-release capsule, hard L04AD L04AD02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tacrolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/07/387/011-013 EU/1/07/387/011-013 Advagraf 3 mg prolonged-release hard capsules Astellas Pharma Europe BV HM Unknown AU Prolonged-release capsule, hard L04AA L04AA05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tacrolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/387/11-13 EU/1/07/387/11-13 Advagraf 3 mg prolonged-release hard capsules Astellas Pharma Europe BV 27/04/2009 HM Unknown AU Prolonged-release capsule, hard L04AD L04AD02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tacrolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/07/387/007-008 EU/1/07/387/007-008 Advagraf 5 mg prolonged-release hard capsules Astellas Pharma Europe BV HM Unknown AU Prolonged-release capsule, hard L04AA L04AA05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tacrolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/387/7-8 EU/1/07/387/7-8 Advagraf 5 mg prolonged-release hard capsules Astellas Pharma Europe BV 23/04/2007 HM Unknown AU Prolonged-release capsule, hard L04AD L04AD02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tacrolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/03/271/009 EU/1/03/271/009 Advate 1000 IU/2 ml powder and solvent for solution for injection Takeda Manufacturing Austria AG HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Recombinant coagulation fviii (octocog alfa) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/03/271/003 EU/1/03/271/003 Advate 1000 IU/5 ml powder and solvent for solution for injection Takeda Manufacturing Austria AG 22/05/2008 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Recombinant coagulation fviii (octocog alfa) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/03/271/004 EU/1/03/271/004 Advate 1500 IU/5 ml powder and solvent for solution for injection Takeda Manufacturing Austria AG HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Recombinant coagulation fviii (octocog alfa) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/03/271/005 EU/1/03/271/005 Advate 2000 IU/5 ml powder and solvent for solution for injection Takeda Manufacturing Austria AG HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Recombinant coagulation fviii (octocog alfa) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/03/271/007 EU/1/03/271/007 Advate 250 IU/2 ml powder and solvent for solution for injection Takeda Manufacturing Austria AG HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Recombinant coagulation fviii (octocog alfa) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/03/271/001 EU/1/03/271/001 Advate 250 IU/5 ml powder and solvent for solution for injection Takeda Manufacturing Austria AG 31/03/2004 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Recombinant coagulation fviii (octocog alfa) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/03/271/006 EU/1/03/271/006 Advate 3000 IU/5 ml powder and solvent for solution for injection Takeda Manufacturing Austria AG HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Recombinant coagulation fviii (octocog alfa) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/03/271/008 EU/1/03/271/008 Advate 500 IU/2 ml powder and solvent for solution for injection Takeda Manufacturing Austria AG HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Recombinant coagulation fviii (octocog alfa) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/03/271/002 EU/1/03/271/002 Advate 500 IU/5 ml powder and solvent for solution for injection Takeda Manufacturing Austria AG 22/05/2008 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Recombinant coagulation fviii (octocog alfa) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA0678/147/001 PA0678/147/001 Advil Cold & Flu Coated Tablets Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg Haleon Ireland Limited 08/09/1994 HM Marketed AU Coated tablet M01AE M01AE51 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Ibuprofen PSEUDOEPHEDRINE HYDROCHLORIDE Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Sale through pharmacies only in packs containing not more than 24 units per pack. Packs containing more than 720 mg pseudoephedrine are subject to medical prescription. Not more than one pack of pseudoephedrine containing medicinal products should be su PA0678/147/002 PA0678/147/002 Advil Cold & Flu Relief Soft Capsules Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg Haleon Ireland Limited 16/03/2016 HM Not marketed AU Capsule, soft M01AE M01AE51 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ibuprofen PSEUDOEPHEDRINE HYDROCHLORIDE Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Sale through pharmacies only in packs containing not more than 24 units per pack. Packs containing more than 720 mg pseudoephedrine are subject to medical prescription. Not more than one pack of pseudoephedrine containing medicinal products should be su PA0678/146/001 PA0678/146/001 Advil Liquid 200mg Soft capsules Haleon Ireland Limited 08/03/2002 HM Marketed AU Capsule, soft M01AE M01AE01 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Subject to the following restriction: maximum strength 200 mg, maximum pack size 50, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children over 12 years. EU/1/17/1247/010-012 EU/1/17/1247/010-012 ADYNOVI 1000 IU Powder and solvent for solution for injection Baxalta Innovations GmbH 08/01/2018 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Rurioctocog alfa pegol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1247/013-014 EU/1/17/1247/013-014 ADYNOVI 2000 IU Powder and solvent for solution for injection Baxalta Innovations GmbH 08/01/2018 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Rurioctocog alfa pegol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1247/001-004 EU/1/17/1247/001-004 ADYNOVI 250 IU Powder and solvent for solution for injection Baxalta Innovations GmbH 08/01/2018 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Rurioctocog alfa pegol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1247/015-016 EU/1/17/1247/015-016 ADYNOVI 3000 IU Powder and solvent for solution for injection Baxalta Innovations GmbH 06/01/2022 HM Unknown AU Powder for solution for injection B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Rurioctocog alfa pegol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription. (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1247/005-008 EU/1/17/1247/005-008 ADYNOVI 500 IU Powder and solvent for solution for injection Baxalta Innovations GmbH 08/01/2018 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Rurioctocog alfa pegol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1837/002 EU/1/24/1837/002 ADZYNMA 1500 IU powder and solvent for solution for injection Takeda Manufacturing Austria AG 01/08/2024 HM Unknown AU Powder and solvent for solution for injection B01AD13 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Apadamtase alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1837/001 EU/1/24/1837/001 ADZYNMA 500 IU powder and solvent for solution for injection Takeda Manufacturing Austria AG 01/08/2024 HM Unknown AU Powder and solvent for solution for injection B01AD13 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Apadamtase alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/399/001-006 EU/1/07/399/001-006 Aerinaze 2.5 mg/120 mg modified-release tablets N.V. Organon 30/07/2007 HM Unknown AU Modified-release tablet R01BA R01BA52 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Pseudoephedrine sulfate Desloratadine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/160/61-69 EU/1/00/160/61-69 IC0153-155-019 Aerius 0.5 mg/ml oral solution N.V. Organon HM Unknown AU Oral solution R06AX R06AX27 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Desloratadine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/160/001-013 EU/1/00/160/001-013 IC0153-001-014 Aerius 5 mg film-coated tablets N.V. Organon HM Unknown AU Film-coated tablet R06AX R06AX27 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Desloratadine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/538/004 EU/1/09/538/004 Afinitor 10 mg Tablet Novartis Europharm Limited 03/08/2009 HM Unknown AU Tablet L01XE L01XE10 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Everolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/09/538/009-010 EU/1/09/538/009-010 Afinitor 2.5 mg Tablet Novartis Europharm Limited 14/03/2013 HM Unknown AU Tablet L01XE L01XE10 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rad n bht Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/538/001 EU/1/09/538/001 Afinitor 5 mg Tablet Novartis Europharm Limited 08/09/2009 HM Unknown AU Tablet L01XE L01XE10 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Everolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1965/001 EU/1/25/1965/001 Afiveg 40 mg/mL solution for injection Stada Arzneimittel AG 18/08/2025 HM Unknown AU Solution for injection in vial S01LA05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravitreal use Aflibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1965/002 EU/1/25/1965/002 Afiveg 40 mg/mL solution for injection in pre-filled syringe Stada Arzneimittel AG 18/08/2025 HM Unknown AU Solution for injection in pre-filled syringe S01LA05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravitreal use Aflibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/10/658/001-002 EU/1/10/658/001-002 AFLUNOV suspension for injection in pre-filled syringe Seqirus S.r.l. HM Unknown AU Suspension for injection in pre-filled syringe J07BB J07BB02 Known active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use H5n1 (a/vietnam/1194/2004) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1867/001 EU/1/24/1867/001 Afqlir Sandoz GmbH 13/11/2024 HM Unknown AU Solution for injection in pre-filled syringe S01LA05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravitreal use Aflibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1867/002 EU/1/24/1867/002 Afqlir Sandoz GmbH 13/11/2024 HM Unknown AU Solution for injection in vial S01LA05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravitreal use Aflibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1158/003 EU/1/16/1158/003 AFSTYLA 1000 IU powder and solvent for solution for injection CSL Behring GmbH 04/01/2017 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Lonoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1158/004 EU/1/16/1158/004 AFSTYLA 1500 IU powder and solvent for solution for injection CSL Behring GmbH 04/01/2017 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Lonoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1158/005 EU/1/16/1158/005 AFSTYLA 2000 IU powder and solvent for solution for injection CSL Behring GmbH 04/01/2017 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Lonoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1158/001 EU/1/16/1158/001 AFSTYLA 250 IU powder and solvent for solution for injection CSL Behring GmbH 04/01/2017 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Lonoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1158/006 EU/1/16/1158/006 AFSTYLA 2500 IU powder and solvent for solution for injection CSL Behring GmbH 04/01/2017 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Lonoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1158/007 EU/1/16/1158/007 AFSTYLA 3000 IU powder and solvent for solution for injection CSL Behring GmbH 04/01/2017 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Lonoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1158/002 EU/1/16/1158/002 AFSTYLA 500 IU powder and solvent for solution for injection CSL Behring GmbH 04/01/2017 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Lonoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA22919/001/001 PA22919/001/001 After Bite 3.5% w/v Cutaneous Emulsion Zenview Limited 10/06/1991 HM Marketed AU Cutaneous emulsion Not Currently Available Cutaneous use Ammonia Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public EU/1/23/1776/001 EU/1/23/1776/001 AGAMREE 40 mg/ml oral suspension Santhera Pharmaceuticals (Deutschland) GmbH 14/12/2023 HM Unknown AU Oral suspension H02AB18 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Vamorolone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23266/075/001 PA23266/075/001 IC0011-039-003 Agerdex 1 mg film-coated tablets Viatris Limited 09/11/2007 HM Marketed AU Film-coated tablet L02BG L02BG03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Anastrozole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1805/001-002 EU/1/24/1805/001-002 Agilus 120 mg powder for solution for injection Norgine B.V. 29/05/2024 HM Unknown AU Powder for solution for injection M03CA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Dantrolene Sodium, Hemiheptahydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only TR2309/017/001 TR2309/017/001 Agnus castus oral drops A.Vogel Ireland Limited 12/12/2014 HM Marketed AU Oral drops, solution Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23266/029/001 PA23266/029/001 IC0136-022-003 Agomelatine Viatris 25 mg film-coated tablets Viatris Limited 26/10/2018 HM Marketed AU Film-coated tablet N06AX22 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Agomelatine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1888/001 EU/1/24/1888/001 Ahzantive 40 mg/ml Solution for injection Formycon AG 13/01/2025 HM Unknown AU Solution for injection in vial S01LA05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravitreal use Aflibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1293/004-006 EU/1/18/1293/004-006 Aimovig 140 mg Solution for injection Novartis Pharma GmbH 26/04/2019 HM Unknown AU Solution for injection in pre-filled syringe N02CX07 Known active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use ERENUMAB Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1293/001-003 EU/1/18/1293/001-003 Aimovig 70 mg Solution for injection Novartis Europharm Limited 26/07/2018 HM Unknown AU Solution for injection N02CX Known active substance (Article 8(3) of Directive No 2001/83/EC) ERENUMAB Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0711/284/001 PA0711/284/001 AirBuFo Forspiro 160 microgram/4.5 microgram/dose inhalation powder, pre-dispensed Rowex Limited, 18/05/2018 HM Marketed AU Inhalation powder, pre-dispensed R03AK R03AK07 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Budesonide Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/284/002 PA0711/284/002 AirBuFo Forspiro 320 microgram/9 microgram/dose inhalation powder, pre-dispensed Rowex Limited, 30/04/2021 HM Marketed AU Inhalation powder, pre-dispensed R03AK07 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Budesonide Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/237/001 PA0711/237/001 AirFluSal Forspiro 50 microgram/250 microgram/dose, inhalation powder, predispensed Rowex Ltd 14/11/2014 HM Marketed AU Inhalation powder, pre-dispensed R03AK R03AK06 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Salmeterol Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/237/002 PA0711/237/002 AirFluSal Forspiro 50 microgram/500 microgram/dose, inhalation powder, predispensed Rowex Ltd 14/11/2014 HM Marketed AU Inhalation powder, pre-dispensed R03AK R03AK06 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Salmeterol Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/270/001 PA0711/270/001 IC0128-176-053 AirFluSal MDI 25 microgram/125 microgram/dose pressurised inhalation, suspension Rowex Limited, 12/05/2017 HM Not marketed AU Pressurised inhalation, suspension R03AK R03AK06 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use SALMETEROL XINAFOATE Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/270/002 PA0711/270/002 IC0128-177-053 AirFluSal MDI 25 microgram/250 microgram/dose pressurised inhalation, suspension Rowex Limited, 12/05/2017 HM Not marketed AU Pressurised inhalation, suspension R03AK R03AK06 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Salmeterol Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1358/001-002 EU/1/19/1358/001-002 AJOVY 225 mg Solution for injection TEVA GmbH 28/03/2019 HM Unknown AU Solution for injection in pre-filled syringe N02CD03 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use FREMANEZUMAB Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1840/001-003 EU/1/24/1840/001-003 AKANTIOR 0.8 mg/mL eye drops, solution in single-dose container SIFI S.p.A. 22/08/2024 HM Unknown AU Eye drops, solution S01AX24 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Polihexanide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/23/1722/002 EU/1/23/1722/002 Akeega 100mg/500 mg Film-coated tablet Janssen-Cilag International NV 19/04/2023 HM Unknown AU Film-coated tablet L01XK52 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Niraparib Tosilate Monohydrate Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/23/1722/001 EU/1/23/1722/001 Akeega 50 mg/500 mg Film-coated tablet Janssen-Cilag International NV 19/04/2023 HM Unknown AU Film-coated tablet L01XK52 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Niraparib Tosilate Monohydrate Abiraterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1253/001/001 PA1253/001/001 Akineton 2 mg tablets Laboratorio Farmaceutico S.I.T. 01/04/1979 HM Marketed AU Tablet N04AA N04AA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Biperiden hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1253/002/001 PA1253/002/001 Akineton Retard 4 mg prolonged release tablets Laboratorio Farmaceutico S.I.T. 01/04/1979 HM Marketed AU Prolonged-release tablet N04AA N04AA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Biperiden hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22743/017/001 PA22743/017/001 Aklief 50 microgram/g Cream Galderma International 21/02/2020 HM Not marketed AU Cream D10AD06 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Trifarotene Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1001/004 EU/1/15/1001/004 Akynzeo 235 mg/0.25 mg concentrate for solution for infusion Helsinn Birex Pharmaceuticals Limited 27/05/2015 HM Unknown AU Concentrate for solution for infusion A04AA55 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use FOSNETUPITANT CHLORIDE HYDROCHLORIDE Palonosetron hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1001/003 EU/1/15/1001/003 Akynzeo 235 mg/0.25 mg powder for concentrate for solution for infusion Helsinn Birex Pharmaceuticals Limited 27/05/2015 HM Unknown AU Powder for concentrate for solution for infusion A04AA55 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use FOSNETUPITANT CHLORIDE HYDROCHLORIDE Palonosetron hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1001/001 EU/1/15/1001/001 Akynzeo 300 mg/0.5 mg hard capsules Helsinn Birex Pharmaceuticals Limited 27/05/2015 HM Unknown AU Capsule, hard A04AA A04AA05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Netupitant Palonosetron (as hydrochloride) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2071/001/001 PA2071/001/001 Alacare 8 mg medicated plaster Photonamic GmbH & Co. KG 28/08/2009 HM Not marketed AU Medicated plaster L01XD L01XD04 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use 5-aminolevulinic acid hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2219/007/002 PA2219/007/002 Albunorm 20%, 200g/l, solution for infusion Octapharma (IP) 25/06/2009 HM Marketed AU Solution for infusion B05AA B05AA01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Human plasma protein not containing less than 96% human albumin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC PA2219/007/001 PA2219/007/001 Albunorm 5%, 50 g/l, solution for infusion Octapharma (IP) 25/06/2009 HM Marketed AU Solution for infusion B05AA B05AA01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Human plasma protein not containing less than 96% human albumin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC PA0800/008/002 PA0800/008/002 Alburex 20, 200 g/l, solution for infusion CSL Behring GmbH 13/06/2014 HM Not marketed AU Solution for infusion B05AA B05AA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Human albumin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0800/008/001 PA0800/008/001 Alburex 5, 50 g/l, solution for infusion CSL Behring GmbH 13/06/2014 HM Not marketed AU Solution for infusion B05AA B05AA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Human albumin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0849/006/002 PA0849/006/002 Albutein, 200 gram(s)/litre, solution for infusion Instituto Grifols S.A. 08/10/2021 HM Not marketed AU Solution for infusion B05AA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Human albumin solution Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0849/006/001 PA0849/006/001 Albutein, 50 gram(s)/litre, solution for infusion Instituto Grifols S.A. 08/10/2021 HM Not marketed AU Solution for infusion B05AA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Human albumin solution Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/223/002 PPA1463/223/002 Aldactone 100 mg Film-coated tablet IMED Healthcare Ltd., 03/05/2024 HM Unknown AU Film-coated tablet C03DA01 Not Currently Available Oral use Spironolactone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/418/002 PPA0465/418/002 Aldactone 100 mg film-coated tablets PCO Manufacturing Ltd. 07/01/2022 HM Unknown AU Film-coated tablet C03DA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Spironolactone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/110/003 PA0822/110/003 Aldactone 100 mg Film-coated tablets Pfizer Healthcare Ireland Unlimited Company 13/03/1975 HM Marketed AU Film-coated tablet C03DA C03DA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Spironolactone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/418/001 PPA0465/418/001 Aldactone 25 mg film-coated tablets PCO Manufacturing Ltd. 17/06/2016 HM Unknown AU Film-coated tablet C03DA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Spironolactone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/110/001 PA0822/110/001 Aldactone 25 mg Film-coated Tablets Pfizer Healthcare Ireland Unlimited Company 01/04/1978 HM Marketed AU Film-coated tablet C03DA C03DA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Spironolactone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/223/001 PPA1463/223/001 Aldactone 25 mg Film-coated Tablets IMED Healthcare Ltd., 03/05/2024 HM Unknown AU Film-coated tablet C03DA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Spironolactone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/110/002 PA0822/110/002 Aldactone 50 mg Film-coated tablets Pfizer Healthcare Ireland Unlimited Company 12/12/1984 HM Marketed AU Film-coated tablet C03DA C03DA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Spironolactone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/080/001 EU/1/98/080/001 Aldara 5% w/w Cream Viatris Healthcare Limited 18/09/1998 HM Unknown AU Cream D06BB D06BB10 Full application (Article 8(3) of Directive No 2001/83/EC) Imiquimod Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/03/253/01-3 EU/1/03/253/01-3 Aldurazyme 100 U/ml concentrate for solution for infusion Sanofi B.V. 10/06/2003 HM Unknown AU Concentrate for solution for infusion A16AB A16AB05 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Laronidase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/16/1169/001 EU/1/16/1169/001 Alecensa 150 mg hard capsules Roche Registration GmbH HM Unknown AU Capsule, hard L01ED03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Alectinib hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0749/196/001 PA0749/196/001 IC0052-102-002 Alendronate/Colecalciferol Teva 70 mg/2800 IU tablets Teva Pharma B.V. 16/04/2014 HM Marketed AU Tablet M05BB M05BB03 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Alendronic acid Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/196/002 PA0749/196/002 IC0052-103-002 Alendronate/Colecalciferol Teva 70 mg/5600 IU tablets Teva Pharma B.V. 16/04/2014 HM Marketed AU Tablet M05BB M05BB03 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Alendronic acid Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/319/001 PA0711/319/001 IC0052-102-002 Alendronic acid/Colecalciferol Rowex 70 mg/2 800 IU tablets Rowex Limited, 31/03/2023 HM Not marketed AU Tablet M05BB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alendronate sodium trihydrate Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/319/002 PA0711/319/002 IC0052-103-002 Alendronic acid/Colecalciferol Rowex 70 mg/5 600 IU tablets Rowex Limited, 31/03/2023 HM Not marketed AU Tablet M05BB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alendronate sodium trihydrate Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1436/004/001 PA1436/004/001 IC0051-101-002 Alendronic Acid Bluefish Once weekly 70 mg tablets Bluefish Pharmaceuticals AB 24/04/2009 HM Marketed AU Tablet M05BA M05BA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Sodium alendronate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1330/009/001 PA1330/009/001 Alexette 0.02mg/3mg film-coated tablets Gedeon Richter Plc 25/05/2012 HM Not marketed AU Film-coated tablet G03AA G03AA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Drospirenone Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1445/018/001 PA1445/018/001 Alfu 10 mg Prolonged-release Tablets Aurobindo Pharma (Malta) Limited 08/08/2014 HM Marketed AU Prolonged-release tablet G04CA G04CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alfuzosin hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1881/001-002 EU/1/24/1881/001-002 Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Novo Nordisk A/S 13/12/2024 HM Unknown AU Solution for injection in pre-filled pen B02BX10 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Concizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/24/1881/005-006 EU/1/24/1881/005-006 Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Novo Nordisk A/S 13/12/2024 HM Unknown AU Solution for injection in pre-filled pen B02BX10 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Concizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/24/1881/007 EU/1/24/1881/007 Alhemo 300 mg/3 mL solution for injection in pre-filled pen Novo Nordisk A/S 13/12/2024 HM Unknown AU Solution for injection in pre-filled pen B02BX10 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Concizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/24/1881/003-004 EU/1/24/1881/003-004 Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Novo Nordisk A/S 13/12/2024 HM Unknown AU Solution for injection in pre-filled pen B02BX10 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Concizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/04/290/002 EU/1/04/290/002 Alimta Eli Lilly Nederland B.V. HM Unknown AU Powder for concentrate for solution for infusion Full application (Article 8(3) of Directive No 2001/83/EC) Pemetrexed Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/290/001 EU/1/04/290/001 Alimta 500 mg powder for concentrate for solution for infusion Eli Lilly Nederland B.V. 14/10/2004 HM Unknown AU Powder for concentrate for solution for infusion L01BA L01BA04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Pemetrexed Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA1410/032/001 PA1410/032/001 Alka-Seltzer Effervescent Tablets Acetylsalicylic Acid (Aspirin) 324mg Sodium Hydrogen Carbonate 1744mg Citric Acid 965mg Bayer Limited 01/04/1978 HM Marketed AU Effervescent tablet N02BA N02BA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Aspirin Sodium hydrogen carbonate Citric acid Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public Promotion to the general public only for indications appropriate for self-diagnosis and self-treatment. Aspirin-containing medicinal products should not be administered to subjects under 16 years of age unless specifically indicated by a healthcare professional. PA1691/004/002 PA1691/004/002 Alkeran 2 mg Film-coated Tablets Aspen Pharma Trading Limited 01/04/1979 HM Marketed AU Film-coated tablet L01AA L01AA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Melphalan Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1691/004/001 PA1691/004/001 Alkeran 50 mg Powder and Solvent for Solution for Infusion Aspen Pharma Trading Limited 25/10/2002 HM Marketed AU Powder and solvent for solution for infusion L01AA L01AA03 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Melphalan Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/17/1260/001 EU/1/17/1260/001 Alkindi 0.5 mg granules in capsules for opening Immedica Pharma AB 09/02/2018 HM Unknown AU Granules H02AB H02AB09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1260/002 EU/1/17/1260/002 Alkindi 1 mg granules in capsules for opening Immedica Pharma AB 09/02/2018 HM Unknown AU Granules H02AB H02AB09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1260/003 EU/1/17/1260/003 Alkindi 2 mg granules in capsules for opening Immedica Pharma AB 09/02/2018 HM Unknown AU Granules H02AB H02AB09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1260/004 EU/1/17/1260/004 Alkindi 5 mg granules in capsules for opening Immedica Pharma AB 09/02/2018 HM Unknown AU Granules H02AB H02AB09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/401/12-15 EU/1/07/401/12-15 Alli GlaxoSmithKline Dungarvan Limited HM Unknown AU Capsule, hard A08AB A08AB01 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Orlistat Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/07/401/1-6 EU/1/07/401/1-6 Alli GlaxoSmithKline Dungarvan Limited HM Unknown AU Capsule, hard A08AB A08AB01 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Orlistat Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/07/401/7-11 EU/1/07/401/7-11 Alli GlaxoSmithKline Dungarvan Limited HM Unknown AU Capsule, hard A08AB A08AB01 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Orlistat Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA2315/219/001 PA2315/219/001 IC0144-024-002 Allopurinol 100 mg tablets Accord Healthcare Ireland Ltd. 19/07/2019 HM Marketed AU Tablet M04AA M04AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Allopurinol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/219/002 PA2315/219/002 IC0144-029-002 Allopurinol 300 mg tablets Accord Healthcare Ireland Ltd. 19/07/2019 HM Marketed AU Tablet M04AA M04AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Allopurinol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/412/001 PA0126/412/001 IC0144-024-002 Allopurinol Clonmel 100 mg tablets Clonmel Healthcare Ltd 19/12/2025 HM Not marketed AU Tablet M04AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Allopurinol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/412/002 PA0126/412/002 Allopurinol Clonmel 200 mg tablets Clonmel Healthcare Ltd 19/12/2025 HM Not marketed AU Tablet M04AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Allopurinol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/412/003 PA0126/412/003 IC0144-029-002 Allopurinol Clonmel 300 mg tablets Clonmel Healthcare Ltd 19/12/2025 HM Not marketed AU Tablet M04AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Allopurinol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/099/001 PA0749/099/001 IC0144-024-002 Allopurinol Teva 100 mg tablets Teva Pharma B.V. 10/09/2010 HM Marketed AU Tablet M04AA M04AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Allopurinol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/099/003 PA0749/099/003 IC0144-029-002 Allopurinol Teva 300 mg tablets Teva Pharma B.V. 10/09/2010 HM Marketed AU Tablet M04AA M04AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Allopurinol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1613/004/001 PA1613/004/001 Alluzience, 200 Speywood units/mL, solution for injection Ipsen Pharma 10/09/2021 HM Marketed AU Solution for injection M03AX01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Botulinum Toxin A - Haemagglutinin Complex Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0968/001/001 PA0968/001/001 Almogran 12.5 mg film-coated tablet Almirall, S.A. 27/10/2000 HM Marketed AU Film-coated tablet N02CC N02CC05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Almotriptan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/154/001 PA0711/154/001 IC0144-024-002 Alopur 100 mg tablets Rowex Limited, 03/04/2009 HM Marketed AU Tablet M04AA M04AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Allopurinol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/154/002 PA0711/154/002 IC0144-029-002 Alopur 300 mg tablets Rowex Limited, 03/04/2009 HM Marketed AU Tablet M04AA M04AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Allopurinol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/306/001 EU/1/04/306/001 Aloxi 250 micrograms solution for injection Helsinn Birex Pharmaceuticals Limited 22/03/2005 HM Unknown AU Solution for injection A04AA A04AA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Palonosetron (as hydrochloride) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/306/002-003 EU/1/04/306/002-003 Aloxi 500 micrograms soft capsules Helsinn Birex Pharmaceuticals Limited 05/05/2010 HM Unknown AU Capsule, soft A04AA A04AA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Palonosetron (as hydrochloride) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1824/007/001 PA1824/007/001 Alphagan 0.2% w/v (2 mg/ml) eye drops, solution AbbVie Limited 14/11/1997 HM Marketed AU Eye drops, solution S01EA05 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Brimonidine tartrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/413/001 PPA0465/413/001 Alphagan 0.2% w/v (2 mg/ml) eye drops, solution PCO Manufacturing Ltd. 01/07/2015 HM Unknown AU Eye drops, solution S01EA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Ocular use Brimonidine tartrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/252/001 PPA1463/252/001 Alphagan 0.2% w/v (2 mg/ml) eye drops, solution IMED Healthcare Ltd., 14/11/2025 HM Unknown AU Eye drops, solution S01EA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Ocular use Brimonidine tartrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/140/001 PA0711/140/001 IC0094-145-002 Alprazolam 0.25 mg tablets Rowex Limited, 17/10/2008 HM Marketed AU Tablet N05BA N05BA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alprazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017. PA0711/140/002 PA0711/140/002 IC0094-040-002 Alprazolam 0.5 mg tablets Rowex Limited, 17/10/2008 HM Marketed AU Tablet N05BA N05BA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alprazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017. PA22992/028/003 PA22992/028/003 IC0094-039-002 Alprazolam Grindeks 1 mg tablets AS Grindeks 02/08/2024 HM Not marketed AU Tablet N05BA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alprazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA22992/028/001 PA22992/028/001 IC0094-145-002 Alprazolam Grindeks 250 microgram tablets AS Grindeks 02/08/2024 HM Not marketed AU Tablet N05BA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alprazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA22992/028/002 PA22992/028/002 IC0094-040-002 Alprazolam Grindeks 500 microgram tablets AS Grindeks 02/08/2024 HM Not marketed AU Tablet N05BA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alprazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA1347/097/003 PA1347/097/003 IC0094-039-002 Alprazolam Krka 1 mg tablets KRKA, d.d., Novo mesto 28/06/2019 HM Marketed AU Tablet N05BA N05BA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alprazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017. PA1347/097/001 PA1347/097/001 IC0094-145-002 Alprazolam Krka 250 microgram tablets KRKA, d.d., Novo mesto 28/06/2019 HM Marketed AU Tablet N05BA N05BA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alprazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017. PA1347/097/002 PA1347/097/002 IC0094-040-002 Alprazolam Krka 500 microgram tablets KRKA, d.d., Novo mesto 28/06/2019 HM Marketed AU Tablet N05BA N05BA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alprazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017. EU/1/16/1098/003 EU/1/16/1098/003 ALPROLIX 1000 IU powder and solvent for solution for injection Swedish Orphan Biovitrum AB 12/05/2016 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Eftrenonacog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1098/004 EU/1/16/1098/004 ALPROLIX 2000 IU powder and solvent for solution for injection Swedish Orphan Biovitrum AB 12/05/2016 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Eftrenonacog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1098/001 EU/1/16/1098/001 ALPROLIX 250 IU powder and solvent for solution for injection Swedish Orphan Biovitrum AB 12/05/2016 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Eftrenonacog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1098/005 EU/1/16/1098/005 ALPROLIX 3000 IU powder and solvent for solution for injection Swedish Orphan Biovitrum AB 12/05/2016 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Eftrenonacog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1098/002 EU/1/16/1098/002 ALPROLIX 500 IU powder and solvent for solution for injection Swedish Orphan Biovitrum AB 12/05/2016 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Eftrenonacog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA22992/038/001 PA22992/038/001 IC0022-002-003 Alsemora 10 mg film-coated tablets AS Grindeks 06/03/2026 HM Not marketed AU Film-coated tablet N06DX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Memantine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22992/038/002 PA22992/038/002 IC0022-003-003 Alsemora 20 mg film-coated tablets AS Grindeks 06/03/2026 HM Not marketed AU Film-coated tablet N06DX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Memantine hydrochloride *** AWAITING VALUE *** *** AWAITING VALUE *** PA1876/002/001 PA1876/002/001 Altavita D3 50,000 IU oral solution Consilient Health Limited 10/07/2015 HM Not marketed AU Oral solution A11CC A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cholecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1876/005/001 PA1876/005/001 altavitaD3 1,000 IU soft capsules Consilient Health Limited 02/09/2016 HM Marketed AU Capsule, soft A11CC A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cholecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1876/004/003 PA1876/004/003 altavitaD3 25,000 IU soft capsules Consilient Health Limited 02/09/2016 HM Marketed AU Capsule, soft A11CC A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cholecalciferol (02) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1876/002/002 PA1876/002/002 AltavitaD3 25,000IU oral solution Consilient Health Limited 03/09/2015 HM Marketed AU Oral solution A11CC A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1876/004/004 PA1876/004/004 altavitaD3 50,000 IU soft capsules Consilient Health Limited 02/09/2016 HM Marketed AU Capsule, soft A11CC A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cholecalciferol (02) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1876/005/002 PA1876/005/002 altavitaD3 7,000 IU soft capsules Consilient Health Limited 02/09/2016 HM Marketed AU Capsule, soft A11CC A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cholecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1824/004 EU/1/24/1824/004 ALTUVOCT 1 000 IU Powder and solvent for solution for injection Swedish Orphan Biovitrum AB(publ) 17/06/2024 HM Unknown AU Powder and solvent for solution for injection B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efanesoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1824/005 EU/1/24/1824/005 ALTUVOCT 2 000 IU Powder and solvent for solution for injection Swedish Orphan Biovitrum AB(publ) 17/06/2024 HM Unknown AU Powder and solvent for solution for injection B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efanesoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1824/001 EU/1/24/1824/001 ALTUVOCT 250 IU Powder and solvent for solution for injection Swedish Orphan Biovitrum AB(publ) 17/06/2024 HM Unknown AU Powder and solvent for solution for injection B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efanesoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1824/006 EU/1/24/1824/006 ALTUVOCT 3 000 IU Powder and solvent for solution for injection Swedish Orphan Biovitrum AB(publ) 17/06/2024 HM Unknown AU Powder and solvent for solution for injection B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efanesoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1824/007 EU/1/24/1824/007 ALTUVOCT 4 000 IU Powder and solvent for solution for injection Swedish Orphan Biovitrum AB(publ) 17/06/2024 HM Unknown AU Powder and solvent for solution for injection B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efanesoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1824/002 EU/1/24/1824/002 ALTUVOCT 500 IU Powder and solvent for solution for injection Swedish Orphan Biovitrum AB(publ) 17/06/2024 HM Unknown AU Powder and solvent for solution for injection B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efanesoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1824/003 EU/1/24/1824/003 ALTUVOCT 750 IU Powder and solvent for solution for injection Swedish Orphan Biovitrum AB(publ) 17/06/2024 HM Unknown AU Powder and solvent for solution for injection B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efanesoctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1264/009-010 EU/1/18/1264/009-010 Alunbrig 180 mg film-coated tablets Takeda Pharma A/S 22/11/2018 HM Unknown AU Film-coated tablet L01XE43 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Brigatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1264/001-004 EU/1/18/1264/001-004 Alunbrig 30 mg film-coated tablets Takeda Pharma A/S 22/11/2018 HM Unknown AU Film-coated tablet L01XE43 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Brigatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1264/005-008 EU/1/18/1264/005-008 Alunbrig 90 mg film-coated tablets Takeda Pharma A/S 22/11/2018 HM Unknown AU Film-coated tablet L01XE43 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Brigatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1255/008/001 PA1255/008/001 ALUTARD SQ Bee 100 000 SQ-U/ml suspension for injection ALK-Abello A/S 12/04/2019 HM Marketed AU Suspension for injection V01AA07 Known active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Apis mellifera Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1255/008/002 PA1255/008/002 ALUTARD SQ Bee Initial Pack (100 SQ-U/ml, 1 000 SQ-U/ml, 10 000 SQ-U/ml and 100 000 SQ-U/ml) suspension for injection ALK-Abello A/S 12/04/2019 HM Marketed AU Suspension for injection V01AA07 Known active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Apis mellifera Apis mellifera Apis mellifera Apis mellifera Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1255/009/001 PA1255/009/001 ALUTARD SQ Wasp 100 000 SQ-U/ml suspension for injection ALK-Abello A/S 12/04/2019 HM Marketed AU Suspension for injection V01AA07 Known active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Vespula spp. Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1255/009/002 PA1255/009/002 ALUTARD SQ Wasp Initial Pack (100 SQ-U/ml, 1 000 SQ-U/ml, 10 000 SQ-U/ml and 100 000 SQ-U/ml) suspension for injection ALK-Abello A/S 12/04/2019 HM Marketed AU Suspension for injection V01AA07 Known active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Vespula spp. Vespula spp. Vespula spp. Vespula spp. Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/515/001 PPA0465/515/001 Alvesco 160 microgram pressurised inhalation, solution PCO Manufacturing Ltd. 04/04/2025 HM Unknown AU Pressurised inhalation, solution R03BA08 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Inhalation use Ciclesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22986/001/002 PA22986/001/002 Alvesco 160 micrograms pressurised inhalation, solution Covis Pharma Europe B.V. 19/05/2017 HM Marketed AU Pressurised inhalation, solution R03BA R03BA08 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Ciclesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/175/001 PPA1463/175/001 Alvesco 160 micrograms pressurised inhalation, solution IMED Healthcare Ltd., 21/01/2022 HM Unknown AU Pressurised inhalation, solution R03BA R03BA08 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Inhalation use Ciclesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22986/001/001 PA22986/001/001 Alvesco 80 micrograms pressurised inhalation, solution Covis Pharma Europe B.V. 19/05/2017 HM Marketed AU Pressurised inhalation, solution R03BA R03BA08 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Ciclesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1943/002 EU/1/25/1943/002 Alyftrek 125 mg/50 mg/10 mg film-coated tablets Vertex Pharmaceuticals (Ireland) Limited 30/06/2025 HM Unknown AU Film-coated tablet R07AX33 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Vanzacaftor TEZACAFTOR Deutivacaftor Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1943/001 EU/1/25/1943/001 Alyftrek 50 mg/20 mg/4 mg film-coated tablets Vertex Pharmaceuticals (Ireland) Limited 30/06/2025 HM Unknown AU Film-coated tablet R07AX33 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Vanzacaftor TEZACAFTOR Deutivacaftor Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1509/001-002 EU/1/20/1509/001-002 Alymsys 25 mg/mL concentrate for solution for infusion Mabxience Research, S.L. 26/03/2021 HM Unknown AU Concentrate for solution for infusion L01XC07 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Bevacizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA22865/005/001 PA22865/005/001 Amantadine hydrochloride Renata 100 mg Capsules, hard Renata Pharmaceuticals (Ireland) Limited 25/02/2022 HM Marketed AU Capsule, hard N04BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use AMANTADINE HYDROCHLORIDE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/224/005 EU/1/02/224/005 Ambirix suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) GlaxoSmithKline Biologicals S.A. 30/08/2002 HM Unknown AU Suspension for injection in pre-filled syringe J07BC J07BC20 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b surface antigen (hbs ag) Hepatitis a virus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/224/001 EU/1/02/224/001 Ambirix Suspension for injection in pre-filled syringeHepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) GlaxoSmithKline Biologicals S.A. 30/08/2002 HM Unknown AU Suspension for injection in pre-filled syringe J07BC J07BC20 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b surface antigen (hbs ag) Hepatitis a virus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/224/002 EU/1/02/224/002 Ambirix Suspension for injection in pre-filled syringeHepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) GlaxoSmithKline Biologicals S.A. 30/08/2002 HM Unknown AU Suspension for injection in pre-filled syringe J07BC J07BC20 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b surface antigen (hbs ag) Hepatitis a virus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/224/003 EU/1/02/224/003 Ambirix, suspension for injection in pre-filled syringeHepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) GlaxoSmithKline Biologicals S.A. 30/08/2002 HM Unknown AU Suspension for injection in pre-filled syringe J07BC J07BC20 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis a virus Hepatitis b surface antigen (hbs ag) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/224/004 EU/1/02/224/004 Ambirix, suspension for injection in pre-filled syringeHepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) GlaxoSmithKline Biologicals S.A. 30/08/2002 HM Unknown AU Suspension for injection in pre-filled syringe J07BC J07BC20 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis a virus Hepatitis b surface antigen (hbs ag) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2322/001/001 PA2322/001/001 AmBisome Liposomal Amphotericin B 50 mg Powder for Concentrate for Dispersion for Infusion Gilead Sciences Ireland UC 13/12/1990 HM Marketed AU Concentrate for solution for infusion J02AA J02AA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Amphotericin b Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/235/002 PA2315/235/002 Ambrisentan Accord 10 mg film-coated tablets Accord Healthcare Ireland Ltd. 22/11/2019 HM Marketed AU Film-coated tablet C02KX C02KX02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ambrisentan Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA2315/235/001 PA2315/235/001 Ambrisentan Accord 5 mg film-coated tablets Accord Healthcare Ireland Ltd. 22/11/2019 HM Marketed AU Film-coated tablet C02KX C02KX02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ambrisentan Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/19/1368/003-004 EU/1/19/1368/003-004 Ambrisentan Viatris 10 mg film-coated tablets Viatris Limited 20/06/2019 HM Unknown AU Film-coated tablet C02KX C02KX02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ambrisentan Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/19/1368/001-002 EU/1/19/1368/001-002 Ambrisentan Viatris 5 mg film-coated tablets Viatris Limited 20/06/2019 HM Unknown AU Film-coated tablet C02KX C02KX02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ambrisentan Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/11/740/001 EU/1/11/740/001 Ameluz 78 mg/g gel Biofrontera Bioscience GmbH 14/12/2012 HM Unknown AU Gel L01XD L01XD04 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use 5-aminolevulinic acid hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2325/002/001 PA2325/002/001 Ametop 40 mg/g Gel Alliance Pharma (Ireland) Limited 06/07/2018 HM Marketed AU Gel N01BA N01BA03 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Tetracaine base Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1164/001 EU/1/16/1164/001 AMGEVITA 20 mg solution for injection in pre-filled syringe Amgen Europe B.V., HM Unknown AU Solution for injection in pre-filled syringe L04AB L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1164/010 EU/1/16/1164/010 AMGEVITA 20 mg solution for injection in pre-filled syringe Amgen Europe B.V., 16/05/2024 HM Unknown AU Solution for injection L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1164/014- 016 EU/1/16/1164/014- 016 AMGEVITA 40 mg solution for injection in pre-filled pen Amgen Europe B.V., 16/05/2024 HM Unknown AU Solution for injection in pre-filled pen L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1164/002-009 EU/1/16/1164/002-009 AMGEVITA 40 mg solution for injection in pre-filled syringe Amgen Europe B.V., HM Unknown AU Solution for injection L04AB L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1164/011-013 EU/1/16/1164/011-013 AMGEVITA 40 mg solution for injection in pre-filled syringe Amgen Europe B.V., 16/05/2024 HM Unknown AU Solution for injection in pre-filled syringe L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1164/020- 022 EU/1/16/1164/020- 022 AMGEVITA 80 mg solution for injection in pre-filled pen Amgen Europe B.V., 16/05/2024 HM Unknown AU Solution for injection in pre-filled pen L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1164/017-019 EU/1/16/1164/017-019 AMGEVITA 80 mg solution for injection in pre-filled syringe Amgen Europe B.V., 16/05/2024 HM Unknown AU Solution for injection in pre-filled syringe L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1279/001-002 EU/1/18/1279/001-002 AMGLIDIA 0.6 mg/mL oral suspension AMMTek 24/05/2018 HM Unknown AU Oral suspension A10BB A10BB01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Glibenclamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/18/1279/003-004 EU/1/18/1279/003-004 AMGLIDIA 6 mg/mL oral suspension AMMTek 24/05/2018 HM Unknown AU Oral suspension A10BB A10BB01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Glibenclamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23520/001/001 PA23520/001/001 AMIDAFLUID 1 mg/ml, eye drops, solution Horus Pharma 13/06/2025 HM Not marketed AU Eye drops, solution S01AX15 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Ocular use Propamidine isetionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/189/001 PA0126/189/001 IC0011-039-003 Amidex 1 mg film-coated tablets Clonmel Healthcare Ltd 24/07/2009 HM Marketed AU Film-coated tablet L02BG L02BG03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Anastrozole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1646/001-003 EU/1/22/1646/001-003 Amifampridine SERB 10 mg tablets SERB S.A. 19/05/2022 HM Unknown AU Tablet N07XX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amifampridine Phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1122/034/001 PA1122/034/001 Amikacin 125 mg/ml Solution for injection/infusion Noridem Enterprises Limited 24/05/2024 HM Not marketed AU Solution for injection/infusion J01GB06 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use AMIKACIN SULFATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1418/012/001 PA1418/012/001 Amikacin 250 mg/ ml Solution for injection/infusion Athlone Pharmaceuticals Limited 27/09/2024 HM Not marketed AU Solution for injection/infusion J01GB06 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intramuscular use Intrapericardial use Intravenous use AMIKACIN SULFATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/034/002 PA1122/034/002 Amikacin 250 mg/ml Solution for injection/infusion Noridem Enterprises Limited 24/05/2024 HM Not marketed AU Solution for injection/infusion J01GB06 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use AMIKACIN SULFATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/072/001 PA2059/072/001 Amikacin 5 mg/ml solution for infusion Fresenius Kabi Deutschland GmbH 11/12/2020 HM Marketed AU Solution for infusion J01GB J01GB06 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Amikacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22939/001/001 PA22939/001/001 Amikacin Caragen 250 mg/ml solution for injection/infusion Caragen Limited 25/06/2021 HM Marketed AU Solution for injection/infusion J01GB06 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Amikacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0073/099/001 PA0073/099/001 Aminophylline Hydrate 25mg/ml Solution for Injection Mercury Pharmaceuticals (Ireland) Ltd 01/09/1988 HM Marketed AU Solution for injection R03DA R03DA05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Aminophylline hydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/025/002 PA2059/025/002 Aminoven 16 solution for infusion, bottle Fresenius Kabi Deutschland GmbH 07/09/1999 HM Not marketed AU Solution for infusion B05BA B05BA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Isoleucine Leucine Lysine acetate Methionine Phenylalanine Threonine Tryptophan Valine Arginine Histidine Alanine Glycine Proline Serine Tyrosine Taurine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/025/003 PA2059/025/003 Aminoven 25 solution for infusion, bottle Fresenius Kabi Deutschland GmbH 07/09/1999 HM Not marketed AU Solution for infusion B05BA B05BA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Isoleucine Leucine Lysine acetate Methionine Phenylalanine Threonine Tryptophan Valine Arginine Histidine Alanine Glycine Proline Serine Tyrosine Taurine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/025/001 PA2059/025/001 Aminoven 8 solution for infusion, bottle Fresenius Kabi Deutschland GmbH 07/09/1999 HM Not marketed AU Solution for infusion B05BA B05BA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Isoleucine Leucine Lysine acetate Methionine Phenylalanine Threonine Tryptophan Valine Arginine Histidine Alanine Glycine Proline Serine Tyrosine Taurine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/064/002 PA23266/064/002 Amisulpride 200 mg Tablets Viatris Limited 19/09/2014 HM Marketed AU Tablet N05AL N05AL05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amisulpride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/064/001 PA23266/064/001 Amisulpride 50 mg Tablets Viatris Limited 19/09/2014 HM Marketed AU Tablet N05AL N05AL05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amisulpride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/041/001 PA0126/041/001 Amitriptyline 25 mg Film-Coated Tablets Clonmel Healthcare Ltd 15/03/1985 HM Marketed AU Film-coated tablet N06AA N06AA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amitriptyline hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22697/002/001 PA22697/002/001 Amitriptyline hydrochloride 10 mg/5 ml Oral Solution Syri Pharma Limited t/a Thame Laboratories 24/04/2015 HM Not marketed AU Oral solution N06AA N06AA09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Amitriptyline hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/233/001 PA0281/233/001 Amitriptyline Hydrochloride 25 mg/ 5 ml Oral Solution Pinewood Laboratories Ltd 26/11/2010 HM Not marketed AU Oral solution N06AA N06AA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amitriptyline hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22697/002/002 PA22697/002/002 Amitriptyline hydrochloride 25 mg/5 ml Oral Solution Syri Pharma Limited t/a Thame Laboratories 24/04/2015 HM Not marketed AU Oral solution N06AA N06AA09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Amitriptyline hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/233/002 PA0281/233/002 Amitriptyline Hydrochloride 50 mg/ 5 ml Oral Solution Pinewood Laboratories Ltd 26/11/2010 HM Not marketed AU Oral solution N06AA N06AA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amitriptyline hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22697/002/003 PA22697/002/003 Amitriptyline hydrochloride 50 mg/5 ml Oral Solution Syri Pharma Limited t/a Thame Laboratories 24/04/2015 HM Not marketed AU Oral solution N06AA N06AA09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Amitriptyline hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/138/002 PA0711/138/002 IC0045-002-008 Amlode 10 mg Tablets Rowex Limited, 01/06/2007 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/138/001 PA0711/138/001 IC0045-001-008 Amlode 5 mg tablets Rowex Limited, 01/06/2007 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/303/002 PA0126/303/002 Amlodipine/Valsartan/Hydrochlorothiazide Clonmel 10 mg/160 mg/12.5 mg film-coated tablets Clonmel Healthcare Ltd 03/05/2019 HM Marketed AU Film-coated tablet C09DX C09DX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/303/004 PA0126/303/004 Amlodipine/Valsartan/Hydrochlorothiazide Clonmel 10 mg/160 mg/25 mg film-coated tablets Clonmel Healthcare Ltd 03/05/2019 HM Not marketed AU Film-coated tablet C09DX C09DX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/303/005 PA0126/303/005 Amlodipine/Valsartan/Hydrochlorothiazide Clonmel 10 mg/320 mg/25 mg film-coated tablets Clonmel Healthcare Ltd 03/05/2019 HM Not marketed AU Film-coated tablet C09DX C09DX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/303/001 PA0126/303/001 Amlodipine/Valsartan/Hydrochlorothiazide Clonmel 5 mg/160 mg/12.5 mg film-coated tablets Clonmel Healthcare Ltd 03/05/2019 HM Marketed AU Film-coated tablet C09DX C09DX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/303/003 PA0126/303/003 Amlodipine/Valsartan/Hydrochlorothiazide Clonmel 5 mg/160 mg/25 mg film-coated tablets Clonmel Healthcare Ltd 03/05/2019 HM Marketed AU Film-coated tablet C09DX C09DX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/106/002 PA1347/106/002 Amlodipine/Valsartan/Hydrochlorothiazide Krka 10 mg/160 mg/12.5 mg film-coated tablets KRKA, d.d., Novo mesto 16/10/2020 HM Marketed AU Film-coated tablet C09DX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/106/001 PA1347/106/001 Amlodipine/Valsartan/Hydrochlorothiazide Krka 5 mg/160 mg/12.5 mg film-coated tablets KRKA, d.d., Novo mesto 16/10/2020 HM Marketed AU Film-coated tablet C09DX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/106/003 PA1347/106/003 Amlodipine/Valsartan/Hydrochlorothiazide Krka 5 mg/160 mg/25 mg film-coated tablets KRKA, d.d., Novo mesto 16/10/2020 HM Marketed AU Film-coated tablet C09DX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/274/003 PA0126/274/003 IC0042-084-003 Amlodipine/Valsartan Clonmel 10 mg/160 mg film-coated tablets Clonmel Healthcare Ltd 09/09/2016 HM Marketed AU Film-coated tablet C09DB C09DB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/274/002 PA0126/274/002 IC0042-086-003 Amlodipine/Valsartan Clonmel 5 mg/160 mg film-coated tablets Clonmel Healthcare Ltd 09/09/2016 HM Marketed AU Film-coated tablet C09DB C09DB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/274/001 PA0126/274/001 IC0042-087-003 Amlodipine/Valsartan Clonmel 5 mg/80 mg film-coated tablets Clonmel Healthcare Ltd 09/09/2016 HM Marketed AU Film-coated tablet C09DB C09DB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/055/003 PA1347/055/003 IC0042-084-003 Amlodipine/Valsartan Krka 10 mg/160 mg film-coated tablets KRKA, d.d., Novo mesto 05/02/2016 HM Marketed AU Film-coated tablet C09DB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/055/005 PA1347/055/005 Amlodipine/Valsartan Krka 10 mg/320 mg film-coated tablets KRKA, d.d., Novo mesto 05/02/2016 HM Not marketed AU Film-coated tablet C09DB01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Amlodipine Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/055/002 PA1347/055/002 IC0042-086-003 Amlodipine/Valsartan Krka 5 mg/ 160 mg film-coated tablets KRKA, d.d., Novo mesto 05/02/2016 HM Marketed AU Film-coated tablet C09DB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/055/001 PA1347/055/001 IC0042-087-003 Amlodipine/Valsartan Krka 5 mg/ 80 mg film-coated tablets KRKA, d.d., Novo mesto 05/02/2016 HM Marketed AU Film-coated tablet C10BX C10BX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/055/004 PA1347/055/004 Amlodipine/Valsartan Krka 5 mg/320 mg film-coated tablets KRKA, d.d., Novo mesto 05/02/2016 HM Not marketed AU Film-coated tablet C09DB01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Amlodipine Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1092/027-039 EU/1/16/1092/027-039 IC0042-084-003 Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets Mylan Pharmaceuticals Limited 22/03/2016 HM Unknown AU Film-coated tablet C09DB C09DB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1092/014-026 EU/1/16/1092/014-026 IC0042-086-003 Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets Mylan Pharmaceuticals Limited 22/03/2016 HM Unknown AU Film-coated tablet C09DB C09DB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1092/001-013 EU/1/16/1092/001-013 IC0042-087-003 Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets Mylan Pharmaceuticals Limited 22/03/2016 HM Unknown AU Film-coated tablet C09DB C09DB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/075/002 PA2315/075/002 Amlodipine 10 mg tablets Accord Healthcare Ireland Ltd. 04/08/2017 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/075/001 PA2315/075/001 Amlodipine 5 mg tablets Accord Healthcare Ireland Ltd. 04/08/2017 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1436/016/002 PA1436/016/002 IC0045-002-008 Amlodipine Bluefish 10 mg tablets Bluefish Pharmaceuticals AB 07/05/2010 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1436/016/001 PA1436/016/001 IC0045-001-008 Amlodipine Bluefish 5 mg tablets Bluefish Pharmaceuticals AB 07/05/2010 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/258/002 PA0126/258/002 IC0045-002-008 Amlodipine Clonmel 10 mg tablets Clonmel Healthcare Ltd 05/12/2014 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/258/001 PA0126/258/001 IC0045-001-008 Amlodipine Clonmel 5 mg tablets Clonmel Healthcare Ltd 05/12/2014 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/034/002 PA1347/034/002 IC0045-002-008 Amlodipine Krka 10 mg Tablets KRKA, d.d., Novo mesto 01/03/2013 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/034/001 PA1347/034/001 IC0045-001-008 Amlodipine Krka 5 mg Tablets KRKA, d.d., Novo mesto 01/03/2013 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA25441/001/002 PA25441/001/002 IC0045-002-008 Amlodipine Masuu 10 mg tablets Masuu Pharma Europe Limited 28/02/2014 HM Not marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA25441/001/001 PA25441/001/001 IC0045-001-008 Amlodipine Masuu 5 mg tablets Masuu Pharma Europe Limited 28/02/2014 HM Not marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/165/002 PA0281/165/002 Amlodipine Pinewood 10 mg tablets Pinewood Laboratories Ltd 22/02/2013 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/165/001 PA0281/165/001 Amlodipine Pinewood 5 mg Tablets Pinewood Laboratories Ltd 22/02/2013 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/067/002 PA0749/067/002 IC0045-002-008 Amlodipine Teva 10 mg Tablets Teva Pharma B.V. 01/08/2008 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/067/001 PA0749/067/001 IC0045-001-008 Amlodipine Teva 5 mg Tablets Teva Pharma B.V. 01/08/2008 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22579/008/002 PA22579/008/002 Amlodipine Teva GmbH 10 mg tablets TEVA GmbH 19/12/2025 HM Not marketed AU Tablet C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22579/008/001 PA22579/008/001 Amlodipine Teva GmbH 5 mg tablets TEVA GmbH 19/12/2025 HM Not marketed AU Tablet C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22697/003/002 PA22697/003/002 Amlodipine Thame 10 mg/5 ml Oral Solution Syri Pharma Limited t/a Thame Laboratories 21/08/2015 HM Not marketed AU Oral solution C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22697/003/001 PA22697/003/001 Amlodipine Thame 5mg/5ml Oral Solution Syri Pharma Limited t/a Thame Laboratories 21/08/2015 HM Not marketed AU Oral solution C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/060/002 PA23355/060/002 IC0045-002-008 Amlodipine Upjohn 10 mg tablets Viatris Healthcare Limited 09/12/2011 HM Not marketed AU Tablet C08CA C08CA01 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/060/001 PA23355/060/001 IC0045-001-008 Amlodipine Upjohn 5 mg tablets Viatris Healthcare Limited 09/12/2011 HM Not marketed AU Tablet C08CA C08CA01 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/002/002 PA23266/002/002 IC0045-002-008 Amlodipine Viatris 10 mg tablets Viatris Limited 10/09/2010 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/002/001 PA23266/002/001 IC0045-001-008 Amlodipine Viatris 5 mg tablets Viatris Limited 10/09/2010 HM Marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1418/003/002 PA1418/003/002 IC0045-002-008 Amlotan 10 mg tablet Athlone Pharmaceuticals Limited 18/08/2006 HM Not marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1418/003/001 PA1418/003/001 IC0045-001-008 Amlotan 5 mg tablet Athlone Pharmaceuticals Limited 18/08/2006 HM Not marketed AU Tablet C08CA C08CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/99/120/001 EU/1/99/120/001 Ammonaps 500 mg Tablets Immedica Pharma AB 08/12/1999 HM Unknown AU Tablet A16AX03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium phenylbutyrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/99/120/002 EU/1/99/120/002 Ammonaps 500 mg Tablets Immedica Pharma AB 08/12/1999 HM Unknown AU Tablet A16AX03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium phenylbutyrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/99/120/003 EU/1/99/120/003 Ammonaps 940 mg/g Granules Immedica Pharma AB 08/12/1999 HM Unknown AU Granules A16AX03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium phenylbutyrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/99/120/004 EU/1/99/120/004 Ammonaps 940 mg/g Granules Immedica Pharma AB 08/12/1999 HM Unknown AU Granules A16AX03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium phenylbutyrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA0711/162/001 PA0711/162/001 IC0037-071-034 Amoclav 125mg/31.25mg per 5ml Powder for Oral Suspension Rowex Limited, 21/03/2003 HM Not marketed AU Powder for oral suspension J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use potassium clavulanate Amoxicillin trihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/162/002 PA0711/162/002 IC0037-074-003 Amoclav 250mg/125mg Film-coated Tablets Rowex Limited, 21/03/2003 HM Not marketed AU Film-coated tablet J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/162/003 PA0711/162/003 IC0037-073-003 Amoclav 500mg/125mg Film-coated tablets Rowex Limited, 11/04/2014 HM Marketed AU Film-coated tablet J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clavulanic acid Amoxicillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/309/001 PA0711/309/001 Amorolfine 5 % w/v medicated nail lacquer Rowex Ltd 22/03/2019 HM Marketed AU Medicated nail lacquer D01AE16 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Amorolfine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1436/029/001 PA1436/029/001 Amorolfine 5% w/v medicated nail lacquer Bluefish Pharmaceuticals AB 21/06/2013 HM Marketed AU Medicated nail lacquer D01AE16 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Amorolfine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/044/001 PA1347/044/001 IC0037-073-003 Amoxicillin/clavulanic acid Krka 500 mg/125 mg Film-Coated Tablets KRKA, d.d., Novo mesto 18/09/2015 HM Not marketed AU Film-coated tablet J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/282/003 PA0126/282/003 IC0163-129-034 Amoxicillin 125 mg/5 ml powder for oral suspension Clonmel Healthcare Ltd 26/08/2016 HM Not marketed AU Powder for oral suspension J01CA J01CA04 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Amoxicillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/282/004 PA0126/282/004 IC0163-131-034 Amoxicillin 250 mg/5 ml powder for oral suspension Clonmel Healthcare Ltd 26/08/2016 HM Marketed AU Powder for oral suspension J01CA J01CA04 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Amoxicillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/282/001 PA0126/282/001 IC0163-130-001 Amoxicillin 250 mg hard capsules Clonmel Healthcare Ltd 26/08/2016 HM Marketed AU Capsule, hard J01CA J01CA04 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Amoxicillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/282/002 PA0126/282/002 IC0163-117-001 Amoxicillin 500 mg hard capsules Clonmel Healthcare Ltd 26/08/2016 HM Marketed AU Capsule, hard J01CA J01CA04 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Amoxicillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1832/001/002 PA1832/001/002 IC0163-117-001 Amoxicillin Centrient 500 mg hard capsules Centrient Pharmaceuticals Netherlands B.V 26/07/2013 HM Not marketed AU Capsule, hard J01CA J01CA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amoxicillin (as trihydrate) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23217/001/001 PA23217/001/001 Amoxicillin Delbert 500 mg powder for solution for injection or infusion Laboratoires DELBERT 01/04/1977 HM Marketed AU Powder for solution for injection/infusion J01CA J01CA04 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Amoxicillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22720/016/001 PA22720/016/001 Amphotericin B Liposomal Tillomed 50 mg Powder for concentrate for dispersion for infusion Tillomed Pharma GmbH 12/09/2025 HM Not marketed AU Powder for dispersion for infusion J02AA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Amphotericin b Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Summary of Product Characteristics, section 4.2) PA1591/003/001 PA1591/003/001 Amsalyo 75 mg powder for concentration for solution infusion Eurocept International BV 26/01/2024 HM Not marketed AU Powder for solution for infusion L01XX01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Amsacrine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1415/001 EU/1/19/1415/001 Amsparity 20 mg solution for injection in pre-filled syringe Pfizer Service Company BVBA 13/02/2020 HM Unknown AU Solution for injection in pre-filled syringe L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1415/002 EU/1/19/1415/002 Amsparity 40 mg/0.8 ml solution for injection Pfizer Service Company BVBA 13/02/2020 HM Unknown AU Solution for injection L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1415/007-010 EU/1/19/1415/007-010 Amsparity 40 mg solution for injection in pre-filled pen Pfizer Service Company BVBA 13/02/2020 HM Unknown AU Solution for injection in pre-filled pen L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1415/003-006 EU/1/19/1415/003-006 Amsparity 40 mg solution for injection in pre-filled syringe Pfizer Service Company BVBA 13/02/2020 HM Unknown AU Solution for injection in pre-filled syringe L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/22/1640/001 EU/1/22/1640/001 Amversio 1 g oral powder SERB S.A. 05/05/2022 HM Unknown AU Oral powder A16AA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Betaine anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/22/1681/001 EU/1/22/1681/001 Amvuttra 25 mg solution for injection in pre-filled syringe Alnylam Netherlands B.V. 15/09/2022 HM Unknown AU Solution for injection in pre-filled syringe N07XX N07XX18 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Vutrisiran Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA25506/001/001 PA25506/001/001 Amylmetacresol/2,4-Dichlorobenzyl alcohol Cooper 0.6 mg/1.2 mg honey & lemon lozenges Cooper Consumer Health B.V. 26/02/2021 HM Not marketed AU Lozenge R02AA R02AA03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oromucosal use 2,4 DICHLOROBENZYL ALCOHOL Amylmetacresol Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA25506/001/002 PA25506/001/002 Amylmetacresol/2,4-Dichlorobenzyl alcohol Cooper 0.6 mg/1.2 mg mint lozenges Cooper Consumer Health B.V. 26/02/2021 HM Not marketed AU Lozenge R02AA R02AA03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oromucosal use Amylmetacresol 2,4 DICHLOROBENZYL ALCOHOL Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public EU/1/12/805/003-004 EU/1/12/805/003-004 Amyvid 1,900 MBq/mL solution for injection Eli Lilly Nederland B.V. HM Unknown AU Solution for injection V09AX V09AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Florbetapir (18f) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/805/001-002 EU/1/12/805/001-002 Amyvid 800 MBq/mL solution for injection Eli Lilly Nederland B.V. 14/01/2013 HM Unknown AU Solution for injection V09AX V09AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Florbetapir (18f) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0678/148/001 PA0678/148/001 Anadin Analgesic Film-coated Tablets Aspirin 325mg Caffeine 15mg Haleon Ireland Limited 10/01/1983 HM Marketed AU Film-coated tablet N02BA N02BA51 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Aspirin Caffeine Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General sale in blister packs containing not more than 24 unit dosage forms. The indications should be for self-diagnosis and self-treatment. Promotion to the general public only for indications appropriate for self-diagnosis and self-treatment. Aspirin c PA0678/148/002 PA0678/148/002 Anadin Maximum Strength Hard Capsules Aspirin 500mg, caffeine 32mg Haleon Ireland Limited 27/01/1984 HM Marketed AU Capsule, hard N02BA N02BA51 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Caffeine Aspirin Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General sale in blister packs containing not more than 16 unit dosage forms. Retail sale through pharmacies only in blister packs containing not more than 24 unit dosage forms forms. Promotion to the general public only for indications appropriat PA23086/001/001 PA23086/001/001 Anafranil SR 75 mg Prolonged-release Tablets pharmaand GmbH 19/09/1988 HM Marketed AU Prolonged-release tablet N06AA N06AA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Clomipramine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1418/006/001 PA1418/006/001 Anagrelide 0.5 mg Hard Capsules Athlone Pharmaceuticals Limited 20/04/2018 HM Not marketed AU Capsule, hard L01XX L01XX35 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Anagrelide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/17/1256/001 EU/1/17/1256/001 Anagrelide Viatris 0.5 mg hard capsules Viatris Limited 15/02/2018 HM Unknown AU Capsule, hard L01XX L01XX35 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Anagrelide hydrochloride monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1253/002 EU/1/17/1253/002 Anagrelide Viatris 1 mg hard capsules Mylan Pharmaceuticals Limited 15/02/2018 HM Unknown AU Capsule, hard L01XX L01XX35 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Anagrelide hydrochloride monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA22580/001/002 PA22580/001/002 Anapen 300 micrograms in 0.3 ml solution for injection in a pre-filled syringe Bioprojet Pharma 21/02/2003 HM Marketed AU Solution for injection in pre-filled syringe C01CA C01CA24 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Epinephrine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22580/001/003 PA22580/001/003 Anapen 500 micrograms/0.3 ml solution for injection in a pre-filled syringe Bioprojet Pharma 10/08/2018 HM Marketed AU Solution for injection in pre-filled syringe C01CA C01CA24 Well-established use application (Article 10a of Directive No 2001/83/EC) Intramuscular use Epinephrine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22580/001/001 PA22580/001/001 Anapen Junior 150 micrograms in 0.3 ml solution for injection in a pre- filled syringe Bioprojet Pharma 21/02/2003 HM Marketed AU Solution for injection in pre-filled syringe C01CA C01CA24 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Epinephrine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/076/001 PA2315/076/001 IC0011-039-003 Anastrozole 1mg Film-coated Tablets Accord Healthcare Ireland Ltd. 02/07/2010 HM Marketed AU Film-coated tablet L02BG L02BG03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Anastrozole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA25364/005/001 PA25364/005/001 Anastrozole Amarox 1 mg film-coated tablets Amarox Pharma B.V. 09/04/2026 HM Not marketed AU Film-coated tablet L02BG03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Anastrozole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0840/004/001 PA0840/004/001 IC0011-039-003 Anastrozole Synthon 1 mg, film-coated tablets Synthon BV 28/09/2007 HM Not marketed AU Film-coated tablet L02BG L02BG03 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Anastrozole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/028/001 PA0749/028/001 IC0011-039-003 Anastrozole Teva 1 mg Film-coated Tablets Teva Pharma B.V. 23/11/2007 HM Marketed AU Film-coated tablet L02BG L02BG03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Anastrozole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2325/003/001 PA2325/003/001 Anbesol Anaesthetic Antiseptic Oromucosal Solution Alliance Pharma (Ireland) Limited 11/05/2012 HM Marketed AU Oromucosal solution N01BB N01BB52 Full application (Article 8(3) of Directive No 2001/83/EC) Oromucosal use Lidocaine hydrochloride Chlorocresol Cetylpyridinium chloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/24/1885/003-004 EU/1/24/1885/003-004 ANDEMBRY 200 mg solution for injection in pre-filled pen CSL Behring GmbH 10/02/2025 HM Unknown AU Solution for injection in pre-filled pen B06AC07 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Garadacimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/24/1885/001-002 EU/1/24/1885/001-002 ANDEMBRY 200 mg solution for injection in pre-filled syringe CSL Behring GmbH 10/02/2025 HM Unknown AU Solution for injection in pre-filled syringe B06AC07 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Garadacimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) PA0678/043/001 PA0678/043/001 Andrews Liver Salts Effervescent Powder Haleon Ireland Limited 25/02/1992 HM Not marketed AU Effervescent powder A06AD A06AD04 A09AB A09AB04 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Sodium hydrogen carbonate Magnesium sulphate dihydrate Citric acid Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23450/004/001 PA23450/004/001 Androcur 100 mg tablets Advanz Pharma Limited 24/01/1997 HM Marketed AU Tablet G03HA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Cyproterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1054/001/002 PA1054/001/002 Androgel 50 mg, transdermal gel in sachet Laboratoires Besins International 03/06/2003 HM Not marketed AU Transdermal gel in sachet G03BA G03BA03 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Testosterone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1868/002/001 PA1868/002/001 Anexate 500 micrograms/5ml, solution for injection or infusion Cheplapharm Arzneimittel GmbH 18/02/1988 HM Marketed AU Solution for injection/infusion V03AB V03AB25 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Flumazenil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1410/013/001 PA1410/013/001 Angeliq 1 mg/2 mg film-coated tablets Bayer Limited 05/03/2004 HM Marketed AU Film-coated tablet G03FA G03FA17 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Estradiol Drospirenone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1336/010/001 PA1336/010/001 Angusta 25 microgram tablets Norgine B.V. 30/10/2020 HM Not marketed AU Tablet G02AD06 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Misoprostol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23128/004/001 PA23128/004/001 Anhydrol Forte 20% w/v Cutaneous Solution Dermal Laboratories (Ireland) Limited 15/03/1982 HM Marketed AU Cutaneous solution D11AA Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Aluminium chloride hexahydrate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA2315/021/001 PA2315/021/001 Anidulafungin 100 mg powder for concentrate for solution for infusion Accord Healthcare Ireland Ltd. 18/01/2019 HM Not marketed AU Powder for concentrate for solution for infusion J02AX06 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Anidulafungin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/278/001 PA0711/278/001 Anidulafungin 100 mg Powder for concentrate for solution for infusion Rowex Ltd 15/02/2019 HM Marketed AU Powder for concentrate for solution for infusion J02AX06 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Anidulafungin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/045/001 PA1986/045/001 Anidulafungin Teva 100 mg Powder for Concentrate for Solution for Infusion Teva B.V. 16/02/2018 HM Not marketed AU Powder for concentrate for solution for infusion J02AX J02AX06 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Anidulafungin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA22871/023/001 PA22871/023/001 Aniva 10 mg film-coated tablets Azure Pharmaceuticals Ltd. 28/02/2025 HM Not marketed AU Film-coated tablet N06AA09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Amitriptyline hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/023/002 PA22871/023/002 Aniva 25 mg film-coated tablets Azure Pharmaceuticals Ltd. 28/02/2025 HM Not marketed AU Film-coated tablet N06AA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amitriptyline hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/023/003 PA22871/023/003 Aniva 50 mg film-coated tablets Azure Pharmaceuticals Ltd. 28/02/2025 HM Not marketed AU Film-coated tablet N06AA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amitriptyline hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/2002/001 EU/1/25/2002/001 Anktiva 400µg/0.4 ml Intravesical solution Serum Life Science Europe GmbH 16/02/2026 HM Unknown AU Intravesical solution L03AC03 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravesical use Nogapendekin alfa Inbakicept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/898/001-003 EU/1/14/898/001-003 ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed GlaxoSmithKline Trading Services Limited 08/05/2014 HM Unknown AU Inhalation powder, pre-dispensed R03AL03 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Vilanterol trifenatate Umeclidinium bromide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/110/001 PA1986/110/001 Antabuse 400 mg Effervescent Tablets Teva B.V. 06/02/1985 HM Marketed AU Effervescent tablet N07BB N07BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Disulfiram Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1113/024/001 PA1113/024/001 Anthisan Cream 2% w/w Phoenix Labs 01/04/1979 HM Marketed AU Cream D04AA D04AA02 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Mepyramine maleate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA0126/267/001 PA0126/267/001 Anti-Hist Allergy 10mg Film-coated tablets Clonmel Healthcare Ltd 23/06/2006 HM Marketed AU Film-coated tablet R06AE R06AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cetirizine dihydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Retail sale through pharmacies only in pack sizes not exceeding 30 tablets. Subject to the following restrictions:maximum strength: 10mg, maximum pack size: 30 tablets, maximum daily dose 10mg PA0126/267/002 PA0126/267/002 Anti-Hist Allergy 1mg/ml Oral Solution Clonmel Healthcare Ltd 29/05/2015 HM Marketed AU Oral solution R06AE R06AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cetrizine dihydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Pack sizes larger than 200 mls are subject to prescription. Promotion to the public for pack sizes of 200 ml or less. Promotion to Healthcare professionals for pack sizes larger than 200 ml. PA22647/001/001 PA22647/001/001 Anusol Cream SOFIBEL 03/04/1990 HM Marketed AU Cream C05AX C05AX04 Well-established use application (Article 10a of Directive No 2001/83/EC) Topical use Bismuth oxide Balsam peru Zinc oxide Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public Supply through general sales subject to the following restriction: maximum pack size of 23g. Supply through pharmacies only for pack sizes in excess of 23g. PA22647/002/001 PA22647/002/001 Anusol HC Ointment SOFIBEL 30/03/1990 HM Marketed AU Ointment D07BA Well-established use application (Article 10a of Directive No 2001/83/EC) Topical HYDROCORTISONE ACETATE Benzyl benzoate Bismuth subgallate Bismuth oxide Balsam peru Zinc oxide Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only Product not subject to prescription and supply through pharmacies only subject to the following restriction: maximum pack size - 15 g Pack sizes in excess of 15 g are subject to medical prescription. PA22647/002/002 PA22647/002/002 Anusol HC Suppositories SOFIBEL 30/03/1990 HM Marketed AU Suppository C05AA C05AA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Rectal use HYDROCORTISONE ACETATE Benzyl benzoate Bismuth oxide Balsam peru Zinc oxide Bismuth subgallate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only Product not subject to prescription and supply through pharmacies only subject to the following restriction: maximum pack size - 12 suppositories Pack sizes in excess of 12 suppositories are subject to medical prescription. PA22647/001/002 PA22647/001/002 Anusol Ointment SOFIBEL 03/04/1990 HM Marketed AU Ointment C05AX C05AX04 Well-established use application (Article 10a of Directive No 2001/83/EC) Topical Bismuth subgallate Bismuth oxide Balsam peru Zinc oxide Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public Supply through general sales subject to the following restriction: maximum pack size of 25g. Supply through pharmacies only for pack sizes in excess of 25g. PA22647/001/003 PA22647/001/003 Anusol Suppositories SOFIBEL 03/04/1990 HM Marketed AU Suppository C05AX C05AX04 Well-established use application (Article 10a of Directive No 2001/83/EC) Rectal use Bismuth oxide Zinc oxide Balsam peru Bismuth subgallate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0126/011/003 PA0126/011/003 Anxicalm 10 mg Tablets Clonmel Healthcare Ltd 25/04/1979 HM Marketed AU Tablet N05BA N05BA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Diazepam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA0126/011/001 PA0126/011/001 Anxicalm 2 mg Tablets Clonmel Healthcare Ltd 25/04/1979 HM Marketed AU Tablet N05BA N05BA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Diazepam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/011/002 PA0126/011/002 Anxicalm 5 mg Tablets Clonmel Healthcare Ltd 25/04/1979 HM Marketed AU Tablet N05BA N05BA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Diazepam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. EU/1/24/1851/001-002 EU/1/24/1851/001-002 Anzupgo 20 mg/g cream LEO Pharma A/S 19/09/2024 HM Unknown AU Cream D11AH11 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Delgocitinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA22766/015/001 PA22766/015/001 Apacross 5 mg/ml powder for dispersion for infusion Seacross Pharma (Europe) Limited 26/09/2025 HM Marketed AU Powder for dispersion for infusion L01CD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Paclitaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See: Summary of Product Characteristics, section 4.2) PA1347/105/002 PA1347/105/002 IC0167-024-024 Apeneta 100 mg prolonged-release tablets KRKA, d.d., Novo mesto 22/10/2021 HM Marketed AU Prolonged-release tablet N02AX06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Tapentadol maleate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017 PA1347/105/003 PA1347/105/003 IC0167-062-024 Apeneta 150 mg prolonged-release tablets KRKA, d.d., Novo mesto 22/10/2021 HM Marketed AU Prolonged-release tablet N02AX06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Tapentadol maleate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017 PA1347/105/004 PA1347/105/004 IC0167-067-024 Apeneta 200 mg prolonged-release tablets KRKA, d.d., Novo mesto 22/10/2021 HM Marketed AU Prolonged-release tablet N02AX06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Tapentadol maleate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017 PA1347/105/005 PA1347/105/005 IC0167-130-024 Apeneta 250 mg prolonged-release tablets KRKA, d.d., Novo mesto 22/10/2021 HM Marketed AU Prolonged-release tablet N02AX06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Tapentadol maleate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017 PA1347/105/001 PA1347/105/001 IC0167-023-024 Apeneta 50 mg prolonged-release tablets KRKA, d.d., Novo mesto 22/10/2021 HM Marketed AU Prolonged-release tablet N02AX06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Tapentadol maleate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017 EU/1/24/1835/001 EU/1/24/1835/001 Apexelsin 5 mg/ml powder for dispersion for infusion. Whiteoak Pharmaceutical B.V. 24/07/2024 HM Unknown AU Powder for dispersion for infusion L01CD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Paclitaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/04/285/021-036 EU/1/04/285/021-036 Apidra 100 Units/ml Solution for injection Sanofi-Aventis Deutschland GmbH 12/01/2010 HM Unknown AU Solution for injection A10AB A10AB06 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Insulin glulisine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/285/1-20 EU/1/04/285/1-20 Apidra 100 Units/ml Solution for injection Aventis Pharma Deutschland GmbH 27/09/2004 HM Unknown AU Solution for injection A10AB Full application (Article 8(3) of Directive No 2001/83/EC) Insulin glulisine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22865/009/001 PA22865/009/001 IC0124-018-003 Apixaban 2.5 mg film-coated tablets Renata Pharmaceuticals (Ireland) Limited 24/11/2023 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22865/009/002 PA22865/009/002 IC0124-001-003 Apixaban 5 mg film-coated tablets Renata Pharmaceuticals (Ireland) Limited 24/11/2023 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23405/002/001 PA23405/002/001 IC0124-018-003 Apixaban Abdi 2.5 mg film-coated tablet Abdi Farma GmbH 15/11/2024 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23405/002/002 PA23405/002/002 IC0124-001-003 Apixaban Abdi 5 mg film-coated tablet Abdi Farma GmbH 15/11/2024 HM Unknown AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1458/001-020 EU/1/20/1458/001-020 IC0124-018-003 Apixaban Accord 2.5 mg film-coated tablets Accord Healthcare S.L.U. 23/07/2020 HM Unknown AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1458/021-046 EU/1/20/1458/021-046 IC0124-001-003 Apixaban Accord 5 mg film-coated tablets Accord Healthcare S.L.U. 23/07/2020 HM Unknown AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1983/011/001 PA1983/011/001 Apixaban Aristo 1.25 mg/ml oral suspension Aristo Pharma GmbH 06/07/2026 HM Not marketed AU Oral suspension B01A B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/328/001 PA0126/328/001 IC0124-018-003 Apixaban Clonmel 2.5 mg film-coated tablets Clonmel Healthcare Ltd 11/03/2022 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/328/002 PA0126/328/002 IC0124-001-003 Apixaban Clonmel 5 mg film-coated tablets Clonmel Healthcare Ltd 11/03/2022 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22992/020/001 PA22992/020/001 IC0124-018-003 Apixaban Grindeks 2.5 mg film-coated tablets AS Grindeks 05/09/2025 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22992/020/002 PA22992/020/002 IC0124-001-003 Apixaban Grindeks 5 mg film-coated tablets AS Grindeks 05/09/2025 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/107/001 PA1347/107/001 IC0124-018-003 Apixaban Krka 2.5 mg film-coated tablets KRKA, d.d., Novo mesto 10/12/2021 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/107/002 PA1347/107/002 IC0124-001-003 Apixaban Krka 5 mg film-coated tablets KRKA, d.d., Novo mesto 10/12/2021 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23250/013/001 PA23250/013/001 IC0124-018-003 Apixaban MSN 2.5 mg film-coated tablets MSN Labs Europe Limited 28/03/2025 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23250/013/002 PA23250/013/002 IC0124-001-003 Apixaban MSN 5 mg film-coated tablets MSN Labs Europe Limited 28/03/2025 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/259/001 PA0281/259/001 IC0124-018-003 Apixaban Pinewood 2.5 mg film-coated tablets Pinewood Laboratories Limited 10/02/2023 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/259/002 PA0281/259/002 IC0124-001-003 Apixaban Pinewood 5 mg film-coated tablets Pinewood Laboratories Limited 10/02/2023 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0074/098/001 PA0074/098/001 IC0124-018-003 Apixaban Rowa 2.5 mg Film-coated tablets Rowa Pharmaceuticals Limited, 28/03/2025 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0074/098/002 PA0074/098/002 IC0124-001-003 Apixaban Rowa 5 mg Film-coated tablets Rowa Pharmaceuticals Limited, 28/03/2025 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/303/001 PA0711/303/001 IC0124-018-003 Apixaban Rowex 2.5 mg film-coated tablets Rowex Limited, 17/09/2021 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/303/002 PA0711/303/002 IC0124-001-003 Apixaban Rowex 5 mg film-coated tablets Rowex Limited, 17/09/2021 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0436/049/001 PA0436/049/001 IC0124-018-003 Apixaban Teva 2.5 mg film-coated tablets Norton Waterford 19/02/2021 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0436/049/002 PA0436/049/002 IC0124-001-003 Apixaban Teva 5 mg film-coated tablets Norton Waterford 19/02/2021 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/058/001 PA23266/058/001 IC0124-018-003 Apixaban Viatris 2.5 mg film-coated tablets Viatris Limited 09/07/2021 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/058/002 PA23266/058/002 IC0124-001-003 Apixaban Viatris 5 mg film-coated tablets Viatris Limited 09/07/2021 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/069/001 PA23266/069/001 IC0124-018-003 Apixaban Viatris Pharma 2.5 mg film-coated tablets Viatris Limited 27/06/2025 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/069/002 PA23266/069/002 IC0124-001-003 Apixaban Viatris Pharma 5 mg film-coated tablets Viatris Limited 27/06/2025 HM Not marketed AU Film-coated tablet B01AF02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0593/043/002 PA0593/043/002 APO-go AMPOULES 10 mg/ml Solution for Injection or Infusion *Abbreviated to APO-go in the text Stada Arzneimittel AG 28/11/2014 HM Not marketed AU Solution for injection/infusion N04BC N04BC07 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Apomorphine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0593/042/004 PA0593/042/004 APO-go POD 5 mg/ml solution for infusion in cartridge Stada Arzneimittel AG 13/11/2020 HM Marketed AU Solution for infusion in cartridge N04BC07 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Apomorphine hydrochloride hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0593/043/001 PA0593/043/001 APO-go® PEN 10 mg/ml Solution for Injection** Abbreviated to APO-go in the text Stada Arzneimittel AG 28/11/2014 HM Marketed AU Solution for injection N04BC N04BC07 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Apomorphine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0593/043/003 PA0593/043/003 APO-go® PFS 5mg/ml Solution for Infusion in Pre-filled Syringe Stada Arzneimittel AG 28/11/2014 HM Marketed AU Solution for infusion in pre-filled syringe N04BC N04BC07 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Apomorphine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22784/001/001 PA22784/001/001 Appizped 10mg/15ml oral solution Proveca Pharma Limited 19/07/2024 HM Not marketed AU Oral solution A02BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Omeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22784/001/002 PA22784/001/002 Appizped 20 mg/15ml oral solution Proveca Pharma Limited 19/07/2024 HM Not marketed AU Oral solution A02BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Omeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1796/005 EU/1/24/1796/005 IC0199-220-003 Apremilast Accord 10 mg film-coated tablets Apremilast Accord 20 mg film-coated tablets Accord Healthcare S.L.U. 19/04/2024 HM Unknown AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/24/1796/001 EU/1/24/1796/001 IC0199-219-003 Apremilast Accord 10 mg film-coated tablets Apremilast Accord 20 mg film-coated tablets Apremilast Accord 30 mg film-coated tablets Accord Healthcare S.L.U. 19/04/2024 HM Unknown AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/24/1796/006-007 EU/1/24/1796/006-007 IC0199-003-003 Apremilast Accord 20 mg film-coated tablets Accord Healthcare S.L.U. 19/04/2024 HM Unknown AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/24/1796/002-004 EU/1/24/1796/002-004 IC0199-033-003 Apremilast Accord 30 mg film-coated tablets Accord Healthcare S.L.U. 19/04/2024 HM Unknown AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) PA1445/027/002 PA1445/027/002 IC0199-033-003 Apremilast Aurobindo 30mg film-coated tablets Aurobindo Pharma (Malta) Limited 31/10/2025 HM Not marketed AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23438/003/001 PA23438/003/001 IC0199-219-003 Apremilast axunio Pharma 10 mg + 20mg + 30 mg film-coated tablets Axunio Pharma GmbH 07/11/2025 HM Not marketed AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Apremilast Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23438/003/002 PA23438/003/002 IC0199-033-003 Apremilast axunio Pharma 30 mg film-coated tablets Axunio Pharma GmbH 07/11/2025 HM Not marketed AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/374/002 PA0126/374/002 IC0199-219-003 Apremilast Clonmel 10 mg film-coated tablets Apremilast Clonmel 20 mg film-coated tablets Apremilast Clonmel 30 mg film-coated tablets Clonmel Healthcare Ltd 25/10/2024 HM Not marketed AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Apremilast Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0126/374/001 PA0126/374/001 IC0199-033-003 Apremilast Clonmel 30 mg film-coated tablets Clonmel Healthcare Ltd 25/10/2024 HM Marketed AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA22645/007/001 PA22645/007/001 IC0199-219-003 Apremilast Glenmark 10 mg + 20 mg + 30 mg film-coated tablets Glenmark Arzneimittel GmbH 03/10/2025 HM Not marketed AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Apremilast Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only *** AWAITING VALUE *** PA22645/007/002 PA22645/007/002 IC0199-033-003 Apremilast Glenmark 30mg film-coated tablets Glenmark Arzneimittel GmbH 03/10/2025 HM Not marketed AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only *** AWAITING VALUE *** PA1347/114/001 PA1347/114/001 IC0199-219-003 Apremilast Krka 10 mg film-coated tablets Apremilast Krka 20 mg film-coated tablets Apremilast Krka 30 mg film-coated tablets KRKA, d.d., Novo mesto 14/06/2024 HM Not marketed AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Apremilast Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1347/114/002 PA1347/114/002 IC0199-033-003 Apremilast Krka 30 mg film-coated tablets KRKA, d.d., Novo mesto 14/06/2024 HM Marketed AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0711/330/002 PA0711/330/002 IC0199-219-003 Apremilast Rowex 10 mg film-coated tablets Apremilast Rowex 20 mg film-coated tablets Apremilast Rowex 30 mg film-coated tablets Rowex Limited, 31/05/2024 HM Not marketed AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0711/330/001 PA0711/330/001 IC0199-033-003 Apremilast Rowex 30 mg film-coated tablets Rowex Limited, 31/05/2024 HM Not marketed AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA23266/072/001 PA23266/072/001 IC0199-219-003 Apremilast Viatris 10 mg film-coated tablets Apremilast Viatris 20 mg film-coated tablets Apremilast Viatris 30 mg film-coated tablets Viatris Limited 07/11/2025 HM Not marketed AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Apremilast Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/072/002 PA23266/072/002 IC0199-033-003 Apremilast Viatris 30 mg film-coated tablets Viatris Limited 07/11/2025 HM Not marketed AU Film-coated tablet L04AA32 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Apremilast Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/148/003 PA2315/148/003 IC0184-213-001 Aprepitant Accord 125 mg/80 mg hard capsules Accord Healthcare Ireland Ltd. 22/03/2019 HM Marketed AU Capsule, hard A04AD12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aprepitant Aprepitant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/148/002 PA2315/148/002 IC0184-212-001 Aprepitant Accord 125 mg hard capsules Accord Healthcare Ireland Ltd. 22/03/2019 HM Marketed AU Capsule, hard A04AD12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aprepitant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/148/001 PA2315/148/001 IC0184-005-001 Aprepitant Accord 80 mg hard capsules Accord Healthcare Ireland Ltd. 22/03/2019 HM Marketed AU Capsule, hard A04AD12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aprepitant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1760/001 EU/1/23/1760/001 Apretude 600 mg prolonged-release suspension for injection ViiV Healthcare BV 15/09/2023 HM Unknown AU Film-coated tablet J05AJ04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Cabotegravir Sodium cabotegravir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1107/006/001 PA1107/006/001 Aprok 50mg powder for solution for injection Laboratoires Thea 07/09/2012 HM Marketed AU Powder for solution for injection S01AA S01AA27 Well-established use application (Article 10a of Directive No 2001/83/EC) Intraocular use Cefuroxime Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/97/046/021-025 EU/1/97/046/021-025 IC0157-062-014 Aprovel 150 mg film-coated tablets Sanofi Winthrop Industrie HM Unknown AU Film-coated tablet C09CA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Irbesartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/97/046/004-006 EU/1/97/046/004-006 IC0157-062-014 Aprovel 150 mg tablets Sanofi Winthrop Industrie HM Unknown AU Tablet C09CA C09CA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Irbesartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/97/046/026-030 EU/1/97/046/026-030 IC0157-029-014 Aprovel 300 mg film-coated tablets Sanofi Winthrop Industrie HM Unknown AU Film-coated tablet C09CA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Irbesartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/97/046/007-009 EU/1/97/046/007-009 IC0157-029-014 Aprovel 300 mg tablets Sanofi Winthrop Industrie HM Unknown AU Tablet C09CA C09CA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Irbesartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/97/046/016-020 EU/1/97/046/016-020 IC0157-028-014 Aprovel 75 mg film-coated tablets Sanofi Winthrop Industrie HM Unknown AU Film-coated tablet C09CA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Irbesartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/97/046/001-003 EU/1/97/046/001-003 IC0157-028-014 Aprovel 75 mg tablets Sanofi Winthrop Industrie HM Unknown AU Tablet C09CA C09CA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Irbesartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/05/315/002 EU/1/05/315/002 Aptivus Boehringer Ingelheim International GmbH 23/06/2009 HM Unknown AU Oral solution J05AE Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tipranavir Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/05/315/001 EU/1/05/315/001 Aptivus 250 mg soft capsules Boehringer Ingelheim International GmbH 25/10/2005 HM Unknown AU Capsule, soft J05AE J05AE09 Full application (Article 8(3) of Directive No 2001/83/EC) Tipranavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/25/1928/001-002 EU/1/25/1928/001-002 Aqneursa 1 g granules for oral suspension in sachet Intrabio Ireland Limited 19/01/2026 HM Unknown AU Granules for oral suspension in sachet N07XX27 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use L-Acetylleucine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0206/021/001 PA0206/021/001 Aqueous Cream Emulsifying Wax 9% w/w, White Soft Parafin 15% w/w, Liquid Paraffin 6% w/w Ovelle Limited 18/11/1988 HM Marketed AU Cream D02AX Well-established use application (Article 10a of Directive No 2001/83/EC) Topical Emulsifying wax White soft paraffin Liquid paraffin Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to healthcare professionals only EU/1/23/1750/001-002 EU/1/23/1750/001-002 AQUIPTA 10 mg tablets AbbVie Deutschland GmbH & Co. KG 11/08/2023 HM Unknown AU Tablet N02C N02CD07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Atogepant monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1750/003-004 EU/1/23/1750/003-004 AQUIPTA 60 mg tablets AbbVie Deutschland GmbH & Co. KG 11/08/2023 HM Unknown AU Tablet N02C N02CD07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Atogepant monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1717/001-003 EU/1/23/1717/001-003 Aqumeldi 0.25 mg Orodispersible tablet Proveca Pharma Limited 15/11/2023 HM Unknown AU Orodispersible tablet C09AA02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Enalapril maleate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/23/1717/004-006 EU/1/23/1717/004-006 Aqumeldi 1 mg orodispersible tablets Proveca Pharma Limited 23/04/2025 HM Unknown AU Orodispersible tablet C09AA02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Enalapril maleate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/01/185/045, 057 EU/1/01/185/045, 057 Aranesp 10 micrograms solution for injection in pre-filled pen Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled pen B03XA02 Not Currently Available Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/001-002 EU/1/01/185/001-002 Aranesp 10 micrograms solution for injection pre-filled syringe Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA02 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/053, 065 EU/1/01/185/053, 065 Aranesp 100 micrograms solution for injection in pre-filled pen Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled pen B03XA02 Not Currently Available Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/017-018 EU/1/01/185/017-018 Aranesp 100 micrograms solution for injection pre-filled syringe Amgen Europe B.V., HM Unknown AU Solution for injection in pre-filled syringe B03XA02 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/072, 073 EU/1/01/185/072, 073 Aranesp 130 micrograms solution for injection in pre-filled pen Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled pen B03XA02 Not Currently Available Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/046, 058 EU/1/01/185/046, 058 Aranesp 15 micrograms solution for injection in pre-filled pen. Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled pen B03XA02 Not Currently Available Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/003-004 EU/1/01/185/003-004 Aranesp 15 micrograms solution for injection pre-filled syringe Amgen Europe B.V., HM Unknown AU Solution for injection in pre-filled syringe B03XA02 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/054, 066 EU/1/01/185/054, 066 Aranesp 150 micrograms solution for injection in pre-filled pen Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled pen B03XA02 Not Currently Available Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/019-020 EU/1/01/185/019-020 Aranesp 150 micrograms solution for injection pre-filled syringe Amgen Europe B.V., HM Unknown AU Solution for injection in pre-filled syringe B03XA02 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/047, 059 EU/1/01/185/047, 059 Aranesp 20 micrograms solution for injection in pre-filled pen Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled pen B03XA02 Not Currently Available Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/005-006 EU/1/01/185/005-006 Aranesp 20 micrograms solution for injection pre-filled syringe Amgen Europe B.V., HM Unknown AU Solution for injection in pre-filled syringe B03XA02 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/048, 060 EU/1/01/185/048, 060 Aranesp 30 micrograms solution for injection in pre-filled pen Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled pen B03XA02 Not Currently Available Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/007-008 EU/1/01/185/007-008 Aranesp 30 micrograms solution for injection pre-filled syringe Amgen Europe B.V., HM Unknown AU Solution for injection in pre-filled syringe B03XA02 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/055, 067 EU/1/01/185/055, 067 Aranesp 300 micrograms solution for injection in pre-filled pen Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled pen B03XA02 Not Currently Available Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/021-022 EU/1/01/185/021-022 Aranesp 300 micrograms solution for injection pre-filled syringe Amgen Europe B.V., HM Unknown AU Solution for injection in pre-filled syringe B03XA New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/049, 061 EU/1/01/185/049, 061 Aranesp 40 micrograms solution for injection in pre-filled pen Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled pen B03XA02 Not Currently Available Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/009-010 EU/1/01/185/009-010 Aranesp 40 micrograms solution for injection pre-filled syringe Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA02 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/050, 062 EU/1/01/185/050, 062 Aranesp 50 micrograms solution for injection in pre-filled pen Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled pen B03XA02 Not Currently Available Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/011-012 EU/1/01/185/011-012 Aranesp 50 micrograms solution for injection pre-filled syringe Amgen Europe B.V., HM Unknown AU Solution for injection in pre-filled syringe B03XA02 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/056, 068 EU/1/01/185/056, 068 Aranesp 500 micrograms solution for injection in pre-filled pen Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled pen B03XA02 Not Currently Available Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/031-032 EU/1/01/185/031-032 Aranesp 500 micrograms solution for injection pre-filled syringe Amgen Europe B.V., HM Unknown AU Solution for injection in pre-filled syringe B03XA New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/051, 063 EU/1/01/185/051, 063 Aranesp 60 micrograms solution for injection in pre-filled pen Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled pen B03XA02 Not Currently Available Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/013-014 EU/1/01/185/013-014 Aranesp 60 micrograms solution for injection pre-filled syringe Amgen Europe B.V., HM Unknown AU Solution for injection in pre-filled syringe B03XA02 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Darbepoetin alfa Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/052, 064 EU/1/01/185/052, 064 Aranesp 80 micrograms solution for injection in pre-filled pen Amgen Europe B.V., 08/06/2001 HM Unknown AU Solution for injection in pre-filled pen B03XA02 Not Currently Available Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/185/015-016 EU/1/01/185/015-016 Aranesp 80 micrograms solution for injection pre-filled syringe Amgen Europe B.V., HM Unknown AU Solution for injection in pre-filled syringe B03XA02 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Darbepoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/99/118/001 EU/1/99/118/001 Arava 10 mg Film-coated tablet Sanofi-Aventis Deutschland GmbH HM Unknown AU Film-coated tablet L04AA L04AA13 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Leflunomide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/99/118/002 EU/1/99/118/002 Arava 10 mg Film-coated tablet Sanofi-Aventis Deutschland GmbH 02/09/1999 HM Unknown AU Film-coated tablet New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Leflunomide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/99/118/003 EU/1/99/118/003 Arava 10 mg Film-coated tablet Sanofi-Aventis Deutschland GmbH 02/09/1999 HM Unknown AU Film-coated tablet New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Leflunomide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/99/118/004 EU/1/99/118/004 Arava 10 mg Film-coated tablet Sanofi-Aventis Deutschland GmbH 02/09/1999 HM Unknown AU Film-coated tablet New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Leflunomide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/99/118/009 EU/1/99/118/009 Arava 100 mg Film-coated tablet Sanofi-Aventis Deutschland GmbH HM Unknown AU Film-coated tablet New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Leflunomide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/99/118/005 EU/1/99/118/005 Arava 20 mg Film-coated tablet Sanofi-Aventis Deutschland GmbH HM Unknown AU Film-coated tablet New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Leflunomide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/99/118/006 EU/1/99/118/006 Arava 20 mg Film-coated tablet Sanofi-Aventis Deutschland GmbH HM Unknown AU Film-coated tablet New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Leflunomide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/99/118/007 EU/1/99/118/007 Arava 20 mg Film-coated tablet Sanofi-Aventis Deutschland GmbH 02/09/1999 HM Unknown AU Film-coated tablet New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Leflunomide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/99/118/008 EU/1/99/118/008 Arava 20 mg Film-coated tablet Sanofi-Aventis Deutschland GmbH HM Unknown AU Film-coated tablet New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Leflunomide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA0964/009/004 PA0964/009/004 IC0108-167-003 Arcoxia 120 mg film-coated tablets NV Organon 11/10/2002 HM Marketed AU Film-coated tablet M01AH M01AH05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0964/009/001 PA0964/009/001 IC0108-033-003 Arcoxia 30 mg film-coated tablets NV Organon 09/11/2007 HM Marketed AU Film-coated tablet M01AH M01AH05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/176/004 PPA0465/176/004 IC0108-033-003 Arcoxia 30 mg film-coated tablets PCO Manufacturing Ltd. 08/10/2010 HM Unknown AU Film-coated tablet M01AH05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0964/009/002 PA0964/009/002 IC0108-127-003 Arcoxia 60 mg film-coated tablets NV Organon 11/10/2002 HM Marketed AU Film-coated tablet M01AH M01AH05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/176/001 PPA0465/176/001 IC0108-127-003 Arcoxia 60 mg film-coated tablets PCO Manufacturing Ltd. 07/04/2006 HM Unknown AU Film-coated tablet M01AH05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/041/001 PPA1463/041/001 IC0108-127-003 Arcoxia 60 mg film-coated tablets IMED Healthcare Ltd., 06/08/2010 HM Unknown AU Film-coated tablet M01AH05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0964/009/003 PA0964/009/003 IC0108-166-003 Arcoxia 90 mg film-coated tablets NV Organon 11/10/2002 HM Marketed AU Film-coated tablet M01AH M01AH05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/041/002 PPA1463/041/002 IC0108-166-003 Arcoxia 90 mg film-coated tablets IMED Healthcare Ltd., 06/08/2010 HM Unknown AU Film-coated tablet M01AH05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0577/057/002 PA0577/057/002 Areloger 15 mg tablets McDermott Laboratories Ltd., T/A Gerard Laboratories 17/09/2004 HM Not marketed AU Tablet M01AC M01AC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Meloxicam Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0577/057/001 PA0577/057/001 Areloger 7.5 mg tablets McDermott Laboratories Ltd., T/A Gerard Laboratories 17/09/2004 HM Not marketed AU Tablet M01AC M01AC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Meloxicam Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1740/001-002 EU/1/23/1740/001-002 Arexvy powder and suspension for suspension for injection Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted) GlaxoSmithKline Biologicals 06/06/2023 HM Unknown AU Powder and suspension for suspension for injection J07BX05 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/002/002 PA0822/002/002 IC0062-002-015 ARICEPT 10 mg film coated tablets Pfizer Healthcare Ireland Unlimited Company 25/02/1997 HM Marketed AU Film-coated tablet N06DA N06DA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/002/001 PA0822/002/001 IC0062-001-015 ARICEPT 5 mg film coated tablets Pfizer Healthcare Ireland Unlimited Company 25/02/1997 HM Marketed AU Film-coated tablet N06DA N06DA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1469/001 EU/1/20/1469/001 ARIKAYCE liposomal 590 mg nebuliser dispersion Insmed Netherlands B.V. 27/10/2020 HM Unknown AU Nebuliser dispersion J01GB06 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use AMIKACIN SULFATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PPA0465/218/001 PPA0465/218/001 IC0011-039-003 Arimidex 1 mg film-coated tablets PCO Manufacturing Ltd. 28/05/2009 HM Unknown AU Film-coated tablet L02BG L02BG03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Anastrozole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/017/001 PPA2306/017/001 IC0011-039-003 Arimidex 1 mg film-coated tablets Originalis B.V. 19/07/2019 HM Unknown AU Film-coated tablet L02BG03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Anastrozole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/070/001 PPA1463/070/001 IC0011-039-003 Arimidex 1 mg Film-coated Tablets IMED Healthcare Ltd., 28/09/2012 HM Unknown AU Film-coated tablet L02BG L02BG03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Anastrozole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23154/001/001 PA23154/001/001 IC0011-039-003 Arimidex 1mg Film-coated Tablets Laboratoires Juvise Pharmaceuticals 11/08/2000 HM Marketed AU Film-coated tablet L02BG L02BG03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Anastrozole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1983/012/001 PA1983/012/001 Arinaya 1.25 mg/ml oral suspension Aristo Pharma GmbH 06/07/2026 HM Not marketed AU Oral suspension B01A B01AF02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/062/002 PA23266/062/002 IC0062-002-015 Aripil 10 mg film-coated tablets Viatris Limited 03/10/2008 HM Marketed AU Film-coated tablet N06DA N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/062/001 PA23266/062/001 IC0062-001-015 Aripil 5 mg film-coated tablets Viatris Limited 03/10/2008 HM Marketed AU Film-coated tablet N06DA N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/016/002 PA22749/016/002 IC0092-002-056 Aripiprazole 10 mg tablets Brillpharma (Ireland) Limited 06/10/2017 HM Not marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/016/003 PA22749/016/003 IC0092-032-056 Aripiprazole 15 mg tablets Brillpharma (Ireland) Limited 06/10/2017 HM Not marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/016/004 PA22749/016/004 IC0092-003-002 Aripiprazole 20 mg tablets Brillpharma (Ireland) Limited 06/10/2017 HM Not marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/016/005 PA22749/016/005 IC0092-033-056 Aripiprazole 30 mg tablets Brillpharma (Ireland) Limited 06/10/2017 HM Not marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/016/001 PA22749/016/001 IC0092-001-002 Aripiprazole 5 mg tablets Brillpharma (Ireland) Limited 06/10/2017 HM Not marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1045/007-012 EU/1/15/1045/007-012 IC0092-002-056 Aripiprazole Accord 10 mg tablets Accord Healthcare S.L.U. 16/11/2015 HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1045/013-018 EU/1/15/1045/013-018 IC0092-032-056 Aripiprazole Accord 15 mg tablets Accord Healthcare S.L.U. 16/11/2015 HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1045/019-022 EU/1/15/1045/019-022 IC0092-033-056 Aripiprazole Accord 30 mg tablets Accord Healthcare S.L.U. 16/11/2015 HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1045/001-006 EU/1/15/1045/001-006 IC0092-001-002 Aripiprazole Accord 5 mg tablets Accord Healthcare S.L.U. 16/11/2015 HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/266/002 PA0126/266/002 IC0092-002-056 Aripiprazole Clonmel 10 mg tablets Clonmel Healthcare Ltd 17/07/2015 HM Marketed AU Tablet N04BD N04BD02 N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/266/003 PA0126/266/003 IC0092-032-056 Aripiprazole Clonmel 15 mg tablets Clonmel Healthcare Ltd 17/07/2015 HM Marketed AU Tablet N04BD N04BD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/266/004 PA0126/266/004 IC0092-033-056 Aripiprazole Clonmel 30 mg tablets Clonmel Healthcare Ltd 17/07/2015 HM Marketed AU Tablet N04BD N04BD02 N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/266/001 PA0126/266/001 IC0092-001-002 Aripiprazole Clonmel 5 mg tablets Clonmel Healthcare Ltd 17/07/2015 HM Marketed AU Tablet N04BD N04BD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/089/002 PA1347/089/002 IC0092-002-056 Aripiprazole Krka 10mg Tablets KRKA, d.d., Novo mesto 13/02/2015 HM Marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/089/003 PA1347/089/003 IC0092-032-056 Aripiprazole Krka 15mg Tablets KRKA, d.d., Novo mesto 13/02/2015 HM Marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/089/004 PA1347/089/004 IC0092-033-056 Aripiprazole Krka 30mg Tablets KRKA, d.d., Novo mesto 13/02/2015 HM Marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/089/001 PA1347/089/001 IC0092-001-002 Aripiprazole Krka 5mg Tablets KRKA, d.d., Novo mesto 13/02/2015 HM Marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1005/004-006 EU/1/15/1005/004-006 IC0092-002-056 Aripiprazole Mylan Pharma 10 mg Tablet Mylan S.A.S. 30/06/2015 HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1005/007-009 EU/1/15/1005/007-009 IC0092-032-056 Aripiprazole Mylan Pharma 15 mg Tablet Mylan S.A.S. 30/06/2015 HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1005/010-012 EU/1/15/1005/010-012 IC0092-033-056 Aripiprazole Mylan Pharma 30 mg Tablet Mylan S.A.S. 30/06/2015 HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1005/001-003 EU/1/15/1005/001-003 IC0092-001-002 Aripiprazole Mylan Pharma 5 mg Tablet Mylan S.A.S. 30/06/2015 HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/274/001 PA0281/274/001 IC0092-047-019 Aripiprazole Pinewood 1 mg/ml Oral Solution Pinewood Laboratories Limited 19/09/2025 HM Marketed AU Oral solution N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/214/002 PA0281/214/002 IC0092-002-056 Aripiprazole Pinewood 10 mg tablets Pinewood Laboratories Ltd 28/08/2015 HM Not marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/214/003 PA0281/214/003 IC0092-032-056 Aripiprazole Pinewood 15 mg tablets Pinewood Laboratories Ltd 28/08/2015 HM Not marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/214/004 PA0281/214/004 IC0092-033-056 Aripiprazole Pinewood 30 mg tablets Pinewood Laboratories Ltd 28/08/2015 HM Not marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/214/001 PA0281/214/001 IC0092-001-002 Aripiprazole Pinewood 5 mg tablets Pinewood Laboratories Ltd 28/08/2015 HM Not marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1029/015-028 EU/1/15/1029/015-028 IC0092-002-056 Aripiprazole Sandoz 10 mg Tablets Sandoz GmbH HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1029/029-042 EU/1/15/1029/029-042 IC0092-032-056 Aripiprazole Sandoz 15 mg Tablets Sandoz GmbH HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1029/043-047 EU/1/15/1029/043-047 IC0092-003-002 Aripiprazole Sandoz 20 mg Tablets Sandoz GmbH HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1029/048-061 EU/1/15/1029/048-061 IC0092-033-056 Aripiprazole Sandoz 30 mg Tablets Sandoz GmbH HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1029/001-014 EU/1/15/1029/001-014 IC0092-001-002 Aripiprazole Sandoz 5 mg Tablets Sandoz GmbH 20/08/2015 HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/019/002 PA1986/019/002 IC0092-002-056 Aripiprazole Teva 10 mg tablets Teva B.V. 05/06/2015 HM Marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/019/003 PA1986/019/003 IC0092-032-056 Aripiprazole Teva 15 mg tablets Teva B.V. 05/06/2015 HM Marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/019/004 PA1986/019/004 IC0092-033-056 Aripiprazole Teva 30 mg tablets Teva B.V. 05/06/2015 HM Marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/019/001 PA1986/019/001 IC0092-001-002 Aripiprazole Teva 5 mg tablets Teva B.V. 05/06/2015 HM Marketed AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1009/021-023 EU/1/15/1009/021-023 IC0092-002-056 Aripiprazole Zentiva 10 mg Orodispersible tablet Zentiva k.s. 25/06/2015 HM Unknown AU Orodispersible tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1009/006-010 EU/1/15/1009/006-010 IC0092-002-056 Aripiprazole Zentiva 10 mg Tablet Zentiva k.s. 25/06/2015 HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1009/024-026 EU/1/15/1009/024-026 IC0092-032-056 Aripiprazole Zentiva 15 mg Orodispersible tablet Zentiva k.s. 25/06/2015 HM Unknown AU Orodispersible tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1009/011-015 EU/1/15/1009/011-015 IC0092-032-056 Aripiprazole Zentiva 15 mg Tablet Zentiva k.s. 25/06/2015 HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1009/027-029 EU/1/15/1009/027-029 IC0092-033-056 Aripiprazole Zentiva 30 mg Orodispersible tablet Zentiva k.s. 25/06/2015 HM Unknown AU Orodispersible tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1009/016-020 EU/1/15/1009/016-020 IC0092-033-056 Aripiprazole Zentiva 30 mg Tablet Zentiva k.s. 25/06/2015 HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1009/001-005 EU/1/15/1009/001-005 IC0092-001-002 Aripiprazole Zentiva 5 mg Tablet Zentiva k.s. 25/06/2015 HM Unknown AU Tablet N05AX N05AX12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Aripiprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/206/015-017 EU/1/02/206/015-017 Arixtra Viatris Healthcare Limited HM Unknown AU Solution for injection in pre-filled syringe B01AX B01AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Fondaparinux sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/206/018 EU/1/02/206/018 Arixtra Viatris Healthcare Limited HM Unknown AU Solution for injection in pre-filled syringe B01AX B01AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Fondaparinux sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/206/005-008 EU/1/02/206/005-008 Arixtra 1.5 mg/0.3 ml solution for injection Viatris Healthcare Limited HM Unknown AU Solution for injection in pre-filled syringe B01AX B01AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Fondaparinux sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/206/031-032 EU/1/02/206/031-032 Arixtra 10 mg/0.8 ml solution for injection Viatris Healthcare Limited HM Unknown AU Solution for injection in pre-filled syringe B01AX B01AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Fondaparinux sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/206/001-004 EU/1/02/206/001-004 Arixtra 2.5 mg/0.5 ml solution for injection Viatris Healthcare Limited 21/03/2002 HM Unknown AU Solution for injection in pre-filled syringe B01AX B01AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Fondaparinux sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/206/009-011 EU/1/02/206/009-011 Arixtra 5 mg/0.4 ml solution for injection Viatris Healthcare Limited HM Unknown AU Solution for injection in pre-filled syringe B01AX B01AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Fondaparinux sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/206/012-014 EU/1/02/206/012-014 Arixtra 7.5 mg/0.6 ml solution for injection Viatris Healthcare Limited HM Unknown AU Solution for injection in pre-filled syringe B01AX B01AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Fondaparinux sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1238/001/001 PA1238/001/001 Arlevert 20 mg/40 mg tablets Hennig Arzneimittel GmbH & Co KG 13/07/2007 HM Not marketed AU Tablet N07CA N07CA52 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Cinnarizine Dimenhydrinate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1063/001-004 EU/1/15/1063/001-004 Armisarte 25 mg/ml concentrate for solution for infusion Actavis Group hf 18/01/2016 HM Unknown AU Concentrate for solution for infusion L01BA L01BA04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Pemetrexed diacid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). HOR22892/002/001 HOR22892/002/001 Arnica Nelsons GmbH 29/10/2010 HM Not marketed AU Pillules Simplified Registration for a Homeopathic Medicinal Product (Article 14, Directive 2001/83/EC) Oral use Arnica montana Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public HOR1149/031/001 HOR1149/031/001 Arnica A. Nelson & Company Limited 31/03/2017 HM Unknown AU Tablet Not Currently Available Oral use Arnica montana Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public HOR23380/001/001 HOR23380/001/001 Arnica 30 C tablets Weleda AG 23/09/2022 HM Marketed AU Tablet Simplified Registration for a Homeopathic Medicinal Product (Article 14, Directive 2001/83/EC) Oral use Arnica planta tota 30X dilution Product not subject to medical prescription *** AWAITING VALUE *** PA0822/111/001 PA0822/111/001 IC0142-022-040 Aromasin 25 mg coated tablets Pfizer Healthcare Ireland Unlimited Company 12/11/1999 HM Marketed AU Coated tablet L02BG L02BG06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Exemestane Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/236/001 PPA0465/236/001 IC0142-022-040 Aromasin 25 mg coated tablets PCO Manufacturing Ltd. 14/08/2009 HM Unknown AU Coated tablet L02BG L02BG06 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Exemestane Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/069/001 PPA1463/069/001 IC0142-022-040 Aromasin 25 mg coated tablets IMED Healthcare Ltd., 31/08/2012 HM Unknown AU Coated tablet L02BG L02BG06 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Exemestane Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/015/001 PPA2306/015/001 IC0142-022-040 Aromasin 25 mg coated tablets Originalis B.V. 19/07/2019 HM Unknown AU Coated tablet L02BG06 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Exemestane Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1963/012/001 PA1963/012/001 Arquist 125 microgram per actuation pressurised inhalation, suspension Cipla Europe 13/01/2017 HM Not marketed AU Pressurised inhalation, suspension R03BA R03BA05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1963/012/002 PA1963/012/002 Arquist 250 microgram per actuation pressurised inhalation, suspension Cipla Europe 13/01/2017 HM Not marketed AU Pressurised inhalation, suspension R03BA R03BA05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/155/001 PPA0465/155/001 Arret 2 mg Hard Capsules PCO Manufacturing Ltd. 28/11/2005 HM Unknown AU Capsule, hard A07DA A07DA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Loperamide hydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA23490/023/001 PA23490/023/001 Arret 2mg Hard Capsules JNTL Consumer Health (Ireland) Limited 03/05/1989 HM Marketed AU Capsule, hard A07DA A07DA03 Not Currently Available Oral use Loperamide hydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1398/001-003 EU/1/19/1398/001-003 Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion Accord Healthcare S.L.U. 14/11/2019 HM Unknown AU Concentrate for solution for infusion L01XX27 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Arsenic trioxide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1475/001 EU/1/20/1475/001 Arsenic trioxide medac 1 mg/ml concentrate for solution for infusion medac Gesellschaft für klinische Spezialpräparate mbH 17/09/2020 HM Unknown AU Concentrate for solution for infusion L01XX27 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Arsenic trioxide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) PA23259/004/001 PA23259/004/001 Artelac 3.2 mg/ml Eye Drops, Solution Bausch + Lomb Ireland Limited 09/07/1996 HM Marketed AU Eye drops, solution S01XA S01XA20 Generic application (Article 10(1) of Directive No 2001/83/EC) Ocular use Hypromellose Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23259/004/002 PA23259/004/002 Artelac Preservative Free Single Dose Unit Bausch + Lomb Ireland Limited 09/07/1996 HM Marketed AU Eye drops, solution in single-dose container S01XA S01XA20 Generic application (Article 10(1) of Directive No 2001/83/EC) Ocular use Hypromellose Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PPA0465/454/001 PPA0465/454/001 Artelac Preservative Free Single Dose Unit 3.2 mg/ml eye drops, solution PCO Manufacturing Ltd. 15/05/2020 HM Unknown AU Eye drops, solution in single-dose container S01XA20 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Ocular use Hypromellose Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/21/1582/001-002 EU/1/21/1582/001-002 Artesunate Amivas 110 mg solvent for solution for injection Amivas Ireland Limited 22/11/2021 HM Unknown AU Solution for injection P01BE03 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Artesunate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1113/011/003 PA1113/011/003 Arthrimel 1500mg Film Coated Tablets Phoenix Labs 15/07/2011 HM Not marketed AU Film-coated tablet M01AX M01AX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Glucosamine sulfate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1113/011/001 PA1113/011/001 Arthrimel 500 mg Film-Coated Tablets Phoenix Labs 22/07/2005 HM Not marketed AU Film-coated tablet M01AX M01AX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Glucosamine sulfate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1113/011/002 PA1113/011/002 Arthrimel 750mg Film Coated Tablets Phoenix Labs 15/07/2011 HM Marketed AU Film-coated tablet M01AX M01AX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Glucosamine sulfate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0822/112/001 PA0822/112/001 IC0058-109-021 Arthrotec 50 modified-release tablets Pfizer Healthcare Ireland Unlimited Company 16/06/1993 HM Marketed AU Modified-release tablet M01AB M01AB55 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Diclofenac sodium Misoprostol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/114/001 PPA0465/114/001 IC0058-109-021 Arthrotec 50 modified-release tablets PCO Manufacturing Ltd. 31/03/2004 HM Unknown AU Modified-release tablet M01AB M01AB55 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Misoprostol Diclofenac sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/112/002 PA0822/112/002 IC0058-113-021 Arthrotec 75 modified-release tablets Pfizer Healthcare Ireland Unlimited Company 07/02/1997 HM Marketed AU Modified-release tablet M01AB M01AB55 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Diclofenac sodium Lactose monohydrate Misoprostol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/114/002 PPA0465/114/002 IC0058-113-021 Arthrotec 75 modified-release tablets PCO Manufacturing Ltd. 31/03/2004 HM Unknown AU Modified-release tablet M01AB M01AB55 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Diclofenac sodium Misoprostol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/159/001 PPA1463/159/001 IC0058-113-021 Arthrotec 75 modified-release tablets IMED Healthcare Ltd., 23/04/2021 HM Unknown AU Modified-release tablet M01AB M01AB55 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Diclofenac sodium Misoprostol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only TR2309/015/001 TR2309/015/001 Artichoke-Milk Thistle Complex Tablets A.Vogel Ireland Limited 25/07/2014 HM Not marketed AU Tablet Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA2299/026/001 PA2299/026/001 ARTISS Solutions for Sealant, deep frozen Baxter Holding B.V. 03/07/2009 HM Marketed AU Solution for sealant B02BC V03AK Full application (Article 8(3) of Directive No 2001/83/EC) Epilesional use Topical use Human fibrinogen Human thrombin Calcium chloride Aprotinin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC as amended. PA1966/001/001 PA1966/001/001 ASACARD 162.5 mg prolonged release hard capsules New Haven Pharma (UK) Limited 01/10/1999 HM Not marketed AU Prolonged-release capsule, hard B01AC B01AC06 Not Currently Available Oral use Acetylsalicylic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2018/005/001 PA2018/005/001 Asacolon 1000 mg Suppository Tillotts Pharma GmbH 29/01/2021 HM Marketed AU Suppository A07EC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Rectal use Mesalazine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2018/004/001 PA2018/004/001 Asacolon 1600 mg modified-release tablets Tillotts Pharma GmbH 23/02/2018 HM Marketed AU Modified-release tablet A07EC A07EC02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Mesalazine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2018/001/001 PA2018/001/001 Asacolon 400mg Gastro-Resistant Tablets Tillotts Pharma GmbH 11/12/1990 HM Marketed AU Gastro-resistant tablet A07EC A07EC02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Mesalazine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2018/001/003 PA2018/001/003 Asacolon 500 mg Suppositories Tillotts Pharma GmbH 26/06/1995 HM Marketed AU Suppository A07EC A07EC02 Full application (Article 8(3) of Directive No 2001/83/EC) Rectal use Mesalazine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/465/001 PPA0465/465/001 Asacolon 800 mg Gastro-resistant Tablets PCO Manufacturing Ltd. 01/04/2021 HM Unknown AU Gastro-resistant tablet A07EC A07EC02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Mesalazine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2018/001/002 PA2018/001/002 Asacolon 800mg Gastro-resistant Tablets Tillotts Pharma GmbH 07/02/2003 HM Marketed AU Gastro-resistant tablet A07EC A07EC02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Mesalazine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/012/001 PA23198/012/001 Asmanex Twisthaler 200 micrograms Inhalation Powder Organon Pharma (Ireland) Limited 05/04/2002 HM Not marketed AU Inhalation powder R03BA R03BA07 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Mometasone furoate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23198/012/002 PA23198/012/002 Asmanex Twisthaler 400 micrograms Inhalation Powder Organon Pharma (Ireland) Limited 05/04/2002 HM Not marketed AU Inhalation powder R03BA R03BA07 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Mometasone furoate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1595/001-002 EU/1/21/1595/001-002 ASPAVELI 1 080 mg solution for infusion Apellis Ireland Limited 13/12/2021 HM Unknown AU Solution for infusion L04AA54 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Pegcetacoplan Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1410/037/001 PA1410/037/001 Aspirin 300mg Effervescent tablets Bayer Limited 08/06/1976 HM Not marketed AU Effervescent tablet N02BA N02BA01 Not Currently Available Oral use Aspirin Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General sale in blister packs containing not more than 24 unit dosage forms. Retail sale through pharmacies only in blister packs containing not more than 50 unit dosage forms. The indications should be appropriate for self-diagnosis and self-treatment. Promotion to the general public only for indications appropriate for self-diagnosis and self-treatment. Aspirin containg medicinal products should not be administered to subjects under 16 years of age unless specifically indicated by a healthcare professional. PA1347/070/001 PA1347/070/001 Aspirin Krka 75 mg gastro-resistant tablets KRKA, d.d., Novo mesto 10/03/2017 HM Marketed AU Gastro-resistant tablet B01AC B01AC06 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Acetylsalicylic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA25506/007/001 PA25506/007/001 Astepro 1.5 mg/ml nasal spray, solution Cooper Consumer Health B.V. 13/09/2013 HM Not marketed AU Nasal spray, solution R01AC R01AC03 Full application (Article 8(3) of Directive No 2001/83/EC) Nasal use Azelastine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23163/001/001 PA23163/001/001 Astilin 10 mg film-coated tablets Ascot Laboratories (Ireland) Limited 01/11/2019 HM Not marketed AU Film-coated tablet N06AA N06AA09 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Amitriptyline hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23163/001/002 PA23163/001/002 Astilin 25 mg film-coated tablets Ascot Laboratories (Ireland) Limited 01/11/2019 HM Not marketed AU Film-coated tablet N06AA N06AA09 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Amitriptyline hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2239/010/003 PA2239/010/003 IC0009-038-002 Atacand 16 mg tablets CHEPLAPHARM Arzneimittel GmbH 29/04/2002 HM Marketed AU Tablet C09CA C09CA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/116/002 PPA0465/116/002 IC0009-038-002 Atacand 16 mg tablets PCO Manufacturing Ltd. 06/02/2004 HM Unknown AU Tablet C09CA C09CA06 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/031/002 PPA1463/031/002 IC0009-038-002 Atacand 16 mg tablets IMED Healthcare Ltd., 05/02/2010 HM Unknown AU Tablet C09CA06 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/010/001 PA2239/010/001 IC0009-008-002 Atacand 4 mg tablets CHEPLAPHARM Arzneimittel GmbH 29/04/2002 HM Not marketed AU Tablet C09CA C09CA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/010/002 PA2239/010/002 IC0009-009-002 Atacand 8 mg tablets CHEPLAPHARM Arzneimittel GmbH 29/04/2002 HM Marketed AU Tablet C09CA C09CA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/116/001 PPA0465/116/001 IC0009-009-002 Atacand 8 mg tablets PCO Manufacturing Ltd. 06/02/2004 HM Unknown AU Tablet C09CA C09CA06 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/031/001 PPA1463/031/001 IC0009-009-002 Atacand 8 mg tablets IMED Healthcare Ltd., 05/02/2010 HM Unknown AU Tablet C09CA C09CA06 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/011/002 PA2239/011/002 IC0029-036-002 Atacand Plus 16 mg/12.5 mg tablets CHEPLAPHARM Arzneimittel GmbH 23/06/2000 HM Marketed AU Tablet C09DA C09DA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/117/001 PPA0465/117/001 IC0029-036-002 Atacand Plus 16 mg/12.5 mg tablets PCO Manufacturing Ltd. 26/01/2004 HM Unknown AU Tablet C09DA06 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/053/001 PPA1463/053/001 IC0029-036-002 Atacand Plus 16 mg/12.5 mg tablets IMED Healthcare Ltd., 07/10/2011 HM Unknown AU Tablet C09DA06 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/011/001 PA2239/011/001 IC0029-058-002 Atacand Plus 8 mg/12.5 mg tablets CHEPLAPHARM Arzneimittel GmbH 27/11/1998 HM Not marketed AU Tablet C09DA C09DA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/287/004 PA0711/287/004 Atazanavir Rowex 300 mg hard capsules Rowex Limited, 22/03/2019 HM Marketed AU Capsule, hard J05AE08 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atazanavir sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/16/1091/001-003 EU/1/16/1091/001-003 Atazanavir Viatris 150 mg hard capsules Viatris Limited 22/08/2016 HM Unknown AU Capsule, hard J05AE J05AE08 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atazanavir sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1091/004-006 EU/1/16/1091/004-006 Atazanavir Viatris 200 mg hard capsules Viatris Limited 22/08/2016 HM Unknown AU Capsule, hard J05AE J05AE08 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atazanavir sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1091/007-010 EU/1/16/1091/007-010 Atazanavir Viatris 200 mg hard capsules Viatris Limited 22/08/2016 HM Unknown AU Capsule, hard J05AE J05AE08 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atazanavir sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/003/003 PA0711/003/003 Atecor 100mg Tablets Rowex Limited, 27/02/1991 HM Marketed AU Film-coated tablet C07AB C07AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Not Currently Available Atenolol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/003/001 PA0711/003/001 Atecor 25mg Tablets Rowex Limited, 29/11/1989 HM Marketed AU Film-coated tablet C07AB C07AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Not Currently Available Atenolol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/003/002 PA0711/003/002 Atecor 50mg Tablets Rowex Limited, 29/11/1989 HM Marketed AU Film-coated tablet C07AB C07AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Not Currently Available Atenolol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/020/002 PA0711/020/002 Atecor CT 100 mg/25 mg Film-coated tablets Rowex Limited, 26/11/1999 HM Marketed AU Film-coated tablet C07CB C07CB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Chlortalidone Atenolol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/020/001 PA0711/020/001 Atecor CT 50 mg/12.5 mg Film-coated tablets Rowex Limited, 26/11/1999 HM Marketed AU Film-coated tablet C07CB C07CB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Chlortalidone Atenolol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1439/005-008 EU/1/20/1439/005-008 Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Novartis Europharm Limited 30/05/2020 HM Unknown AU Inhalation powder, hard capsule R03AK14 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Indacaterol acetate Mometasone furoate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1439/009-012 EU/1/20/1439/009-012 Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules Novartis Europharm Limited 30/05/2020 HM Unknown AU Inhalation powder, hard capsule R03AK14 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Indacaterol acetate Mometasone furoate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1439/001-004 EU/1/20/1439/001-004 Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Novartis Europharm Limited 30/05/2020 HM Unknown AU Inhalation powder, hard capsule R03AK14 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Indacaterol acetate Mometasone furoate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/069/002 PA0126/069/002 Atenomel 100 mg Tablets Clonmel Healthcare Ltd 25/07/1988 HM Marketed AU Tablet C07AB C07AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atenolol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/069/003 PA0126/069/003 Atenomel 25 mg Tablets Clonmel Healthcare Ltd 25/07/1988 HM Marketed AU Tablet C07AB C07AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atenolol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/069/001 PA0126/069/001 Atenomel 50 mg Tablets Clonmel Healthcare Ltd 25/07/1988 HM Marketed AU Tablet C07AB C07AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atenolol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0822/238/001 PA0822/238/001 Atgam 50 mg/ml concentrate for solution for infusion Pfizer Healthcare Ireland Unlimited Company 04/03/2022 HM Marketed AU Concentrate for solution for infusion L04AA03 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Anti-T Lymphocyte Immunoglobulin for Human Use, Horse Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/090/001 PA0822/090/001 Ativan 1 mg Tablets Pfizer Healthcare Ireland Unlimited Company 10/01/1997 HM Marketed AU Tablet N05BA N05BA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Lorazepam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/019/001 PA2315/019/001 Atomoxetine Accord 10 mg Hard Capsules Accord Healthcare Ireland Ltd. 14/01/2019 HM Marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/019/007 PA2315/019/007 Atomoxetine Accord 100 mg Hard Capsules Accord Healthcare Ireland Ltd. 14/01/2019 HM Marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/019/002 PA2315/019/002 Atomoxetine Accord 18 mg Hard Capsules Accord Healthcare Ireland Ltd. 14/01/2019 HM Marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/019/003 PA2315/019/003 Atomoxetine Accord 25 mg Hard Capsules Accord Healthcare Ireland Ltd. 14/01/2019 HM Marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/019/004 PA2315/019/004 Atomoxetine Accord 40 mg Hard Capsules Accord Healthcare Ireland Ltd. 14/01/2019 HM Marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/019/005 PA2315/019/005 Atomoxetine Accord 60 mg hard capsules Accord Healthcare Ireland Ltd. 14/01/2019 HM Marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/019/006 PA2315/019/006 Atomoxetine Accord 80 mg hard capsules Accord Healthcare Ireland Ltd. 14/01/2019 HM Marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/034/001 PA22871/034/001 Atomoxetine Azure 10 mg hard capsules Azure Pharmaceuticals Ltd. 08/05/2026 HM Not marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/034/007 PA22871/034/007 Atomoxetine Azure 100 mg hard capsules Azure Pharmaceuticals Ltd. 08/05/2026 HM Not marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/034/002 PA22871/034/002 Atomoxetine Azure 18 mg hard capsules Azure Pharmaceuticals Ltd. 08/05/2026 HM Not marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/034/003 PA22871/034/003 Atomoxetine Azure 25 mg hard capsules Azure Pharmaceuticals Ltd. 08/05/2026 HM Not marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/034/004 PA22871/034/004 Atomoxetine Azure 40 mg hard capsules Azure Pharmaceuticals Ltd. 08/05/2026 HM Not marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/034/005 PA22871/034/005 Atomoxetine Azure 60 mg hard capsules Azure Pharmaceuticals Ltd. 08/05/2026 HM Not marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/034/006 PA22871/034/006 Atomoxetine Azure 80 mg hard capsules Azure Pharmaceuticals Ltd. 08/05/2026 HM Not marketed AU Capsule, hard N06BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atomoxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/180/001 PA0711/180/001 IC0001-002-003 Atorvas 10 mg film-coated tablets Rowex Limited, 03/09/2010 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/180/002 PA0711/180/002 IC0001-003-003 Atorvas 20 mg film-coated tablets Rowex Limited, 03/09/2010 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/180/003 PA0711/180/003 IC0001-004-003 Atorvas 40 mg film-coated tablets Rowex Limited, 03/09/2010 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/180/004 PA0711/180/004 IC0001-005-003 Atorvas 80 mg film-coated tablets Rowex Limited, 03/09/2010 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/195/001 PA2315/195/001 IC0001-002-003 Atorvastatin 10 mg Film-coated tablets Accord Healthcare Ireland Ltd. 28/07/2017 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/236/001 PA0281/236/001 IC0001-002-003 Atorvastatin 10 mg Film-Coated Tablets Pinewood Laboratories Limited 22/06/2012 HM Not marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2050/003/001 PA2050/003/001 IC0001-002-003 Atorvastatin 10mg film-coated tablets Sun Pharmaceutical Industries Europe B.V. 07/09/2012 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2050/003/002 PA2050/003/002 IC0001-003-003 Atorvastatin 20 mg film-coated tablets Sun Pharmaceutical Industries Europe B.V. 07/09/2012 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/195/002 PA2315/195/002 IC0001-003-003 Atorvastatin 20 mg Film-coated tablets Accord Healthcare Ireland Ltd. 28/07/2017 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/236/002 PA0281/236/002 IC0001-003-003 Atorvastatin 20 mg Film-Coated Tablets Pinewood Laboratories Limited 22/06/2012 HM Not marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2050/003/003 PA2050/003/003 IC0001-004-003 Atorvastatin 40 mg film-coated tablets Sun Pharmaceutical Industries Europe B.V. 07/09/2012 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/195/003 PA2315/195/003 IC0001-004-003 Atorvastatin 40 mg Film-coated tablets Accord Healthcare Ireland Ltd. 28/07/2017 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/236/003 PA0281/236/003 IC0001-004-003 Atorvastatin 40 mg Film-Coated Tablets Pinewood Laboratories Limited 22/06/2012 HM Not marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2050/003/004 PA2050/003/004 IC0001-005-003 Atorvastatin 80 mg film-coated tablets Sun Pharmaceutical Industries Europe B.V. 07/09/2012 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/195/004 PA2315/195/004 IC0001-005-003 Atorvastatin 80 mg Film-coated tablets Accord Healthcare Ireland Ltd. 28/07/2017 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/236/004 PA0281/236/004 IC0001-005-003 Atorvastatin 80 mg Film-Coated Tablets Pinewood Laboratories Limited 22/06/2012 HM Not marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/277/001 PA2315/277/001 IC0001-002-003 Atorvastatin Accord 10 mg film-coated tablets Accord Healthcare Ireland Ltd. 03/05/2024 HM Not marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/277/002 PA2315/277/002 IC0001-003-003 Atorvastatin Accord 20 mg film-coated tablets Accord Healthcare Ireland Ltd. 03/05/2024 HM Not marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/277/003 PA2315/277/003 IC0001-004-003 Atorvastatin Accord 40 mg film-coated tablets Accord Healthcare Ireland Ltd. 03/05/2024 HM Not marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1436/027/001 PA1436/027/001 IC0001-002-003 Atorvastatin Bluefish 10 mg Film-coated tablets Bluefish Pharmaceuticals AB 30/11/2018 HM Marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1436/027/002 PA1436/027/002 IC0001-003-003 Atorvastatin Bluefish 20 mg Film-coated tablets Bluefish Pharmaceuticals AB 30/11/2018 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1436/027/003 PA1436/027/003 Atorvastatin Bluefish 30 mg Film-coated tablets Bluefish Pharmaceuticals AB 30/11/2018 HM Marketed AU Film-coated tablet C10AA C10AA05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1436/027/004 PA1436/027/004 IC0001-004-003 Atorvastatin Bluefish 40 mg Film-coated tablets Bluefish Pharmaceuticals AB 30/11/2018 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1436/027/005 PA1436/027/005 Atorvastatin Bluefish 60 mg Film-coated tablets Bluefish Pharmaceuticals AB 30/11/2018 HM Marketed AU Film-coated tablet C10AA C10AA05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1436/027/006 PA1436/027/006 IC0001-005-003 Atorvastatin Bluefish 80 mg Film-coated tablets Bluefish Pharmaceuticals AB 30/11/2018 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/271/001 PA0126/271/001 IC0001-002-003 Atorvastatin Clonmel 10 mg film-coated tablets Clonmel Healthcare Ltd 11/03/2016 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/271/002 PA0126/271/002 IC0001-003-003 Atorvastatin Clonmel 20 mg film-coated tablets Clonmel Healthcare Ltd 11/03/2016 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/271/003 PA0126/271/003 IC0001-004-003 Atorvastatin Clonmel 40 mg film-coated tablets Clonmel Healthcare Ltd 11/03/2016 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/271/004 PA0126/271/004 IC0001-005-003 Atorvastatin Clonmel 80 mg film-coated tablets Clonmel Healthcare Ltd 11/03/2016 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/023/001 PA1347/023/001 IC0001-002-003 Atorvastatin Krka 10 mg film-coated tablets KRKA, d.d., Novo mesto 21/07/2010 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/023/002 PA1347/023/002 IC0001-003-003 Atorvastatin Krka 20 mg film-coated tablets KRKA, d.d., Novo mesto 21/07/2010 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/023/003 PA1347/023/003 IC0001-004-003 Atorvastatin Krka 40 mg film-coated tablets KRKA, d.d., Novo mesto 21/07/2010 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/009/004 PA1347/009/004 IC0001-005-003 Atorvastatin Krka 80 mg film-coated tablets KRKA, d.d., Novo mesto 23/09/2011 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1239/028/001 PA1239/028/001 IC0001-002-003 Atorvastatin Liconsa 10 mg film-coated tablets Laboratorios Liconsa S.A. 28/10/2022 HM Not marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1239/028/002 PA1239/028/002 IC0001-003-003 Atorvastatin Liconsa 20 mg film-coated tablets Laboratorios Liconsa S.A. 28/10/2022 HM Not marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1239/028/003 PA1239/028/003 IC0001-004-003 Atorvastatin Liconsa 40 mg film-coated tablets Laboratorios Liconsa S.A. 28/10/2022 HM Not marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1239/028/004 PA1239/028/004 IC0001-005-003 Atorvastatin Liconsa 80 mg film-coated tablets Laboratorios Liconsa S.A. 28/10/2022 HM Not marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23271/001/001 PA23271/001/001 IC0001-004-003 Atorvastatin OPKO 40 mg film coated tablets Opko Health Spain S.L.U. 09/06/2023 HM Not marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/218/001 PA0281/218/001 IC0001-002-003 Atorvastatin Pinewood 10 mg film-coated tablets Pinewood Laboratories Limited 16/09/2022 HM Marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/218/002 PA0281/218/002 IC0001-003-003 Atorvastatin Pinewood 20 mg film-coated tablets Pinewood Laboratories Limited 16/09/2022 HM Marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/218/003 PA0281/218/003 IC0001-004-003 Atorvastatin Pinewood 40 mg film-coated tablets Pinewood Laboratories Limited 16/09/2022 HM Marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/218/004 PA0281/218/004 IC0001-005-003 Atorvastatin Pinewood 80 mg film-coated tablets Pinewood Laboratories Limited 16/09/2022 HM Marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0074/079/001 PA0074/079/001 IC0001-002-003 Atorvastatin Rowa 10 mg film-coated tablets Rowa Pharmaceuticals Limited, 22/11/2019 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0074/079/002 PA0074/079/002 IC0001-003-003 Atorvastatin Rowa 20 mg film-coated tablets Rowa Pharmaceuticals Limited, 22/11/2019 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0074/079/003 PA0074/079/003 IC0001-004-003 Atorvastatin Rowa 40 mg film-coated tablets Rowa Pharmaceuticals Limited, 22/11/2019 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0074/079/004 PA0074/079/004 IC0001-005-003 Atorvastatin Rowa 80 mg film-coated tablets Rowa Pharmaceuticals Limited, 22/11/2019 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/110/001 PA0749/110/001 IC0001-002-003 Atorvastatin Teva 10 mg Film-coated Tablets Teva Pharma B.V. 08/10/2010 HM Not marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/110/002 PA0749/110/002 IC0001-003-003 Atorvastatin Teva 20 mg Film-coated Tablets Teva Pharma B.V. 08/10/2010 HM Not marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/110/003 PA0749/110/003 IC0001-004-003 Atorvastatin Teva 40 mg Film-coated Tablets Teva Pharma B.V. 08/10/2010 HM Not marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/110/004 PA0749/110/004 IC0001-005-003 Atorvastatin Teva 80 mg Film-coated Tablets Teva Pharma B.V. 08/10/2010 HM Not marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/125/001 PA1986/125/001 IC0001-002-003 Atorvastatin Teva Pharma 10 mg Film-coated tablets Teva B.V. 08/11/2024 HM Marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/125/002 PA1986/125/002 IC0001-003-003 Atorvastatin Teva Pharma 20 mg Film-coated tablets Teva B.V. 08/11/2024 HM Marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/125/003 PA1986/125/003 IC0001-004-003 Atorvastatin Teva Pharma 40 mg Film-coated tablets Teva B.V. 08/11/2024 HM Marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/125/004 PA1986/125/004 IC0001-005-003 Atorvastatin Teva Pharma 80 mg Film-coated tablets Teva B.V. 08/11/2024 HM Marketed AU Film-coated tablet C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/001/001 PA23266/001/001 IC0001-002-003 Atorvastatin Viatris 10 mg film-coated tablets Viatris Limited 04/02/2011 HM Not marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/001/002 PA23266/001/002 IC0001-003-003 Atorvastatin Viatris 20 mg film-coated tablets Viatris Limited 04/02/2011 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/001/003 PA23266/001/003 IC0001-004-003 Atorvastatin Viatris 40 mg film-coated tablets Viatris Limited 04/02/2011 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/001/004 PA23266/001/004 IC0001-005-003 Atorvastatin Viatris 80 mg film-coated tablets Viatris Limited 04/02/2011 HM Marketed AU Film-coated tablet C10AA C10AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/852/002 EU/1/13/852/002 Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion Sun Phamaceutical Industries Europe B.V. 31/07/2013 HM Unknown AU Concentrate for solution for infusion G02CX G02CX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Atosiban Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/13/852/001 EU/1/13/852/001 Atosiban SUN 6.75 mg/0.9 ml solution for injection Sun Phamaceutical Industries Europe B.V. HM Unknown AU Solution for injection G02CX G02CX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Atosiban Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA22645/006/001 PA22645/006/001 Atovaquone/Proguanil Hydrochloride 250 mg /100 mg film-coated tablets Glenmark Arzneimittel GmbH 07/07/2017 HM Not marketed AU Film-coated tablet P01BB P01BB51 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atovaquone PROGUANIL HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/053/001 PA23266/053/001 Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets Viatris Limited 31/05/2013 HM Marketed AU Film-coated tablet P01BB P01BB51 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Atovaquone PROGUANIL HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23198/022/001 PA23198/022/001 IC0118-017-003 Atozet 10 mg/10 mg film-coated tablets Organon Pharma (Ireland) Limited 07/11/2014 HM Marketed AU Film-coated tablet C10BA05 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/470/001 PPA0465/470/001 IC0118-017-003 Atozet 10 mg/10 mg film-coated tablets PCO Manufacturing Ltd. 23/04/2021 HM Unknown AU Film-coated tablet C10BA C10BA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Atorvastatin Ezetimibe Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/215/003 PPA1463/215/003 IC0118-017-003 Atozet 10 mg/10 mg film-coated tablets IMED Healthcare Ltd. 26/07/2024 HM Unknown AU Film-coated tablet C10BA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Ezetimibe Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/022/002 PA23198/022/002 IC0118-051-003 Atozet 10 mg/20 mg film-coated tablets Organon Pharma (Ireland) Limited 07/11/2014 HM Marketed AU Film-coated tablet C10BA05 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/470/002 PPA0465/470/002 IC0118-051-003 Atozet 10 mg/20 mg film-coated tablets PCO Manufacturing Ltd. 23/04/2021 HM Unknown AU Film-coated tablet C10BA C10BA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Ezetimibe Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/022/003 PA23198/022/003 IC0118-059-003 Atozet 10 mg/40 mg film-coated tablets Organon Pharma (Ireland) Limited 07/11/2014 HM Marketed AU Film-coated tablet C10BA05 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/470/003 PPA0465/470/003 IC0118-059-003 Atozet 10 mg/40 mg film-coated tablets PCO Manufacturing Ltd. 23/04/2021 HM Unknown AU Film-coated tablet C10BA C10BA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Ezetimibe Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/215/001 PPA1463/215/001 IC0118-059-003 Atozet 10 mg/40 mg film-coated tablets IMED Healthcare Ltd. 27/10/2023 HM Unknown AU Film-coated tablet C10BA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Ezetimibe Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/022/004 PA23198/022/004 IC0118-060-003 Atozet 10 mg/80 mg film-coated tablets Organon Pharma (Ireland) Limited 07/11/2014 HM Marketed AU Film-coated tablet C10BA05 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/470/004 PPA0465/470/004 IC0118-060-003 Atozet 10 mg/80 mg film-coated tablets PCO Manufacturing Ltd. 25/06/2021 HM Unknown AU Film-coated tablet C10BA C10BA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Ezetimibe Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/215/002 PPA1463/215/002 IC0118-060-003 Atozet 10 mg/80 mg film-coated tablets IMED Healthcare Ltd. 27/10/2023 HM Unknown AU Film-coated tablet C10BA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Ezetimibe Atorvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1217/011/001 PA1217/011/001 Atracurium 10 mg/ml solution for injection/infusion Hikma Farmacêutica (Portugal) S.A. 04/07/2014 HM Not marketed AU Solution for injection/infusion M03AC M03AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Atracurium besilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2165/001/001 PA2165/001/001 Atracurium besilate 10 mg/ml solution for injection/infusion AS Kalceks 24/11/2017 HM Marketed AU Solution for injection/infusion M03AC M03AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Atracurium besilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/403/001 EU/1/07/403/001 ATRIANCE 5mg/ml Solution for Infusion Sandoz Pharmaceuticals d.d. 22/08/2007 HM Unknown AU Solution for infusion L01BB L01BB07 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Nelarabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) TR2309/001/001 TR2309/001/001 Atrogel Arnica Gel A.Vogel Ireland Limited 14/01/2011 HM Marketed AU Gel Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Cutaneous use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA1968/003/001 PA1968/003/001 Atropine Sulfate Aguettant 0.1 mg/ml solution for injection in pre-filled syringe Laboratoire Aguettant 02/10/2015 HM Marketed AU Solution for injection in pre-filled syringe A03BA A03BA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intramuscular use Intravenous use Atropine Sulfate Monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1968/003/002 PA1968/003/002 Atropine Sulfate Aguettant 0.2mg/ml Solution for Injection in Pre-Filled Syringe Laboratoire Aguettant 24/07/2015 HM Marketed AU Solution for injection in pre-filled syringe A03BA A03BA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intramuscular use Intravenous use Atropine sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only TR2309/003/001 TR2309/003/001 Atrosan Devil's Claw film-coated tablets A.Vogel Ireland Limited 09/12/2011 HM Marketed AU Film-coated tablet Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA0775/012/002 PA0775/012/002 IC0174-145-052 Atrovent 250 UDVs 250 micrograms/ 1ml Nebuliser Solution Boehringer Ingelheim International GmbH 10/06/1996 HM Marketed AU Nebuliser solution R03BB R03BB01 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Ipratropium bromide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0775/012/003 PA0775/012/003 Atrovent 500 UDVs, 500 micrograms/ 2ml Nebuliser Solution Boehringer Ingelheim International GmbH 27/09/1985 HM Marketed AU Nebuliser solution R03BB R03BB01 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Ipratropium bromide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0775/012/001 PA0775/012/001 Atrovent Inhaler CFC-Free 20 micrograms per metered dose pressurised inhalation solution Boehringer Ingelheim International GmbH 14/05/2004 HM Not marketed AU Pressurised inhalation, solution R03BB R03BB01 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Ipratropium bromide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1929/001 EU/1/25/1929/001 Attrogy 250 mg film-coated tablets AO Pharma AB 17/07/2025 HM Unknown AU Film-coated tablet N02BA11 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Diflunisal Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. EU/1/13/838/001-005 EU/1/13/838/001-005 IC0170-207-003 AUBAGIO 14 mg film-coated tablets Sanofi Winthrop Industrie HM Unknown AU Film-coated tablet L04AA L04AA31 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Teriflunomide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products on restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/13/838/006 EU/1/13/838/006 IC0170-206-003 AUBAGIO 7 mg film-coated tablets Sanofi Winthrop Industrie 23/06/2021 HM Unknown AU Film-coated tablet L04AA31 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Teriflunomide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1951/001 EU/1/25/1951/001 Aucatzyl 410 × 106 cells dispersion for infusion Autolus GmbH 17/07/2025 HM Unknown AU Dispersion for infusion L01XL12 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Obecabtagene autoleucel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics,section 4.2) PA22702/003/001 PA22702/003/001 Audax Ear Drops Solution Choline Salicylate 20%w/v Glycerol 12.6%w/v LanesHealth (Ireland) Limited 01/04/1983 HM Not marketed AU Ear drops, solution S02DA Well-established use application (Article 10a of Directive No 2001/83/EC) Topical Choline salicylate Glycerol Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1077/093/007 PA1077/093/007 IC0037-074-003 Augmentin 250 mg/125 mg film-coated tablets GlaxoSmithKline (Ireland) Limited 06/09/1982 HM Marketed AU Film-coated tablet J01CR J01CR02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1077/019/003 PA1077/019/003 IC0037-073-003 Augmentin 500 mg/125 mg film-coated tablets GlaxoSmithKline (Ireland) Limited 19/02/1999 HM Marketed AU Film-coated tablet J01CR J01CR02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1077/019/005 PA1077/019/005 IC0037-072-003 Augmentin 875 mg/125 mg film-coated tablets GlaxoSmithKline (Ireland) Limited 12/11/2004 HM Marketed AU Film-coated tablet J01CR J01CR02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/242/001 PPA1463/242/001 IC0037-072-003 Augmentin 875 mg/125 mg film-coated tablets IMED Healthcare Ltd., 11/04/2025 HM Unknown AU Film-coated tablet J01CR02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1077/019/006 PA1077/019/006 IC0037-076-034 Augmentin Duo Mixed Fruit 400 mg/57 mg/5 ml Powder for Oral Suspension GlaxoSmithKline (Ireland) Limited 14/07/2017 HM Marketed AU Powder for oral suspension J01CR J01CR02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1077/093/004 PA1077/093/004 IC0037-071-034 Augmentin Paediatric 125 mg/31.25 mg per 5 ml Powder for Oral Suspension GlaxoSmithKline (Ireland) Limited 28/07/1983 HM Marketed AU Powder for oral suspension J01CR J01CR02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1883/003-004 EU/1/24/1883/003-004 AUGTYRO 160 mg hard capsules Bristol-Myers Squibb Pharma EEIG 13/01/2025 HM Unknown AU Capsule, hard L01EX28 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Repotrectinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1883/001-002 EU/1/24/1883/001-002 AUGTYRO 40 mg hard capsules Bristol-Myers Squibb Pharma EEIG 13/01/2025 HM Unknown AU Capsule, hard L01EX28 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Repotrectinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/2006/001 EU/1/25/2006/001 Aumseqa 55 mg film-coated tablets SFL Pharmaceuticals Deutschland GmbH 12/02/2026 HM Unknown AU Film-coated tablet L01EB11 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Aumolertinib mesilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1956/002-003 EU/1/25/1956/002-003 Austedo 24 mg prolonged-release tablets TEVA GmbH 08/01/2026 HM Unknown AU Prolonged-release tablet N07XX16 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Deutetrabenazine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1956/004-005 EU/1/25/1956/004-005 Austedo 30 mg prolonged-release tablets TEVA GmbH 08/01/2026 HM Unknown AU Prolonged-release tablet N07XX16 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Deutetrabenazine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1956/006-007 EU/1/25/1956/006-007 Austedo 36 mg prolonged-release tablets TEVA GmbH 08/01/2026 HM Unknown AU Prolonged-release tablet N07XX16 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Deutetrabenazine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1956/001 EU/1/25/1956/001 Austedo 36 mg prolonged-release tablets Austedo 42 mg prolonged-release tablets Austedo 48 mg prolonged-release tablets TEVA GmbH 08/01/2026 HM Unknown AU Prolonged-release tablet N07XX16 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Deutetrabenazine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1956/008-009 EU/1/25/1956/008-009 Austedo 42 mg prolonged-release tablets TEVA GmbH 08/01/2026 HM Unknown AU Prolonged-release tablet N07XX16 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Deutetrabenazine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1956/010-011 EU/1/25/1956/010-011 Austedo 48 mg prolonged-release tablets TEVA GmbH 08/01/2026 HM Unknown AU Prolonged-release tablet N07XX16 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Deutetrabenazine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/434/001-003 EU/1/07/434/001-003 IC0188-214-070 AVAMYS 27.5 micrograms/spray, nasal spray suspension GlaxoSmithKline Trading Services Limited 11/01/2008 HM Unknown AU Nasal spray, suspension R01AD R01AD12 Full application (Article 8(3) of Directive No 2001/83/EC) Intranasal use Fluticasone furoate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/082/001 PA23266/082/001 Avarante 10 mg film-coated tablets Viatris Limited 12/06/2026 HM Not marketed AU Film-coated tablet G04BE08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Tadalafil Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/04/300/001-002 EU/1/04/300/001-002 Avastin 25 mg/ml concentrate for solution for infusion Roche Registration GmbH 12/01/2005 HM Unknown AU Concentrate for solution for infusion L01FG01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Bevacizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/04/300/1-2 EU/1/04/300/1-2 Avastin 25 mg/ml Concentrate for solution for infusion Roche Registration Limited 12/01/2005 HM Unknown AU Concentrate for solution for infusion L01FG01 Full application (Article 8(3) of Directive No 2001/83/EC) Bevacizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23458/003/001 PA23458/003/001 AVAXIM, suspension for injection in a pre-filled syringe Hepatitis A vaccine (inactivated, adsorbed) Sanofi Winthrop Industrie 21/02/1997 HM Marketed AU Suspension for injection in pre-filled syringe J07BC J07BC02 Full application (Article 8(3) of Directive No 2001/83/EC) Not Currently Available Hepatitis a virus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22720/010/001 PA22720/010/001 Aveleris 167 mg hard capsules Tillomed Pharma GmbH 26/08/2022 HM Marketed AU Capsule, hard A16AX12 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use TRIENTINE DIHYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PPA0465/230/001 PPA0465/230/001 Avelox 400 mg film-coated tablets PCO Manufacturing Ltd. 24/07/2009 HM Unknown AU Film-coated tablet J01MA J01MA14 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Moxifloxacin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1077/104/001 PA1077/104/001 IC0140-040-001 Avodart 0.5 mg soft capsules GlaxoSmithKline (Ireland) Limited 17/12/2004 HM Marketed AU Capsule, soft G04CB G04CB02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Dutasteride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/211/001 PPA0465/211/001 IC0140-040-001 Avodart 0.5 mg soft capsules PCO Manufacturing Ltd. 20/06/2008 HM Unknown AU Capsule, soft G04CB G04CB02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Dutasteride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/149/001 PPA1463/149/001 IC0140-040-001 Avodart 0.5 mg soft capsules IMED Healthcare Ltd., 18/09/2009 HM Unknown AU Capsule, soft G04CB02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Dutasteride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/97/033/003 EU/1/97/033/003 AVONEX 30 micrograms/0.5 ml solution for injection. Biogen Netherlands B.V. 24/06/2003 HM Unknown AU Solution for injection in pre-filled syringe L03AB L03AB07 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Interferon beta - 1a Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/24/1896/010-012 EU/1/24/1896/010-012 Avtozma 162 mg solution for injection in pre-filled pen Celltrion Healthcare Hungary Kft. 14/02/2025 HM Unknown AU Solution for injection in pre-filled pen L04AC07 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Tocilizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of ProductCharacteristics, section 4.2). EU/1/24/1896/007-009 EU/1/24/1896/007-009 Avtozma 162 mg solution for injection in pre-filled syringe Celltrion Healthcare Hungary Kft. 14/02/2025 HM Unknown AU Solution for injection in pre-filled syringe L04AC07 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Tocilizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of ProductCharacteristics, section 4.2). EU/1/24/1896/001-006 EU/1/24/1896/001-006 Avtozma 20 mg/mL concentrate for solution for infusion Celltrion Healthcare Hungary Kft. 14/02/2025 HM Unknown AU Concentrate for solution for infusion L04AC07 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Tocilizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of ProductCharacteristics, section 4.2). EU/1/24/1834/001-002 EU/1/24/1834/001-002 Avzivi 25 mg/mL concentrate for solution for infusion FGK Representative Service GmbH 26/07/2024 HM Unknown AU Concentrate for solution for infusion L01FG01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Bevacizumab Biosimilar Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1815/001-014 EU/1/24/1815/001-014 Awiqli 700 units/mL solution for injection in pre-filled pen Novo Nordisk A/S 17/05/2024 HM Unknown AU Solution for injection in pre-filled pen A10AE07 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Insulin icodec Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0988/003/001 PA0988/003/001 Axhidrox 2.2 mg/pump actuation cream Dr. August Wolff GmbH & Co. KG Arzneimittel 03/03/2023 HM Marketed AU Cream D11AA Full application (Article 8(3) of Directive No 2001/83/EC) Topical Glycopyrronium bromide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1847/001-005 EU/1/24/1847/001-005 IC0196-039-003 Axitinib Accord 1 mg Film-coated tablet Accord Healthcare S.L.U. 19/09/2024 HM Unknown AU Film-coated tablet L01EK01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Axitinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1847/006-010 EU/1/24/1847/006-010 IC0196-045-003 Axitinib Accord 3 mg Film-coated tablet Accord Healthcare S.L.U. 19/09/2024 HM Unknown AU Film-coated tablet L01EK01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Axitinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1847/011-015 EU/1/24/1847/011-015 IC0196-001-003 Axitinib Accord 5 mg Film-coated tablet Accord Healthcare S.L.U. 19/09/2024 HM Unknown AU Film-coated tablet L01EK01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Axitinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23369/004/001 PA23369/004/001 Axsain 0.075% w/w Cream Ennogen Healthcare (Europe) Limited 26/03/2010 HM Marketed AU Cream M02AB01 Informed consent application (Article 10c of Directive No 2001/83/EC) Topical Capsaicin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1186/001 EU/1/17/1186/001 Axumin 1,600 MBq/mL solution for injection Blue Earth Diagnostics Ireland Ltd 22/05/2017 HM Unknown AU Solution for injection V09IX V09IX12 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Fluciclovine (18f) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1186/002 EU/1/17/1186/002 Axumin 3,200 MBq/mL solution for injection Blue Earth Diagnostics Ireland Ltd 22/05/2017 HM Unknown AU Solution for injection V09IX V09IX12 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Fluciclovine (18f) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/218/1-3 EU/1/02/218/1-3 IC0022-002-003 Axura 10 mg film-coated tablets Merz Pharmaceuticals GmbH HM Unknown AU Film-coated tablet N06DX N06DX01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Memantine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/02/218/17-22 EU/1/02/218/17-22 IC0022-003-003 Axura 20 mg film-coated tablets Merz Pharmaceuticals GmbH HM Unknown AU Film-coated tablet N06DX N06DX01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Memantine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/02/218/5-6 EU/1/02/218/5-6 IC0022-107-019 Axura 5 mg/pump actuation oral solution Merz Pharmaceuticals GmbH HM Unknown AU Oral solution N06DX N06DX01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Memantine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/02/218/16 EU/1/02/218/16 IC0022-106-003 Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets Merz Pharmaceuticals GmbH HM Unknown AU Film-coated tablet N06DX N06DX01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Memantine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1454/001 EU/1/20/1454/001 Aybintio 25 mg/ml concentrate for solution for infusion Samsung Bioepis NL B.V. 19/08/2020 HM Unknown AU Concentrate for solution for infusion L01XC07 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Bevacizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1454/002 EU/1/20/1454/002 Aybintio 25 mg/ml concentrate for solution for infusion Samsung Bioepis NL B.V. 19/08/2020 HM Unknown AU Concentrate for solution for infusion L01XC07 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Bevacizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1473/001 EU/1/20/1473/001 AYVAKYT 100 mg film-coated tablets Blueprint Medicines (Netherlands) B.V. 24/09/2020 HM Unknown AU Film-coated tablet L01EX18 L01XE Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Avapritinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1473/002 EU/1/20/1473/002 AYVAKYT 200 mg film-coated tablets Blueprint Medicines (Netherlands) B.V. 24/09/2020 HM Unknown AU Film-coated tablet L01EX18 L01XE Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Avapritinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1473/004 EU/1/20/1473/004 AYVAKYT 25 mg film-coated tablets Blueprint Medicines (Netherlands) B.V. 24/03/2022 HM Unknown AU Film-coated tablet L01EX18 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Avapritinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1473/003 EU/1/20/1473/003 AYVAKYT 300 mg film-coated tablets Blueprint Medicines (Netherlands) B.V. 24/09/2020 HM Unknown AU Film-coated tablet L01EX18 L01XE Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Avapritinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1473/005 EU/1/20/1473/005 AYVAKYT 50 mg film-coated tablets Blueprint Medicines (Netherlands) B.V. 24/03/2022 HM Unknown AU Film-coated tablet L01EX18 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Avapritinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0126/362/001 PA0126/362/001 Azacitidine 25 mg/ml powder for suspension for injection Clonmel Healthcare Ltd 29/07/2022 HM Not marketed AU Powder for suspension for injection L01BC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Azacitidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) EU/1/19/1413/003-010 EU/1/19/1413/003-010 Azacitidine Accord 200 mg film-coated tablets Accord Healthcare S.L.U. 17/09/2025 HM Unknown AU Film-coated tablet L01BC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Azacitidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/19/1413/001 EU/1/19/1413/001 Azacitidine Accord 25 mg/mL powder for suspension for injection Accord Healthcare S.L.U. 13/02/2020 HM Unknown AU Powder for suspension for injection L01BC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Azacitidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1413/002 EU/1/19/1413/002 Azacitidine Accord 25 mg/mL powder for suspension for injection Accord Healthcare S.L.U. 13/02/2020 HM Unknown AU Powder for suspension for injection L01BC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Azacitidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1413/011-018 EU/1/19/1413/011-018 Azacitidine Accord 300 mg film-coated tablets Accord Healthcare S.L.U. 17/09/2025 HM Unknown AU Film-coated tablet L01BC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Azacitidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/19/1416/001 EU/1/19/1416/001 Azacitidine betapharm 25 mg/mL powder for suspension for injection Betapharm Arzneimittel GmbH 24/03/2020 HM Unknown AU Powder for suspension for injection L01BC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Azacitidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA0126/316/001 PA0126/316/001 Azacitidine Clonmel 25 mg/ml powder for suspension for injection Clonmel Healthcare Ltd 05/06/2020 HM Not marketed AU Powder for suspension for injection L01BC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Azacitidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) EU/1/23/1777/001 EU/1/23/1777/001 Azacitidine Kabi 25 mg/mL powder for suspension for injection Fresenius Kabi Deutschland GmbH 05/01/2024 HM Unknown AU Powder for suspension for injection L01BC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Azacitidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/20/1426/001-002 EU/1/20/1426/001-002 Azacitidine Mylan 25 mg/mL powder for suspension for injection Mylan Pharmaceuticals Limited 27/03/2020 HM Unknown AU Powder for suspension for injection L01BC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Azacitidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA0711/297/001 PA0711/297/001 Azacitidine Rowex 25 mg/ml Powder for suspension for injection Rowex Limited, 12/06/2020 HM Not marketed AU Powder for suspension for injection L01BC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Azacitidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA22766/005/001 PA22766/005/001 Azacitidine Seacross 25 mg/ml powder for suspension for injection Seacross Pharma (Europe) Limited 08/10/2021 HM Marketed AU Powder for suspension for injection L01BC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Azacitidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA1418/021/001 PA1418/021/001 Azactam 1 g Powder for Solution for Injection or Infusion Athlone Pharmaceuticals Limited 05/03/1985 HM Not marketed AU Powder for solution for injection/infusion J01DF J01DF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Aztreonam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1418/021/002 PA1418/021/002 Azactam 2 g Powder for Solution for Injection or Infusion Athlone Pharmaceuticals Limited 05/03/1985 HM Not marketed AU Powder for solution for injection/infusion J01DF J01DF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Aztreonam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1330/010/001 PA1330/010/001 IC0190-217-003 Azalia 75 microgram film-coated tablets Gedeon Richter Plc 08/10/2010 HM Marketed AU Film-coated tablet G03AC G03AC09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Desogestrel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/482/1-2 EU/1/08/482/1-2 Azarga 10 mg/ml + 5 mg/ml eye drops, suspension Novartis Europharm Limited 25/11/2008 HM Unknown AU Eye drops, suspension S01ED S01ED51 New active substance (Article 8(3) of Directive No 2001/83/EC) Ocular use Timolol Maleate Brinzolamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/041/001 PA23355/041/001 IC0166-204-070 Azecort 137 micrograms/50 micrograms per actuation nasal spray, suspension Viatris Healthcare Limited 22/02/2013 HM Marketed AU Nasal spray, suspension R01AD R01AD58 Fixed combination application (Article 10b of Directive No 2001/83/EC) Nasal use Azelastine hydrochloride Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA25506/008/001 PA25506/008/001 Azelastine Eye Drops 0.5 mg/ml Eye Drops, solution Cooper Consumer Health B.V. 28/08/1998 HM Not marketed AU Eye drops, solution S01GX S01GX07 Not Currently Available Ocular use Azelastine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/324/001 PA0711/324/001 IC0166-204-070 Azelastine hydrochloride /Fluticasone propionate Rowex 137 micrograms/50 micrograms per actuation, nasal spray suspension Rowex Limited, 27/10/2023 HM Marketed AU Nasal spray, suspension R01AD58 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Nasal use Azelastine hydrochloride Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/304/1-7 EU/1/04/304/1-7 IC0112-039-002 AZILECT 1 mg tablets Teva B.V. 21/02/2005 HM Unknown AU Tablet N04BD N04BD02 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Rasagiline Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/150/001 PA0126/150/001 IC0113-130-009 Azithromycin Clonmel 250 mg film-coated tablets Clonmel Healthcare Ltd 18/11/2005 HM Marketed AU Film-coated tablet J01FA J01FA10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Azithromycin dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/047/001 PA1347/047/001 IC0113-130-009 Azithromycin Krka 250 mg film-coated tablets KRKA, d.d., Novo mesto 09/05/2014 HM Not marketed AU Film-coated tablet J01FA J01FA10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Azithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/039/002 PA0749/039/002 IC0113-130-009 Azithromycin Teva 250 mg film-coated tablets Teva Pharma B.V. 15/02/2013 HM Marketed AU Film-coated tablet J01FA J01FA10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Azithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/157/59-67 EU/1/00/157/59-67 IC0153-155-019 Azomyr 0.5 mg/ml oral solution N.V. Organon 23/04/2007 HM Unknown AU Oral solution R06AX R06AX27 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Desloratadine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/157/001-013 EU/1/00/157/001-013 IC0153-001-014 Azomyr 5 mg film-coated tablets N.V. Organon HM Unknown AU Film-coated tablet R06AX R06AX27 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Desloratadine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/129/001 EU/1/00/129/001 Azopt 10 mg/ml eye drops, suspension Novartis Europharm Limited 09/03/2000 HM Unknown AU Eye drops, suspension S01EC S01EC04 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Brinzolamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/129/002 EU/1/00/129/002 Azopt 10 mg/ml eye drops, suspension Novartis Europharm Limited 09/03/2000 HM Unknown AU Eye drops, suspension S01EC S01EC04 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Brinzolamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/043/001 PA23266/043/001 IC0113-130-009 Azromax 250 mg film-coated tablets Viatris Limited 04/06/2010 HM Marketed AU Film-coated tablet J01FA J01FA10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Azithromycin dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/001/001 PA22871/001/001 Azuzote 30 mg film-coated tablets Azure Pharmaceuticals Ltd. 24/01/2020 HM Marketed AU Film-coated tablet N02BG06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Nefopam hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1107/004/001 PA1107/004/001 Azyter 15 mg/g eye drops, solution, in single-dose container Laboratoires Thea 20/05/2011 HM Marketed AU Eye drops, solution S01AA S01AA26 Known active substance (Article 8(3) of Directive No 2001/83/EC) Ocular use Azithromycin dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1613/001/001 PA1613/001/001 Azzalure, 125 Speywood units, powder for solution for injection Ipsen Pharma 26/03/2010 HM Marketed AU Powder for solution for injection M03AX M03AX01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Clostridium botulinum toxin type a haemagglutinin complex Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA22697/005/001 PA22697/005/001 Baclofen 5 mg/5 ml oral solution Syri Pharma Limited t/a Thame Laboratories 12/02/2016 HM Not marketed AU Oral solution M03BX M03BX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Baclofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/019/001 PA23266/019/001 Baclopar 10 mg Tablets Viatris Limited 21/11/1989 HM Marketed AU Tablet M03BX M03BX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Baclofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/094/002 PA1077/094/002 Bactroban 2% w/w Nasal Ointment GlaxoSmithKline (Ireland) Limited 17/07/1989 HM Marketed AU Nasal ointment D06AX D06AX09 Full application (Article 8(3) of Directive No 2001/83/EC) Nasal use Mupirocin calcium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1077/094/001 PA1077/094/001 Bactroban 2% w/w Ointment GlaxoSmithKline (Ireland) Limited 29/04/1986 HM Marketed AU Ointment D06AX D06AX09 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Mupirocin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1887/001 EU/1/24/1887/001 Baiama 40 mg/mL solution for injection in a vial Formycon AG 13/01/2025 HM Unknown AU Solution for injection in vial S01LA05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravitreal use Aflibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/24/1841/001-004 EU/1/24/1841/001-004 Balversa 3 mg Film-coated tablet Janssen-Cilag International NV 22/08/2024 HM Unknown AU Film-coated tablet L01EN01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Erdafitinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1841/005-009 EU/1/24/1841/005-009 Balversa 4 mg Film-coated tablet Janssen-Cilag International NV 22/08/2024 HM Unknown AU Film-coated tablet L01EN01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Erdafitinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1841/010-011 EU/1/24/1841/010-011 Balversa 5 mg Film-coated tablet Janssen-Cilag International NV 22/08/2024 HM Unknown AU Film-coated tablet L01EN01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Erdafitinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1406/001-002 EU/1/19/1406/001-002 Baqsimi 3 mg nasal powder in single-dose container Amphastar France Pharmaceuticals, S.A.S. 16/12/2019 HM Unknown AU Nasal powder in single-dose container H04AA H04AA01 Full application (Article 8(3) of Directive No 2001/83/EC) Nasal use GLUCAGON Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1//06/343/01 EU/1//06/343/01 Baraclude Bristol-Myers Squibb Pharma EEIG HM Unknown AU Film-coated tablet J05AF J05AF10 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Entecavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/06/343/05 EU/1/06/343/05 Baraclude 0.05 mg/ml oral solution Bristol-Myers Squibb Pharma EEIG 26/06/2006 HM Unknown AU Oral solution J05AF10 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Entecavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/06/343/001,3,6 EU/1/06/343/001,3,6 Baraclude 0.5 mg film-coated tablets Bristol-Myers Squibb Pharma EEIG 26/06/2006 HM Unknown AU Film-coated tablet J05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Entecavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/06/343/02,04,07 EU/1/06/343/02,04,07 Baraclude 1 mg film-coated tablets Bristol-Myers Squibb Pharma EEIG 26/06/2006 HM Unknown AU Film-coated tablet J05AF10 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Entecavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1214/001 EU/1/17/1214/001 Bavencio 20 mg/mL concentrate for solution for infusion Merck Europe B.V. 18/09/2017 HM Unknown AU Concentrate for solution for infusion L01XC Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Avelumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0623/004/001 PA0623/004/001 BCG medac, powder and solvent for intravesical suspension medac Gesellschaft für klinische Spezialpräparate mbH 05/04/2002 HM Marketed AU Powder and solvent for intravesical suspension L03AX L03AX03 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravesical use Bacillus Calmette Guérin (BCG) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2160/003/001 PA2160/003/001 BCG VACCINE AJV AJ Vaccines A/S 14/12/2001 HM Not marketed AU Powder and solvent for suspension for injection J07AN J07AN01 Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93 Intradermal use Mycobacterium bovis (bcg) stam 1331 Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0436/021/010 PA0436/021/010 Beclazone 100 micrograms CFC-Free Inhaler Pressurised Inhalation Solution Norton Waterford 14/11/1997 HM Marketed AU Pressurised inhalation, solution R03BA R03BA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0436/021/014 PA0436/021/014 Beclazone 100 micrograms Easi-Breathe CFC-Free Inhaler Pressurised Inhalation Solution Norton Waterford 14/11/1997 HM Marketed AU Pressurised inhalation, solution R03BA R03BA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0436/021/011 PA0436/021/011 Beclazone 200 micrograms CFC-Free Inhaler, Pressurised Inhalation Solution Norton Waterford 14/11/1997 HM Marketed AU Pressurised inhalation, solution R03BA R03BA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0436/021/015 PA0436/021/015 Beclazone 200 micrograms Easi-Breathe CFC-Free Inhaler, Pressurised Inhalation Solution Norton Waterford 14/11/1997 HM Marketed AU Pressurised inhalation, solution R03BA R03BA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0436/021/012 PA0436/021/012 Beclazone 250 micrograms CFC-Free Inhaler Pressurised Inhalation Solution Norton Waterford 14/11/1997 HM Marketed AU Pressurised inhalation, solution R03BA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0436/021/016 PA0436/021/016 Beclazone 250 micrograms Easi-Breathe CFC-Free Inhaler Pressurised Inhalation Solution Norton Waterford 14/11/1997 HM Marketed AU Pressurised inhalation, solution R03BA R03BA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0436/021/009 PA0436/021/009 Beclazone 50 micrograms CFC-Free Inhaler Pressurised Inhalation Solution Norton Waterford 14/11/1997 HM Marketed AU Pressurised inhalation, solution R03BA R03BA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23010/002/001 PA23010/002/001 Beclometasone/formoterol 100 micrograms /6 micrograms per actuation pressurised inhalation, solution Genetic S.p.A. 20/12/2024 HM Not marketed AU Pressurised inhalation, solution R03AK08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23010/002/002 PA23010/002/002 Beclometasone/formoterol 200 micrograms /6 micrograms per actuation pressurised inhalation, solution Genetic S.p.A. 20/12/2024 HM Not marketed AU Pressurised inhalation, solution R03AK08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0584/003/001 PA0584/003/001 Becloneb 400 micrograms/1 ml nebuliser suspension Chiesi Farmaceutici S.p.A. 18/03/2005 HM Not marketed AU Nebuliser suspension R03BA R03BA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0584/003/002 PA0584/003/002 Becloneb 800 micrograms/2 ml nebuliser suspension Chiesi Farmaceutici S.p.A. 18/03/2005 HM Not marketed AU Nebuliser suspension R03BA R03BA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0584/004/001 PA0584/004/001 Beclospin 400 micrograms/1 ml nebuliser suspension Chiesi Farmaceutici S.p.A. 18/03/2005 HM Not marketed AU Nebuliser suspension R03BA R03BA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate anhydrous Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0584/004/002 PA0584/004/002 Beclospin 800 micrograms/2 ml nebuliser suspension Chiesi Farmaceutici S.p.A. 18/03/2005 HM Not marketed AU Nebuliser suspension R03BA R03BA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1186/008/001 PA1186/008/001 Beconase Hayfever nasal spray 50 micrograms per spray Chefaro Ireland DAC, 17/09/1999 HM Marketed AU Nasal spray, suspension R01AD R01AD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Nasal use Beclometasone dipropionate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA1077/042/007 PA1077/042/007 Becotide Evohaler 100 micrograms, Pressurised Inhalation Solution GlaxoSmithKline (Ireland) Limited 07/01/2005 HM Marketed AU Pressurised inhalation, solution R03BA R03BA01 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/042/009 PA1077/042/009 Becotide Evohaler 250 micrograms, Pressurised Inhalation Solution GlaxoSmithKline (Ireland) Limited 07/01/2007 HM Marketed AU Pressurised inhalation, solution R03BA R03BA01 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/042/006 PA1077/042/006 Becotide Evohaler 50 micrograms, Pressurised Inhalation Solution GlaxoSmithKline (Ireland) Limited 07/01/2005 HM Marketed AU Pressurised inhalation, solution R03BA R03BA01 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1727/001 EU/1/23/1727/001 BEKEMV 300 mg Concentrate for solution for infusion Amgen Technology (Ireland) Unlimited Company 19/04/2023 HM Unknown AU Concentrate for solution for infusion L04AJ01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Eculizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) HOR1149/006/001 HOR1149/006/001 Belladonna A. Nelson & Company Limited 11/03/2011 HM Not marketed AU Not assigned Not Currently Available Oral use Atropa belladonna Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23188/002/001 PA23188/002/001 Belladonna 0.25% w/w Medicated Plaster Cuxson Gerrard Healthcare Limited 01/04/1983 HM Marketed AU Medicated plaster M02AX M02AX10 Not Currently Available Topical use Belladonna alkaloids Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23514/001/001 PA23514/001/001 Belnifrem 1.5 mg film-coated tablets Adamed Pharma S.A. 21/04/2023 HM Not marketed AU Film-coated tablet N07BA Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cytisinicline Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/909/001-005 EU/1/13/909/001-005 Bemfola Gedeon Richter Plc HM Unknown AU Solution for injection G03GA G03GA05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Follitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1441/005-008 EU/1/20/1441/005-008 Bemrist Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Novartis Europharm Limited 30/05/2020 HM Unknown AU Inhalation powder, hard capsule R03AK14 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Indacaterol acetate Indacaterol Mometasone furoate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1441/009-012 EU/1/20/1441/009-012 Bemrist Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules Novartis Europharm Limited 30/05/2020 HM Unknown AU Inhalation powder, hard capsule R03AK14 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Indacaterol acetate Indacaterol Mometasone furoate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1441/001-004 EU/1/20/1441/001-004 Bemrist Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Novartis Europharm Limited 30/05/2020 HM Unknown AU Inhalation powder, hard capsule R03AK14 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Indacaterol acetate Indacaterol Mometasone furoate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/077/002 PA2315/077/002 Bendamustine 100 mg powder for concentrate for solution for infusion Accord Healthcare Ireland Ltd. 17/10/2014 HM Not marketed AU Powder for concentrate for solution for infusion L01AA L01AA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Bendamustine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/121/002 PA1986/121/002 Bendamustine 100 mg Powder for Concentrate for Solution for Infusion Teva B.V. 15/05/2015 HM Marketed AU Powder for concentrate for solution for infusion L01AA L01AA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Bendamustine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/077/003 PA2315/077/003 Bendamustine 25 mg/ml concentrate for solution for infusion Accord Healthcare Ireland Ltd. 26/08/2022 HM Marketed AU Concentrate for solution for infusion L01AA09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Bendamustine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/077/001 PA2315/077/001 Bendamustine 25 mg powder for concentrate for solution for infusion Accord Healthcare Ireland Ltd. 17/10/2014 HM Marketed AU Powder for concentrate for solution for infusion L01AA L01AA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Bendamustine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/121/001 PA1986/121/001 Bendamustine 25 mg Powder for Concentrate for Solution for Infusion Teva B.V. 15/05/2015 HM Marketed AU Powder for concentrate for solution for infusion L01AA L01AA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Bendamustine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/028/002 PA2059/028/002 Bendamustine HCl 100 mg Powder for Concentrate for Solution for Infusion Fresenius Kabi Deutschland GmbH 28/10/2016 HM Marketed AU Powder for concentrate for solution for infusion L01AA L01AA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Bendamustine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/028/001 PA2059/028/001 Bendamustine HCl 25 mg Powder for Concentrate for Solution for Infusion Fresenius Kabi Deutschland GmbH 28/10/2016 HM Marketed AU Powder for concentrate for solution for infusion L01AA L01AA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Bendamustine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/021/001 PA22749/021/001 Bendroflumethiazide 2.5 mg Tablets Brillpharma (Ireland) Limited 23/11/2018 HM Marketed AU Tablet C03AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bendroflumethiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22749/021/002 PA22749/021/002 Bendroflumethiazide 5 mg Tablets Brillpharma (Ireland) Limited 23/11/2018 HM Marketed AU Tablet C03AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bendroflumethiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/97/047/006 EU/1/97/047/006 BeneFIX 1000 IU powder and solvent for solution for injection Pfizer Europe MA EEIG HM Unknown AU Powder and solvent for solution for injection B02BD B02BD04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Nonacog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/97/047/009 EU/1/97/047/009 BeneFIX 1500 IU powder and solvent for solution for injection Pfizer Europe MA EEIG 22/03/2017 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD09 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Nonacog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/97/047/007 EU/1/97/047/007 BeneFIX 2000 IU powder and solvent for solution for injection Pfizer Europe MA EEIG HM Unknown AU Powder and solvent for solution for injection B02BD B02BD04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Nonacog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/97/047/004 EU/1/97/047/004 BeneFIX 250 IU powder and solvent for solution for injection Pfizer Europe MA EEIG 30/07/2007 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Nonacog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/97/047/008 EU/1/97/047/008 BeneFIX 3000 IU powder and solvent for solution for injection Pfizer Europe MA EEIG HM Unknown AU Powder and solvent for solution for injection B02BD B02BD04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Nonacog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/97/047/005 EU/1/97/047/005 BeneFIX 500 IU powder and solvent for solution for injection Pfizer Europe MA EEIG HM Unknown AU Powder and solvent for solution for injection B02BD B02BD04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Nonacog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1074/005-007 EU/1/15/1074/005-007 Benepali 25 mg solution for injection in pre-filled syringe Samsung Bioepis NL B.V. 31/05/2017 HM Unknown AU Solution for injection in pre-filled syringe L04AB L04AB01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1074/002 EU/1/15/1074/002 Benepali 50 mg solution for injection in pre-filled pen Samsung Bioepis NL B.V. HM Unknown AU Solution for injection in pre-filled pen L04AB L04AB01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1074/001 EU/1/15/1074/001 Benepali 50 mg solution for injection in pre-filled syringe Samsung Bioepis NL B.V. HM Unknown AU Solution for injection in pre-filled syringe L04AB L04AB01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/11/700/001-002 EU/1/11/700/001-002 Benlysta 120 mg powder for concentrate for solution for infusion GlaxoSmithKline (Ireland) Limited 13/07/2011 HM Unknown AU Powder for concentrate for solution for infusion L04AA L04AA26 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Belimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/11/700/003-005 EU/1/11/700/003-005 Benlysta 200 mg solution for injection in pre-filled pen GlaxoSmithKline (Ireland) Limited 10/11/2017 HM Unknown AU Solution for injection in pre-filled pen L04AA L04AA26 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Belimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/11/700/006-007 EU/1/11/700/006-007 Benlysta 200 mg solution for injection in pre-filled syringe GlaxoSmithKline (Ireland) Limited 10/11/2017 HM Unknown AU Solution for injection in pre-filled syringe L04AA L04AA26 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Belimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA23490/011/001 PA23490/011/001 Benylin Children’s Chesty Cough 50 mg/5 ml Syrup JNTL Consumer Health (Ireland) Limited 27/07/1998 HM Marketed AU Syrup R05CA R05CA03 ZZZ Article 8.3(i) Oral use Guaifenesin Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23490/008/001 PA23490/008/001 Benylin Children’s Dry Coughs Syrup Diphenhydramine Hydrochloride 7 mg/5 ml Levomenthol 0.55 mg/5 ml JNTL Consumer Health (Ireland) Limited 24/08/1992 HM Marketed AU Syrup R06AA R06AA02 Not Currently Available Oral use Levomenthol Diphenhydramine hydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA23490/005/001 PA23490/005/001 Benylin Cough Medicine Syrup Diphenhydramine hydrochloride 14 mg/5 ml Levomenthol 1.1 mg/5 ml JNTL Consumer Health (Ireland) Limited 01/04/1979 HM Not marketed AU Syrup R06AA R06AA02 Not Currently Available Oral use Diphenhydramine hydrochloride Levomenthol Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23490/006/001 PA23490/006/001 BENYLIN Day & Night Tablets, 500mg/60mg tablets and 500/25mg film-coated tablets JNTL Consumer Health (Ireland) Limited 10/11/1988 HM Marketed AU Film-coated tablet N02BE51 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Paracetamol PSEUDOEPHEDRINE HYDROCHLORIDE Paracetamol Diphenhydramine hydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Sale through pharmacies only in packs containing not more than 16 units per pack. Packs containing more than 720mg pseudoephedrine are subject to medical prescription. PA23490/004/001 PA23490/004/001 Benylin Dry Coughs Syrup Diphenhydramine hydrochloride 14 mg/5 ml Dextromethorphan hydrobromide 6.5 mg/5 ml Levomenthol 2 mg/5 ml JNTL Consumer Health (Ireland) Limited 29/09/1987 HM Marketed AU Syrup R06AA R06AA52 ZZZ --Unknown-- Oral use Diphenhydramine hydrochloride Dextromethorphan hydrobromide Levomenthol Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23490/002/001 PA23490/002/001 Benylin Dual Action Dry Syrup, Pseudoephedrine 30mg, Dextromethorphan 10mg, Triprolidine 1.25mg JNTL Consumer Health I (Ireland) Limited 15/03/2004 HM Marketed AU Syrup R01BA R01BA52 Competence of personnel (Article 23 of Directive No 2010/63/EU) Oral use Dextromethorphan hydrobromide PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only Sale through pharmacies only in packs containing not more than 100ml per pack. Packs containing more than 720mg pseudoephedrine are subject to medical prescription. PA23490/013/001 PA23490/013/001 Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5mg JNTL Consumer Health (Ireland) Limited 02/06/1998 HM Marketed AU Film-coated tablet N02BE N02BE51 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Paracetamol PSEUDOEPHEDRINE HYDROCHLORIDE Diphenhydramine hydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Sale through pharmacies only in packs containing not more than 24 units per pack. Packs containing more than 720mg pseudoephedrine are subject to medical prescription. Warnings Do not exceed stated dose. May cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma or emphysema or if accompanied by excessive phlegm, unless directed by a doctor. a) The statement “CONTAINS PARACETAMOL” should be clearly carried in contrasting boxed bold type on the package together with the following warning: “DO NOT TAKE ANY OTHER PARACETAMOL CONTAINING PRODUCTS”. b) The package label should also contain the following precaution “IMMEDIATE MEDICAL ADVICE SHOULD BE SOUGHT IN THE EVENT OF OVERDOSAGE EVEN IF YOU FEEL WELL. PLEASE READ THE ENCLOSED LEAFLET CAREFULLY”. The package leaflet should contain the following statement, (over word restriction) TR23490/001/001 TR23490/001/001 Benylin Herbal Chesty Coughs Syrup JNTL Consumer Health I (Ireland) Limited 15/11/2024 HM Not marketed AU Syrup R05CA12 Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23490/041/001 PA23490/041/001 Benylin Mucus Cough Honey & Lemon 100mg/5ml Syrup JNTL Consumer Health (Ireland) Limited 22/03/2024 HM Marketed AU Syrup R05CA03 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Guaifenesin Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23490/040/001 PA23490/040/001 Benylin Mucus Cough Menthol 100 mg/5 ml oral solution JNTL Consumer Health (Ireland) Limited 07/10/2011 HM Marketed AU Oral solution R05CA R05CA03 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Guaifenesin Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23490/031/001 PA23490/031/001 Benylin Mucus Cough Syrup Guaifenesin 100 mg/5 ml Levomenthol 1.1 mg/5 ml JNTL Consumer Health I (Ireland) Limited 09/09/2011 HM Marketed AU Syrup R05CA R05CA03 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Levomenthol Guaifenesin Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23490/037/001 PA23490/037/001 Benylin Mucus Relief 250 mg/5 ml Syrup JNTL Consumer Health I (Ireland) Limited 27/07/2001 HM Not marketed AU Syrup R05CB R05CB03 Not Currently Available Oral use Carbocisteine Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23490/010/001 PA23490/010/001 Benylin Non-Drowsy Dry Coughs, Syrup Dextromethorphan hydrobromide 7.5 mg/5 ml JNTL Consumer Health (Ireland) Limited 10/11/1994 HM Marketed AU Syrup R05DA R05DA09 Not Currently Available Oromucosal use Dextromethorphan hydrobromide Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23490/007/001 PA23490/007/001 Benylin Non-drowsy for Chesty Coughs Syrup Guaifenesin 100 mg/5 ml Levomenthol 1.1 mg/5 ml JNTL Consumer Health (Ireland) Limited 20/10/1992 HM Marketed AU Syrup R05CA R05CA03 Competence of personnel (Article 23 of Directive No 2010/63/EU) Oral use Levomenthol Guaifenesin Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23490/015/001 PA23490/015/001 Benylin Phlegm Cough plus Decongestant SyrupGuaifenesin 100 mg/5 mlPseudoephedrine Hydrochloride 30 mg/5 ml JNTL Consumer Health I (Ireland) Limited 07/04/1997 HM Not marketed AU Syrup R01BA R01BA52 Not Currently Available Oral use PSEUDOEPHEDRINE HYDROCHLORIDE Guaifenesin Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Sale through pharmacies only in packs containing not more than 100ml per pack. Packs containing more than 720mg pseudoephedrine are subject to medical prescription. PA0206/023/001 PA0206/023/001 Benzyl Benzoate 25% w/v Application Cutaneous Emulsion Ovelle Limited 01/09/1988 HM Marketed AU Cutaneous emulsion P03AX P03AX01 Well-established use application (Article 10a of Directive No 2001/83/EC) Cutaneous use Topical use Benzyl benzoate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA2059/085/002 PA2059/085/002 Benzylpenicillin sodium 1200 mg powder for solution for injection/infusion Fresenius Kabi Deutschland GmbH 14/06/2024 HM Not marketed AU Powder for solution for injection/infusion J01CE01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Benzylpenicillin Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/038/002 PA1122/038/002 Benzylpenicillin sodium 1200 mg powder for solution for injection/infusion Noridem Enterprises Limited 30/01/2026 HM Not marketed AU Powder for solution for injection/infusion J01CE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Benzylpenicillin Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/038/003 PA1122/038/003 Benzylpenicillin sodium 3000 mg powder for solution for injection/infusion Noridem Enterprises Limited 30/01/2026 HM Not marketed AU Powder for solution for injection/infusion J01CE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Benzylpenicillin Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/310/002 PA0711/310/002 Benzylpenicillin sodium 3000 mg Powder for Solution for Injection/Infusion Rowex Ltd 29/01/2021 HM Not marketed AU Powder for solution for injection/infusion J01CE01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Benzylpenicillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/085/001 PA2059/085/001 Benzylpenicillin sodium 600 mg powder for solution for injection/infusion Fresenius Kabi Deutschland GmbH 14/06/2024 HM Marketed AU Powder for solution for injection/infusion J01CE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Benzylpenicillin Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/038/001 PA1122/038/001 Benzylpenicillin sodium 600 mg powder for solution for injection/infusion Noridem Enterprises Limited 30/01/2026 HM Not marketed AU Powder for solution for injection/infusion J01CE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Benzylpenicillin Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/310/001 PA0711/310/001 Benzylpenicillin sodium 600 mg Powder for Solution for Injection/Infusion Rowex Ltd 29/01/2021 HM Not marketed AU Powder for solution for injection/infusion J01CE01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Benzylpenicillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/038/004 PA1122/038/004 Benzylpenicillin sodium 6000 mg powder for solution for injection/infusion Noridem Enterprises Limited 30/01/2026 HM Not marketed AU Powder for solution for injection/infusion J01CE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Benzylpenicillin Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1417/001-002 EU/1/19/1417/001-002 Beovu 120 mg/ml solution for injection in pre-filled syringe Novartis Europharm Limited 13/02/2020 HM Unknown AU Solution for injection in pre-filled syringe S01LA06 Full application (Article 8(3) of Directive No 2001/83/EC) Intravitreal use Brolucizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA1410/047/001 PA1410/047/001 Bepantiseptic First Aid Cream Bayer Limited 02/01/1987 HM Marketed AU Cream D08AC D08AC52 Full application (Article 8(3) of Directive No 2001/83/EC) Not Currently Available Phenol Chlorhexidine digluconate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA0800/013/002 PA0800/013/002 Berinert 1500 IU Powder and solvent for solution for injection CSL Behring GmbH 27/08/2021 HM Not marketed AU Powder and solvent for solution for injection B06AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use C1 Esterase Inhibitor (Human) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0800/013/003 PA0800/013/003 Berinert 2000 IU Powder and solvent for solution for injection CSL Behring GmbH 27/08/2021 HM Not marketed AU Powder and solvent for solution for injection B06AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use C1 Esterase Inhibitor (Human) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0800/013/004 PA0800/013/004 Berinert 3000 IU Powder and solvent for solution for injection CSL Behring GmbH 27/08/2021 HM Not marketed AU Powder and solvent for solution for injection B06AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use C1 Esterase Inhibitor (Human) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0800/013/001 PA0800/013/001 Berinert 500 IU Powder and solvent for solution for injection/infusion. CSL Behring GmbH 27/08/2021 HM Marketed AU Powder and solvent for solution for injection B06AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use C1 Esterase Inhibitor (Human) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0800/010/003 PA0800/010/003 Beriplex P/N 1000 IU, powder and solvent for solution for injection CSL Behring GmbH 06/05/2016 HM Not marketed AU Powder and solvent for solution for injection B02BD B02BD01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Factor ii activity Factor vii activity Factor x activity Factor ix activity Protein c activity Protein s antigen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches of blood products marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC as amended. PA0800/010/001 PA0800/010/001 Beriplex P/N 250 IU, powder and solvent for solution for injection CSL Behring GmbH 06/05/2016 HM Not marketed AU Powder and solvent for solution for injection B02BD B02BD01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Factor ii activity Factor vii activity Factor x activity Factor ix activity Protein c activity Protein s antigen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches of blood products marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC as amended. PA0800/010/002 PA0800/010/002 Beriplex P/N 500 IU, powder and solvent for solution for injection CSL Behring GmbH 06/05/2016 HM Marketed AU Powder and solvent for solution for injection B02BD B02BD01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Factor ii activity Factor vii activity Factor x activity Factor ix activity Protein c activity Protein s antigen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches of blood products marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC as amended. EU/1/99/097/001 EU/1/99/097/001 Beromun 1 mg powder for solution for infusion Belpharma S.A. 13/04/1999 HM Unknown AU Powder for solution for infusion L03AX L03AX11 Full application (Article 8(3) of Directive No 2001/83/EC) Unknown Tumour necrosis factor alfa 1a Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1200/001 EU/1/17/1200/001 BESPONSA 1 mg powder for concentrate for solution for infusion Pfizer Europe MA EEIG 29/06/2017 HM Unknown AU Powder for concentrate for solution for infusion L01XC26 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Inotuzumab ozogamicin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1352/001 EU/1/18/1352/001 Besremi 250 micogram/0.5 ml Solution for injection in pre-filled pen Aop Orphan Pharmaceuticals GmbH 15/02/2019 HM Unknown AU Solution for injection in pre-filled pen L03AB15 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Ropeginterferon alfa-2b Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1352/002 EU/1/18/1352/002 Besremi 500 microgram/0.5 ml Solution for injection in pre-filled pen Aop Orphan Pharmaceuticals GmbH 15/02/2019 HM Unknown AU Solution for injection in pre-filled syringe L03AB15 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Ropeginterferon alfa-2b Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA22720/002/001 PA22720/002/001 Beta-Prograne 160mg Prolonged-Release Capsules Tillomed Pharma GmbH 09/09/1994 HM Marketed AU Prolonged-release capsule, hard C07AA C07AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Propranolol hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23128/010/001 PA23128/010/001 Betacap Scalp Application 0.1 % w/w cutaneous solution Dermal Laboratories (Ireland) Limited 11/10/1993 HM Marketed AU Cutaneous solution D07AC D07AC01 Informed consent application (Article 10c of Directive No 2001/83/EC) Topical use Betamethasone valerate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/95/003/005-012 EU/1/95/003/005-012 Betaferon 250 microgram/ml, powder and solvent for solution for injection Schering AG HM Unknown AU Powder and solvent for solution for injection L03AB L03AB08 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Interferon beta-1b Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA1824/012/001 PA1824/012/001 Betagan 0.5% w/v Unit Dose Eye Drops, Solution AbbVie Limited 11/10/1993 HM Not marketed AU Eye drops, solution S01ED S01ED03 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Levobunolol hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22871/017/002 PA22871/017/002 IC0084-038-002 Betahistine dihydrochloride 16 mg Tablets Azure Pharmaceuticals Ltd. 21/01/2022 HM Marketed AU Tablet N07CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Betahistine dihydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/078/002 PA2315/078/002 IC0084-038-002 Betahistine dihydrochloride 16mg tablets Accord Healthcare Ireland Ltd. 07/10/2011 HM Marketed AU Tablet N07CA N07CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Betahistine dihydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22871/017/003 PA22871/017/003 Betahistine dihydrochloride 24 mg Tablets Azure Pharmaceuticals Ltd. 21/01/2022 HM Not marketed AU Tablet N07CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Betahistine dihydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22871/017/001 PA22871/017/001 IC0084-009-002 Betahistine dihydrochloride 8 mg Tablets Azure Pharmaceuticals Ltd. 21/01/2022 HM Marketed AU Tablet N07CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Betahistine dihydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/078/001 PA2315/078/001 IC0084-009-002 Betahistine dihydrochloride 8mg tablets Accord Healthcare Ireland Ltd. 07/10/2011 HM Marketed AU Tablet N07CA N07CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Betahistine dihydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1404/007/001 PA1404/007/001 Betaloc 1 mg/ml solution for injection Recordati Ireland Limited 02/05/1983 HM Marketed AU Solution for injection C07AB C07AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use METOPROLOL TARTRATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/809/001-007 EU/1/12/809/001-007 Betmiga 25 mg prolonged-release tablets Astellas Pharma Europe BV HM Unknown AU Prolonged-release tablet G04BD G04BD12 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Mirabegron (ym178) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/809/008-014 EU/1/12/809/008-014 Betmiga 50 mg prolonged-release tablets Astellas Pharma Europe BV HM Unknown AU Prolonged-release tablet G04BD G04BD12 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Mirabegron (ym178) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/809/019-020 EU/1/12/809/019-020 Betmiga 8 mg/ml Granules for prolonged-release oral suspension Astellas Pharma Europe B.V. 22/08/2024 HM Unknown AU Prolonged-release granules for oral suspension G04BD12 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Mirabegron Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1638/001/001 PA1638/001/001 Betnesol 0.1% w/v Eye, Ear and Nasal Drops, solution RPH Pharmaceuticals AB 01/04/1978 HM Marketed AU Ear/eye/nasal drops, solution S02BA S02BA07 Informed consent application (Article 10c of Directive No 2001/83/EC) Ocular use BETAMETHASONE SODIUM PHOSPHATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1638/002/001 PA1638/002/001 Betnesol-N 0.1% w/v, 3500 IU/ml Eye, Ear and Nasal Drops, solution RPH Pharmaceuticals AB 13/08/1993 HM Marketed AU Ear/eye/nasal drops, solution S03CA S03CA06 Full application (Article 8(3) of Directive No 2001/83/EC) Auricular use Nasal use Ocular use Neomycin sulfate BETAMETHASONE SODIUM PHOSPHATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1077/001/001 PA1077/001/001 Betnovate Cream 0.1% w/w GlaxoSmithKline (Ireland) Limited 13/12/1983 HM Marketed AU Cream D07AC D07AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Betamethasone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/001/002 PA1077/001/002 Betnovate Ointment 0.1% w/w GlaxoSmithKline (Ireland) Limited 13/12/1983 HM Marketed AU Ointment D07AC D07AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Topical Betamethasone valerate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/001/003 PA1077/001/003 Betnovate Scalp Application 0.1% w/w Cutaneous Solution GlaxoSmithKline (Ireland) Limited 05/03/1984 HM Marketed AU Cutaneous solution D07AC D07AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Topical Betamethasone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1638/009/001 PA1638/009/001 Bettamousse 1 mg/g (0.1%) cutaneous foam RPH Pharmaceuticals AB 13/11/1998 HM Marketed AU Cutaneous foam D07AC D07AC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Betamethasone valerate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/18/1339/001 EU/1/18/1339/001 Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension AstraZeneca AB 18/12/2018 HM Unknown AU Pressurised inhalation, suspension R03AL07 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Formoterol fumarate dihydrate GLYCOPYRRONIUM Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/812/001-004 EU/1/12/812/001-004 Bexsero 0.5 ml suspension for injection in pre-filled syringe Glaxosmithkline Vaccines S.r.l. HM Unknown AU Suspension for injection in pre-filled syringe J07AH09 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Recombinant neisseria meningitidis serogroup b nhba fusion protein Recombinant neisseria meningitidis serogroup b nada fusion protein Recombinant neisseria meningitidis serogroup b fhbp fusion protein Outer rmembrane vesicles (omv) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1689/004-006 EU/1/22/1689/004-006 Beyfortus 100 mg solution for injection in pre-filled syringe Sanofi Winthrop Industrie 31/10/2022 HM Unknown AU Solution for injection in pre-filled syringe J06BD08 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Nirsevimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1689/001-003 EU/1/22/1689/001-003 Beyfortus 50 mg solution for injection in pre-filled syringe Sanofi Winthrop Industrie 31/10/2022 HM Unknown AU Solution for injection in pre-filled syringe J06B J06BD08 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Nirsevimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1906/001 EU/1/24/1906/001 BEYONTTRA 356 mg film-coated tablets Bayer AG 10/02/2025 HM Unknown AU Film-coated tablet C01EB25 Generic (abridged application) - art 10(1) Oral use Acoramidis hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2315/079/001 PA2315/079/001 IC0137-023-003 Bicalutamide 50 mg film-coated tablets Accord Healthcare Ireland Ltd. 08/12/2008 HM Marketed AU Film-coated tablet L02BB L02BB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bicalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1789/001/002 PA1789/001/002 Bicalutamide Fair-Med 150mg Film-coated Tablets Fairmed Healthcare GmbH 14/09/2012 HM Not marketed AU Film-coated tablet L02BB L02BB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bicalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1789/001/001 PA1789/001/001 IC0137-023-003 Bicalutamide Fair-Med 50 mg film-coated tablets Fairmed Healthcare GmbH 14/09/2012 HM Not marketed AU Film-coated tablet L02BB L02BB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bicalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/032/001 PA0749/032/001 IC0137-023-003 Bicalutamide Teva 50 mg film-coated tablets Teva Pharma B.V. 18/05/2007 HM Marketed AU Film-coated tablet L02BB L02BB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bicalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/18/1289/005-006 EU/1/18/1289/005-006 Biktarvy 30 mg/120 mg/15 mg Film-coated tablet Gilead Sciences Ireland UC 21/11/2022 HM Unknown AU Film-coated tablet J05AR20 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bictegravir Sodium Emtricitabine Tenofovir alafenamide fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1289/001-002 EU/1/18/1289/001-002 Biktarvy 50 mg/200 mg/25 mg Film-coated tablet Gilead Sciences Ireland UC 21/06/2018 HM Unknown AU Film-coated tablet J05AR J05AR20 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bictegravir Emtricitabine Tenofovir alafenamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1978/002 EU/1/25/1978/002 Bildyos 60 mg solution for injection Sciencepharma Sp. z o.o. 17/09/2025 HM Unknown AU Solution for injection M05BX04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Denosumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1978/001 EU/1/25/1978/001 Bildyos 60 mg solution for injection in pre-filled syringe Sciencepharma Sp. z o.o. 17/09/2025 HM Unknown AU Solution for injection in pre-filled syringe M05BX04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Denosumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1178/021/001 PA1178/021/001 Bilhista 20 mg tablets Alfred E Tiefenbacher (GmbH & Co. KG) 17/04/2025 HM Not marketed AU Tablet R06AX29 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bilastine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1979/001 EU/1/25/1979/001 Bilprevda 120 mg solution for injection Henlius Europe GmbH 17/09/2025 HM Unknown AU Solution for injection M05BX04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Denosumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0711/100/001 PA0711/100/001 IC0137-023-003 Biluta 50 mg film-coated tablets Rowex Ltd 27/04/2007 HM Marketed AU Film-coated tablet L02BB L02BB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bicalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1709/001-004 EU/1/22/1709/001-004 BIMERVAX emulsion for injection COVID-19 Vaccine (recombinant, adjuvanted) Hipra Human Health S.L. 30/03/2023 HM Unknown AU Emulsion for injection J07BN01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use SARS-CoV-2 virus, variants B.1.351-B.1.1.7, spike protein, receptor binding domain fusion heterodimer Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1709/005-007 EU/1/22/1709/005-007 BIMERVAX XBB.1.16. COVID-19 Vaccine (recombinant, adjuvanted) Hipra Human Health S.L. 12/12/2024 HM Unknown AU Emulsion for injection J07BN04 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use SARS-CoV-2, variant XBB.1.16, spike protein, receptor binding domain fusion homodimer Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. • Official batch release In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. EU/1/21/1575/005-008 EU/1/21/1575/005-008 Bimzelx 160 mg solution for injection in pre-filled pen UCB Pharma S.A. 20/08/2021 HM Unknown AU Solution for injection in pre-filled pen L04AC21 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Bimekizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1575/001-004 EU/1/21/1575/001-004 Bimzelx 160 mg solution for injection in pre-filled syringe UCB Pharma S.A. 20/08/2021 HM Unknown AU Solution for injection in pre-filled syringe L04AC21 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Bimekizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1575/011-012 EU/1/21/1575/011-012 Bimzelx 320 mg solution for injection in pre-filled pen UCB Biopharma SPRL 20/08/2021 HM Unknown AU Solution for injection in pre-filled pen L04AC21 Known active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Bimekizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1575/009-010 EU/1/21/1575/009-010 Bimzelx 320 mg solution for injection in pre-filled syringe UCB Biopharma SPRL 20/08/2021 HM Unknown AU Solution for injection in pre-filled syringe L04AC21 Known active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Bimekizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/410/1-2 EU/1/07/410/1-2 Binocrit 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Sandoz GmbH 28/08/2007 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/410/15-16 EU/1/07/410/15-16 Binocrit 10 000 IU/1 mL solution for injection in a pre-filled syringe Sandoz GmbH HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/410/3-4 EU/1/07/410/3-4 Binocrit 2 000 IU/1 mL solution for injection in a pre-filled syringe Sandoz GmbH HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/410/21-22 EU/1/07/410/21-22 Binocrit 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Sandoz GmbH HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Epoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/410/5-6 EU/1/07/410/5-6 Binocrit 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Sandoz GmbH HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/410/23-24 EU/1/07/410/23-24 Binocrit 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Sandoz GmbH HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Epoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/410/7-8 EU/1/07/410/7-8 Binocrit 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Sandoz GmbH HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/410/25-26 EU/1/07/410/25-26 Binocrit 40 000 IU/1 mL solution for injection in a pre-filled syringe Sandoz GmbH HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Epoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/410/9-10 EU/1/07/410/9-10 Binocrit 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Sandoz GmbH HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/410/11-12 EU/1/07/410/11-12 Binocrit 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Sandoz GmbH HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/410/13-014 EU/1/07/410/13-014 Binocrit 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Sandoz GmbH HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA0126/280/001 PA0126/280/001 Binosto Once Weekly 70 mg effervescent tablets Clonmel Healthcare Ltd 02/03/2012 HM Marketed AU Effervescent tablet M05BA M05BA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alendronic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/565/1-2 EU/1/09/565/1-2 Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe TEVA GmbH 23/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/565/11-16 EU/1/09/565/11-16 Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe TEVA GmbH 23/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/565/3-4 EU/1/09/565/3-4 Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe TEVA GmbH 23/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/565/17-22 EU/1/09/565/17-22 Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe TEVA GmbH 23/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/565/5-6 EU/1/09/565/5-6 Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe TEVA GmbH 23/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/565/23-28 EU/1/09/565/23-28 Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe TEVA GmbH 23/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/565/7-8 EU/1/09/565/7-8 Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe TEVA GmbH 23/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/565/9-10 EU/1/09/565/9-10 Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe TEVA GmbH 23/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA25288/009/001 PA25288/009/001 Biphozyl Solution for haemodialysis/haemofiltration Vantive Belgium SRL 28/11/2014 HM Not marketed AU Solution for haemodialysis/haemofiltration B05ZB Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Magnesium chloride hexahydrate Sodium chloride Sodium hydrogen carbonate Potassium chloride Disodium phosphate dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/921/001-003 EU/1/14/921/001-003 BiResp Spiromax 160 micrograms/4.5 micrograms inhalation powder Teva Pharma B.V. 28/04/2014 HM Unknown AU Inhalation powder R03AK07 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Budesonide Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/921/004-006 EU/1/14/921/004-006 BiResp Spiromax 320 micrograms/9 micrograms inhalation powder Teva Pharma B.V. 28/04/2014 HM Unknown AU Inhalation powder R03AK07 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Budesonide Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22654/003/002 PA22654/003/002 IC0065-002-014 Bisocor 10 mg Tablets Unichem Laboratories Ltd 29/06/2001 HM Not marketed AU Tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22654/003/001 PA22654/003/001 IC0065-001-014 Bisocor 5 mg Tablets Unichem Laboratories Ltd 29/06/2001 HM Not marketed AU Tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2261/007/001 PA2261/007/001 Bisodol Antacid Chewable Tablets Calcium Carbonate 522mg Magnesium Carbonate Light 68mg Sodium Hydrogen Carbonate 64mg Dexcel Pharma GmbH 01/04/1983 HM Marketed AU Chewable tablet A02AC A02AC01 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium hydrogen carbonate Calcium carbonate Light magnesium carbonate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23180/015/001 PA23180/015/001 Bisolvon 4mg/5ml Oral Solution Opella Healthcare France SAS T/A Sanofi 14/11/1984 HM Not marketed AU Oral solution R05CB R05CB02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bromhexine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/159/001 PA0711/159/001 IC0065-044-014 Bisop 1.25 mg film-coated tablets Rowex Limited, 08/12/2008 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/159/006 PA0711/159/006 IC0065-002-014 Bisop 10 mg film-coated tablets Rowex Limited, 08/12/2008 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/159/002 PA0711/159/002 IC0065-018-014 Bisop 2.5 mg film-coated tablets Rowex Limited, 08/12/2008 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/159/003 PA0711/159/003 IC0065-108-014 Bisop 3.75 mg film-coated tablets Rowex Limited, 08/12/2008 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/159/004 PA0711/159/004 IC0065-001-014 Bisop 5 mg film-coated tablets Rowex Limited, 08/12/2008 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/159/005 PA0711/159/005 IC0065-041-014 Bisop 7.5 mg film-coated tablets Rowex Limited, 08/12/2008 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/194/003 PA2315/194/003 IC0065-002-014 Bisoprolol 10 mg film-coated tablets Accord Healthcare Ireland Ltd. 30/10/2015 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/194/001 PA2315/194/001 IC0065-018-014 Bisoprolol 2.5 mg film-coated tablets Accord Healthcare Ireland Ltd. 30/10/2015 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/194/002 PA2315/194/002 IC0065-001-014 Bisoprolol 5 mg film-coated tablets Accord Healthcare Ireland Ltd. 30/10/2015 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/400/001 PA0126/400/001 IC0065-044-014 Bisoprolol Clonmel 1.25 mg film-coated tablets Clonmel Healthcare Ltd 17/04/2025 HM Not marketed AU Film-coated tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/400/006 PA0126/400/006 IC0065-002-014 Bisoprolol Clonmel 10 mg film-coated tablets Clonmel Healthcare Ltd 17/04/2025 HM Not marketed AU Film-coated tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/400/002 PA0126/400/002 IC0065-018-014 Bisoprolol Clonmel 2.5 mg film-coated tablets Clonmel Healthcare Ltd 17/04/2025 HM Not marketed AU Film-coated tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/400/003 PA0126/400/003 IC0065-108-014 Bisoprolol Clonmel 3.75 mg film-coated tablets Clonmel Healthcare Ltd 17/04/2025 HM Not marketed AU Film-coated tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/400/004 PA0126/400/004 IC0065-001-014 Bisoprolol Clonmel 5 mg film-coated tablets Clonmel Healthcare Ltd 17/04/2025 HM Not marketed AU Film-coated tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/400/005 PA0126/400/005 IC0065-041-014 Bisoprolol Clonmel 7.5 mg film-coated tablets Clonmel Healthcare Ltd 17/04/2025 HM Not marketed AU Film-coated tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0688/014/001 PA0688/014/001 IC0065-044-014 Bisoprolol Fumarate 1.25mg Tablets Chanelle Medical Unlimited Company 01/02/2008 HM Marketed AU Tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0688/014/005 PA0688/014/005 IC0065-002-014 Bisoprolol Fumarate 10 mg Tablets Chanelle Medical Unlimited Company 01/02/2008 HM Marketed AU Tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22654/002/001 PA22654/002/001 IC0065-018-014 Bisoprolol Fumarate 2.5 mg tablets Unichem Laboratories Ltd 16/04/2010 HM Not marketed AU Tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0688/014/002 PA0688/014/002 IC0065-018-014 Bisoprolol Fumarate 2.5 mg Tablets Chanelle Medical Unlimited Company 01/02/2008 HM Marketed AU Tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0688/014/003 PA0688/014/003 IC0065-108-014 Bisoprolol Fumarate 3.75 mg Tablets Chanelle Medical Unlimited Company 01/02/2008 HM Marketed AU Tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0688/014/004 PA0688/014/004 IC0065-001-014 Bisoprolol Fumarate 5 mg Tablets Chanelle Medical Unlimited Company 01/02/2008 HM Marketed AU Tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/264/001 PA0281/264/001 IC0065-044-014 Bisoprolol fumarate Pinewood 1.25 mg film-coated tablets Pinewood Laboratories Ltd 16/02/2024 HM Not marketed AU Film-coated tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/264/006 PA0281/264/006 IC0065-002-014 Bisoprolol fumarate Pinewood 10 mg film-coated tablets Pinewood Laboratories Ltd 16/02/2024 HM Not marketed AU Film-coated tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/264/002 PA0281/264/002 IC0065-018-014 Bisoprolol fumarate Pinewood 2.5 mg film-coated tablets Pinewood Laboratories Ltd 16/02/2024 HM Not marketed AU Film-coated tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/264/003 PA0281/264/003 IC0065-108-014 Bisoprolol fumarate Pinewood 3.75 mg film-coated tablets Pinewood Laboratories Ltd 16/02/2024 HM Not marketed AU Film-coated tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/264/004 PA0281/264/004 IC0065-001-014 Bisoprolol fumarate Pinewood 5 mg film-coated tablets Pinewood Laboratories Ltd 16/02/2024 HM Not marketed AU Film-coated tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/264/005 PA0281/264/005 IC0065-041-014 Bisoprolol fumarate Pinewood 7.5 mg film-coated tablets Pinewood Laboratories Ltd 16/02/2024 HM Not marketed AU Film-coated tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/031/003 PA1347/031/003 IC0065-002-014 Bisoprolol Krka 10 mg film-coated tablets KRKA, d.d., Novo mesto 13/12/2013 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/031/001 PA1347/031/001 IC0065-018-014 Bisoprolol Krka 2.5 mg film-coated tablets KRKA, d.d., Novo mesto 13/12/2013 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/031/002 PA1347/031/002 IC0065-001-014 Bisoprolol Krka 5 mg film-coated tablets KRKA, d.d., Novo mesto 13/12/2013 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22697/019/001 PA22697/019/001 Bisoprolol Syri Pharma 0.5 mg/ml Syri Pharma Limited t/a Thame Laboratories 06/06/2025 HM Not marketed AU Oral solution C07AB07 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/055/001 PA23266/055/001 IC0065-044-014 Bisoprolol Viatris 1.25 mg film-coated tablets Viatris Limited 19/08/2011 HM Not marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/055/006 PA23266/055/006 IC0065-002-014 Bisoprolol Viatris 10 mg film-coated tablets Viatris Limited 19/08/2011 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/055/002 PA23266/055/002 IC0065-018-014 Bisoprolol Viatris 2.5 mg film-coated tablets Viatris Limited 19/08/2011 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/055/003 PA23266/055/003 IC0065-108-014 Bisoprolol Viatris 3.75 mg film-coated tablets Viatris Limited 19/08/2011 HM Not marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/055/004 PA23266/055/004 IC0065-001-014 Bisoprolol Viatris 5 mg film-coated tablets Viatris Limited 19/08/2011 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/055/005 PA23266/055/005 IC0065-041-014 Bisoprolol Viatris 7.5 mg film-coated tablets Viatris Limited 19/08/2011 HM Marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/010/001 PA1701/010/001 IC0065-044-014 Bisoprolol Zentiva 1.25mg tablets Zentiva k.s. 23/06/2023 HM Marketed AU Tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/010/006 PA1701/010/006 IC0065-002-014 Bisoprolol Zentiva 10 mg tablets Zentiva k.s. 23/06/2023 HM Marketed AU Tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/010/002 PA1701/010/002 IC0065-018-014 Bisoprolol Zentiva 2.5mg tablets Zentiva k.s. 23/06/2023 HM Marketed AU Tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/010/003 PA1701/010/003 IC0065-108-014 Bisoprolol Zentiva 3.75mg tablets Zentiva k.s. 23/06/2023 HM Marketed AU Tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/010/004 PA1701/010/004 IC0065-001-014 Bisoprolol Zentiva 5mg tablets Zentiva k.s. 23/06/2023 HM Marketed AU Tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/010/005 PA1701/010/005 IC0065-041-014 Bisoprolol Zentiva 7.5mg tablets Zentiva k.s. 23/06/2023 HM Marketed AU Tablet C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0740/007/002 PA0740/007/002 IC0065-002-014 Bisoprololhemifumaraat Genthon 10 mg, film-coated tablets Genthon B.V. 22/11/2002 HM Not marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bisoprolol hemifumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0740/007/001 PA0740/007/001 IC0065-001-014 Bisoprololhemifumaraat Genthon 5 mg film-coated tablets Genthon B.V. 22/11/2002 HM Not marketed AU Film-coated tablet C07AB C07AB07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bisoprolol hemifumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1391/005/001 PA1391/005/001 Bitifrin 0.3 mg/ml + 5 mg/ml eye drops, solution Farmaprojects S.A.U 02/09/2022 HM Not marketed AU Eye drops, solution S01ED51 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Ocular use Bimatoprost Timolol Maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1948/002 EU/1/25/1948/002 BLENREP 100 mg powder for concentrate for solution for infusion GlaxoSmithKline Trading Services Limited 23/07/2025 HM Unknown AU Powder for concentrate for solution for infusion L01FX15 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Belantamab Mafodotin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1948/001 EU/1/25/1948/001 BLENREP 70 mg powder for concentrate for solution for infusion GlaxoSmithKline Trading Services Limited 23/07/2025 HM Unknown AU Powder for concentrate for solution for infusion L01FX15 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Belantamab Mafodotin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1047/001 EU/1/15/1047/001 BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion Amgen Europe B.V., 23/11/2015 HM Unknown AU Powder for concentrate and solution for solution for infusion L01XC19 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Blinatumomab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2102/001/001 PA2102/001/001 Blissel 50 micrograms/g vaginal gel Italfarmaco S.A. 09/09/2016 HM Not marketed AU Vaginal gel G03CA G03CA04 Full application (Article 8(3) of Directive No 2001/83/EC) Vaginal use Estriol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1205/001-002 EU/1/17/1205/001-002 Blitzima 100 mg concentrate for solution for infusion Celltrion Healthcare Hungary Kft. 13/07/2017 HM Unknown AU Concentrate for solution for infusion L01XC L01XC02 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Rituximab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2239/014/004 PA2239/014/004 IC0009-038-002 Blopress 16 mg Tablets CHEPLAPHARM Arzneimittel GmbH 14/11/1997 HM Not marketed AU Tablet C09CA C09CA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/014/005 PA2239/014/005 IC0009-037-002 Blopress 32 mg Tablets CHEPLAPHARM Arzneimittel GmbH 12/08/2005 HM Not marketed AU Tablet C09CA C09CA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/014/002 PA2239/014/002 IC0009-008-002 Blopress 4 mg Tablets CHEPLAPHARM Arzneimittel GmbH 14/11/1997 HM Not marketed AU Tablet C09CA C09CA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/014/003 PA2239/014/003 IC0009-009-002 Blopress 8 mg Tablets CHEPLAPHARM Arzneimittel GmbH 14/11/1997 HM Not marketed AU Tablet C09CA C09CA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/015/002 PA2239/015/002 IC0029-036-002 Blopress Plus 16 mg/12.5 mg tablets CHEPLAPHARM Arzneimittel GmbH 31/03/2000 HM Not marketed AU Tablet C09CA C09CA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/015/003 PA2239/015/003 IC0029-035-002 Blopress Plus 32 mg/12.5 mg tablets CHEPLAPHARM Arzneimittel GmbH 19/06/2009 HM Not marketed AU Tablet C09DA C09DA06 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/015/004 PA2239/015/004 IC0029-034-002 Blopress Plus 32 mg/25 mg tablets CHEPLAPHARM Arzneimittel GmbH 19/06/2009 HM Not marketed AU Tablet C09DA C09DA06 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/015/001 PA2239/015/001 IC0029-058-002 Blopress Plus 8 mg/12.5 mg tablets CHEPLAPHARM Arzneimittel GmbH 10/12/1998 HM Not marketed AU Tablet C09DA C09DA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1907/003/002 PA1907/003/002 BOCOUTURE 100 units powder for solution for injection Merz Pharmaceuticals GmbH 12/02/2021 HM Marketed AU Powder for solution for injection M03AX01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1907/003/001 PA1907/003/001 BOCOUTURE 50 units powder for solution for injection Merz Pharmaceuticals GmbH 12/02/2021 HM Marketed AU Powder for solution for injection M03AX01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/25/1953/04-06 EU/1/25/1953/04-06 BOMYNTRA 120 mg solution for injection in pre-filled syringe Fresenius Kabi Deutschland GmbH 17/07/2025 HM Unknown AU Solution for injection in pre-filled syringe M05BX04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Denosumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1953/01-03 EU/1/25/1953/01-03 BOMYNTRA 120 mg solution for injection in vial Fresenius Kabi Deutschland GmbH 17/07/2025 HM Unknown AU Solution for injection in vial M05BX04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Denosumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1572/001/001 PA1572/001/001 Bonasol Once Weekly 70 mg Oral Solution Xeolas Pharmaceuticals Limited 25/02/2011 HM Marketed AU Oral solution M05BA M05BA04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Alendronate sodium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/96/012/004 EU/1/96/012/004 Bondronat 2 mg concentrate for solution for infusion. Atnahs Pharma Netherlands B.V. HM Unknown AU Concentrate for solution for infusion M05BA Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Ibandronic acid monosodium monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/96/012/009-010 EU/1/96/012/009-010 IC0141-023-003 Bondronat 50 mg film-coated tablets Atnahs Pharma Netherlands B.V. HM Unknown AU Film-coated tablet M05BA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ibandronic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/96/012/011-13 EU/1/96/012/011-13 Bondronat 6 mg concentrate for solution for infusion Atnahs Pharma Netherlands B.V. HM Unknown AU Concentrate for solution for infusion M05BA06 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Ibandronic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA0979/001/001 PA0979/001/001 Bonjela Oromucosal Gel Choline Salicylate 8.714% Cetalkonium Chloride 0.010% Reckitt Benckiser Ireland Limited 01/04/1983 HM Marketed AU Oromucosal gel N02BA N02BA03 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Choline salicylate Cetalkonium chloride Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA0979/001/003 PA0979/001/003 Bonjela Teething Gel Oromucosal Gel Choline Salicylate 8.714% Cetalkonium Chloride 0.010% Reckitt Benckiser Ireland Limited 12/03/2010 HM Marketed AU Oromucosal gel N02BA N02BA03 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Choline salicylate Cetalkonium chloride Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public EU/1/03/265/3-4 EU/1/03/265/3-4 IC0141-062-003 Bonviva 150 mg film-coated tablets Atnahs Pharma Netherlands B.V. 15/09/2005 HM Unknown AU Film-coated tablet M05BA M05BA06 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Ibandronic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/03/265/5-6 EU/1/03/265/5-6 Bonviva 3 mg solution for injection Atnahs Pharma Netherlands B.V. HM Unknown AU Solution for injection M05BA M05BA06 New active substance (Article 8(3) of Directive No 2001/83/EC) Ibandronic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1077/020/001 PA1077/020/001 Boostrix suspension for injection in pre-filled syringe Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) GlaxoSmithKline (Ireland) Limited 20/04/2001 HM Marketed AU Suspension for injection in pre-filled syringe J07AJ52 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Pertactin Filamentous haemagglutinin Pertussis toxoid Tetanus toxoid Diphtheria toxoid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.1 of Directive 2001/83/EC, as amended. PA23142/012/001 PA23142/012/001 Bortezomib 1 mg powder for solution for injection Aspire Pharma (Malta) Limited 02/06/2017 HM Not marketed AU Powder for solution for injection L01XX L01XX32 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1774/008/001 PA1774/008/001 Bortezomib 2.5 mg/ml solution for injection EVER Valinject GmbH 19/11/2021 HM Marketed AU Solution for injection L01XX32 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA23142/012/003 PA23142/012/003 Bortezomib 2.5 mg powder for solution for injection Aspire Pharma (Malta) Limited 22/03/2019 HM Not marketed AU Powder for solution for injection L01XX32 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23142/012/002 PA23142/012/002 Bortezomib 3.5 mg powder for solution for injection Aspire Pharma (Malta) Limited 02/06/2017 HM Not marketed AU Powder for solution for injection L01XX L01XX32 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA23092/003/001 PA23092/003/001 Bortezomib 3.5 mg powder for solution for injection Reddy Holding GmbH 23/09/2022 HM Unknown AU Powder for solution for injection L01XX32 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA23250/003/001 PA23250/003/001 Bortezomib 3.5 mg powder for solution for injection MSN Labs Europe Limited 01/04/2022 HM Marketed AU Powder for solution for injection L01XX32 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/15/1019/002 EU/1/15/1019/002 Bortezomib Accord 1 mg Powder for solution for injection Accord Healthcare S.L.U. 28/05/2018 HM Unknown AU Powder for solution for injection L01XX L01XX32 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1019/003-006 EU/1/15/1019/003-006 Bortezomib Accord 2.5 mg/ml Solution for injection Accord Healthcare S.L.U. 23/07/2021 HM Unknown AU Solution for injection L01XX32 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1019/001 EU/1/15/1019/001 Bortezomib Accord 3.5 mg Powder for solution for injection Accord Healthcare S.L.U. 20/07/2015 HM Unknown AU Powder for solution for injection L01XX L01XX32 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA25233/001/001 PA25233/001/001 Bortezomib Biotech Pharma 3.5 mg powder for solution for injection Target Healthcare Limited 26/06/2020 HM Not marketed AU Powder for solution for injection L01XX32 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA0126/297/001 PA0126/297/001 Bortezomib Clonmel 2.5 mg/ml Solution for Injection Clonmel Healthcare Ltd 20/04/2018 HM Marketed AU Solution for injection L01XX L01XX32 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1397/001 EU/1/19/1397/001 Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection Fresenius Kabi Deutschland GmbH 14/11/2019 HM Unknown AU Powder for solution for injection L01XX32 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0623/018/001 PA0623/018/001 Bortezomib medac 3.5 mg powder for solution for injection medac Gesellschaft für klinische Spezialpräparate mbH 18/05/2018 HM Not marketed AU Powder for solution for injection L01XX L01XX32 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0711/288/001 PA0711/288/001 Bortezomib Rowex 3.5 mg Powder for solution for injection Rowex Limited, 13/04/2018 HM Marketed AU Powder for solution for injection L01XG01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) EU/1/16/1102/001 EU/1/16/1102/001 Bortezomib SUN 3.5 mg powder for solution for injection Sun Phamaceutical Industries Europe B.V. 22/07/2016 HM Unknown AU Powder for solution for injection L01XX L01XX32 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Bortezomib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2315/286/002 PA2315/286/002 Bosentan Accord 125 mg film-coated tablets Accord Healthcare Ireland Ltd. 31/10/2025 HM Not marketed AU Film-coated tablet C02KX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bosentan monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA2315/286/001 PA2315/286/001 Bosentan Accord 62.5 mg film-coated tablets Accord Healthcare Ireland Ltd. 31/10/2025 HM Not marketed AU Film-coated tablet C02KX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bosentan monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1701/011/002 PA1701/011/002 Bosentan Zentiva 125 mg film-coated tablets Zentiva k.s. 23/02/2024 HM Not marketed AU Film-coated tablet C02KX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bosentan monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA1701/011/001 PA1701/011/001 Bosentan Zentiva 62.5 mg film-coated tablets Zentiva k.s. 23/02/2024 HM Not marketed AU Film-coated tablet C02KX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bosentan monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) EU/1/13/818/001-002 EU/1/13/818/001-002 IC0169-024-003 Bosulif 100 mg film-coated tablets Pfizer Europe MA EEIG HM Unknown AU Film-coated tablet L01EA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bosutinib monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/13/818/009 EU/1/13/818/009 Bosulif 100 mg hard capsules Pfizer Europe MA EEIG 02/06/2025 HM Unknown AU Capsule, hard L01EA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bosutinib monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/13/818/006-007 EU/1/13/818/006-007 IC0169-068-003 Bosulif 400 mg film-coated tablets Pfizer Europe MA EEIG 22/05/2018 HM Unknown AU Film-coated tablet L01EA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bosutinib monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/13/818/008 EU/1/13/818/008 Bosulif 50 mg hard capsules Pfizer Europe MA EEIG 02/06/2025 HM Unknown AU Capsule, hard L01EA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bosutinib monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/13/818/003-004 EU/1/13/818/003-004 IC0169-117-003 Bosulif 500 mg film-coated tablets Pfizer Europe MA EEIG 27/03/2013 HM Unknown AU Film-coated tablet L01EA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bosutinib monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0126/369/001 PA0126/369/001 IC0169-024-003 Bosutinib Clonmel 100 mg film-coated tablets Clonmel Healthcare Ltd 19/04/2024 HM Marketed AU Film-coated tablet L01EA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bosutinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0126/369/002 PA0126/369/002 IC0169-068-003 Bosutinib Clonmel 400 mg film-coated tablets Clonmel Healthcare Ltd 19/04/2024 HM Not marketed AU Film-coated tablet L01EA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bosutinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0126/369/003 PA0126/369/003 IC0169-117-003 Bosutinib Clonmel 500 mg film-coated tablets Clonmel Healthcare Ltd 19/04/2024 HM Marketed AU Film-coated tablet L01EA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bosutinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0711/323/001 PA0711/323/001 IC0169-024-003 Bosutinib Rowex 100 mg film-coated tablets Rowex Limited, 18/07/2025 HM Not marketed AU Film-coated tablet L01EA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bosutinib dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/323/002 PA0711/323/002 IC0169-068-003 Bosutinib Rowex 400 mg film-coated tablets Rowex Limited, 18/07/2025 HM Not marketed AU Film-coated tablet L01EA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bosutinib dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/323/003 PA0711/323/003 IC0169-117-003 Bosutinib Rowex 500 mg film-coated tablets Rowex Limited, 18/07/2025 HM Not marketed AU Film-coated tablet L01EA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Bosutinib dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1824/017/001 PA1824/017/001 BOTOX 100 Allergan Units powder for solution for injection AbbVie Limited 07/01/2000 HM Marketed AU Powder and solvent for solution for injection M03AX M03AX01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Botulinum Toxin Type A Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PPA0465/521/001 PPA0465/521/001 BOTOX 100 Allergan Units powder for solution for injection PCO Manufacturing Ltd. 30/01/2026 HM Unknown AU Powder for solution for injection M03AX01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Intradermal use Intramuscular use Botulinum toxin type A Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1824/017/003 PA1824/017/003 BOTOX 200 Allergan Units powder for solution for injection AbbVie Limited 18/01/2008 HM Marketed AU Powder for solution for injection M03AX M03AX01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Botulinum Toxin Type A Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1824/017/002 PA1824/017/002 BOTOX 50 Allergan Units powder for solution for injection AbbVie Limited 18/01/2008 HM Marketed AU Powder for solution for injection M03AX M03AX01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Botulinum Toxin Type A Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA23266/010/001 PA23266/010/001 Brabio 20 mg/ml solution for injection, pre-filled syringe Viatris Limited 04/11/2016 HM Marketed AU Solution for injection in pre-filled syringe L03AX L03AX13 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Glatiramer acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/011/001 PA23266/011/001 Brabio 40 mg/ml solution for injection in pre-filled syringe Viatris Limited 24/11/2017 HM Marketed AU Solution for injection in pre-filled syringe L03AX L03AX13 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Glatiramer acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/18/1314/001 EU/1/18/1314/001 Braftovi 50 mg Hard capsule Pierre Fabre Medicament 20/09/2018 HM Unknown AU Capsule, hard L01EC03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use ENCORAFENIB Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1314/002 EU/1/18/1314/002 Braftovi 75 mg Hard capsule Pierre Fabre Medicament 20/09/2018 HM Unknown AU Capsule, hard L01EC03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use ENCORAFENIB Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1986/006/001 PA1986/006/001 Braltus 10 microgram per delivered dose inhalation powder, hard capsule Teva B.V. 08/07/2016 HM Marketed AU Inhalation powder, hard capsule R03BB R03BB04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Tiotropium bromide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0584/007/001 PA0584/007/001 Bramitob 300mg/4ml Nebuliser Solution Chiesi Farmaceutici S.p.A. 01/06/2007 HM Marketed AU Nebuliser solution J01GB J01GB01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Tobramycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/781/001-003 EU/1/12/781/001-003 Bretaris Genuair 322 micrograms inhalation powder Covis Pharma Europe B.V. HM Unknown AU Inhalation powder R03BB R03BB05 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Micronized aclidinium bromide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2299/021/002 PA2299/021/002 Brevibloc Premixed 10 mg/ml solution for Infusion Baxter Holding B.V. 10/12/2010 HM Marketed AU Solution for infusion C07AB C07AB09 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Esmolol Hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/021/001 PA2299/021/001 Brevibloc Premixed 10 mg/ml Solution for Injection Baxter Holding B.V. 10/12/2010 HM Marketed AU Solution for injection C07AB C07AB09 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Esmolol Hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23354/001/001 PA23354/001/001 Brevoxyl 40 mg/g cream Avianta Pharma EU Limited 13/11/1995 HM Not marketed AU Cream D10AE D10AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Topical use Benzoyl Peroxide Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1631/001 EU/1/22/1631/001 Breyanzi 1.1-70 x 10^6 cells/mL/1.1-70 x 10^6 cells/mL dispersion for infusion Celgene Europe B.V. 04/04/2022 HM Unknown AU Dispersion for infusion L01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Lisocabtagene Maraleucel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1019/007/001 PA1019/007/001 Bricanyl 500 micrograms/ml solution for injection or infusion AstraZeneca AB 01/04/1999 HM Not marketed AU Solution for injection/infusion R03CC R03CC03 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Subcutaneous use Terbutaline sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1019/007/002 PA1019/007/002 Bricanyl Turbohaler 500 micrograms per metered dose, inhalation powder AstraZeneca AB 07/02/1989 HM Marketed AU Inhalation powder R03AC R03AC03 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Not Currently Available Terbutaline sulfate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/466/1-2 EU/1/08/466/1-2 Bridion 100 mg/ml solution for injection Merck Sharp & Dohme BV 25/07/2008 HM Unknown AU Solution for injection V03AB V03AB35 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Sugammadex Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/10/655/007-011 EU/1/10/655/007-011 IC0193-127-003 Brilique 60 mg film-coated tablets AstraZeneca AB 18/02/2016 HM Unknown AU Film-coated tablet B01AC24 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Ticagrelor Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/10/655/001-006 EU/1/10/655/001-006 IC0193-166-003 Brilique 90 mg film-coated tablets AstraZeneca AB 03/12/2010 HM Unknown AU Film-coated tablet B01AC24 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Ticagrelor Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/10/655/012-014 EU/1/10/655/012-014 Brilique 90 mg orodispersible tablets AstraZeneca AB 18/05/2017 HM Unknown AU Orodispersible tablet B01AC24 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Ticagrelor Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22749/011/001 PA22749/011/001 Brillphalac 3.335 g/5 ml oral solution Brillpharma (Ireland) Limited 28/10/2016 HM Marketed AU Oral solution A06AD A06AD11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Lactulose Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/963/001-003 EU/1/14/963/001-003 Brimica Genuair 340 micrograms /12 micrograms inhalation powder Covis Pharma Europe B.V. HM Unknown AU Inhalation powder R03AL R03AL05 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Micronized formoterol fumarate dihydrate Micronized aclidinium bromide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/10/645/001-002 EU/1/10/645/001-002 BRINAVESS 20 mg/ml concentrate for solution for infusion Correvio 01/09/2010 HM Unknown AU Concentrate for solution for infusion C01BG C01BG11 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Vernakalant hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1192/001 EU/1/17/1192/001 Brineura 150 mg solution for infusion BioMarin International Limited HM Unknown AU Solution for infusion A16AB Full application (Article 8(3) of Directive No 2001/83/EC) Intracerebral use Cerliponase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1995/001 EU/1/25/1995/001 Brinsupri 25 mg film-coated tablets Insmed Netherlands B.V. 18/11/2025 HM Unknown AU Film-coated tablet R03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Brensocatib monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/891/008-017 EU/1/13/891/008-017 Brintellix 10 mg film-coated tablets H. Lundbeck A/S HM Unknown AU Film-coated tablet N06AX26 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Vortioxetine hydrobromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/891/018-026 EU/1/13/891/018-026 Brintellix 15 mg film-coated tablets H. Lundbeck A/S HM Unknown AU Film-coated tablet N06AX26 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Vortioxetine hydrobromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/891/036 EU/1/13/891/036 Brintellix 20 mg/ml oral drops, solution H. Lundbeck A/S HM Unknown AU Oral drops, solution N06AX26 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Vortioxetine-dl-lactate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/891/027-035 EU/1/13/891/027-035 Brintellix 20 mg film-coated tablets H. Lundbeck A/S HM Unknown AU Film-coated tablet N06AX26 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Vortioxetine hydrobromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/891/001-007 EU/1/13/891/001-007 Brintellix 5 mg film-coated tablets H. Lundbeck A/S 18/12/2013 HM Unknown AU Film-coated tablet N06AX N06AX26 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Vortioxetine hydrobromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/149/001 PA2315/149/001 Brinzolamide 10 mg/ml eye drops, Suspension Accord Healthcare Ireland Ltd. 02/10/2015 HM Marketed AU Eye drops, suspension S01EC S01EC04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Ocular use Brinzolamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/343/001 PA0711/343/001 Brinzolamide Rowex 10 mg/ml eye drops, suspension Rowex Limited, 20/02/2026 HM Not marketed AU Eye drops, suspension S01EC04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Ocular use Brinzolamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/226/001 PA0711/226/001 Brinzolamide Sandoz 10mg/ml eye drops, suspension Rowex Limited, 04/07/2014 HM Marketed AU Eye drops, suspension S01EC S01EC04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Ocular use Brinzolamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1730/001 EU/1/23/1730/001 Briumvi 150 mg Concentrate for solution for infusion Neuraxpharm Pharmaceuticals S.L. 31/05/2023 HM Unknown AU Concentrate for solution for infusion L04 L04AG14 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Ublituximab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0126/403/001 PA0126/403/001 Brivaracetam Clonmel 10 mg film-coated tablets Clonmel Healthcare Ltd 28/03/2025 HM Not marketed AU Film-coated tablet N03AX23 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Brivaracetam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/403/005 PA0126/403/005 Brivaracetam Clonmel 100 mg film-coated tablets Clonmel Healthcare Ltd 28/03/2025 HM Not marketed AU Film-coated tablet N03AX23 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Brivaracetam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/403/002 PA0126/403/002 Brivaracetam Clonmel 25 mg film-coated tablets Clonmel Healthcare Ltd 28/03/2025 HM Not marketed AU Film-coated tablet N03AX23 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Brivaracetam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/403/003 PA0126/403/003 Brivaracetam Clonmel 50 mg film-coated tablets Clonmel Healthcare Ltd 28/03/2025 HM Not marketed AU Film-coated tablet N03AX23 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Brivaracetam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/403/004 PA0126/403/004 Brivaracetam Clonmel 75 mg film-coated tablets Clonmel Healthcare Ltd 28/03/2025 HM Not marketed AU Film-coated tablet N03AX23 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Brivaracetam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1073/021 EU/1/15/1073/021 Briviact 10 mg/ml oral solution UCB Pharma S.A. 14/01/2016 HM Unknown AU Oral solution N03AX23 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Brivaracetam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1073/022 EU/1/15/1073/022 Briviact 10 mg/ml solution for injection/infusion UCB Pharma S.A. 14/01/2016 HM Unknown AU Solution for injection/infusion N03AX23 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Brivaracetam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1073/001-004 EU/1/15/1073/001-004 Briviact 10 mg film-coated tablets UCB Pharma S.A. 14/01/2016 HM Unknown AU Film-coated tablet N03AX23 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Brivaracetam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1073/017-020 EU/1/15/1073/017-020 Briviact 100 mg film-coated tablets UCB Pharma S.A. 14/01/2016 HM Unknown AU Film-coated tablet N03AX23 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Brivaracetam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1073/005-008 EU/1/15/1073/005-008 Briviact 25 mg film-coated tablets UCB Pharma S.A. 14/01/2016 HM Unknown AU Film-coated tablet N03AX23 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Brivaracetam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1073/009-012 EU/1/15/1073/009-012 Briviact 50 mg film-coated tablets UCB Pharma S.A. 14/01/2016 HM Unknown AU Film-coated tablet N03AX23 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Brivaracetam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1073/013-016 EU/1/15/1073/013-016 Briviact 75 mg film-coated tablets UCB Pharma S.A. 14/01/2016 HM Unknown AU Film-coated tablet N03AX23 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Brivaracetam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/024/001 PA1122/024/001 Brodilaten 1.25 mg/2.5 ml Nebuliser solution Noridem Enterprises Limited 13/09/2019 HM Not marketed AU Nebuliser solution R03AC02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Salbutamol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1122/024/002 PA1122/024/002 IC0078-137-052 Brodilaten 2.5 mg/2.5 ml nebuliser solution Noridem Enterprises Limited 13/09/2019 HM Not marketed AU Nebuliser solution R03AC R03AC03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Salbutamol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1122/024/003 PA1122/024/003 IC0078-139-052 Brodilaten 5.0 mg/2.5 ml Nebuliser solution Noridem Enterprises Limited 13/09/2019 HM Not marketed AU Nebuliser solution R03AC R03AC02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Salbutamol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/357/001 PA0126/357/001 Brolene 0.1% w/v Eye Drops Solution Clonmel Healthcare Ltd 01/04/1983 HM Marketed AU Eye drops, solution S01AX S01AX15 Informed consent application (Article 10c of Directive No 2001/83/EC) Ocular use Propamidine isetionate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0126/357/002 PA0126/357/002 Brolene 0.15 % w/w Eye Ointment Clonmel Healthcare Ltd 01/04/1983 HM Marketed AU Eye ointment S01AX S01AX14 Informed consent application (Article 10c of Directive No 2001/83/EC) Ocular use Dibrompropamidine isetionate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/760/001-002 EU/1/12/760/001-002 Bronchitol 40 mg inhalation powder, hard capsules Pharmaxis Europe Limited 26/09/2012 HM Unknown AU Inhalation powder, hard capsule R05CB R05CB16 New active substance (Article 8(3) of Directive No 2001/83/EC) Inhalation use Mannitol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). TR2309/010/001 TR2309/010/001 Bronchoforce chesty cough oral drops A.Vogel Ireland Limited 27/02/2015 HM Marketed AU Oral drops, solution Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public TR2309/008/001 TR2309/008/001 Bronchosan dry, tickly cough syrup A.Vogel Ireland Limited 07/03/2014 HM Marketed AU Syrup Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23030/001/001 PA23030/001/001 Bronx Airmaster 50 microgram/100 microgram/ dose inhalation powder, pre-dispensed Neutec Inhaler Ireland Limited 03/04/2020 HM Unknown AU Inhalation powder, pre-dispensed R03AK06 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Salmeterol Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23030/001/002 PA23030/001/002 Bronx Airmaster 50 microgram/250 microgram/ dose inhalation powder, pre-dispensed Neutec Inhaler Ireland Limited 03/04/2020 HM Unknown AU Inhalation powder, pre-dispensed R03AK06 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Salmeterol Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23030/001/003 PA23030/001/003 Bronx Airmaster 50 microgram/500 microgram/ dose inhalation powder, pre-dispensed Neutec Inhaler Ireland Limited 03/04/2020 HM Unknown AU Inhalation powder, pre-dispensed R03AK06 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Salmeterol Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/012/001 PA23355/012/001 Brufen 400mg film-coated tablets Viatris Healthcare Limited 14/04/1975 HM Marketed AU Film-coated tablet M01AE M01AE01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/012/002 PA23355/012/002 Brufen 600mg film-coated tablets Viatris Healthcare Limited 01/06/1982 HM Marketed AU Film-coated tablet M01AE M01AE01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/012/003 PA23355/012/003 Brufen Paediatric 100 mg/5 ml Oral Suspension Viatris Healthcare Limited 02/03/1981 HM Marketed AU Oral suspension M01AE01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/012/004 PA23355/012/004 Brufen Retard 800mg prolonged release tablets Viatris Healthcare Limited 03/01/1990 HM Marketed AU Prolonged-release tablet M01AE M01AE01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1576/002 EU/1/21/1576/002 BRUKINSA 160 mg film-coated tablets BeiGene Ireland Limited 14/08/2025 HM Unknown AU Film-coated tablet L01EL03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Zanubrutinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1576/001 EU/1/21/1576/001 BRUKINSA 80 mg hard capsules BeiGene Ireland Limited 22/11/2021 HM Unknown AU Capsule, hard L01 L01EL03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Zanubrutinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0074/067/001 PA0074/067/001 Brupro 200mg Film-coated tablets Rowa Pharmaceuticals Limited, 13/03/2015 HM Marketed AU Film-coated tablet M01AE M01AE01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Subject to the following restriction: maximum strength 200 mg, maximum pack size 50, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children over 12 years. PA0074/067/006 PA0074/067/006 Brupro Cold & Flu 200 mg/30 mg film-coated tablets Rowa Pharmaceuticals Limited, 30/04/2021 HM Marketed AU Film-coated tablet R05X Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen PSEUDOEPHEDRINE HYDROCHLORIDE Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0074/067/004 PA0074/067/004 Brupro for Children 100 mg/5 ml oral suspension Rowa Pharmaceuticals Limited, 11/03/2022 HM Marketed AU Oral suspension M01AE01 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0074/067/005 PA0074/067/005 Brupro for Children Six Plus 200 mg/5 ml oral suspension Rowa Pharmaceuticals Limited, 11/03/2022 HM Marketed AU Oral suspension M01AE01 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0074/067/002 PA0074/067/002 Brupro Max 400mg Film-coated tablets Rowa Pharmaceuticals Limited 13/03/2015 HM Marketed AU Film-coated tablet M01AE M01AE01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Subject to the following restrictions: maximum strength 400 mg, maximum pack size 25, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children over 12 years. PA0074/067/003 PA0074/067/003 Brupro Rx 600mg Film-coated tablets Rowa Pharmaceuticals Limited 13/03/2015 HM Not marketed AU Film-coated tablet M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only HOR1149/007/001 HOR1149/007/001 Bryonia A. Nelson & Company Limited 29/10/2010 HM Not marketed AU Pillules Not Currently Available Oral use Bryonia cretica Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public EU/1/11/709/004 EU/1/11/709/004 BUCCOLAM 10 mg oromucosal solution Laboratorios Lesvi, S.L. 05/09/2011 HM Unknown AU Oromucosal solution N05CD N05CD08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oromucosal use Midazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. EU/1/11/709/001 EU/1/11/709/001 BUCCOLAM 2.5 mg oromucosal solution Laboratorios Lesvi, S.L. HM Unknown AU Oromucosal solution N05CD N05CD08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oromucosal use Midazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. EU/1/11/709/002 EU/1/11/709/002 BUCCOLAM 5 mg oromucosal solution Laboratorios Lesvi, S.L. 26/10/2011 HM Unknown AU Oromucosal solution N05CD N05CD08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oromucosal use Midazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. EU/1/11/709/003 EU/1/11/709/003 BUCCOLAM 7.5 mg oromucosal solution Laboratorios Lesvi, S.L. 05/09/2011 HM Unknown AU Oromucosal solution N05CD N05CD08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oromucosal use Midazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA0573/002/002 PA0573/002/002 Budenofalk 2mg/dose rectal foam Dr. Falk Pharma GmbH 05/06/2009 HM Marketed AU Rectal foam A07EA A07EA06 Full application (Article 8(3) of Directive No 2001/83/EC) Rectal use Budesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0573/002/001 PA0573/002/001 Budenofalk 3 mg gastro-resistant capsules Dr. Falk Pharma GmbH 06/04/2001 HM Marketed AU Gastro-resistant capsule, hard A07EA A07EA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Budesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0573/008/001 PA0573/008/001 Budenofalk 4 mg suppositories Dr. Falk Pharma GmbH 10/02/2023 HM Not marketed AU Suppository A07EA06 Full application (Article 8(3) of Directive No 2001/83/EC) Rectal use Budesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0573/002/003 PA0573/002/003 Budenofalk® 9mg gastro-resistant granules Dr. Falk Pharma GmbH 25/02/2011 HM Marketed AU Gastro-resistant granules A07EA A07EA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Budesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22871/035/001 PA22871/035/001 Budesonide Azure 0.5 mg/2 ml Nebuliser Suspension Azure Pharmaceuticals Ltd. 06/02/2026 HM Not marketed AU Nebuliser suspension R03BA02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Budesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22871/035/002 PA22871/035/002 Budesonide Azure 1 mg/2 ml Nebuliser Suspension Azure Pharmaceuticals Ltd. 06/02/2026 HM Not marketed AU Nebuliser suspension R03BA02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Budesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/207/002 PA0749/207/002 Budesonide Teva Pharma 0.5 mg/2 ml Nebuliser Suspension Teva Pharma B.V. 07/03/2014 HM Marketed AU Nebuliser suspension R03BA R03BA02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Budesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/207/003 PA0749/207/003 Budesonide Teva Pharma 1 mg/2 ml Nebuliser Suspension Teva Pharma B.V. 07/03/2014 HM Marketed AU Nebuliser suspension R03BA R03BA02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Budesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1327/015/002 PA1327/015/002 Bufomix Easyhaler 160 micrograms/4.5 micrograms/inhalation, inhalation powder Orion Corporation 11/04/2014 HM Marketed AU Inhalation powder R03AK R03AK07 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Budesonide Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1327/015/003 PA1327/015/003 Bufomix Easyhaler 320 micrograms/9 micrograms/inhalation, inhalation powder Orion Corporation 11/04/2014 HM Marketed AU Inhalation powder R03AK R03AK07 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Budesonide Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1327/015/004 PA1327/015/004 Bufomix Easyhaler 80 micrograms/4.5 micrograms/inhalation, inhalation powder Orion Corporation 29/04/2016 HM Marketed AU Inhalation powder R03AK R03AK07 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Budesonide Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/267/001 PA0281/267/001 Bulexin 2 mg/0.5 mg sublingual tablets Pinewood Laboratories Limited 20/12/2024 HM Marketed AU Sublingual tablet N07BC51 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Buprenorphine hydrochloride Naloxone hydrochloride dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. PA0281/267/002 PA0281/267/002 Bulexin 4 mg/1 mg sublingual tablets Pinewood Laboratories Limited 20/12/2024 HM Not marketed AU Sublingual tablet N07BC51 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Buprenorphine hydrochloride Naloxone hydrochloride dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. PA0281/267/003 PA0281/267/003 Bulexin 8 mg/2 mg sublingual tablets Pinewood Laboratories Limited 20/12/2024 HM Marketed AU Sublingual tablet N07BC51 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Buprenorphine hydrochloride Naloxone hydrochloride dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. PA2299/035/001 PA2299/035/001 Bupivacaine 2.5 mg/ml Solution for Injection Baxter Holding B.V. 03/09/2010 HM Not marketed AU Solution for injection N01BB N01BB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Epidural use Intraarticular use Perineural use Subcutaneous use Bupivacaine hydrochloride, monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/029/001 PA1122/029/001 Bupivacaine 2.5 mg/ml Solution for injection Noridem Enterprises Limited 14/05/2021 HM Not marketed AU Solution for injection N01BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Epidural use Infiltration Intraarticular use Bupivacaine hydrochloride, anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/029/002 PA1122/029/002 Bupivacaine 5 mg/ml Solution for injection Noridem Enterprises Limited 14/05/2021 HM Not marketed AU Solution for injection N01BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Epidural use Infiltration Intraarticular use Bupivacaine hydrochloride, anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/035/002 PA2299/035/002 Bupivacaine 5 mg/ml Solution for Injection Baxter Holding B.V. 03/09/2010 HM Marketed AU Solution for injection N01BB N01BB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Epidural use Intraarticular use Perineural use Subcutaneous use Bupivacaine hydrochloride, monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1968/025/001 PA1968/025/001 Bupivacaine Heavy 5 mg/ml solution for injection Laboratoire Aguettant 10/01/2025 HM Marketed AU Solution for injection N01BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intrathecal use Bupivacaine hydrochloride monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0073/091/001 PA0073/091/001 Bupivacaine Hydrochloride 0.25% w/v Solution for Injection Mercury Pharmaceuticals (Ireland) Ltd 21/01/1988 HM Marketed AU Solution for injection N01BB N01BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Epidural use Intraarticular use Bupivacaine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0073/091/002 PA0073/091/002 Bupivacaine Hydrochloride 0.5% w/v Solution for Injection Mercury Pharmaceuticals (Ireland) Ltd 21/01/1988 HM Marketed AU Solution for injection N01BB N01BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Epidural use Intraarticular use Bupivacaine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/116/001 PA1986/116/001 Buplex 200mg film-coated tablets Teva B.V. 03/07/2009 HM Marketed AU Film-coated tablet M01AE M01AE01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Subject to the following restriction: maximum strength 200 mg, maximum pack size 50, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. PA1986/116/002 PA1986/116/002 Buplex 400mg film-coated tablets Teva B.V. 03/07/2009 HM Marketed AU Film-coated tablet M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Subject to the following restrictions: maximum strength 400 mg, maximum pack size 25, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children over 12 years. PA1986/117/001 PA1986/117/001 Buplex Rx 200 mg film-coated tablets Teva B.V. 03/07/2009 HM Marketed AU Film-coated tablet M01AE M01AE01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/117/002 PA1986/117/002 Buplex Rx 400 mg film-coated tablets Teva B.V. 03/07/2009 HM Not marketed AU Film-coated tablet M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/117/003 PA1986/117/003 Buplex Rx 600 mg film-coated tablets Teva B.V. 03/07/2009 HM Not marketed AU Film-coated tablet M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1567/001/001 PA1567/001/001 Buprenorphine 0.4 mg Sublingual Tablets Activase Pharmaceuticals Limited 10/12/2010 HM Not marketed AU Sublingual tablet N07BC N07BC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Sublingual use Buprenorphine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA23142/003/001 PA23142/003/001 Buprenorphine 2 mg Sublingual Tablets Aspire Pharma (Malta) Limited 10/09/2010 HM Not marketed AU Sublingual tablet N02AE N02AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Buprenorphine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1567/001/002 PA1567/001/002 Buprenorphine 2 mg Sublingual Tablets Activase Pharmaceuticals Limited 10/12/2010 HM Not marketed AU Sublingual tablet N07BC N07BC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Sublingual use Buprenorphine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA23142/003/002 PA23142/003/002 Buprenorphine 8 mg Sublingual Tablets Aspire Pharma (Malta) Limited 10/09/2010 HM Not marketed AU Sublingual tablet N02AE N02AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Buprenorphine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1567/001/003 PA1567/001/003 Buprenorphine 8 mg Sublingual Tablets Activase Pharmaceuticals Limited 10/12/2010 HM Not marketed AU Sublingual tablet N07BC N07BC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Sublingual use Buprenorphine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/24/1809/001-003 EU/1/24/1809/001-003 Buprenorphine Neuraxpharm Laboratorios Lesvi, S.L. 19/12/2024 HM Unknown AU Sublingual film N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Buprenorphine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/24/1809/004-006 EU/1/24/1809/004-006 Buprenorphine Neuraxpharm Laboratorios Lesvi, S.L. 19/12/2024 HM Unknown AU Sublingual film N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Buprenorphine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/24/1809/007-009 EU/1/24/1809/007-009 Buprenorphine Neuraxpharm Laboratorios Lesvi, S.L. 19/12/2024 HM Unknown AU Sublingual film N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Buprenorphine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/24/1809/010-012 EU/1/24/1809/010-012 Buprenorphine Neuraxpharm Laboratorios Lesvi, S.L. 19/12/2024 HM Unknown AU Sublingual film N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Buprenorphine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. PA22650/001/001 PA22650/001/001 Burinex 1 mg Tablets Karo Pharma AB 01/04/1978 HM Marketed AU Tablet C03CA C03CA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bumetanide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22650/001/002 PA22650/001/002 Burinex 5 mg Tablets Karo Pharma AB 01/04/1978 HM Not marketed AU Tablet C03CA C03CA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bumetanide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23180/016/002 PA23180/016/002 Buscopan 10 mg Coated Tablets Opella Healthcare France SAS T/A Sanofi 01/04/1979 HM Marketed AU Coated tablet A03BB A03BB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Hyoscine butylbromide Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23180/016/001 PA23180/016/001 Buscopan Ampoules 20 mg/ml Solution for Injection Opella Healthcare France SAS T/A Sanofi 01/04/1979 HM Marketed AU Solution for injection A03BB A03BB01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Hyoscine butylbromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23180/022/001 PA23180/022/001 Buscopan Rx 10mg Coated Tablets Opella Healthcare France SAS T/A Sanofi 02/12/2016 HM Not marketed AU Coated tablet A03BB A03BB01 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Hyoscine butylbromide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/951/001 EU/1/14/951/001 Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion Fresenius Kabi Deutschland GmbH 22/09/2014 HM Unknown AU Concentrate for solution for infusion L01AB L01AB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Busulfan Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1688/002/002 PA1688/002/002 BuTrans 10 micrograms/hour transdermal patch Mundipharma Pharmaceuticals Limited 24/06/2005 HM Marketed AU Transdermal patch N02AE N02AE01 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1688/002/004 PA1688/002/004 BuTrans 15 microgram/hour transdermal patch Mundipharma Pharmaceuticals Limited 13/08/2015 HM Marketed AU Transdermal patch N02AE N02AE01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Transdermal use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1688/002/003 PA1688/002/003 BuTrans 20 micrograms/hour transdermal patch Mundipharma Pharmaceuticals Limited 24/06/2005 HM Marketed AU Transdermal patch N02AE N02AE01 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1688/002/001 PA1688/002/001 BuTrans 5 micrograms/hour transdermal patch Mundipharma Pharmaceuticals Limited 24/06/2005 HM Marketed AU Transdermal patch N02AE N02AE01 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. TR2006/001/002 TR2006/001/002 Buttercup Bronchostop Berry Flavour Cough Pastilles Kwizda Pharma GmbH 13/03/2015 HM Unknown AU Pastille R05CA R05CA10 Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public TR2006/001/001 TR2006/001/001 Buttercup Bronchostop Cough Syrup Kwizda Pharma GmbH 13/03/2015 HM Unknown AU Syrup R05CA R05CA10 Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public TR2006/002/001 TR2006/002/001 Buttercup Bronchostop Day & Night Oral Solution Kwizda Pharma GmbH 26/02/2021 HM Not marketed AU Oral solution R05X Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/18/1336/007 EU/1/18/1336/007 Buvidal 128 mg Prolonged-release solution for injection Camurus AB 20/11/2018 HM Unknown AU Prolonged-release solution for injection N07BC N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/18/1336/002 EU/1/18/1336/002 Buvidal 16 mg Prolonged-release solution for injection Camurus AB 20/11/2018 HM Unknown AU Prolonged-release solution for injection N07BC N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/18/1336/009 EU/1/18/1336/009 Buvidal 160 mg Prolonged-release solution for injection Camurus AB 20/08/2018 HM Unknown AU Prolonged-release solution for injection N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/18/1336/003 EU/1/18/1336/003 Buvidal 24 mg Prolonged-release solution for injection Camurus AB 20/11/2018 HM Unknown AU Prolonged-release solution for injection N07BC N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/18/1336/004 EU/1/18/1336/004 Buvidal 32 mg Prolonged-release solution for injection Camurus AB 20/11/2018 HM Unknown AU Prolonged-release solution for injection N07BC N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/18/1336/005 EU/1/18/1336/005 Buvidal 64 mg Prolonged-release solution for injection Camurus AB 20/11/2018 HM Unknown AU Prolonged-release solution for injection N07BC N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/18/1336/001 EU/1/18/1336/001 Buvidal 8 mg Prolonged-release solution for injection Camurus AB 20/11/2018 HM Unknown AU Prolonged-release solution for injection N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/18/1336/006 EU/1/18/1336/006 Buvidal 96 mg Prolonged-release solution for injection Camurus AB 20/11/2018 HM Unknown AU Prolonged-release solution for injection N07BC N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/20/1453/008 EU/1/20/1453/008 BYANNLI 1 000 mg prolonged-release suspension for injection in pre-filled syringe Janssen-Cilag International NV 22/11/2021 HM Unknown AU Prolonged-release suspension for injection N05AX13 Informed consent application (Article 10c of Directive No 2001/83/EC) Intramuscular use Paliperidone palmitate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1453/007 EU/1/20/1453/007 BYANNLI 700 mg prolonged-release suspension for injection in pre-filled syringe Janssen-Cilag International NV 22/11/2021 HM Unknown AU Prolonged-release suspension for injection N05AX13 Informed consent application (Article 10c of Directive No 2001/83/EC) Intramuscular use Paliperidone palmitate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/696/001-004 EU/1/11/696/001-004 Bydureon 2 mg powder and solvent for prolonged-release suspension for injection AstraZeneca AB HM Unknown AU Powder and solvent for prolonged-release suspension for injection in pre-filled pen A10BX A10BX04 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Exenatide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/696/005-006 EU/1/11/696/005-006 Bydureon 2 mg prolonged-release suspension for injection in pre-filled pen AstraZeneca AB 27/08/2018 HM Unknown AU Prolonged-release suspension for injection in pre-filled pen A10BJ01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Exenatide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/362/3-4 EU/1/06/362/3-4 BYETTA 10 micrograms Solution for injection AstraZeneca AB 20/11/2006 HM Unknown AU Solution for injection in pre-filled pen A10BJ01 Full application (Article 8(3) of Directive No 2001/83/EC) Exenatide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/362/1-2 EU/1/06/362/1-2 BYETTA 5 micrograms Solution for injection AstraZeneca AB HM Unknown AU Solution for injection in pre-filled pen A10BJ01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Exenatide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1505/001 EU/1/20/1505/001 Byfavo 20 mg powder for solution for injection Paion Pharma GmbH 26/03/2021 HM Unknown AU Powder for solution for injection N05CD Known active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Remimazolam besilate Remimazolam (in house) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1505/002 EU/1/20/1505/002 Byfavo 50 mg powder for concentrate for solution for injection/infusion Paion Pharma GmbH 31/03/2023 HM Unknown AU Powder for concentrate for solution for injection/infusion N05CD14 Known active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Remimazolam besilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/21/1566/004 EU/1/21/1566/004 Bylvay 1 200 micrograms hard capsules Ipsen Pharma 16/07/2021 HM Unknown AU Capsule, hard A05AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Odevixibat sesquihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1566/001 EU/1/21/1566/001 Bylvay 200 micrograms hard capsules Ipsen Pharma 16/07/2021 HM Unknown AU Capsule, hard A05AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Odevixibat sesquihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1566/002 EU/1/21/1566/002 Bylvay 400 micrograms hard capsules Ipsen Pharma 16/07/2021 HM Unknown AU Capsule, hard A05AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Odevixibat sesquihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1566/003 EU/1/21/1566/003 Bylvay 600 micrograms hard capsules Ipsen Pharma 16/07/2021 HM Unknown AU Capsule, hard A05AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Odevixibat sesquihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1572/001 EU/1/21/1572/001 Byooviz 10 mg/ml solution for injection Samsung Bioepis NL B.V. 18/08/2021 HM Unknown AU Solution for injection S01LA04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravitreal use Ranibizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0822/114/001 PA0822/114/001 Cabaser 1 mg Tablet Pfizer Healthcare Ireland Unlimited Company 29/10/1999 HM Marketed AU Tablet N04BC N04BC06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Cabergoline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1448/001 EU/1/20/1448/001 Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion Accord Healthcare S.L.U. 28/08/2020 HM Unknown AU Concentrate for solution for infusion L01CD04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Cabazitaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA1774/004/001 PA1774/004/001 Cabazitaxel EVER Pharma 10 mg/ml concentrate for solution for infusion EVER Valinject GmbH 11/12/2020 HM Marketed AU Concentrate for solution for infusion L01CD04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Cabazitaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA2059/082/001 PA2059/082/001 Cabazitaxel Fresenius Kabi 20 mg/ml concentrate for solution for infusion Fresenius Kabi Deutschland GmbH 06/01/2023 HM Not marketed AU Concentrate for solution for infusion L01CD04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Cabazitaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA23250/002/001 PA23250/002/001 Cabazitaxel MSN 60 mg concentrate and solvent for solution for infusion MSN Labs Europe Limited 28/01/2022 HM Not marketed AU Concentrate and solvent for solution for infusion L01CD04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cabazitaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA22865/011/001 PA22865/011/001 Cabergoline 1 mg Tablets Renata Pharmaceuticals (Ireland) Limited 13/10/2023 HM Not marketed AU Tablet N04BC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cabergoline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22865/011/002 PA22865/011/002 Cabergoline 2 mg Tablets Renata Pharmaceuticals (Ireland) Limited 13/10/2023 HM Not marketed AU Tablet N04BC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cabergoline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22865/014/001 PA22865/014/001 Cabergoline 500 micrograms Tablets Renata Pharmaceuticals (Ireland) Limited 11/10/2024 HM Not marketed AU Film-coated tablet G02CB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cabergoline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/18/1305/001 EU/1/18/1305/001 Cablivi 10 mg Powder and solvent for solution for injection Ablynx HM Unknown AU Powder and solvent for solution for injection B01AX07 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use caplacizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1136/001-002 EU/1/16/1136/001-002 CABOMETYX 20 mg film-coated tablets Ipsen Pharma HM Unknown AU Film-coated tablet L01XE L01XE26 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Cabozantinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1136/003-004 EU/1/16/1136/003-004 CABOMETYX 40 mg film-coated tablets Ipsen Pharma 09/09/2016 HM Unknown AU Film-coated tablet L01XE L01XE26 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Cabozantinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1136/005-006 EU/1/16/1136/005-006 CABOMETYX 60 mg film-coated tablets Ipsen Pharma 09/09/2016 HM Unknown AU Film-coated tablet L01XE L01XE26 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Cabozantinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2102/002/001 PA2102/002/001 Cadelius 600 mg/1000 IU ordispersible tablet Italfarmaco S.A. 13/04/2017 HM Marketed AU Orodispersible tablet A12AX Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Calcium carbonate Cholecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2102/002/002 PA2102/002/002 Cadelius 600 mg/2000 IU orodispersible tablets Italfarmaco S.A. 25/08/2020 HM Not marketed AU Orodispersible tablet A12AX Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Calcium carbonate Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/96/011/001-004 EU/1/96/011/001-004 Caelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion Baxter Holding B.V. 21/06/1996 HM Unknown AU Concentrate for solution for infusion L01DB L01DB01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use DOXORUBICIN HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA0206/016/002 PA0206/016/002 Calamine Lotion, cutaneous suspension Ovelle Limited 14/10/1992 HM Marketed AU Cutaneous suspension D02AB Well-established use application (Article 10a of Directive No 2001/83/EC) Topical use Zinc oxide Calamine Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to healthcare professionals only PA1418/018/001 PA1418/018/001 Calasu 2 mg prolonged-release tablets Athlone Pharmaceuticals Limited 14/08/2026 HM Unknown AU Prolonged-release tablet N05CH01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Melatonin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2239/013/001 PA2239/013/001 Calcichew 500 mg chewable tablets CHEPLAPHARM Arzneimittel GmbH 20/12/1993 HM Marketed AU Chewable tablet A12AA A12AA04 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Calcium carbonate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PPA0465/156/001 PPA0465/156/001 Calcichew 500 mg chewable tablets PCO Manufacturing Ltd. 02/12/2005 HM Unknown AU Chewable tablet A12AA A12AA04 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Calcium Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PPA1463/218/001 PPA1463/218/001 Calcichew 500 mg Chewable Tablets IMED Healthcare Ltd., 14/06/2024 HM Unknown AU Chewable tablet A12AA04 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Calcium carbonate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA2239/013/002 PA2239/013/002 Calcichew-D3 Forte 500 mg/400 IU Chewable Tablets CHEPLAPHARM Arzneimittel GmbH 10/10/1996 HM Marketed AU Chewable tablet A12AX Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cholecalciferol Calcium carbonate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PPA0465/156/003 PPA0465/156/003 Calcichew-D3 Forte 500 mg/400 IU Chewable Tablets PCO Manufacturing Ltd. 28/10/2022 HM Unknown AU Chewable tablet A12AA04 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Calcium carbonate Colecalciferol Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA2239/013/003 PA2239/013/003 Calcichew-D3 Forte Double Strength 1000 mg/800 IU Chewable Tablets CHEPLAPHARM Arzneimittel GmbH 11/12/2009 HM Marketed AU Chewable tablet A12AX Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Calcium carbonate Cholecalciferol concentrate (powder form) Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PPA0465/156/004 PPA0465/156/004 Calcichew-D3 Forte Double Strength 1000 mg/800 IU Chewable Tablets PCO Manufacturing Ltd. 03/10/2025 HM Unknown AU Chewable tablet A12AX Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Calcium carbonate Cholecalciferol concentrate (powder form) Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0864/003/001 PA0864/003/001 Calcifediol Faes 72 microgram soft capsules Faes Farma S.A. 23/08/2024 HM Not marketed AU Capsule, soft A11CC06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Calcifediol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1983/005/001 PA1983/005/001 Calcipotriol/Betamethasone 50 microgram/g + 0.5 mg/g gel Aristo Pharma GmbH 18/06/2021 HM Marketed AU Gel D05AX52 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Betamethasone Calcipotriol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/254/001 PA0711/254/001 Calcipotriol/Betamethasone Rowex 50 microgram/g + 0.5 mg/g Ointment Rowex Limited, 29/01/2016 HM Marketed AU Ointment D05AX D05AX52 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Calcipotriol Betamethasone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/063/001 PA0281/063/001 Calcium Acetate 500mg Tablets Pinewood Laboratories Ltd 23/01/1998 HM Not marketed AU Tablet A12AA A12AA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Calcium acetate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/141/001 PA0540/141/001 Calcium Resonium 99.934% Powder for oral or rectal suspension Sanofi-Aventis Ireland Limited T/A SANOFI 01/04/1983 HM Marketed AU Powder for oral/rectal suspension V03AE V03AE01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rectal use Calcium polystyrene sulphonate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/217/002 PA0711/217/002 Calciup D3 500 mg/440 IU chewable tablet Rowex Ltd 01/08/2014 HM Not marketed AU Chewable tablet A12AX Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Calcium carbonate Cholecalciferol concentrate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0711/217/001 PA0711/217/001 Calciup D3 Forte 1000mg/880 IU Chewable Tablets Rowex Limited, 17/02/2012 HM Marketed AU Chewable tablet A12AX Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Calcium Colecalciferol Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0126/153/001 PA0126/153/001 Caldease 15% w/w Medicated Ointment Clonmel Healthcare Ltd 08/01/1985 HM Marketed AU Ointment D02AB Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Zinc oxide Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA0126/152/001 PA0126/152/001 Caldesene 10% w/w Medicated Powder Clonmel Healthcare Ltd 03/04/1977 HM Marketed AU Cutaneous powder D01AE D01AE54 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Calcium undecylenate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA0126/247/001 PA0126/247/001 Caldesene Adult 10% w/w Medicated Powder Clonmel Healthcare Ltd 14/03/2014 HM Marketed AU Cutaneous powder D01AE D01AE04 Informed consent application (Article 10c of Directive No 2001/83/EC) Topical Calcium undecylenate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA22743/003/001 PA22743/003/001 Calmurid HC 10%/5%/1% w/w Cream Galderma International 01/04/1978 HM Not marketed AU Cream D07XA D07XA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Cutaneous use Hydrocortisone Urea Lactic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23490/003/004 PA23490/003/004 Calpol 120 mg/ 5 ml Sugar Free Infant Oral Suspension JNTL Consumer Health I (Ireland) Limited 22/03/1993 HM Marketed AU Oral suspension N02BE N02BE01 ZZZ --Unknown-- Oral use Paracetamol Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General sale in child resistant packs containing not more than 60ml of the 120mg/5ml unit dosage form. Only one pack should be supplied in the course of any one retail transaction. Retail sale through pharmacies only in child resistant packs containing PA23490/003/001 PA23490/003/001 Calpol 120 mg/5 ml Infant Oral Suspension JNTL Consumer Health I (Ireland) Limited 01/04/1993 HM Marketed AU Oral suspension N02BE N02BE01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Paracetamol Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General Sale: MAXIMUM PACK SIZE 60ml. Maximum one pack per sale.Contains only paracetamol as analgesic. Pharmacy only: MAXIMUM PACK SIZE 140ml. Maximum two packs per sale. Promotion to the public: Pack size not more than 140ml PA23490/003/002 PA23490/003/002 Calpol Six Plus 250 mg/5 ml Oral Suspension JNTL Consumer Health I (Ireland) Limited 25/01/1995 HM Not marketed AU Oral suspension N02BE N02BE01 Not Currently Available Oral use Paracetamol Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General Sale: MAXIMUM PACK SIZE 60ml. Maximum one pack per sale.Contains only paracetamol as analgesic. Pharmacy only: MAXIMUM PACK SIZE 140ml for product for children aged 6 – 12 years. MAXIMUM PACK SIZE 240ml if not for use in under 12’s. Maximum two p PA23490/003/003 PA23490/003/003 Calpol Six Plus 250 mg/5 ml Sugar/Colour Free Oral Suspension JNTL Consumer Health I (Ireland) Limited 14/10/1994 HM Marketed AU Oral suspension N02BE N02BE01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Paracetamol Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General Sale: MAXIMUM PACK SIZE 60ml. Maximum one pack per sale.Contains only paracetamol as analgesic. Pharmacy only: MAXIMUM PACK SIZE 140ml for product for children aged 6 – 12 years. MAXIMUM PACK SIZE 240ml if not for use in under 12’s. Maximum two p PA23490/003/005 PA23490/003/005 Calpol Six Plus Fastmelts 250 mg Paracetamol orodispersible tablets JNTL Consumer Health I (Ireland) Limited 23/02/2001 HM Marketed AU Orodispersible tablet N02BE N02BE01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Paracetamol Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public None EU/1/20/1479/001-002 EU/1/20/1479/001-002 Calquence 100 mg hard capsules AstraZeneca AB 05/11/2020 HM Unknown AU Capsule, hard L01XE L01XE51 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Acalabrutinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1479/001-004 EU/1/20/1479/001-004 Calquence film-coated tablets AstraZeneca AB 20/02/2023 HM Unknown AU Film-coated tablet L01 L01EL02 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Acalabrutinib maleate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1350/006/001 PA1350/006/001 Calrecia 100 mmol/l, solution for infusion Fresenius Medical Care Deutschland GmbH 12/04/2019 HM Marketed AU Solution for infusion B05XA B05XA07 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Calcium chloride dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0678/156/001 PA0678/156/001 Caltrate 600 mg/400 IU, Film-coated Tablets Haleon Ireland Limited 24/04/2009 HM Marketed AU Film-coated tablet A12AX Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Calcium Cholecalciferol concentrate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0126/137/003 PA0126/137/003 Calvepen 250 mg/5 ml Powder for Oral Suspension Clonmel Healthcare Ltd 20/01/1986 HM Marketed AU Powder for oral suspension J01CE J01CE02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use PHENOXYMETHYLPENICILLIN CALCIUM Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/137/001 PA0126/137/001 Calvepen 333 mg Tablets Clonmel Healthcare Ltd 01/04/1977 HM Marketed AU Film-coated tablet J01CE J01CE02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use PHENOXYMETHYLPENICILLIN CALCIUM Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/137/002 PA0126/137/002 Calvepen 666 mg Tablets Clonmel Healthcare Ltd 01/04/1977 HM Marketed AU Film-coated tablet J01CE J01CE02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use PHENOXYMETHYLPENICILLIN CALCIUM Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1647/002 EU/1/22/1647/002 CAMCEVI 21 mg prolonged-release suspension for injection Accord Healthcare S.L.U. 20/04/2026 HM Unknown AU Prolonged-release suspension for injection L02AE02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Leuprorelin mesilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1647/001 EU/1/22/1647/001 CAMCEVI 42 mg prolonged-release suspension for injection Accord Healthcare S.L.U. 24/06/2022 HM Unknown AU Prolonged-release suspension for injection L02AE02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Leuprorelin Mesilate Leuprorelin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22644/001/001 PA22644/001/001 CAMCOLIT 250 mg film-coated tablets Essential Pharma (M) Limited 19/09/2014 HM Not marketed AU Film-coated tablet N05AN N05AN01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Lithium carbonate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22644/001/002 PA22644/001/002 CAMCOLIT 400 mg film-coated tablets Essential Pharma (M) Limited 19/09/2014 HM Not marketed AU Film-coated tablet N05AN N05AN01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Lithium carbonate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/177/001 PPA1463/177/001 Campral EC 333 mg Gastro-resistant tablets IMED Healthcare Ltd., 02/07/2021 HM Unknown AU Gastro-resistant tablet N07BB N07BB03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Acamprosate calcium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2286/007/001 PA2286/007/001 Campral EC 333mg Gastro-resistant tablets Merck Serono (Ireland) Limited 16/02/1996 HM Marketed AU Gastro-resistant tablet N07BB N07BB03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Acamprosate calcium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/504/001 PPA0465/504/001 Campral EC 333mg Gastro-resistant tablets PCO Manufacturing Ltd. 26/01/2024 HM Unknown AU Gastro-resistant tablet N07BB03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Acamprosate calcium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0822/212/001 PA0822/212/001 CAMPTO 20 mg/mL concentrate for solution for infusion Pfizer Healthcare Ireland Unlimited Company 15/02/2008 HM Not marketed AU Concentrate for solution for infusion L01XX19 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Irinotecan hydrochloride trihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1716/005-006/011 EU/1/23/1716/005-006/011 Camzyos 10 mg Capsule hard Bristol-Myers Squibb Pharma EEIG 26/06/2023 HM Unknown AU Capsule, hard C01EB C01EB24 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Mavacamten Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/23/1716/007-008/012 EU/1/23/1716/007-008/012 Camzyos 15 mg Capsule hard Bristol-Myers Squibb Pharma EEIG 26/06/2023 HM Unknown AU Capsule, hard C01EB C01EB24 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Mavacamten Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/23/1716/001-002/009 EU/1/23/1716/001-002/009 Camzyos 2.5 mg Capsule hard Bristol-Myers Squibb Pharma EEIG 26/06/2023 HM Unknown AU Capsule, hard C01EB C01EB24 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Mavacamten Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/23/1716/003-004/010 EU/1/23/1716/003-004/010 Camzyos 5 mg Capsule hard Bristol-Myers Squibb Pharma EEIG 26/06/2023 HM Unknown AU Capsule, hard C01EB C01EB24 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Mavacamten Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/01/196/001 EU/1/01/196/001 Cancidas 50 mg powder for concentrate for solution for infusion Merck Sharp & Dohme BV 24/10/2001 HM Unknown AU Powder for concentrate for solution for infusion J02AX J02AX04 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Caspofungin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/01/196/003 EU/1/01/196/003 Cancidas 70 mg powder for concentrate for solution for infusion Merck Sharp & Dohme BV 24/10/2001 HM Unknown AU Powder for concentrate for solution for infusion J02AX J02AX04 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Caspofungin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA2315/150/003 PA2315/150/003 IC0009-038-002 Candesartan 16 mg tablets Accord Healthcare Ireland Ltd. 15/04/2011 HM Marketed AU Tablet C09CA C09CA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/150/001 PA2315/150/001 IC0009-008-002 Candesartan 4 mg Tablets Accord Healthcare Ireland Ltd. 15/04/2011 HM Marketed AU Tablet C09CA C09CA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/150/002 PA2315/150/002 IC0009-009-002 Candesartan 8 mg tablets Accord Healthcare Ireland Ltd. 15/04/2011 HM Marketed AU Tablet C09CA C09CA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/399/003 PA0126/399/003 IC0009-038-002 Candesartan Clonmel 16 mg tablets Clonmel Healthcare Ltd 31/01/2025 HM Marketed AU Tablet C09CA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/399/001 PA0126/399/001 IC0009-008-002 Candesartan Clonmel 4 mg tablets Clonmel Healthcare Ltd 31/01/2025 HM Marketed AU Tablet C09CA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/399/002 PA0126/399/002 IC0009-009-002 Candesartan Clonmel 8 mg tablets Clonmel Healthcare Ltd 31/01/2025 HM Marketed AU Tablet C09CA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/011/002 PA1347/011/002 IC0029-036-002 Candesartan Hydrochlorothiazide Krka 16mg/12.5mg tablets KRKA, d.d., Novo mesto 12/08/2011 HM Marketed AU Tablet C09DA C09DA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/011/003 PA1347/011/003 IC0029-035-002 Candesartan Hydrochlorothiazide Krka 32mg/12.5mg tablets KRKA, d.d., Novo mesto 12/08/2011 HM Not marketed AU Tablet C09DA C09DA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/011/004 PA1347/011/004 IC0029-034-002 Candesartan Hydrochlorothiazide Krka 32mg/25mg Tablets KRKA, d.d., Novo mesto 12/08/2011 HM Not marketed AU Tablet C09DA C09DA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/011/001 PA1347/011/001 IC0029-058-002 Candesartan Hydrochlorothiazide Krka 8mg/12.5mg tablets KRKA, d.d., Novo mesto 12/08/2011 HM Not marketed AU Tablet C09DA C09DA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/026/003 PA1347/026/003 IC0009-038-002 Candesartan Krka 16 mg tablets KRKA, d.d., Novo mesto 09/03/2012 HM Marketed AU Tablet C09CA C09CA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/026/004 PA1347/026/004 IC0009-037-002 Candesartan Krka 32 mg Tablets KRKA, d.d., Novo mesto 09/03/2012 HM Not marketed AU Tablet C09CA C09CA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/026/001 PA1347/026/001 IC0009-008-002 Candesartan Krka 4 mg tablets KRKA, d.d., Novo mesto 09/03/2012 HM Marketed AU Tablet C09CA C09CA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/026/002 PA1347/026/002 IC0009-009-002 Candesartan Krka 8 mg tablets KRKA, d.d., Novo mesto 09/03/2012 HM Marketed AU Tablet C09CA C09CA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/206/003 PA0126/206/003 IC0009-038-002 Candist 16 mg Tablets Clonmel Healthcare Ltd 23/09/2011 HM Not marketed AU Tablet C09CA C09CA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/206/001 PA0126/206/001 IC0009-008-002 Candist 4 mg Tablets Clonmel Healthcare Ltd 23/09/2011 HM Not marketed AU Tablet C09CA C09CA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/206/002 PA0126/206/002 IC0009-009-002 Candist 8 mg Tablets Clonmel Healthcare Ltd 23/09/2011 HM Not marketed AU Tablet C09CA C09CA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/207/002 PA0126/207/002 IC0029-036-002 Candist Plus 16 mg/12.5 mg Tablets Clonmel Healthcare Ltd 21/10/2011 HM Marketed AU Tablet C09DA C09DA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1113/013/001 PA1113/013/001 IC0151-062-001 Caneclear 150 mg hard capsule Phoenix Labs 18/12/2012 HM Not marketed AU Capsule, hard J02AC J02AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fluconazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1410/083/001 PA1410/083/001 Canespor 10 mg/g cream Bayer Limited 09/03/2018 HM Not marketed AU Cream D01AC D01AC10 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Bifonazole Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PPA0465/048/001 PPA0465/048/001 Canesten 10 mg/g Cream PCO Manufacturing Ltd. 14/04/2000 HM Unknown AU Cream D01AC D01AC01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Topical use Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1410/039/007 PA1410/039/007 Canesten 100 mg Pessary Bayer Limited 01/04/1977 HM Not marketed AU Pessary G01AF G01AF02 Full application (Article 8(3) of Directive No 2001/83/EC) Not Currently Available Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1410/039/008 PA1410/039/008 Canesten 200 mg Pessary Bayer Limited 10/10/1979 HM Not marketed AU Pessary G01AF G01AF02 Full application (Article 8(3) of Directive No 2001/83/EC) Vaginal use Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1410/039/009 PA1410/039/009 Canesten 500 mg Pessary Bayer Limited 14/03/1983 HM Marketed AU Pessary G01AF G01AF02 Full application (Article 8(3) of Directive No 2001/83/EC) Vaginal use Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PPA0465/048/002 PPA0465/048/002 Canesten 500 mg Pessary. PCO Manufacturing Ltd. 03/03/2006 HM Unknown AU Pessary G01AF02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Vaginal use Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA1410/039/010 PA1410/039/010 Canesten 500 mg Soft Vaginal Capsule Bayer Limited 12/12/2014 HM Not marketed AU Vaginal capsule, soft G01AF G01AF02 Full application (Article 8(3) of Directive No 2001/83/EC) Vaginal use Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA1410/039/013 PA1410/039/013 Canesten Athlete’s Foot Cream Bayer Limited 20/02/2015 HM Not marketed AU Cream D01AC D01AC01 Informed consent application (Article 10c of Directive No 2001/83/EC) Topical Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1410/039/001 PA1410/039/001 Canesten Combi Pessary & Cream Bayer Limited 24/08/2001 HM Marketed AU Cream + pessary G01AF G01AF02 Full application (Article 8(3) of Directive No 2001/83/EC) Vaginal use Clotrimazole Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA1410/039/014 PA1410/039/014 Canesten Combi Soft Vaginal Capsule & Cream 500 mg Soft Vaginal Capsule and 2 % w/w Cream Bayer Limited 24/03/2016 HM Marketed AU Cream + vaginal capsule, soft G01AF G01AF02 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Vaginal use Clotrimazole Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA1410/039/002 PA1410/039/002 Canesten Cream Bayer Limited 01/04/1977 HM Marketed AU Cream D01AC D01AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1410/039/003 PA1410/039/003 Canesten Cream Combi Internal & External Creams Bayer Limited 28/07/2006 HM Not marketed AU Vaginal cream G01AF G01AF02 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Vaginal use Clotrimazole Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1410/039/005 PA1410/039/005 Canesten Duopak Bayer Limited 01/04/1977 HM Not marketed AU Cream + pessary G01AF G01AF02 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Vaginal use Clotrimazole Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1410/040/002 PA1410/040/002 Canesten HC 1% w/w + 1% w/w Cream Bayer Limited 29/06/2018 HM Unknown AU Cream D01AC D01AC20 Full application (Article 8(3) of Directive No 2001/83/EC) Topical Clotrimazole HYDROCORTISONE ACETATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1410/040/001 PA1410/040/001 Canesten HC CreamClotrimazole 1.0% w/w Hydrocortisone 1.0% w/w Bayer Limited 15/08/1984 HM Marketed AU Cream D01AC D01AC20 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Clotrimazole Hydrocortisone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1410/039/006 PA1410/039/006 Canesten Internal Cream Bayer Limited 19/05/1986 HM Not marketed AU Vaginal cream G01AF G01AF02 Full application (Article 8(3) of Directive No 2001/83/EC) Vaginal use Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1410/039/012 PA1410/039/012 Canesten Thrush Cream Bayer Limited 02/03/1981 HM Marketed AU Vaginal cream G01AF G01AF02 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PPA0465/048/004 PPA0465/048/004 Canesten Thrush Cream PCO Manufacturing Ltd. 07/05/2010 HM Unknown AU Vaginal cream G01AF02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Cutaneous use Topical Topical use Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PPA1463/226/001 PPA1463/226/001 Canesten Thrush Cream IMED Healthcare Ltd. 31/05/2024 HM Unknown AU Vaginal cream G01AF G01AF02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Topical use Clotrimazole Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA1410/041/001 PA1410/041/001 IC0151-062-001 CanOral 150 mg capsule Bayer Limited 15/04/2005 HM Not marketed AU Capsule, hard J02AC J02AC01 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Fluconazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23128/008/001 PA23128/008/001 Capasal Therapeutic Shampoo Dermal Laboratories (Ireland) Limited 10/01/1991 HM Marketed AU Shampoo D05AA Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Salicylic acid Coconut oil Coal tar Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/12/762/001-006 EU/1/12/762/001-006 IC0079-062-003 Capecitabine Accord 150 mg film-coated tablets Accord Healthcare S.L.U. HM Unknown AU Film-coated tablet L01BC L01BC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Capecitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/762/007-012 EU/1/12/762/007-012 IC0079-029-003 Capecitabine Accord 300 mg film-coated tablets Accord Healthcare S.L.U. 20/04/2012 HM Unknown AU Film-coated tablet L01BC L01BC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Capecitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/762/013-018 EU/1/12/762/013-018 IC0079-117-003 Capecitabine Accord 500 mg film-coated tablets Accord Healthcare S.L.U. 20/04/2012 HM Unknown AU Film-coated tablet L01BC L01BC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Capecitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/802/001-014 EU/1/12/802/001-014 IC0079-062-003 Capecitabine medac 150 mg film-coated tablets medac Gesellschaft für klinische Spezialpräparate mbH 19/11/2012 HM Unknown AU Film-coated tablet L01BC L01BC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Capecitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/802/029-042 EU/1/12/802/029-042 IC0079-117-003 Capecitabine medac 500 mg film-coated tablets medac Gesellschaft für klinische Spezialpräparate mbH HM Unknown AU Film-coated tablet L01BC L01BC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Capecitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/761/001 EU/1/12/761/001 IC0079-062-003 Capecitabine Teva 150 mg film-coated tablets Teva B.V. HM Unknown AU Film-coated tablet L01BC L01BC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Capecitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/761/002 EU/1/12/761/002 IC0079-117-003 Capecitabine Teva 500 mg film-coated tablets Teva B.V. 20/04/2012 HM Unknown AU Film-coated tablet L01BC L01BC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Capecitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/11/749/001 EU/1/11/749/001 Caprelsa 100 mg film-coated tablets Esteve Pharmaceuticals S.A. 17/02/2012 HM Unknown AU Film-coated tablet L01XE L01XE12 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Vandetanib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/11/749/002 EU/1/11/749/002 Caprelsa 300 mg film-coated tablets Esteve Pharmaceuticals S.A. HM Unknown AU Film-coated tablet L01XE L01XE12 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Vandetanib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0281/268/001 PA0281/268/001 Caprin 75 mg gastro-resistant tablets Pinewood Laboratories Limited 31/05/2024 HM Marketed AU Gastro-resistant tablet B01AC06 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Acetylsalicylic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1913/001-006 EU/1/25/1913/001-006 CAPVAXIVE solution for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (21-valent) Merck Sharp & Dohme BV, 24/03/2025 HM Unknown AU Solution for injection in pre-filled syringe J07AL02 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Pneumococcal Polysaccharide Serotype 3 Conjugated to CRM197 Pneumococcal Polysaccharide Serotype 6A Conjugated to CRM197 Pneumococcal polysaccharide serotype 7F conjugated to CRM197 Pneumococcal polysaccharide serotype 8 conjugated to CRM197 Pneumococcal polysaccharide serotype 9N conjugated to CRM197 Pneumococcal polysaccharide serotype 10A conjugated to CRM197 Pneumococcal polysaccharide serotype 11A conjugated to CRM197 Pneumococcal polysaccharide serotype 12F conjugated to CRM197 Pneumococcal polysaccharide serotype 15A conjugated to CRM197 Pneumococcal polysaccharide serotype 15B de-O-acetylated conjugated to CRM197 Pneumococcal polysaccharide serotype 16F conjugated to CRM197 Pneumococcal polysaccharide serotype 17F conjugated to CRM197 Pneumococcal Polysaccharide Serotype 19A Conjugated to CRM197 Pneumococcal polysaccharide serotype 20A conjugated to CRM197 Pneumococcal Polysaccharide Serotype 22F Conjugated to CRM197 Pneumococcal polysaccharide serotype 23B conjugated to CRM197 Pneumococcal polysaccharide serotype 24F conjugated to CRM197 Pneumococcal polysaccharide serotype 31 conjugated to CRM197 Pneumococcal Polysaccharide Serotype 33F Conjugated to CRM197 Pneumococcal polysaccharide serotype 35B conjugated to CRM197 Pneumococcal polysaccharide serotype 23A conjugated to CRM197 Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. EU/1/02/246/1-2 EU/1/02/246/1-2 Carbaglu 200 mg dispersible tablets Recordati Rare Diseases HM Unknown AU Dispersible tablet A16AA A16AA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Carglumic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA22871/010/001 PA22871/010/001 Carbamazepine 100 mg Tablets Azure Pharmaceuticals Ltd. 30/10/2020 HM Not marketed AU Tablet N03AF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carbamazepine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22871/010/002 PA22871/010/002 Carbamazepine 200 mg Tablets Azure Pharmaceuticals Ltd. 30/10/2020 HM Not marketed AU Tablet N03AF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carbamazepine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22871/010/003 PA22871/010/003 Carbamazepine 400 mg Tablets Azure Pharmaceuticals Ltd. 30/10/2020 HM Not marketed AU Tablet N03AF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carbamazepine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22644/003/001 PA22644/003/001 Carbamazepine Essential Pharma 125 mg Suppositories Essential Pharma (M) Limited 13/05/2016 HM Not marketed AU Suppository N03AF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Rectal use Carbamazepine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22644/003/002 PA22644/003/002 Carbamazepine Essential Pharma 250 mg Suppositories Essential Pharma (M) Limited 13/05/2016 HM Not marketed AU Suppository N03AF N03AF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Rectal use Carbamazepine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1789/007/002 PA1789/007/002 Carbidopa/Levodopa Fair-Med 10 mg/100 mg Tablets Fairmed Healthcare GmbH 04/03/2016 HM Not marketed AU Tablet N04BA N04BA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Levodopa Carbidopa monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1789/007/001 PA1789/007/001 Carbidopa/Levodopa Fair-Med 12.5mg/50mg Tablets Fairmed Healthcare GmbH 04/03/2016 HM Not marketed AU Tablet N04BA N04BA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Levodopa Carbidopa monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1789/007/003 PA1789/007/003 Carbidopa/Levodopa Fair-Med 25 mg/100 mg Tablets Fairmed Healthcare GmbH 04/03/2016 HM Not marketed AU Tablet N04BA N04BA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Levodopa Carbidopa monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1789/007/004 PA1789/007/004 Carbidopa/Levodopa Fair-Med 25 mg/250 mg Tablets Fairmed Healthcare GmbH 04/03/2016 HM Not marketed AU Tablet N04BA N04BA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Levodopa Carbidopa monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2130/001/002 PA2130/001/002 Carbimazole 20 mg Tablets Essential-Healthcare Ltd. 14/06/2018 HM Not marketed AU Tablet H03BB H03BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carbimazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22865/006/002 PA22865/006/002 Carbimazole 20 mg Tablets Renata Pharmaceuticals (Ireland) Limited 18/11/2022 HM Marketed AU Tablet H03BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carbimazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2130/001/001 PA2130/001/001 Carbimazole 5 mg Tablets Essential-Healthcare Ltd. 14/06/2018 HM Not marketed AU Tablet H03BB H03BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carbimazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22865/006/001 PA22865/006/001 Carbimazole 5 mg Tablets Renata Pharmaceuticals (Ireland) Limited 18/11/2022 HM Marketed AU Tablet H03BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carbimazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1418/007/001 PA1418/007/001 Carbomix 50 g Granules for Oral Suspension Athlone Pharmaceuticals Limited 03/12/1992 HM Marketed AU Granules for oral suspension A07BA A07BA01 Competence of personnel (Article 23 of Directive No 2010/63/EU) Oral use Charcoal, activated Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA2315/080/001 PA2315/080/001 Carboplatin 10 mg/ml concentrate for solution for infusion Accord Healthcare Ireland Ltd. 09/01/2009 HM Not marketed AU Concentrate for solution for infusion L01XA L01XA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Carboplatin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/032/001 PA2059/032/001 Carboplatin 10 mg/ml concentrate for solution for infusion Fresenius Kabi Deutschland GmbH 17/02/2012 HM Marketed AU Concentrate for solution for infusion L01XA L01XA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Carboplatin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA0749/004/001 PA0749/004/001 Carboplatin-Teva 10 mg/ml Concentrate for Solution for Infusion Teva Pharma B.V. 09/03/2001 HM Marketed AU Concentrate for solution for infusion L01XA L01XA02 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Carboplatin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0074/011/001 PA0074/011/001 Carbosan 2% w/w Gel Rowa Pharmaceuticals Limited 13/03/1987 HM Marketed AU Gel A02BX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Cutaneous use CARBENOXOLONE SODIUM Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0345/001/001 PA0345/001/001 Carbosylane 140mg/45mg Capsules Laboratoires Grimberg 21/05/1987 HM Marketed AU Capsule Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Simeticone Charcoal, activated Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA2286/004/001 PA2286/004/001 IC0065-044-014 Cardicor 1.25 mg film-coated tablets Merck Serono (Ireland) Limited 20/03/2000 HM Marketed AU Film-coated tablet C07AB C07AB07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bisoprolol hemifumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2286/004/006 PA2286/004/006 IC0065-002-014 Cardicor 10 mg film-coated tablets Merck Serono (Ireland) Limited 20/03/2000 HM Marketed AU Film-coated tablet C07AB C07AB07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bisoprolol hemifumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2286/004/002 PA2286/004/002 IC0065-018-014 Cardicor 2.5 mg film-coated tablets Merck Serono (Ireland) Limited 20/03/2000 HM Marketed AU Film-coated tablet C07AB C07AB07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bisoprolol hemifumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2286/004/003 PA2286/004/003 IC0065-108-014 Cardicor 3.75 mg film-coated tablets Merck Serono (Ireland) Limited 20/03/2000 HM Marketed AU Film-coated tablet C07AB C07AB07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bisoprolol hemifumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2286/004/004 PA2286/004/004 IC0065-001-014 Cardicor 5 mg film-coated tablets Merck Serono (Ireland) Limited 20/03/2000 HM Marketed AU Film-coated tablet C07AB C07AB07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bisoprolol hemifumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2286/004/005 PA2286/004/005 IC0065-041-014 Cardicor 7.5 mg film-coated tablets Merck Serono (Ireland) Limited 20/03/2000 HM Marketed AU Film-coated tablet C07AB C07AB07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bisoprolol hemifumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/003/001 PA23355/003/001 IC0021-039-002 CARDURA 1mg Tablets Viatris Healthcare Limited 21/12/1987 HM Marketed AU Tablet C02CA C02CA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Doxazosin mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/003/002 PA23355/003/002 IC0021-006-002 CARDURA 2mg Tablets Viatris Healthcare Limited 21/12/1987 HM Marketed AU Tablet C02CA C02CA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Doxazosin mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/001/001 PA23355/001/001 IC0021-008-024 Cardura XL 4 mg Prolonged-release tablets Viatris Healthcare Limited 29/10/1999 HM Marketed AU Prolonged-release tablet C02CA C02CA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Doxazosin mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/001/002 PA23355/001/002 IC0021-009-024 Cardura XL 8 mg Prolonged-release tablets Viatris Healthcare Limited 29/10/1999 HM Marketed AU Prolonged-release tablet C02CA C02CA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Doxazosin mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1776/002/001 PA1776/002/001 Cariban 10 mg/10 mg modified-release hard capsules Italfarmaco S.p.A. 15/05/2020 HM Marketed AU Modified-release capsule, hard R06AA59 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use DOXYLAMINE SUCCINATE Pyridoxine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/040/001 PPA2306/040/001 Cariban 10 mg/10 mg modified-release hard capsules Originalis B.V. 19/09/2025 HM Unknown AU Modified-release capsule, hard R06AA59 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use DOXYLAMINE SUCCINATE Pyridoxine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22720/003/001 PA22720/003/001 Carmustine 100 mg powder and solvent for concentrate for solution for infusion Tillomed Pharma GmbH 17/01/2020 HM Marketed AU Powder and solvent for concentrate for solution for infusion L01AD L01AD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Carmustine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/239/001 PA2315/239/001 Carmustine 100 mg powder and solvent for concentrate for solution for infusion Accord Healthcare Ireland Ltd. 16/12/2022 HM Marketed AU Powder and solvent for concentrate for solution for infusion L01AD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Carmustine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/250/002 PA2315/250/002 Carmustine 300 mg powder and solvent for concentrate for solution for infusion Accord Healthcare Ireland Ltd. 31/03/2023 HM Not marketed AU Powder and solvent for concentrate for solution for infusion L01AD01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Carmustine Product subject to prescription which may not be renewed (A) Advertising to healthcare professionals only PA2315/250/001 PA2315/250/001 Carmustine 50 mg powder and solvent for concentrate for solution for infusion Accord Healthcare Ireland Ltd. 31/03/2023 HM Not marketed AU Powder and solvent for concentrate for solution for infusion L01AD01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Carmustine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/18/1278/001 EU/1/18/1278/001 Carmustine medac 100 mg powder and solvent for concentrate for solution for infusion medac Gesellschaft für klinische Spezialpräparate mbH HM Unknown AU Powder and solvent for concentrate for solution for infusion L01AD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Carmustine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23188/001/002 PA23188/001/002 Carnation Callous Caps 40% w/w Medicated plasters Cuxson Gerrard Healthcare Limited 01/04/1983 HM Marketed AU Medicated plaster D11AF Full application (Article 8(3) of Directive No 2001/83/EC) Route of administration not applicable Salicylic acid Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23188/001/001 PA23188/001/001 Carnation Corn Caps 40% w/w Medicated plasters Cuxson Gerrard Healthcare Limited 01/04/1983 HM Marketed AU Medicated plaster D11AF Full application (Article 8(3) of Directive No 2001/83/EC) Route of administration not applicable Salicylic acid Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23188/001/003 PA23188/001/003 Carnation Vericap Verruca Treatment 10% w/w medicated plaster Cuxson Gerrard Healthcare Limited 08/01/1990 HM Marketed AU Medicated plaster D02AF Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Salicylic acid Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA1347/037/003 PA1347/037/003 Carvedilol Krka 12.5 mg Tablets KRKA, d.d., Novo mesto 22/08/2003 HM Marketed AU Tablet C07AG C07AG02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carvedilol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/037/004 PA1347/037/004 Carvedilol Krka 25 mg Tablets KRKA, d.d., Novo mesto 22/08/2003 HM Marketed AU Tablet C07AG C07AG02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carvedilol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/037/001 PA1347/037/001 Carvedilol Krka 3.125 mg Tablets KRKA, d.d., Novo mesto 22/08/2003 HM Marketed AU Tablet C07AG C07AG02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carvedilol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/037/002 PA1347/037/002 Carvedilol Krka 6.25 mg tablets KRKA, d.d., Novo mesto 22/08/2003 HM Marketed AU Tablet C07AG C07AG02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carvedilol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1648/001 EU/1/22/1648/001 CARVYKTI 3.2 × 10^6 – 1 × 10^8 cells dispersion for infusion Janssen Pharmaceutica NV 25/05/2022 HM Unknown AU Dispersion for infusion L01XL05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Ciltacabtagene autoleucel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characterististics, section 4.2) PA1113/007/001 PA1113/007/001 Casacol Expectorant SyrupMethoxyphenamine hydrochloride 20 mg/5 ml Guaiphenesin 100 mg/5 ml Sodium Citrate 200 mg/5 ml Phoenix Labs Unlimited Company 23/05/1979 HM Marketed AU Syrup R05CA R05CA10 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Methoxyphenamine hydrochloride Sodium citrate Guaiphenesin Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1787/001 EU/1/23/1787/001 Casgevy 4 - 13 × 10^6 cells/mL dispersion for infusion Vertex Pharmaceuticals (Ireland) Limited 09/02/2024 HM Unknown AU Dispersion for infusion B06AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Exagamglogene autotemcel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23154/002/001 PA23154/002/001 IC0137-023-003 Casodex 50 mg film-coated tablets Laboratoires Juvise Pharmaceuticals 21/04/2000 HM Marketed AU Film-coated tablet L02BB L02BB03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bicalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/144/001 PPA0465/144/001 IC0137-023-003 Casodex 50 mg film-coated tablets PCO Manufacturing Ltd. 02/07/2004 HM Unknown AU Film-coated tablet L02BB L02BB03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Bicalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/107/001 PPA1463/107/001 IC0137-023-003 Casodex 50 mg film-coated tablets IMED Healthcare Ltd., 15/04/2016 HM Unknown AU Film-coated tablet L02BB L02BB03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Bicalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1226/013/001 PA1226/013/001 Caspofungin 50mg powder for concentrate for solution for infusion Flynn Pharma Limited 13/01/2017 HM Not marketed AU Powder for concentrate for solution for infusion J02AX J02AX04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Caspofungin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/246/001 PA0281/246/001 Caspofungin 50mg powder for concentrate for solution for infusion Pinewood Laboratories Limited 03/02/2017 HM Marketed AU Powder for concentrate for solution for infusion J02AX J02AX04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Caspofungin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA1989/001/001 PA1989/001/001 Caspofungin 50mg powder for concentrate for solution for infusion Demo S.A. 16/09/2016 HM Marketed AU Powder for concentrate for solution for infusion J02AX J02AX04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Caspofungin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1226/013/002 PA1226/013/002 Caspofungin 70mg powder for concentrate for solution for infusion Flynn Pharma Limited 13/01/2017 HM Not marketed AU Powder for concentrate for solution for infusion J02AX J02AX04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Caspofungin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/246/002 PA0281/246/002 Caspofungin 70mg powder for concentrate for solution for infusion Pinewood Laboratories Limited 03/02/2017 HM Marketed AU Powder for concentrate for solution for infusion J02AX J02AX04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Caspofungin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA1989/001/002 PA1989/001/002 Caspofungin 70mg powder for concentrate for solution for infusion Demo S.A. 16/09/2016 HM Marketed AU Powder for concentrate for solution for infusion J02AX J02AX04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Caspofungin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1081/001 EU/1/15/1081/001 Caspofungin Accord Accord Healthcare S.L.U. 11/02/2016 HM Unknown AU Powder for concentrate for solution for infusion J02AX J02AX04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Caspofungin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1081/002 EU/1/15/1081/002 Caspofungin Accord Accord Healthcare S.L.U. 11/02/2016 HM Unknown AU Powder for concentrate for solution for infusion J02AX J02AX04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Caspofungin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0126/341/001 PA0126/341/001 Caspofungin Clonmel 50 mg powder for concentrate for solution for infusion Clonmel Healthcare Ltd 19/02/2021 HM Marketed AU Powder for concentrate for solution for infusion J02AX04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Caspofungin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0126/341/002 PA0126/341/002 Caspofungin Clonmel 70 mg powder for concentrate for solution for infusion Clonmel Healthcare Ltd 19/02/2021 HM Marketed AU Powder for concentrate for solution for infusion J02AX04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Caspofungin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0896/004/001 PA0896/004/001 Cataflam 50mg Coated Tablets Novartis Ireland Limited 13/03/1995 HM Marketed AU Coated tablet M01AB M01AB05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Diclofenac potassium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2256/002/001 PA2256/002/001 Catapres Ampoules 150 micrograms in 1 ml Solution for Injection Glenwood GmbH 01/04/1979 HM Marketed AU Solution for injection C02AC C02AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Clonidine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2256/003/001 PA2256/003/001 Catapres Tablets 100 micrograms Glenwood GmbH 01/04/1979 HM Marketed AU Tablet C02AC C02AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Clonidine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/164/001 PA0711/164/001 IC0029-036-002 Catasart Plus 16mg/12.5mg tablets Rowex Limited, 02/07/2010 HM Marketed AU Tablet C09DA C09DA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Candesartan cilexetil Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1748/003/001 PA1748/003/001 Catephen 10 % ointment Kora Corporation Limited trading as Kora Healthcare 17/04/2015 HM Not marketed AU Ointment D06BB D06BB12 Full application (Article 8(3) of Directive No 2001/83/EC) Topical Green tea dry extract Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1763/001-004 EU/1/23/1763/001-004 Catiolanze 50 micrograms/mL eye drops, emulsion Santen OY 15/11/2023 HM Unknown AU Eye drops, emulsion in single-dose container S01EE01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Ocular use Latanoprost Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription PA0822/115/002 PA0822/115/002 Caverject 10 micrograms Powder and Solvent for Solution for Injection Pfizer Healthcare Ireland Unlimited Company 04/04/1997 HM Marketed AU Powder and solvent for solution for injection G04BE G04BE01 Full application (Article 8(3) of Directive No 2001/83/EC) Intracavernous use Alprostadil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/115/003 PA0822/115/003 Caverject 20 micrograms Powder and Solvent for Solution for Injection Pfizer Healthcare Ireland Unlimited Company 13/03/1995 HM Marketed AU Powder and solvent for solution for injection G04BE G04BE01 Full application (Article 8(3) of Directive No 2001/83/EC) Intracavernous use Alprostadil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/543/001 EU/1/09/543/001 Cayston 75 mg powder and solvent for nebuliser solution. Gilead Sciences Ireland UC 21/09/2009 HM Unknown AU Powder and solvent for nebuliser solution J01DF01 New active substance (Article 8(3) of Directive No 2001/83/EC) Inhalation use Aztreonam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1335/002/001 PA1335/002/001 Cefixime 200 mg film-coated tablets Orchid Europe Limited 15/10/2010 HM Not marketed AU Film-coated tablet J01D Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use CEFIXIME TRIHYDRATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22914/001/001 PA22914/001/001 Cefixime Nectar Lifesciences 100 mg/5 ml Powder for Oral Suspension NECLIFE PT UNIPESSOAL LDA 16/11/2018 HM Not marketed AU Powder for oral suspension J01DA08 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cefixime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/019/002 PA1122/019/002 Cefotaxime 1 g powder for solution for injection/infusion Noridem Enterprises Limited 26/06/2020 HM Not marketed AU Powder for solution for injection/infusion J01DD J01DD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Cefotaxime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/223/002 PA0281/223/002 Cefotaxime 1g Powder for solution for injection or infusion Pinewood Laboratories Ltd 19/09/2003 HM Marketed AU Powder for solution for injection/infusion J01DD J01DD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Cefotaxime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/019/003 PA1122/019/003 Cefotaxime 2 g powder for solution for injection/infusion Noridem Enterprises Limited 26/06/2020 HM Not marketed AU Powder for solution for injection/infusion J01DD J01DD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cefotaxime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/019/001 PA1122/019/001 Cefotaxime 500 mg powder for solution for injection/infusion Noridem Enterprises Limited 26/06/2020 HM Not marketed AU Powder for solution for injection/infusion J01DD J01DD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Cefotaxime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/223/001 PA0281/223/001 Cefotaxime 500mg Powder for solution for injection or infusion Pinewood Laboratories Ltd 19/09/2003 HM Not marketed AU Powder for solution for injection/infusion J01DD J01DD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Cefotaxime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2237/008/001 PA2237/008/001 Cefotaxime hameln 1 g powder for solution for injection/infusion hameln pharma gmbh 11/04/2025 HM Not marketed AU Powder for concentrate for solution for injection/infusion J01DD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Cefotaxime sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2237/008/002 PA2237/008/002 Cefotaxime hameln 2 g powder for solution for injection/infusion hameln pharma gmbh 11/04/2025 HM Not marketed AU Powder for concentrate for solution for injection/infusion J01DD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Cefotaxime sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA25363/001/001 PA25363/001/001 Cefotaxime Reiwa Healthcare 1g powder for solution for injection/infusion Reiwa Healthcare S.L. 06/04/2018 HM Not marketed AU Powder for solution for injection/infusion J01DD J01DD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Not Currently Available Cefotaxime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/101/002 PA0711/101/002 Ceftal 250mg coated tablets Rowex Limited, 13/10/2006 HM Not marketed AU Coated tablet J01DC J01DC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cefuroxime Axetil Crystalline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/101/003 PA0711/101/003 Ceftal 500 mg Coated Tablets Rowex Limited, 13/10/2006 HM Not marketed AU Coated tablet J01DC J01DC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cefuroxime Axetil Crystalline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1217/012/002 PA1217/012/002 Ceftazidime 1 g powder for solution for injection/infusion Hikma Farmacêutica (Portugal) S.A. 12/09/2014 HM Not marketed AU Powder for solution for injection/infusion J01DD J01DD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Ceftazidime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/224/001 PA0281/224/001 Ceftazidime 1g Powder for solution for injection or infusion Pinewood Laboratories Ltd 17/12/2004 HM Marketed AU Powder for solution for injection/infusion J01DD J01DD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Ceftazidime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1217/012/003 PA1217/012/003 Ceftazidime 2 g powder for solution for injection/infusion Hikma Farmacêutica (Portugal) S.A. 12/09/2014 HM Not marketed AU Powder for solution for injection/infusion J01DD J01DD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Ceftazidime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/224/002 PA0281/224/002 Ceftazidime 2g Powder for solution for injection or infusion Pinewood Laboratories Ltd 17/12/2004 HM Marketed AU Powder for solution for injection/infusion J01DD J01DD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Ceftazidime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1217/012/001 PA1217/012/001 Ceftazidime 500 mg powder for solution for injection Hikma Farmacêutica (Portugal) S.A. 12/09/2014 HM Not marketed AU Powder for solution for injection J01DD J01DD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Ceftazidime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2237/010/002 PA2237/010/002 Ceftazidime hameln 1 g powder for solution for injection/infusion hameln pharma gmbh 10/10/2025 HM Not marketed AU Powder for solution for injection/infusion J01DD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Ceftazidime pentahydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2237/010/003 PA2237/010/003 Ceftazidime hameln 2 g powder for solution for injection/infusion hameln pharma gmbh 10/10/2025 HM Not marketed AU Powder for solution for injection/infusion J01DD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Ceftazidime pentahydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2237/010/001 PA2237/010/001 Ceftazidime hameln 500 mg powder for solution for injection hameln pharma gmbh 10/10/2025 HM Not marketed AU Powder for solution for injection J01DD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Ceftazidime pentahydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2165/017/001 PA2165/017/001 Ceftriaxone 1 g powder for solution for injection/infusion AS Kalceks 13/01/2023 HM Not marketed AU Powder for solution for injection/infusion J01DD J01DD04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Ceftriaxone sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23183/006/001 PA23183/006/001 Ceftriaxone 1g powder for solution for injection/infusion Jed Pharma Limited 10/03/2023 HM Marketed AU Solution for injection/infusion J01DD04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous bolus use Intravenous drip use Intravenous use Ceftriaxone sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/054/001 PA1122/054/001 Ceftriaxone 1g powder for solution for injection/infusion Noridem Enterprises Limited 26/06/2026 HM Not marketed AU Powder for solution for injection/infusion J01DD04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Ceftriaxone sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/225/001 PA0281/225/001 Ceftriaxone 1g Powder for solution for injection or infusion Pinewood Laboratories Limited 19/09/2003 HM Marketed AU Powder for solution for injection/infusion J01DD J01DD04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Ceftriaxone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2165/017/002 PA2165/017/002 Ceftriaxone 2 g powder for solution for injection/infusion AS Kalceks 13/01/2023 HM Not marketed AU Powder for solution for injection/infusion J01DD J01DD04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Ceftriaxone sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/225/002 PA0281/225/002 Ceftriaxone 2g Powder for Solution for Injection or Infusion Pinewood Laboratories Limited 19/03/2003 HM Not marketed AU Powder for solution for injection/infusion J01DD J01DD04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Ceftriaxone sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2237/011/001 PA2237/011/001 Ceftriaxone hameln 1 g powder for solution for injection/infusion hameln pharma gmbh 26/09/2025 HM Not marketed AU Powder for solution for injection/infusion J01DD04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Ceftriaxone sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2237/011/002 PA2237/011/002 Ceftriaxone hameln 2 g powder for solution for injection/infusion hameln pharma gmbh 26/09/2025 HM Not marketed AU Powder for solution for injection/infusion J01DD04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Ceftriaxone sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1226/009/002 PA1226/009/002 Cefuroxime 1.5 g Powder for Injection/Infusion Flynn Pharma Limited 23/06/2000 HM Marketed AU Powder for solution for injection/infusion J01DC J01DC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cefuroxime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/006/002 PA2059/006/002 Cefuroxime 1.5 g powder for solution for injection/infusion Fresenius Kabi Deutschland GmbH 21/08/2009 HM Marketed AU Powder for solution for injection/infusion J01DC J01DC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cefuroxime Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1947/002/003 PA1947/002/003 Cefuroxime 1500 mg Powder for solution for injection or infusion Stravencon Ltd 13/08/2015 HM Not marketed AU Powder for solution for injection/infusion J01DC J01DC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Cefuroxime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1947/002/001 PA1947/002/001 Cefuroxime 250 mg Powder for solution for injection Stravencon Ltd 13/08/2015 HM Not marketed AU Powder for solution for injection J01DC J01DC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Cefuroxime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1226/009/001 PA1226/009/001 Cefuroxime 750 mg Powder for Injection/Infusion Flynn Pharma Limited 23/06/2000 HM Marketed AU Powder for solution for injection/infusion J01DC J01DC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Cefuroxime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1947/002/002 PA1947/002/002 Cefuroxime 750 mg Powder for solution for injection Stravencon Ltd 13/08/2015 HM Not marketed AU Powder for solution for injection J01DC J01DC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Cefuroxime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/006/001 PA2059/006/001 Cefuroxime 750 mg powder for solution for injection/infusion Fresenius Kabi Deutschland GmbH 21/08/2009 HM Marketed AU Powder for solution for injection/infusion J01DC J01DC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cefuroxime Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1445/022/001 PA1445/022/001 Cefuroxime Aurobindo 250mg Film-coated tablets Aurobindo Pharma (Malta) Limited 23/10/2015 HM Not marketed AU Film-coated tablet J01DC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cefuroxime axetil (amorphous) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1445/022/002 PA1445/022/002 Cefuroxime Aurobindo 500mg Film-coated tablets Aurobindo Pharma (Malta) Limited 23/10/2015 HM Not marketed AU Film-coated tablet J01DC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cefuroxime axetil (amorphous) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1409/001 EU/1/19/1409/001 Cegfila 6 mg solution for injection in pre-filled syringe Mundipharma Corporation (Ireland) Limited 19/12/2019 HM Unknown AU Solution for injection in pre-filled syringe L03AA13 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Pegfilgrastim Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1833/001 EU/1/24/1833/001 Cejemly 600 mg concentrate for solution for infusion Cstone Pharmaceuticals Ireland Limited 24/07/2024 HM Unknown AU Concentrate for solution for infusion L01FF11 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Sugemalimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23355/053/001 PA23355/053/001 IC0156-024-001 Celebrex 100 mg hard capsules Viatris Healthcare Limited 12/05/2000 HM Marketed AU Capsule, hard M01AH M01AH01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Celecoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/053/002 PA23355/053/002 IC0156-067-001 Celebrex 200 mg hard capsules Viatris Healthcare Limited 12/05/2000 HM Marketed AU Capsule, hard M01AH M01AH01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Celecoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/118/002 PPA0465/118/002 IC0156-067-001 Celebrex 200 mg hard capsules PCO Manufacturing Ltd. 19/03/2004 HM Unknown AU Capsule, hard M01AH M01AH01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Celecoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/228/001 PA2315/228/001 IC0156-024-001 Celecoxib 100 mg hard capsules Accord Healthcare Ireland Ltd. 14/02/2014 HM Not marketed AU Capsule, hard M01AH M01AH01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Celecoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/228/002 PA2315/228/002 IC0156-067-001 Celecoxib 200 mg hard capsules Accord Healthcare Ireland Ltd. 14/02/2014 HM Not marketed AU Capsule, hard M01AH M01AH01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Celecoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/033/001 PA1347/033/001 IC0156-024-001 Celecoxib Krka 100 mg capsules, hard KRKA, d.d., Novo mesto 29/11/2013 HM Marketed AU Capsule, hard M01AH M01AH01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Celecoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/033/002 PA1347/033/002 IC0156-067-001 Celecoxib Krka 200 mg capsules, hard KRKA, d.d., Novo mesto 29/11/2013 HM Marketed AU Capsule, hard M01AH M01AH01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Celecoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/96/005/006 EU/1/96/005/006 CellCept 1 g/5 ml Powder for oral suspension Roche Registration GmbH HM Unknown AU Powder for oral suspension L04AA L04AA06 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Mycophenolate mofetil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/96/005/001 EU/1/96/005/001 CellCept 250 mg Capsule, hard Roche Registration GmbH HM Unknown AU Capsule, hard L04AA L04AA06 New active substance (Article 8(3) of Directive No 2001/83/EC) Mycophenolate mofetil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/96/005/003 EU/1/96/005/003 CellCept 250 mg Capsule, hard Roche Registration GmbH 13/05/1997 HM Unknown AU Capsule, hard L04AA L04AA06 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Mycophenolate mofetil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/96/005/007 EU/1/96/005/007 CellCept 250 mg hard capsules Roche Registration GmbH 14/02/1996 HM Unknown AU Capsule, hard L04AA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Mycophenolate mofetil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/96/005/002 EU/1/96/005/002 CellCept 500 mg Film-coated tablet Roche Registration GmbH HM Unknown AU Film-coated tablet L04AA L04AA06 New active substance (Article 8(3) of Directive No 2001/83/EC) Mycophenolate mofetil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/96/005/004 EU/1/96/005/004 CellCept 500 mg Film-coated tablet Roche Registration GmbH HM Unknown AU Film-coated tablet L04AA L04AA06 New active substance (Article 8(3) of Directive No 2001/83/EC) Mycophenolate mofetil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/96/005/005 EU/1/96/005/005 CellCept 500 mg Powder for concentrate for solution for infusion Roche Registration GmbH HM Unknown AU Powder for concentrate for solution for infusion L04AA L04AA06 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Mycophenolate mofetil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1806/001 EU/1/24/1806/001 Celldemic suspension for injection in pre-filled syringe Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures). Seqirus Netherlands B.V. 19/04/2024 HM Unknown AU Suspension for injection in pre-filled syringe J07BB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1824/016/002 PA1824/016/002 Celluvisc 0.5 % w/v eye drops solution, unit dose AbbVie Limited 10/11/2006 HM Marketed AU Eye drops, solution S01XA S01XA20 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Carmellose sodium Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PPA0465/259/001 PPA0465/259/001 Celluvisc 1.0% w/v eye drops, solution, unit dose PCO Manufacturing Ltd. 15/04/2011 HM Unknown AU Eye drops, solution S01XA20 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Ocular use Carmellose sodium Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1824/016/001 PA1824/016/001 Celluvisc 1% w/v Eye drops, solution, unit dose AbbVie Limited 23/04/1997 HM Marketed AU Eye drops, solution S01XA S01XA20 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Carmellose sodium Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PPA1463/147/001 PPA1463/147/001 Celluvisc 1% w/v Eye drops, solution, unit dose IMED Healthcare Ltd., 28/08/2009 HM Unknown AU Eye drops, solution S01XA20 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Ocular use Carmellose sodium Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/418/1-5 EU/1/07/418/1-5 Celsentri 150 mg Film-coated tablet ViiV Healthcare BV 18/09/2007 HM Unknown AU Film-coated tablet J05AX J05AX09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Maraviroc Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/01/07/418/013 EU/01/07/418/013 Celsentri 20mg/ ml oral solution ViiV Healthcare BV 06/07/2017 HM Unknown AU Oral solution J05AX J05AX09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Maraviroc Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/418/011 EU/1/07/418/011 Celsentri 25 mg Film-coated tablet ViiV Healthcare BV 06/07/2017 HM Unknown AU Film-coated tablet J05AX J05AX09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Maraviroc Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/418/6-10 EU/1/07/418/6-10 Celsentri 300 mg Film-coated tablet ViiV Healthcare BV HM Unknown AU Film-coated tablet J05AX J05AX09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Maraviroc Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/418/012 EU/1/07/418/012 Celsentri 75 mg Film-coated tablet ViiV Healthcare BV 06/07/2017 HM Unknown AU Film-coated tablet J05AX J05AX09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Maraviroc Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1996/001/001 PA1996/001/001 Celsior solution for organ preservation Institut Georges Lopez - IGL 01/04/2011 HM Marketed AU Solution for organ preservation V07AB Known active substance (Article 8(3) of Directive No 2001/83/EC) Extracorporeal use Glutathione Mannitol Lactobionic acid Glutamic acid Sodium hydroxide Calcium chloride 2 h2o Potassium chloride Magnesium chloride 6 h2o Histidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/21/1560/001-002 EU/1/21/1560/001-002 Celsunax 74 MBq/mL solution for injection Pinax Pharma GmbH 17/06/2021 HM Unknown AU Solution for injection V09AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Ioflupane (123I) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA22650/002/002 PA22650/002/002 Centyl K 2.5 mg/573 mg modified-release tablets Karo Pharma AB 01/04/1978 HM Marketed AU Modified-release tablet C03AB C03AB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bendroflumethiazide Potassium chloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/477/1 EU/1/08/477/1 Ceplene 0.5 mg/0.5 ml solution for injection Laboratoires DELBERT 07/10/2008 HM Unknown AU Solution for injection L03AX L03AX14 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Histamine dihydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/01/190/001 EU/1/01/190/001 Ceprotin Baxter Vaccine AG HM Unknown AU Powder and solvent for solution for injection B01AD B01AD12 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Protein c Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/01/190/002 EU/1/01/190/002 Ceprotin Baxter Vaccine AG HM Unknown AU Powder and solvent for solution for injection B01AD12 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Protein c Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA23198/016/001 PA23198/016/001 IC0190-217-003 Cerazette 75 microgram film-coated tablets Organon Pharma (Ireland) Limited 14/08/1998 HM Marketed AU Film-coated tablet G03AC G03AC09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Desogestrel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/974/004 EU/1/14/974/004 Cerdelga 21mg Hard capsule Sanofi B.V. 06/12/2024 HM Unknown AU Capsule, hard A16AX10 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Eliglustat tartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/14/974/001-002 EU/1/14/974/001-002 Cerdelga 84mg Hard capsule Sanofi B.V. HM Unknown AU Capsule, hard A16AX A16AX10 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Eliglustat (as tartrate) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/97/053/003 EU/1/97/053/003 Cerezyme 400 Units Powder for concentrate for solution for infusion Sanofi B.V. 28/01/2000 HM Unknown AU Powder for concentrate for solution for infusion A16AB A16AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Imiglucerase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/97/053/004 EU/1/97/053/004 Cerezyme 400 Units Powder for concentrate for solution for infusion Sanofi B.V. 28/01/2000 HM Unknown AU Powder for concentrate for solution for infusion A16AB A16AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Imiglucerase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/97/053/005 EU/1/97/053/005 Cerezyme 400 Units Powder for concentrate for solution for infusion Sanofi B.V. 28/01/2000 HM Unknown AU Powder for concentrate for solution for infusion A16AB A16AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Imiglucerase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA2299/019/001 PA2299/019/001 Cernevit, Powder for Solution for Injection or Infusion Baxter Holding B.V. 04/01/1993 HM Marketed AU Powder for solution for injection/infusion A11BA Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Retinol palmitate Cholecalciferol Dl-a-tocopherol Ascorbic acid Cocarboxylase tetrahydrate Riboflavin sodium phosphate Pyridoxine hydrochloride Cyanocobalamin Folic acid Dexpanthenol D-biotin Nicotinamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0896/005/001 PA0896/005/001 Certican 0.25mg Tablets Novartis Ireland Limited 12/12/2014 HM Not marketed AU Tablet L04AA L04AA18 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Everolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0896/005/003 PA0896/005/003 Certican 0.75mg Tablets Novartis Ireland Limited 12/12/2014 HM Not marketed AU Tablet L04AA L04AA18 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Everolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0540/096/001 PA0540/096/001 Cerubidin 20 mg Powder for Concentrate for Solution for Infusion Sanofi-Aventis Ireland Limited T/A SANOFI 20/04/1995 HM Marketed AU Powder for concentrate for solution for infusion L01DB L01DB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Daunorubicin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/419/1-12 EU/1/07/419/1-12 Cervarix suspension for injection Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) GlaxoSmithKline Biologicals S.A. 20/09/2007 HM Unknown AU Suspension for injection J07BM J07BM02 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hpv 16 l1 protein Hpv 18 l1 protein Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1113/014/001 PA1113/014/001 Cetirelief Allergy 10 mg film-coated tablets Phoenix Labs 30/06/2006 HM Not marketed AU Film-coated tablet R06AE R06AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cetirizine dihydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Supply through pharmacies only and promotion to the public subject to the following restrictions: maximum strength of 10 mg, maximum daily dose of 10 mg and maximum pack size of 30 tablets PA0678/162/001 PA0678/162/001 Cetirizine dihydrochloride Haleon 1 mg/ml oral solution Haleon Ireland Limited 30/01/2026 HM Not marketed AU Oral solution R06AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cetirizine dihydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0281/252/001 PA0281/252/001 IC0088-002-003 Cetirizine dihydrochloride Pinewood 10 mg film-coated Tablets Pinewood Laboratories Limited 03/06/2022 HM Marketed AU Film-coated tablet R06AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cetirizine dihydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0678/162/002 PA0678/162/002 Cetirizine Haleon 10mg Film Coated Tablets Haleon Ireland Limited 30/01/2026 HM Not marketed AU Film-coated tablet R06AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cetirizine dihydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0678/161/001 PA0678/161/001 Cetirizine Haleon Pharma 1 mg/ml oral solution Haleon Ireland Limited 23/01/2026 HM Not marketed AU Oral solution R06AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cetirizine dihydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/075/001 PA0711/075/001 IC0088-002-003 Cetrine 10 mg Film-coated Tablets Rowex Ltd 06/08/2004 HM Marketed AU Film-coated tablet R06AE R06AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cetirizine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/075/003 PA0711/075/003 Cetrine Allergy 1 mg/ml oral solution Rowex Ltd 15/07/2019 HM Marketed AU Oral solution R06AE R06AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cetirizine dihydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Pack sizes larger than 200 mls are subject to prescription. Promotion to the public for pack sizes of 200 ml or less. Promotion to Healthcare professionals for pack sizes larger than 200 ml. PA0711/075/002 PA0711/075/002 Cetrine Allergy 10mg Film-coated Tablets Rowex Ltd 06/08/2004 HM Marketed AU Film-coated tablet R06AE R06AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cetirizine hydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Product not subject to medical prescription, supply through pharmacies only and promotion to the public subject to the following restrictions: maximum strength: 10 mg, maximum pack size: 30, maximum daily dose: 10 mg. PA1986/114/001 PA1986/114/001 Cetriz 10mg Film-coated Tablets Teva B.V. 07/07/2006 HM Marketed AU Film-coated tablet R06AE R06AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cetirizine hydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/99/100/001 EU/1/99/100/001 Cetrotide 0.25 mg powder and solvent for solution for injection Merck Europe B.V. 13/04/1999 HM Unknown AU Powder and solvent for solution for injection H01CC H01CC02 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Cetrorelix acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/99/100/002 EU/1/99/100/002 Cetrotide 0.25 mg powder and solvent for solution for injection Merck Europe B.V. 13/04/1999 HM Unknown AU Powder and solvent for solution for injection H01CC H01CC02 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Cetrorelix acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1664/001 EU/1/22/1664/001 CEVENFACTA 1 mg (45 KIU) powder and solvent for solution for injection Laboratoire francais du Fractionnement et des Biotechnolgies 15/09/2022 HM Unknown AU Powder and solvent for solution for injection B02BD08 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Eptacog beta (activated) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1664/002 EU/1/22/1664/002 CEVENFACTA 2 mg (90 KIU) powder and solvent for solution for injection Laboratoire francais du Fractionnement et des Biotechnolgies 15/09/2022 HM Unknown AU Powder and solvent for solution for injection B02BD08 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Eptacog beta (activated) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1664/003 EU/1/22/1664/003 CEVENFACTA 5 mg (225 KIU) powder and solvent for solution for injection Laboratoire francais du Fractionnement et des Biotechnolgies 15/09/2022 HM Unknown AU Powder and solvent for solution for injection B02BD08 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Eptacog beta (activated) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2050/005/001 PA2050/005/001 Ceziboe 0.25 mg solution for injection in pre-filled syringe Sun Pharmaceutical Industries Europe B.V. 12/02/2021 HM Not marketed AU Solution for injection in pre-filled syringe H01CC02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Cetrorelix Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only HOR0407/018/001 HOR0407/018/001 Chamomilla - Tablets Weleda (UK) Limited HM Unknown AU Tablet Simplified Registration for a Homeopathic Medicinal Product (Article 14, Directive 2001/83/EC) Oral use Chamomilla recutita Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public EU/1/06/360/01 EU/1/06/360/01 Champix 0.5 mg Film-coated tablet Pfizer Europe MA EEIG 26/09/2006 HM Unknown AU Film-coated tablet N07BA N07BA03 New active substance (Article 8(3) of Directive No 2001/83/EC) Varenicline tartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/360/003 EU/1/06/360/003 Champix 0.5mg & 1mg Film-coated tablets Pfizer Europe MA EEIG 25/09/2006 HM Unknown AU Film-coated tablet N07BA03 Not Currently Available Varenicline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/360/02 EU/1/06/360/02 Champix 1 mg Film-coated tablet Pfizer Europe MA EEIG 26/09/2006 HM Unknown AU Film-coated tablet N07BA N07BA03 New active substance (Article 8(3) of Directive No 2001/83/EC) Varenicline tartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1110/001 EU/1/16/1110/001 Chenodeoxycholic acid Leadiant 250 mg hard capsules Leadiant Gmbh 10/04/2017 HM Unknown AU Capsule, hard A05AA A05AA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Chenodeoxycholic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2287/001/002 PA2287/001/002 ChloraPrep 2% w/v/ 70% v/v cutaneous solution Becton Dickinson France 14/12/2012 HM Marketed AU Cutaneous solution D08AC D08AC52 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Chlorhexidine gluconate Isopropyl alcohol Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA2287/001/003 PA2287/001/003 ChloraPrep 2% w/v/70% v/v impregnated cutaneous swab Becton Dickinson France 25/02/2022 HM Marketed AU Impregnated cutaneous swab D08AC52 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Chlorhexidine digluconate Isopropyl alcohol Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA2287/001/001 PA2287/001/001 ChloraPrep with Tint 2% w/v/70% v/v cutaneous solution Becton Dickinson France 02/07/2010 HM Marketed AU Cutaneous solution D08AC D08AC52 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Chlorhexidine gluconate Isopropyl alcohol Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA2299/005/001 PA2299/005/001 Chlorhexidine acetate 0.015% w/v and Cetrimide 0.15% w/v Irrigation solution Baxter Holding B.V. 01/04/1983 HM Not marketed AU Irrigation solution D08AC D08AC52 Well-established use application (Article 10a of Directive No 2001/83/EC) Topical Chlorhexidine acetate Cetrimide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/004/001 PA2299/004/001 Chlorhexidine Acetate BP 0.05% w/v Irrigation solution Baxter Holding B.V. 01/04/1983 HM Marketed AU Irrigation solution B05CA B05CA02 Well-established use application (Article 10a of Directive No 2001/83/EC) Topical Chlorhexidine acetate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1142/021/001 PA1142/021/001 Chloromycetin 0.5% w/v Redidrops eye drops, solution Amdipharm Limited 20/12/1974 HM Marketed AU Eye drops, solution S01AA S01AA01 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Chloramphenicol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2262/003/001 PA2262/003/001 Chlorphenamine 10 mg/ml Solution for Injection Evolan Pharma AB 10/06/1995 HM Marketed AU Solution for injection R06AB R06AB04 Not Currently Available Intramuscular use Intravenous use Subcutaneous use Chlorphenamine maleate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/124/001 PA0281/124/001 Chlorpromazine Elixir BP 25 mg/5 ml Oral Solution Pinewood Laboratories Ltd 23/06/1983 HM Not marketed AU Oral solution N05AA N05AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use CHLORPROMAZINE HYDROCHLORIDE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/03/268/1-3 EU/1/03/268/1-3 Cholestagel 625 mg film-coated tablets CHEPLAPHARM Arzneimittel GmbH 31/03/2004 HM Unknown AU Film-coated tablet C10AC C10AC04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/866/001-002 EU/1/13/866/001-002 Cholib 145 mg/20 mg film-coated tablets Viatris Healthcare Limited 26/08/2013 HM Unknown AU Film-coated tablet C10BA C10BA04 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Micronized fenofibrate Simvastatin with 0.2% butylated hydroxyanisole (bha), (E320) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/866/003-004 EU/1/13/866/003-004 Cholib 145 mg/40 mg film-coated tablets Viatris Healthcare Limited 26/08/2013 HM Unknown AU Film-coated tablet C10BA C10BA04 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Micronized fenofibrate Simvastatin with 0.2% butylated hydroxyanisole (bha), (E320) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1913/002/001 PA1913/002/001 Cholurso 250 mg film-coated tablets Laboratoires Mayoly Spindler 13/10/2017 HM Not marketed AU Film-coated tablet A05AA A05AA02 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Ursodeoxycholic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1913/002/002 PA1913/002/002 Cholurso 500 mg film-coated tablets Laboratoires Mayoly Spindler 13/10/2017 HM Not marketed AU Film-coated tablet A05AA A05AA02 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Ursodeoxycholic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1104/003/001 PA1104/003/001 Chondromel 400 mg Capsules IBSA Farmaceutici Italia S.r.l 22/12/2005 HM Not marketed AU Capsule, hard M01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Chondroitin sulfate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/237/1-5 EU/1/02/237/1-5 CIALIS Eli Lilly Nederland B.V. HM Unknown AU Film-coated tablet G04BE G04BE08 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Tadalafil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/237/006 EU/1/02/237/006 Cialis 2.5 mg film-coated tablets Eli Lilly Nederland B.V. 20/06/2007 HM Unknown AU Film-coated tablet G04BE G04BE08 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Tadalafil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/237/7-8 EU/1/02/237/7-8 Cialis 5 mg film-coated tablets Eli Lilly Nederland B.V. 20/06/2007 HM Unknown AU Film-coated tablet G04BE G04BE08 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Tadalafil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA25208/001/001 PA25208/001/001 Cialis for men 10 mg film-coated tablets A. Nattermann & Cie. GmbH 01/12/2023 HM Marketed AU Film-coated tablet G04BE08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Tadalafil Product not subject to medical prescription Supply through pharmacies only Advertising to the general public HCP consultation required for OTC supply EU/1/15/1055/001 EU/1/15/1055/001 Ciambra Menarini International Operations Luxembourg S.A. 02/12/2015 HM Unknown AU Powder for concentrate for solution for infusion L01BA L01BA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Pemetrexed disodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1055/002 EU/1/15/1055/002 Ciambra Menarini International Operations Luxembourg S.A. 02/12/2015 HM Unknown AU Powder for concentrate for solution for infusion L01BA L01BA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Pemetrexed disodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1593/006-010 EU/1/21/1593/006-010 Cibinqo 100 mg film-coated tablets Pfizer Europe MA EEIG 09/12/2021 HM Unknown AU Film-coated tablet D11AH D11AH08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Abrocitinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1593/011-015 EU/1/21/1593/011-015 Cibinqo 200 mg film-coated tablets Pfizer Europe MA EEIG 09/12/2021 HM Unknown AU Film-coated tablet D11AH D11AH08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Abrocitinib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1593/001-005 EU/1/21/1593/001-005 Cibinqo 50 mg film-coated tablets Pfizer Europe MA EEIG 09/12/2021 HM Unknown AU Film-coated tablet D11AH D11AH08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Abrocitinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA25239/002/001 PA25239/002/001 Cidofovir Tillomed 75 mg/ml concentrate for solution for infusion Tillomed Malta Limited 19/09/2025 HM Not marketed AU Concentrate for solution for infusion J05AB12 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cidofovir dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Summary of Product Characteristics, section 4.2). PA23266/038/001 PA23266/038/001 IC0185-130-003 Cifloxager 250 mg film-coated tablets Viatris Limited 04/02/2005 HM Marketed AU Film-coated tablet J01MA J01MA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ciprofloxacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/038/002 PA23266/038/002 IC0185-117-003 Cifloxager 500 mg film-coated tablets Viatris Limited 04/02/2005 HM Marketed AU Film-coated tablet J01MA J01MA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ciprofloxacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1350/008/001 PA1350/008/001 Cifoban 136 mmol/l solution for infusion Fresenius Medical Care Deutschland GmbH 28/01/2022 HM Not marketed AU Solution for injection B05ZB Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Trisodium citrate dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/122/001 PA0711/122/001 IC0185-130-003 Cifox 250 mg film-coated tablets Rowex Limited, 22/09/2006 HM Marketed AU Film-coated tablet J01MA J01MA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ciprofloxacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/122/002 PA0711/122/002 IC0185-117-003 Cifox 500 mg film-coated tablets Rowex Limited, 22/09/2006 HM Marketed AU Film-coated tablet J01MA J01MA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ciprofloxacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/122/003 PA0711/122/003 IC0185-141-003 Cifox 750 mg film-coated tablets Rowex Limited, 22/09/2006 HM Not marketed AU Film-coated tablet J01MA J01MA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ciprofloxacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1330/029/001 PA1330/029/001 Cilique 250/35 microgram tablets Gedeon Richter Plc 11/12/2015 HM Marketed AU Tablet G03AA G03AA11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Norgestimate Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0896/006/001 PA0896/006/001 Ciloxan 3 mg/ml ear drops, solution Novartis Ireland Limited 03/02/2006 HM Marketed AU Ear drops, solution S02AA S02AA15 Full application (Article 8(3) of Directive No 2001/83/EC) Auricular use Ciprofloxacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/077/002 PA0126/077/002 Cimeldine 400 mg Film-coated tablets Clonmel Healthcare Ltd 06/11/1989 HM Marketed AU Film-coated tablet A02BA A02BA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cimetidine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/544/1-2 EU/1/09/544/1-2 Cimzia 200 mg solution for injection in pre-filled syringe UCB Pharma S.A. HM Unknown AU Solution for injection in pre-filled syringe L04AB L04AB05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Certolizumab pegol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1429/001-004 EU/1/20/1429/001-004 IC0134-033-003 Cinacalcet Accordpharma 30 mg film-coated tablets Accord Healthcare S.L.U. 03/04/2020 HM Unknown AU Film-coated tablet H05BX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cinacalcet hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1429/005-008 EU/1/20/1429/005-008 IC0134-127-003 Cinacalcet Accordpharma 60 mg film-coated tablets Accord Healthcare S.L.U. 03/04/2020 HM Unknown AU Film-coated tablet H05BX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cinacalcet hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1429/009-012 EU/1/20/1429/009-012 IC0134-166-003 Cinacalcet Accordpharma 90 mg film-coated tablets Accord Healthcare S.L.U. 03/04/2020 HM Unknown AU Film-coated tablet H05BX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cinacalcet hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/306/001 PA0126/306/001 IC0134-033-003 Cinacalcet Clonmel 30 mg film-coated tablets Clonmel Healthcare Ltd 15/03/2019 HM Marketed AU Film-coated tablet H05BX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cinacalcet hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/306/002 PA0126/306/002 IC0134-127-003 Cinacalcet Clonmel 60 mg film-coated tablets Clonmel Healthcare Ltd 15/03/2019 HM Marketed AU Film-coated tablet H05BX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cinacalcet hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/306/003 PA0126/306/003 IC0134-166-003 Cinacalcet Clonmel 90 mg film-coated tablets Clonmel Healthcare Ltd 15/03/2019 HM Marketed AU Film-coated tablet H05BX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cinacalcet hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1054/001-004 EU/1/15/1054/001-004 IC0134-033-003 Cinacalcet Mylan 30 mg film-coated tablets Mylan Pharmaceuticals Limited 19/11/2015 HM Unknown AU Film-coated tablet H05BX H05BX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cinacalcet hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1054/005-007 EU/1/15/1054/005-007 IC0134-127-003 Cinacalcet Mylan 60 mg film-coated tablets Mylan Pharmaceuticals Limited 19/11/2015 HM Unknown AU Film-coated tablet H05BX H05BX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cinacalcet hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1054/008-010 EU/1/15/1054/008-010 IC0134-166-003 Cinacalcet Mylan 90 mg film-coated tablets Mylan Pharmaceuticals Limited 19/11/2015 HM Unknown AU Film-coated tablet H05BX H05BX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cinacalcet hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/007/001 PA1986/007/001 IC0134-033-003 Cinacalcet Teva 30 mg film-coated tablets Teva B.V. 05/02/2016 HM Marketed AU Film-coated tablet H05B Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use TALC PH.EUR. Cinacalcet Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/007/002 PA1986/007/002 IC0134-127-003 Cinacalcet Teva 60 mg film-coated tablets Teva B.V. 05/02/2016 HM Marketed AU Film-coated tablet H05B Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cinacalcet Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/007/003 PA1986/007/003 IC0134-166-003 Cinacalcet Teva 90 mg film-coated tablets Teva B.V. 05/02/2016 HM Marketed AU Film-coated tablet H05B Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cinacalcet Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1125/001 EU/1/16/1125/001 CINQAERO 10 mg/mL concentrate for solution for infusion Teva B.V. HM Unknown AU Concentrate for solution for infusion Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Reslizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/11/688/001 EU/1/11/688/001 Cinryze 500 IU powder and solvent for solution for injection Takeda Manufacturing Austria AG 15/06/2011 HM Unknown AU Powder and solvent for solution for injection B06AC01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use C1 inhibitor Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA23266/046/001 PA23266/046/001 IC0073-002-003 Ciprager 10 mg Film-coated tablets Viatris Limited 03/06/2003 HM Marketed AU Film-coated tablet N06AB N06AB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Citalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/046/002 PA23266/046/002 IC0073-003-003 Ciprager 20 mg Film-coated tablets Viatris Limited 03/06/2003 HM Marketed AU Film-coated tablet N06AB N06AB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Citalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/046/003 PA23266/046/003 IC0073-004-003 Ciprager 40 mg Film-coated tablets Viatris Limited 30/07/2004 HM Marketed AU Film-coated tablet N06AB N06AB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Citalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0776/001/001 PA0776/001/001 IC0073-002-003 Cipramil 10 mg film-coated tablets Lundbeck ( Ireland ) Limited 22/09/1995 HM Marketed AU Film-coated tablet N06AB N06AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Citalopram hydrobromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0776/001/002 PA0776/001/002 IC0073-003-003 Cipramil 20 mg film-coated tablets Lundbeck ( Ireland ) Limited 22/09/1995 HM Marketed AU Film-coated tablet N06AB N06AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Citalopram hydrobromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0776/001/004 PA0776/001/004 Cipramil 40 mg/ml Oral drops, solution Lundbeck ( Ireland ) Limited 16/04/1999 HM Marketed AU Oral drops, solution N06AB N06AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Citalopram hydrobromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/005/001 PA1122/005/001 Ciprofloxacin 2 mg/ml Solution for infusion Noridem Enterprises Limited 13/06/2008 HM Marketed AU Solution for infusion J01MA J01MA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Ciprofloxacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/035/001 PA1347/035/001 IC0185-130-003 Ciprofloxacin Krka 250 mg film-coated tablets KRKA, d.d., Novo mesto 07/10/2005 HM Marketed AU Film-coated tablet J01MA J01MA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ciprofloxacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/035/002 PA1347/035/002 IC0185-117-003 Ciprofloxacin Krka 500 mg film-coated tablets KRKA, d.d., Novo mesto 07/10/2005 HM Marketed AU Film-coated tablet J01MA J01MA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ciprofloxacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/035/003 PA1347/035/003 IC0185-141-003 Ciprofloxacin Krka 750 mg film-coated tablets KRKA, d.d., Novo mesto 07/10/2005 HM Marketed AU Film-coated tablet J01MA J01MA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ciprofloxacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/031/002 PA0749/031/002 IC0185-130-003 Ciprofloxacin Teva 250 mg film-coated tablets Teva Pharma B.V. 20/04/2007 HM Not marketed AU Film-coated tablet J01MA J01MA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ciprofloxacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/031/003 PA0749/031/003 IC0185-117-003 Ciprofloxacin Teva 500 mg film-coated tablets Teva Pharma B.V. 20/04/2007 HM Marketed AU Film-coated tablet J01MA J01MA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ciprofloxacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/131/001 PA0126/131/001 IC0073-002-003 Ciprotan 10mg film-coated tablets Clonmel Healthcare Ltd 17/11/2004 HM Marketed AU Film-coated tablet N06AB N06AB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Citalopram hydrobromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/131/002 PA0126/131/002 IC0073-003-003 Ciprotan 20mg film-coated tablets Clonmel Healthcare Ltd 17/11/2004 HM Marketed AU Film-coated tablet N06AB N06AB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Citalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/392/001 EU/1/07/392/001 Circadin 2 mg prolonged-release tablets RAD Neurim Pharmaceuticals EEC SARL 29/06/2007 HM Unknown AU Prolonged-release tablet N05CH N05CH01 New active substance (Article 8(3) of Directive No 2001/83/EC) Melatonin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/017/001 PA1122/017/001 Cisatracurium 2 mg/ml solution for injection/infusion Noridem Enterprises Limited 12/07/2013 HM Not marketed AU Solution for injection/infusion M03AC M03AC11 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cisatracurium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2165/008/001 PA2165/008/001 Cisatracurium 2 mg/ml solution for injection/infusion AS Kalceks 13/09/2019 HM Marketed AU Solution for injection/infusion M03AC11 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cisatracurium Besilate Cisatracurium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/199/001 PA0822/199/001 Cisplatin 1 mg/ml Concentrate for Solution for Infusion Pfizer Healthcare Ireland Unlimited Company 19/11/1986 HM Marketed AU Concentrate for solution for infusion L01XA L01XA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cisplatin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/081/001 PA2315/081/001 Cisplatin 1 mg/ml Concentrate for Solution for Infusion Accord Healthcare Ireland Ltd. 07/10/2011 HM Marketed AU Concentrate for solution for infusion L01XA L01XA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cisplatin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/019/001 PA0749/019/001 IC0073-002-003 Citalopram Teva 10 mg film-coated tablets Teva Pharma B.V. 19/01/2007 HM Marketed AU Film-coated tablet N06AB N06AB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Citalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/019/002 PA0749/019/002 IC0073-003-003 Citalopram Teva 20 mg film-coated tablets Teva Pharma B.V. 19/01/2007 HM Marketed AU Film-coated tablet N06AB N06AB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Citalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/019/003 PA0749/019/003 IC0073-004-003 Citalopram Teva 40mg film-coated tablets Teva Pharma B.V. 19/01/2007 HM Marketed AU Film-coated tablet N06AB N06AB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Citalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1045/001/001 PA1045/001/001 Citanest with Octapressin Dental, Prilocaine Hydrochloride 3 % w/v, Felypressin 0.54 micrograms/ml Solution for Injection DENTSPLY DeTrey GmbH 01/04/1980 HM Marketed AU Solution for injection N01BB N01BB54 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Prilocaine hydrochloride Felypressin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22714/001/001 PA22714/001/001 Citidaron 1.5 mg tablets Aflofarm Farmacja Polska Sp. z o.o. 05/03/2018 HM Marketed AU Tablet N07BA Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cytisine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/041/001 PPA2306/041/001 Citidaron 1.5 mg tablets Originalis B.V. 17/07/2026 HM Unknown AU Tablet N07BA Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Cytisinicline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2028/002/002 PA2028/002/002 CitraFleet oral solution Casen-Recordati S.L. 03/03/2023 HM Not marketed AU Oral solution A06AB58 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium picosulfate Magnesium oxide, light Citric acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2028/002/001 PA2028/002/001 CitraFleet, Powder for oral solution in sachet Casen-Recordati S.L. 18/04/2008 HM Marketed AU Powder for oral solution in sachet A06AB A06AB58 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium picosulfate Light magnesium oxide Citric acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/064/001 PA0711/064/001 IC0073-002-003 Citrol 10 mg Film-Coated Tablets Rowex Limited, 12/11/2004 HM Marketed AU Film-coated tablet N06AB N06AB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Citalopram hydrobromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/064/002 PA0711/064/002 IC0073-003-003 CITROL 20 mg Film-Coated Tablets Rowex Limited, 12/11/2004 HM Marketed AU Film-coated tablet N06AB N06AB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Citalopram hydrobromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/064/003 PA0711/064/003 Citrol 30 mg Film-Coated Tablets Rowex Limited, 12/11/2004 HM Marketed AU Film-coated tablet N06AB N06AB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Citalopram hydrobromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/041/002 PA1142/041/002 Claforan Powder for Solution for Injection 1g Amdipharm Limited 13/05/1981 HM Marketed AU Powder for solution for injection J01DD J01DD01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Cefotaxime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/041/001 PA1142/041/001 Claforan Powder for Solution for Injection 500mg Amdipharm Limited 13/05/1981 HM Marketed AU Powder for solution for injection J01DD J01DD01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Cefotaxime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1113/015/001 PA1113/015/001 Clareeze Allergy 10 mg Tablets Phoenix Labs 24/08/2001 HM Not marketed AU Tablet R06AX R06AX13 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Loratadine Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Product not subject to prescription for pack sizes of up to 30 tablets. Supply as an over the counter item through pharmacies only. PA0735/011/001 PA0735/011/001 Clariscan 279.32 mg/ml solution for injection GE Healthcare AS 22/12/2017 HM Marketed AU Solution for injection V08CA V08CA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Gadoteric acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0735/011/002 PA0735/011/002 Clariscan 279.32 mg/ml solution for injection in pre-filled syringe GE Healthcare AS 22/12/2017 HM Marketed AU Solution for injection in pre-filled syringe V08CA V08CA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Gadoteric acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/197/001 PA2315/197/001 IC0072-130-003 Clarithromycin 250 mg film-coated tablets Accord Healthcare Ireland Ltd. 21/04/2017 HM Marketed AU Film-coated tablet J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2050/002/001 PA2050/002/001 IC0072-130-003 Clarithromycin 250 mg film-coated tablets Sun Pharmaceutical Industries Europe B.V. 20/10/2006 HM Marketed AU Film-coated tablet J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/197/002 PA2315/197/002 IC0072-117-003 Clarithromycin 500 mg film-coated tablets Accord Healthcare Ireland Ltd. 21/04/2017 HM Marketed AU Film-coated tablet J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2050/002/002 PA2050/002/002 IC0072-117-003 Clarithromycin 500 mg film-coated tablets Sun Pharmaceutical Industries Europe B.V. 20/10/2006 HM Marketed AU Film-coated tablet J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2237/003/001 PA2237/003/001 Clarithromycin 500 mg powder for concentrate for solution for infusion hameln pharma gmbh 19/03/2021 HM Not marketed AU Powder for concentrate for solution for infusion J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/025/001 PA1122/025/001 Clarithromycin 500 mg Powder for concentrate for solution for infusion Noridem Enterprises Limited 22/03/2019 HM Marketed AU Powder for concentrate for solution for infusion J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Clarithromycin lactobionate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/022/001 PA1142/022/001 Clarithromycin 500 mg Powder for Concentrate for Solution for Infusion Amdipharm Limited 13/08/2010 HM Not marketed AU Powder for concentrate for solution for infusion J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/068/001 PA1347/068/001 IC0072-130-003 Clarithromycin Krka 250 mg film-coated tablets KRKA, d.d., Novo mesto 13/01/2017 HM Not marketed AU Film-coated tablet J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/068/002 PA1347/068/002 IC0072-117-003 Clarithromycin Krka 500 mg film-coated tablets KRKA, d.d., Novo mesto 13/01/2017 HM Not marketed AU Film-coated tablet J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/148/001 PA0749/148/001 IC0072-130-003 Clarithromycin Teva 250 mg film-coated tablets Teva Pharma B.V. 04/05/2012 HM Marketed AU Film-coated tablet J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/148/002 PA0749/148/002 IC0072-117-003 Clarithromycin Teva 500 mg film-coated tablets Teva Pharma B.V. 04/05/2012 HM Marketed AU Film-coated tablet J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/222/001 PPA1463/222/001 Clarityn 10 mg tablets IMED Healthcare Ltd. 21/06/2024 HM Unknown AU Tablet R06AX13 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Loratadine Product not subject to medical prescription Supply through pharmacies only Advertising to the general public For pack sizes of up to 30 tablets: Product not subject to medical prescription. Supply as an over the counter item through pharmacies only. For pack sizes of more than 30 tablets: Product subject to medical prescription Supply through pharmaci PA1410/075/001 PA1410/075/001 Clarityn 10 mg Tablets Bayer Limited 18/11/1988 HM Marketed AU Tablet R06AX R06AX13 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Loratadine Product not subject to medical prescription Supply through pharmacies only Advertising to the general public For pack sizes of up to 30 tablets: Product not subject to medical prescription. Supply as an over the counter item through pharmacies only. For pack sizes of more than 30 tablets: Product subject to medical prescription Supply through pharmacies only. Pack sizes not exceeding 30 tablets: Promotion to the public. Pack sizes exceeding 30 tablets: Promotion to healthcare professionals. PPA0465/510/001 PPA0465/510/001 Clarityn 10 mg Tablets PCO Manufacturing Ltd. 13/12/2024 HM Unknown AU Tablet R06AX13 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Loratadine Product not subject to medical prescription Supply through pharmacies only Advertising to the general public For pack sizes of up to 30 tablets: Product not subject to medical prescription. Supply as an over the counter item through pharmacies only. For pack sizes of more than 30 tablets: Product subject to medical prescription Supply through phar PA1410/075/002 PA1410/075/002 Clarityn 1mg/1ml Syrup Bayer Limited 18/01/1994 HM Not marketed AU Syrup R06AX R06AX13 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Loratadine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/243/001 PA0126/243/001 IC0037-073-003 Clavamel Forte 500mg/125mg film-coated tablet Clonmel Healthcare Ltd 21/03/2014 HM Marketed AU Film-coated tablet J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2028/001/001 PA2028/001/001 Cleenema Ready-to-Use 21.4 g/9.4 g Enema Casen-Recordati S.L. 16/02/1995 HM Marketed AU Rectal solution A06AG A06AG01 Well-established use application (Article 10a of Directive No 2001/83/EC) Rectal use Sodium dihydrogen phosphate dihydrate Disodium phosphate dodecahydrate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0584/006/002 PA0584/006/002 Clenil Modulite 100 micrograms per metered dose Pressurised Inhalation Solution Chiesi Farmaceutici S.p.A. 30/09/2005 HM Not marketed AU Pressurised inhalation, solution R03BA R03BA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0584/006/003 PA0584/006/003 Clenil Modulite 200 micrograms per metered dose Pressurised Inhalation Solution Chiesi Farmaceutici S.p.A. 30/09/2005 HM Not marketed AU Pressurised inhalation, solution R03BA R03BA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0584/006/004 PA0584/006/004 Clenil Modulite 250 micrograms per metered dose Pressurised Inhalation Solution Chiesi Farmaceutici S.p.A. 30/09/2005 HM Not marketed AU Pressurised inhalation, solution R03BA R03BA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0584/006/001 PA0584/006/001 Clenil Modulite 50 micrograms per metered dose Pressurised Inhalation Solution Chiesi Farmaceutici S.p.A. 30/09/2005 HM Not marketed AU Pressurised inhalation, solution R03BA R03BA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/477/001 PPA0465/477/001 Clexane 10,000 IU (100 mg)/1 ml Solution for Injection in pre-filled syringes PCO Manufacturing Ltd. 13/08/2021 HM Unknown AU Solution for injection in pre-filled syringe B01AB05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Intravenous use Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0540/097/001 PA0540/097/001 Clexane 10,000 IU (100mg)/1ml Solution for Injection in pre-filled syringes Sanofi-Aventis Ireland Limited T/A SANOFI 22/08/1989 HM Marketed AU Solution for injection in pre-filled syringe B01AB B01AB05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0540/097/004 PA0540/097/004 Clexane 2,000 IU (20mg)/0.2 mL Solution for Injection in pre-filled syringes Sanofi-Aventis Ireland Limited T/A SANOFI 14/07/2017 HM Unknown AU Solution for injection in pre-filled syringe B01AB B01AB05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/477/002 PPA0465/477/002 Clexane 4,000 IU (40 mg) /0.4 ml Solution for Injection in pre-filled syringes PCO Manufacturing Ltd. 19/11/2021 HM Unknown AU Solution for injection in pre-filled syringe B01AB05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0540/097/005 PA0540/097/005 Clexane 4,000 IU (40mg)/0.4 mL Solution for Injection in pre-filled syringes Sanofi-Aventis Ireland Limited T/A SANOFI 14/07/2017 HM Unknown AU Solution for injection in pre-filled syringe B01AB B01AB05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/477/003 PPA0465/477/003 Clexane 6,000 IU (60 mg) /0.6 ml Solution for Injection in pre-filled syringes PCO Manufacturing Ltd. 19/11/2021 HM Unknown AU Solution for injection in pre-filled syringe B01AB05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0540/097/006 PA0540/097/006 Clexane 6,000 IU (60mg)/0.6 mL Solution for Injection in pre-filled syringes Sanofi-Aventis Ireland Limited T/A SANOFI 14/07/2017 HM Unknown AU Solution for injection in pre-filled syringe B01AB B01AB05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/477/004 PPA0465/477/004 Clexane 8,000 IU (80 mg) /0.8 ml Solution for Injection in pre-filled syringes PCO Manufacturing Ltd. 19/11/2021 HM Unknown AU Solution for injection in pre-filled syringe B01AB05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0540/097/007 PA0540/097/007 Clexane 8,000 IU (80mg)/0.8 mL Solution for Injection in pre-filled syringes Sanofi-Aventis Ireland Limited T/A SANOFI 14/07/2017 HM Unknown AU Solution for injection in pre-filled syringe B01AB B01AB05 Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93 Intravenous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/477/005 PPA0465/477/005 Clexane Forte 12,000 IU (120 mg)/0.8 ml Solution for Injection in pre-filled syringes PCO Manufacturing Ltd. 19/11/2021 HM Unknown AU Solution for injection in pre-filled syringe B01AB05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0540/097/008 PA0540/097/008 Clexane Forte 12,000 IU (120mg)/0.8 mL Solution for Injection in pre-filled syringes Sanofi-Aventis Ireland Limited T/A SANOFI 14/07/2017 HM Unknown AU Solution for injection in pre-filled syringe B01AB B01AB05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0540/097/002 PA0540/097/002 Clexane Forte 15,000 IU (150mg)/1ml Solution for Injection in pre-filled syringes Sanofi-Aventis Ireland Limited T/A SANOFI 15/06/2001 HM Marketed AU Solution for injection in pre-filled syringe B01AB B01AB05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23142/015/001 PA23142/015/001 Clindamycin + Benzoyl Peroxide 10 mg/g + 50 mg/g gel Aspire Pharma (Malta) Limited 24/09/2021 HM Not marketed AU Gel D10AF51 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Clindamycin Anhydrous Benzoyl Peroxide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/007/001 PA2059/007/001 Clindamycin 150 mg/ml solution for injection Fresenius Kabi Deutschland GmbH 30/05/2008 HM Marketed AU Solution for injection J01FF J01FF01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use CLINDAMYCIN PHOSPHATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2165/021/001 PA2165/021/001 Clindamycin 150 mg/ml solution for injection/infusion AS Kalceks 09/08/2024 HM Not marketed AU Solution for injection/infusion J01FF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use CLINDAMYCIN PHOSPHATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/033/001 PA1122/033/001 Clindamycin 150 mg/ml Solution for injection/infusion Noridem Enterprises Limited 12/05/2023 HM Not marketed AU Solution for injection/infusion J01FF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use CLINDAMYCIN PHOSPHATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22865/004/002 PA22865/004/002 Clindamycin 150 mg Capsules, hard Renata Pharmaceuticals (Ireland) Limited 12/04/2019 HM Marketed AU Capsule, hard J01FF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clindamycin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA25213/001/001 PA25213/001/001 Clindamycin 300 mg Capsules EG (Eurogenerics) 15/05/2009 HM Marketed AU Capsule, hard D10AF D10AF01 G01AA G01AA10 J01F Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clindamycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22865/004/003 PA22865/004/003 Clindamycin 300 mg Capsules, hard Renata Pharmaceuticals (Ireland) Limited 12/04/2019 HM Not marketed AU Capsule, hard J01FF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clindamycin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22865/004/001 PA22865/004/001 Clindamycin 75 mg Capsules, hard Renata Pharmaceuticals (Ireland) Limited 12/04/2019 HM Not marketed AU Capsule, hard J01FF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clindamycin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/020/001 PA2299/020/001 CLINIMIX N14G30E, solution for infusion Baxter Holding B.V. 30/04/1996 HM Marketed AU Solution for infusion B05BA B05BA01 Informed consent application (Article 10c of Directive No 2001/83/EC) Intravenous use L-leucine L-phenylalanine L-methionine L-isoleucine L-valine L-histidine L-threonine L-tryptophan L-alanine L-arginine Glycine L-proline L-serine L-tyrosine Sodium acetate trihydrate Dibasic potassium phosphate Sodium chloride Magnesium chloride hexahydrate Calcium chloride dihydrate L-lysine hydrochloride Glucose monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23148/009/001 PA23148/009/001 Clobazam Brown & Burk 10mg Tablets Brown & Burk IR Limited 17/04/2026 HM Not marketed AU Tablet N05BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clobazam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA23148/009/002 PA23148/009/002 Clobazam Brown & Burk 20 mg Tablets Brown & Burk IR Limited 17/04/2026 HM Not marketed AU Tablet N05BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clobazam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA22662/004/001 PA22662/004/001 Clobazam Essential Pharmaceuticals 1 mg/ml oral suspension Essential Pharmaceuticals Limited 26/11/2021 HM Not marketed AU Oral suspension N05BA09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Clobazam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA22697/006/002 PA22697/006/002 Clobazam Thame 10 mg/5 ml Oral Suspension Syri Pharma Limited t/a Thame Laboratories 19/02/2016 HM Not marketed AU Oral suspension N05BA N05BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clobazam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA22697/006/001 PA22697/006/001 Clobazam Thame 5 mg/5 ml Oral Suspension Syri Pharma Limited t/a Thame Laboratories 19/02/2016 HM Not marketed AU Oral suspension N05BA N05BA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clobazam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA0711/166/001 PA0711/166/001 IC0005-028-003 Clodel 75 mg film-coated tablets Rowex Limited, 14/08/2009 HM Marketed AU Film-coated tablet B01AC B01AC04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Clopidogrel hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0814/004/001 PA0814/004/001 Clomid 50 mg Tablets Fidia Farmaceutici S.p.A. 01/12/1982 HM Marketed AU Tablet G03GB G03GB02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Clomiphene citrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/026/002 PA0126/026/002 Clonactil 100 mg film-coated tablets Clonmel Healthcare Ltd 01/04/1977 HM Marketed AU Film-coated tablet N05AA N05AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use CHLORPROMAZINE HYDROCHLORIDE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/026/003 PA0126/026/003 Clonactil 25 mg film-coated tablets Clonmel Healthcare Ltd 08/04/1987 HM Marketed AU Film-coated tablet N05AA N05AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use CHLORPROMAZINE HYDROCHLORIDE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/026/001 PA0126/026/001 Clonactil 50 mg film-coated tablets Clonmel Healthcare Ltd 01/04/1977 HM Marketed AU Film-coated tablet N05AA N05AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use CHLORPROMAZINE HYDROCHLORIDE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23081/009/001 PA23081/009/001 Clonazepam Rosemont 0.5 mg/5 ml oral solution Taw Pharma (Ireland) Limited 24/02/2012 HM Marketed AU Oral solution N03AE N03AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clonazepam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017. PA0126/095/001 PA0126/095/001 Clonfolic 0.4 mg Tablets Clonmel Healthcare Ltd 15/02/1995 HM Marketed AU Tablet B03BB B03BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Folic acid Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA22697/020/001 PA22697/020/001 Clonidine hydrochloride 100 micrograms/ 5 ml Oral Solution Syri Pharma Limited t/a Thame Laboratories 01/08/2025 HM Not marketed AU Oral solution C02AC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Clonidine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/136/001 PA0126/136/001 IC0072-130-003 Clonocid 250 mg film-coated Tablets Clonmel Healthcare Ltd 15/04/2005 HM Marketed AU Film-coated tablet J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/136/002 PA0126/136/002 IC0072-117-003 Clonocid 500 mg film-coated tablets Clonmel Healthcare Ltd 15/04/2005 HM Marketed AU Film-coated tablet J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/465/1-14 EU/1/08/465/1-14 IC0005-028-003 Clopidogrel Zentiva 75 mg film-coated tablets Zentiva k.s. 16/07/2008 HM Unknown AU Film-coated tablet B01AC B01AC04 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Clopidogrel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1395/006-010 EU/1/19/1395/006-010 IC0043-031-003 Clopidogrel/Acetylsalicylic acid Viatris 75 mg/100 mg film-coated tablets Mylan Pharmaceuticals Limited 09/01/2020 HM Unknown AU Film-coated tablet B01AC30 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel hydrogensulfate Acetylsalicylic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1395/001-005 EU/1/19/1395/001-005 IC0043-030-003 Clopidogrel/Acetylsalicylic acid Viatris 75 mg/75 mg film-coated tablets Mylan Pharmaceuticals Limited 09/01/2020 HM Unknown AU Film-coated tablet B01AC30 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel hydrogensulfate Acetylsalicylic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/10/623/8-14 EU/1/10/623/8-14 IC0043-031-003 Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets Sanofi-Aventis Groupe 15/03/2010 HM Unknown AU Film-coated tablet B01AC B01AC30 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Acetylsalicylic acid Clopidogrel hydrogensulfate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/10/623/1-7 EU/1/10/623/1-7 IC0043-030-003 Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Sanofi-Aventis Groupe 15/03/2010 HM Unknown AU Film-coated tablet B01AC B01AC30 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Acetylsalicylic acid Clopidogrel hydrogensulfate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/198/001 PA2315/198/001 IC0005-028-003 Clopidogrel 75mg Film-coated Tablets Accord Healthcare Ireland Ltd. 17/05/2013 HM Marketed AU Film-coated tablet B01AC B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel hydrogensulfate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22871/027/001 PA22871/027/001 IC0005-028-003 Clopidogrel Azure 75 mg film-coated tablets Azure Pharmaceuticals Ltd. 30/01/2026 HM Not marketed AU Film-coated tablet B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel Hydrogen Sulfate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/558/1-12 EU/1/09/558/1-12 Clopidogrel BGR 75 mg film-coated tablets Laboratoires BIOGARAN 21/09/2009 HM Unknown AU Film-coated tablet B01AC B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/279/001 PA0126/279/001 IC0005-028-003 Clopidogrel Clonmel 75mg Film-coated Tablets Clonmel Healthcare Ltd 25/11/2016 HM Marketed AU Film-coated tablet B01AC B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/556/1-9 EU/1/09/556/1-9 IC0005-028-003 Clopidogrel Krka 75 mg film-coated tablets KRKA, d.d., Novo mesto 23/09/2009 HM Unknown AU Film-coated tablet B01AC B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/562/001-9 EU/1/09/562/001-9 IC0005-028-003 Clopidogrel Krka d.d. 75 mg film-coated tablet KRKA, d.d., Novo mesto HM Unknown AU Film-coated tablet B01AC B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23250/005/001 PA23250/005/001 IC0005-028-003 Clopidogrel MSN 75 mg film-coated tablets MSN Labs Europe Limited 05/01/2024 HM Marketed AU Film-coated tablet B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel Hydrogen Sulfate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/271/001 PA0281/271/001 IC0005-028-003 Clopidogrel Pinewood 75 mg film-coated tablets Pinewood Laboratories Limited 12/12/2025 HM Not marketed AU Film-coated tablet B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel Hydrogen Sulfate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/975/001-017 EU/1/14/975/001-017 IC0005-028-003 Clopidogrel ratiopharm 75 mg film-coated tablets Teva B.V. 19/02/2015 HM Unknown AU Film-coated tablet B01AC B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/555/1-9 EU/1/09/555/1-9 IC0005-028-003 Clopidogrel TAD 75 mg film-coated tablets TAD Pharma GmbH HM Unknown AU Film-coated tablet B01AC B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/559/001-016 EU/1/09/559/001-016 Clopidogrel Taw Pharma 75 mg film-coated tablets Taw Pharma (Ireland) Limited 21/09/2009 HM Unknown AU Film-coated tablet B01AC B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/540/1-16 EU/1/09/540/1-16 IC0005-028-003 Clopidogrel Teva 75 mg film-coated tablets Teva B.V. 28/07/2009 HM Unknown AU Film-coated tablet B01AC B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel hydrogensulfate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/568/001-020 EU/1/09/568/001-020 IC0005-028-003 Clopidogrel Viatris 75 mg film-coated tablets Viatris Limited 16/10/2009 HM Unknown AU Film-coated tablet B01AC B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/465/15-17 EU/1/08/465/15-17 IC0005-029-003 Clopidogrel Zentiva 300 mg film-coated tablets Zentiva k.s. 16/07/2008 HM Unknown AU Film-coated tablet B01AC B01AC04 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Clopidogrel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0776/002/003 PA0776/002/003 Clopixol 10mg Film-coated Tablets Lundbeck ( Ireland ) Limited 01/11/1982 HM Marketed AU Film-coated tablet N05AF N05AF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Zuclopenthixol hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0776/002/001 PA0776/002/001 Clopixol 200 mg/ml Solution for Injection Lundbeck ( Ireland ) Limited 13/06/1977 HM Marketed AU Solution for injection N05AF N05AF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use ZUCLOPENTHIXOL DECANOATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0776/002/002 PA0776/002/002 Clopixol Conc. 500 mg/ml Solution for Injection Lundbeck ( Ireland ) Limited 12/10/1983 HM Marketed AU Solution for injection N05AF N05AF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Submucosal use ZUCLOPENTHIXOL DECANOATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/061/001 PA0711/061/001 IC0072-130-003 Clorom 250 mg Film-Coated Tablets Rowex Limited, 08/10/2004 HM Marketed AU Film-coated tablet J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/061/002 PA0711/061/002 IC0072-117-003 Clorom 500 mg film-coated tablets Rowex Limited, 08/10/2004 HM Marketed AU Film-coated tablet J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23142/006/001 PA23142/006/001 IC0072-117-050 Clorom XL 500 mg Prolonged-Release Tablets Aspire Pharma (Malta) Limited 15/04/2011 HM Marketed AU Prolonged-release tablet J01FA J01FA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clarithromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23355/022/006 PA23355/022/006 Clozaril 100 mg orodispersible tablets Viatris Healthcare Limited 17/04/2025 HM Marketed AU Orodispersible tablet N05AH02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Clozapine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only To be dispensed under strict medical supervision in accordance with official recommendations. Use of clozapine is restricted to patients who are registered with a monitoring service to manage the risk of agranulocytosis associated with treatment. Both doctor and pharmacist concerned must be registered with this service. (See SmPC for full details). PA23355/022/002 PA23355/022/002 Clozaril 100 mg tablets Viatris Healthcare Limited 14/05/1992 HM Marketed AU Tablet N05AH N05AH02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Clozapine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only To be dispensed under strict medical supervision in accordance with official recommendations. Use of clozapine is restricted to patients who are registered with a monitoring service to manage the risk of agranulocytosis associated with treatment. Both doctor and pharmacist concerned must be registered with this service. (See SmPC for full details). PA23355/022/004 PA23355/022/004 Clozaril 12.5 mg orodispersible tablets Viatris Healthcare Limited 17/04/2025 HM Marketed AU Orodispersible tablet N05AH02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Clozapine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only To be dispensed under strict medical supervision in accordance with official recommendations. Use of clozapine is restricted to patients who are registered with a monitoring service to manage the risk of agranulocytosis associated with treatment. Both doctor and pharmacist concerned must be registered with this service. (See SmPC for full details). PA23355/022/003 PA23355/022/003 Clozaril 200 mg tablets Viatris Healthcare Limited 15/11/2024 HM Marketed AU Tablet N05AH02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Clozapine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only To be dispensed under strict medical supervision in accordance with official recommendations. Use of clozapine is restricted to patients who are registered with a monitoring service to manage the risk of agranulocytosis associated with treatment. Both doctor and pharmacist concerned must be registered with this service. (See SmPC for full details). PA23355/022/005 PA23355/022/005 Clozaril 25 mg orodispersible tablets Viatris Healthcare Limited 17/04/2025 HM Marketed AU Orodispersible tablet N05AH02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Clozapine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only To be dispensed under strict medical supervision in accordance with official recommendations. Use of clozapine is restricted to patients who are registered with a monitoring service to manage the risk of agranulocytosis associated with treatment. Both doctor and pharmacist concerned must be registered with this service. (See SmPC for full details). PA23355/022/001 PA23355/022/001 Clozaril 25 mg Tablets Viatris Healthcare Limited 14/05/1992 HM Marketed AU Tablet N05AH N05AH02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Clozapine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only To be dispensed under strict medical supervision in accordance with official recommendations. Use of clozapine is restricted to patients who are registered with a monitoring service to manage the risk of agranulocytosis associated with treatment. Both doctor and pharmacist concerned must be registered with this service. (See SmPC for full details). PA2220/002/002 PA2220/002/002 Co-amoxiclav 1000 mg/200 mg powder for solution for injection/infusion Instituto Biochimico Italiano G. Lorenzini S.p.A. 22/11/2019 HM Marketed AU Powder for solution for injection/infusion J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/026/001 PA2059/026/001 Co-amoxiclav 1000mg/200mg powder for solution for injection/infusion Fresenius Kabi Deutschland GmbH 28/02/2014 HM Marketed AU Powder for solution for injection/infusion J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2220/002/003 PA2220/002/003 Co-amoxiclav 2000 mg/200 mg powder for solution for infusion Instituto Biochimico Italiano G. Lorenzini S.p.A. 22/11/2019 HM Not marketed AU Powder for solution for infusion J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23148/004/001 PA23148/004/001 IC0037-074-003 Co-amoxiclav 250mg/125mg Film-coated tablets Brown & Burk IR Limited 09/03/2012 HM Marketed AU Film-coated tablet J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2220/002/001 PA2220/002/001 Co-amoxiclav 500 mg/100 mg powder for solution for injection/infusion Instituto Biochimico Italiano G. Lorenzini S.p.A. 22/11/2019 HM Marketed AU Powder for solution for injection/infusion J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23148/004/002 PA23148/004/002 IC0037-073-003 Co-amoxiclav 500mg/125mg Film-coated tablets Brown & Burk IR Limited 09/03/2012 HM Marketed AU Film-coated tablet J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23148/004/003 PA23148/004/003 IC0037-072-003 Co-amoxiclav 875mg/125mg Film-coated Tablets Brown & Burk IR Limited 09/03/2012 HM Marketed AU Film-coated tablet J01CA J01CA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1436/002/002 PA1436/002/002 IC0037-073-003 Co-amoxiclav Bluefish 500 mg/125 mg film- coated tablets Bluefish Pharmaceuticals AB 06/11/2009 HM Marketed AU Film-coated tablet J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clavulanic acid Amoxicillin trihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1436/002/003 PA1436/002/003 IC0037-072-003 Co-amoxiclav Bluefish 875 mg/125 mg film- coated tablets Bluefish Pharmaceuticals AB 06/11/2009 HM Marketed AU Film-coated tablet J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clavulanic acid Amoxicillin trihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23148/005/001 PA23148/005/001 Co-amoxiclav Sugar Free 200 mg/28.5 mg/5 ml Powder for Oral Suspension Brown & Burk IR Limited 09/11/2012 HM Marketed AU Powder for oral suspension J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23148/005/002 PA23148/005/002 IC0037-076-034 Co-Amoxiclav Sugar Free 400 mg/57 mg/5 ml Powder for Oral Suspension Brown & Burk IR Limited 09/11/2012 HM Marketed AU Powder for oral suspension J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/011/002 PA0749/011/002 Co-Amoxiclav TEVA 1000 mg/200 mg Powder for Solution for Injection/Infusion Teva Pharma B.V. 04/08/2006 HM Marketed AU Powder for solution for injection/infusion J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/011/001 PA0749/011/001 Co-Amoxiclav TEVA 500 mg/100 mg Powder for Solution for Injection/Infusion Teva Pharma B.V. 04/08/2006 HM Marketed AU Powder for solution for injection/infusion J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/020/001 PA22871/020/001 Co-codamol 15 mg/500 mg film-coated tablets Azure Pharmaceuticals Ltd. 12/08/2022 HM Marketed AU Film-coated tablet N02AJ06 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Paracetamol Codeine phosphate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 5 to the Misuse of Drugs Regulations 2017. PA0896/007/002 PA0896/007/002 IC0040-077-003 Co-Diovan 160 mg/12.5 mg film-coated tablets Novartis Ireland Limited 04/11/2003 HM Marketed AU Film-coated tablet C09DA C09DA03 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/226/002 PPA0465/226/002 IC0040-077-003 Co-Diovan 160 mg/12.5 mg film-coated tablets PCO Manufacturing Ltd. 31/07/2009 HM Unknown AU Film-coated tablet C09DA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Hydrochlorothiazide Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/043/002 PPA1463/043/002 IC0040-077-003 Co-Diovan 160 mg/12.5 mg film-coated tablets IMED Healthcare Ltd., 21/01/2011 HM Unknown AU Film-coated tablet C09DA C09DA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0896/007/003 PA0896/007/003 IC0040-078-003 Co-Diovan 160 mg/25 mg film-coated tablets Novartis Ireland Limited 03/12/2004 HM Marketed AU Film-coated tablet C09DA C09DA03 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/226/003 PPA0465/226/003 IC0040-078-003 Co-Diovan 160 mg/25 mg film-coated tablets PCO Manufacturing Ltd. 31/07/2009 HM Unknown AU Film-coated tablet C09DA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Hydrochlorothiazide Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/043/003 PPA1463/043/003 IC0040-078-003 Co-Diovan 160 mg/25 mg film-coated tablets IMED Healthcare Ltd., 16/09/2011 HM Unknown AU Film-coated tablet C09DA C09DA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Hydrochlorothiazide Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0896/007/004 PA0896/007/004 IC0040-079-003 Co-Diovan 320 mg/12.5 mg film-coated tablets Novartis Ireland Limited 01/02/2008 HM Marketed AU Film-coated tablet C09DA C09DA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/226/005 PPA0465/226/005 IC0040-079-003 Co-Diovan 320 mg/12.5 mg film-coated tablets PCO Manufacturing Ltd. 12/04/2013 HM Unknown AU Film-coated tablet C09DA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0896/007/005 PA0896/007/005 IC0040-080-003 Co-Diovan 320 mg/25 mg film-coated tablets Novartis Ireland Limited 01/02/2008 HM Marketed AU Film-coated tablet C09DA C09DA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/226/004 PPA0465/226/004 IC0040-080-003 Co-Diovan 320 mg/25 mg film-coated tablets PCO Manufacturing Ltd. 30/11/2012 HM Unknown AU Film-coated tablet C09DA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0896/007/001 PA0896/007/001 IC0040-081-003 Co-Diovan 80 mg/12.5 mg film-coated tablets Novartis Ireland Limited 10/12/1998 HM Marketed AU Film-coated tablet C09DA C09DA03 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/226/001 PPA0465/226/001 IC0040-081-003 Co-Diovan 80 mg/12.5 mg film-coated tablets PCO Manufacturing Ltd. 31/07/2009 HM Unknown AU Film-coated tablet C09DA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Hydrochlorothiazide Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/043/001 PPA1463/043/001 IC0040-081-003 Co-Diovan 80 mg/12.5 mg film-coated tablets IMED Healthcare Ltd., 21/01/2011 HM Unknown AU Film-coated tablet C09DA C09DA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Hydrochlorothiazide Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/332/001 PA0126/332/001 Co-Tipol 500 mg/30 mg hard capsules Clonmel Healthcare Ltd 29/11/2013 HM Not marketed AU Capsule, hard N02AJ N02AJ06 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Paracetamol Codeine phosphate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 5 to the Misuse of Drugs Regulations 2017. PA0126/332/002 PA0126/332/002 Co-Tipol 500 mg/30 mg suppositories Clonmel Healthcare Ltd 29/11/2013 HM Not marketed AU Suppository N02AJ N02AJ06 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Paracetamol Codeine phosphate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 5 to the Misuse of Drugs Regulations 2017. PA0126/332/003 PA0126/332/003 Co-Tipol Max 1000 mg/60 mg suppositories Clonmel Healthcare Ltd 29/11/2013 HM Marketed AU Suppository N02AJ N02AJ06 Well-established use application (Article 10a of Directive No 2001/83/EC) Rectal use Paracetamol Codeine phosphate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 5 to the Misuse of Drugs Regulations 2017. PA0711/182/002 PA0711/182/002 IC0040-077-003 Co-Vatan 160 mg/12.5 mg Film-coated Tablets Rowex Limited, 01/10/2010 HM Marketed AU Film-coated tablet C09CA C09CA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/182/003 PA0711/182/003 IC0040-078-003 Co-Vatan 160 mg/25 mg Film-coated Tablets Rowex Limited, 01/10/2010 HM Marketed AU Film-coated tablet C09CA C09CA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Valsartan Hydrocholothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/182/001 PA0711/182/001 IC0040-081-003 Co-Vatan 80 mg/12.5 mg Film-coated Tablets Rowex Limited, 01/10/2010 HM Marketed AU Film-coated tablet C09CA C09CA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Valsartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1087/001 EU/1/16/1087/001 Coagadex 250 IU powder and solvent for solution for injection Kedrion S.p.A. 16/03/2016 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD13 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Human coagulation factor x Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1087/002 EU/1/16/1087/002 Coagadex 500 IU powder and solvent for solution for injection Kedrion S.p.A. 16/03/2016 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD13 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Human coagulation factor x Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/98/086/011-015 EU/1/98/086/011-015 IC0158-192-014 CoAprovel 150 mg/12.5 mg film-coated tablets Sanofi Winthrop Industrie HM Unknown AU Film-coated tablet C09DA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Irbesartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/086/001-003 EU/1/98/086/001-003 IC0158-192-014 CoAprovel 150 mg/12.5 mg tablets Sanofi Winthrop Industrie 15/10/1998 HM Unknown AU Tablet C09DA C09DA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Irbesartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/086/016-020 EU/1/98/086/016-020 IC0158-199-014 CoAprovel 300 mg/12.5 mg film-coated tablets Sanofi Winthrop Industrie HM Unknown AU Film-coated tablet C09DA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Irbesartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/086/004-006 EU/1/98/086/004-006 IC0158-199-014 CoAprovel 300 mg/12.5 mg tablets Sanofi Winthrop Industrie 15/10/1998 HM Unknown AU Tablet C09DA C09DA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Irbesartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/086/023-028 EU/1/98/086/023-028 IC0158-200-003 CoAprovel 300 mg/25 mg film-coated tablets Sanofi Pharma Bristol-Myers Squibb SNC 28/08/2006 HM Unknown AU Film-coated tablet C09DA C09DA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Irbesartan Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1638/005/001 PA1638/005/001 Cocois Ointment, coal tar 12.0% sulphur for external use 4.0%, salicylic acid 2.0% RPH Pharmaceuticals AB 01/05/1996 HM Marketed AU Ointment D11AC D11AC08 Informed consent application (Article 10c of Directive No 2001/83/EC) Topical use Coal tar solution Sulphur for external use Salicylic acid Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0073/029/001 PA0073/029/001 Codant 30 mg Tablets Mercury Pharmaceuticals (Ireland) Ltd 01/04/1978 HM Not marketed AU Tablet R05DA R05DA04 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Codeine phosphate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 5 to the Misuse of Drugs Regulations 2017. PA25390/002/001 PA25390/002/001 Codeine phosphate hemihydrate 10 mg tablets Extractum Pharma zrt 13/06/2025 HM Not marketed AU Tablet R05DA04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Codeine phosphate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 5 to the Misuse of Drugs Regulations 2017. PA25390/002/002 PA25390/002/002 Codeine phosphate hemihydrate 15 mg tablets Extractum Pharma zrt 13/06/2025 HM Not marketed AU Tablet R05DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Codeine phosphate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 5 to the Misuse of Drugs Regulations 2017. PA25390/002/003 PA25390/002/003 Codeine phosphate hemihydrate 20 mg tablets Extractum Pharma zrt 13/06/2025 HM Not marketed AU Tablet R05DA04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Codeine phosphate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 5 to the Misuse of Drugs Regulations 2017. PA25390/002/004 PA25390/002/004 Codeine phosphate hemihydrate 30 mg tablets Extractum Pharma zrt 13/06/2025 HM Not marketed AU Tablet R05DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Codeine phosphate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 5 to the Misuse of Drugs Regulations 2017. PA0281/005/001 PA0281/005/001 Codinex Codeine Phosphate 15mg/5ml Oral Solution Pinewood Laboratories Ltd 25/08/1981 HM Marketed AU Oral solution R05DA R05DA04 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Codeine phosphate hemihydrate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 5 to the Misuse of Drugs Regulations 2017. Retail sale through pharmacies only in child-resistant containers with a pack size not greater than 100 ml. Prescription only in pack sizes greater than 100 m PA1142/023/002 PA1142/023/002 Codipar 15 mg/ 500 mg Capsules Amdipharm Limited 13/07/2012 HM Marketed AU Capsule, hard N02AJ N02AJ06 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Paracetamol Codeine phosphate hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 5 to the Misuse of Drugs Regulations 2017. PA22865/002/001 PA22865/002/001 Colchicine 500 microgram Tablets Renata Pharmaceuticals (Ireland) Limited 15/12/2017 HM Marketed AU Tablet M04AC M04AC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Colchicine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22902/002/001 PA22902/002/001 Colchicine Halewood 500 microgram Tablets Halewood Chemicals (Ireland) Limited 11/04/2025 HM Not marketed AU Tablet M04AC01 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Colchicine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23337/001/001 PA23337/001/001 Colchicine Indoco 500 microgram tablets Indoco Remedies Czech s.r.o. 06/12/2024 HM Not marketed AU Tablet M04AC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Colchicine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2200/001/002 PA2200/001/002 Colchicine Tiofarma 1000 microgram tablets Tiofarma B.V. 29/09/2017 HM Not marketed AU Tablet M04AC M04AC01 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use COLCHICINE PH. EUR. Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2200/001/001 PA2200/001/001 Colchicine Tiofarma 500 microgram tablets Tiofarma B.V. 29/09/2017 HM Marketed AU Tablet M04AC M04AC01 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use COLCHICINE PH. EUR. Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only HOA1149/005/001 HOA1149/005/001 Coldenza 6C Tablets A. Nelson & Company Limited 23/12/2016 HM Not marketed AU Tablet Not Currently Available Oral use Gelsemium sempervirens (ghp) Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA1876/008/004 PA1876/008/004 Colecalciferol 30000 IU film-coated tablets Consilient Health Limited 30/01/2015 HM Not marketed AU Film-coated tablet A11CC A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1876/008/002 PA1876/008/002 Colecalciferol 1000 IU film-coated tablets Consilient Health Limited 30/01/2015 HM Not marketed AU Film-coated tablet A11CC A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cholecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1876/008/003 PA1876/008/003 Colecalciferol 7000 IU film-coated tablets Consilient Health Limited 30/01/2015 HM Not marketed AU Film-coated tablet A11CC A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cholecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1876/008/001 PA1876/008/001 Colecalciferol 800 IU film-coated tablets Consilient Health Limited 30/01/2015 HM Not marketed AU Film-coated tablet A11CC A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cholecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1983/002/001 PA1983/002/001 Colecalciferol Aristo 20,000 IU soft capsules Aristo Pharma GmbH 23/02/2018 HM Not marketed AU Capsule, soft A11CC A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22981/001/002 PA22981/001/002 Colecalciferol EQL Pharma 2000 IU tablet EQL Pharma AB 09/07/2021 HM Not marketed AU Tablet A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22981/001/001 PA22981/001/001 Colecalciferol EQL Pharma 800 IU tablet EQL Pharma AB 09/07/2021 HM Not marketed AU Tablet A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only HOA1149/001/001 HOA1149/001/001 Colica Colic Granules A. Nelson & Company Limited 31/05/2019 HM Not marketed AU Granules National Rules Authorisation (Article 16.2 Directive 2001/83/EC.) CITRULLUS COLOCYNTHIS 30C HAP/PH.EUR Dioscorea villosa Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA1122/030/001 PA1122/030/001 Colistimethate sodium 1 million IU Powder for nebuliser solution Noridem Enterprises Limited 17/02/2023 HM Not marketed AU Powder for nebuliser solution J01XB01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Colistimethate sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/031/001 PA1122/031/001 Colistimethate sodium 1 million IU Powder for solution for injection/infusion Noridem Enterprises Limited 09/06/2023 HM Not marketed AU Powder for solution for injection/infusion J01XB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intrathecal use Intravenous use Colistimethate sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/030/002 PA1122/030/002 Colistimethate sodium 2 million IU Powder for nebuliser solution Noridem Enterprises Limited 17/02/2023 HM Not marketed AU Powder for nebuliser solution J01XB01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Colistimethate sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/031/002 PA1122/031/002 Colistimethate sodium 2 million IU Powder for solution for injection/infusion Noridem Enterprises Limited 09/06/2023 HM Not marketed AU Powder for solution for injection/infusion J01XB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intrathecal use Intravenous use Colistimethate sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/283/001 PA2315/283/001 Colistimethate sodium Accord 1 million IU powder for solution for injection/infusion Accord Healthcare Ireland Ltd. 26/09/2025 HM Not marketed AU Powder for solution for injection/infusion J01XB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intracerebroventricular use Intrathecal use Intravenous use Colistimethate sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/283/002 PA2315/283/002 Colistimethate sodium Accord 2 million IU powder for solution for injection/infusion Accord Healthcare Ireland Ltd. 26/09/2025 HM Not marketed AU Powder for solution for injection/infusion J01XB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intracerebroventricular use Intrathecal use Intravenous use Colistimethate sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/747/001 EU/1/11/747/001 Colobreathe 1,662,500 IU inhalation powder, hard capsules Essential Pharma Limited 13/02/2012 HM Unknown AU Inhalation powder, hard capsule J01XB01 New active substance (Article 8(3) of Directive No 2001/83/EC) Inhalation use Colistimethate sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23355/019/001 PA23355/019/001 IC0180-210-040 Colofac 135 mg Tablets Viatris Healthcare Limited 07/02/1983 HM Marketed AU Coated tablet A03AA A03AA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Mebeverine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/046/001 PA1986/046/001 COLOMYCIN 1 million International Units (IU) Powder for solution for injection, infusion or inhalation Teva B.V. 07/06/2005 HM Marketed AU Powder for solution for injection/infusion J01XB J01XB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Colistimethate sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/046/002 PA1986/046/002 COLOMYCIN 2 million International Units (IU) Powder for solution for injection, infusion or inhalation Teva B.V. 07/06/2005 HM Marketed AU Powder for solution for injection/infusion J01XB J01XB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Colistimethate sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23490/016/001 PA23490/016/001 Colpermin Gastro-resistant Capsules Peppermint oil 0.2ml JNTL Consumer Health I (Ireland) Limited 10/03/2006 HM Marketed AU Gastro-resistant capsule, hard A03AX Not Currently Available Oral use Peppermint oil Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public EU/1/23/1742/002 EU/1/23/1742/002 Columvi 10 mg concentrate for solution for infusion Roche Registration GmbH 07/07/2023 HM Unknown AU Concentrate for solution for infusion L01 L01FX28 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Glofitamab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/23/1742/001 EU/1/23/1742/001 Columvi 2.5 mg concentrate for solution for infusion Roche Registration GmbH 07/07/2023 HM Unknown AU Concentrate for solution for infusion L01 L01FX28 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Glofitamab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1824/019/001 PA1824/019/001 Combigan 2 mg/ml + 5 mg/ml eye drops, solution AbbVie Limited 22/12/2005 HM Not marketed AU Eye drops, solution S01ED S01ED51 Fixed combination application (Article 10b of Directive No 2001/83/EC) Ocular use Brimonidine tartrate Timolol Maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1113/032/001 PA1113/032/001 Combileve 500 mg/200 mg film-coated tablets Phoenix Labs 27/06/2025 HM Not marketed AU Film-coated tablet N02BE51 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Paracetamol Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public MAXIMUM PACK SIZE 24. Maximum two packs per retail transaction with pharmacist interview. Promotion to the public: Pack sizes not more than 24. PA1815/001/001 PA1815/001/001 IC0081-136-052 Combiprasal 0.5 mg/2.5 mg per 2.5 ml nebuliser solution Pharma Stulln GmbH 10/01/2014 HM Marketed AU Nebuliser solution R03AL R03AL02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Ipratropium bromide SALBUTAMOL SULFATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/058/001 EU/1/98/058/001 Combivir 150 mg/300 mg film-coated tablets ViiV Healthcare BV HM Unknown AU Film-coated tablet J05AR J05AR01 Full application (Article 8(3) of Directive No 2001/83/EC) Zidovudine Lamivudine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/98/058/002 EU/1/98/058/002 Combivir 150 mg/300 mg film-coated tablets ViiV Healthcare BV HM Unknown AU Film-coated tablet J05AR J05AR01 Full application (Article 8(3) of Directive No 2001/83/EC) Zidovudine Lamivudine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA1077/118/001 PA1077/118/001 IC0036-065-001 Combodart 0.5 mg/ 0.4 mg hard capsules GlaxoSmithKline (Ireland) Limited 07/05/2010 HM Marketed AU Capsule, hard G04CA G04CA52 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Dutasteride Tamsulosin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/068/001 PPA1463/068/001 IC0036-065-001 Combodart 0.5 mg/ 0.4 mg hard capsules IMED Healthcare Ltd., 19/10/2012 HM Unknown AU Capsule, hard G04CA G04CA52 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Dutasteride Tamsulosin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA23080/025/001 PPA23080/025/001 IC0036-065-001 Combodart 0.5 mg/ 0.4 mg hard capsules Merit Pharmaceuticals Limited 09/06/2023 HM Unknown AU Capsule, hard G04CA G04CA52 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Dutasteride Tamsulosin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/334/001 PPA0465/334/001 IC0036-065-001 Combodart 0.5 mg/0.4 mg hard capsules PCO Manufacturing Ltd. 28/02/2014 HM Unknown AU Capsule, hard G04CA G04CA52 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Dutasteride Tamsulosin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23183/002/001 PA23183/002/001 Combogesic 10 mg/ml Paracetamol + 3 mg/ml Ibuprofen solution for infusion Jed Pharma Limited 08/10/2021 HM Marketed AU Solution for infusion N02BE51 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Paracetamol Ibuprofen sodium dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/890/001 EU/1/13/890/001 COMETRIQ 20 mg hard capsules Ipsen Pharma HM Unknown AU Capsule, hard L01XE L01XE26 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Cabozantinib (s)-malate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription. (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/13/890/002-003 EU/1/13/890/002-003 COMETRIQ 80 mg hard capsules Ipsen Pharma 21/03/2014 HM Unknown AU Capsule, hard L01XE L01XE26 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Cabozantinib (s)-malate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription. (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/20/1528/001 EU/1/20/1528/001 Comirnaty BioNTech Manufacturing GmbH 21/12/2020 HM Unknown AU Concentrate for dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Tozinameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/002-003 EU/1/20/1528/002-003 Comirnaty BioNTech Manufacturing GmbH 03/11/2021 HM Unknown AU Concentrate for dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Tozinameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/004-005 EU/1/20/1528/004-005 Comirnaty BioNTech Manufacturing GmbH 26/11/2021 HM Unknown AU Concentrate for dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Tozinameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/010 EU/1/20/1528/010 Comirnaty BioNTech Manufacturing GmbH 20/10/2022 HM Unknown AU Concentrate for dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Tozinameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/028-031 EU/1/20/1528/028-031 Comirnaty BioNTech Manufacturing GmbH 03/07/2024 HM Unknown AU Concentrate for dispersion for injection J07BN01 Tozinameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/034 EU/1/20/1528/034 COMIRNATY JN.1 10 micrograms/dose concentrate for dispersion for injection children 5 to 11 years BioNTech Manufacturing GmbH 21/12/2020 HM Unknown AU Concentrate for dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Bretovameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/032-033 EU/1/20/1528/032-033 COMIRNATY JN.1 10 micrograms/dose dispersion for injection children 5 to 11 years BioNTech Manufacturing GmbH 21/12/2020 HM Unknown AU Dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Bretovameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/035 EU/1/20/1528/035 COMIRNATY JN.1 3 micrograms/dose concentrate for dispersion for injection children 6 months to 4 years BioNTech Manufacturing GmbH 21/12/2020 HM Unknown AU Concentrate for dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Bretovameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/036 EU/1/20/1528/036 COMIRNATY JN.1 3 micrograms/dose concentrate for dispersion for injection children 6 months to 4 years BioNTech Manufacturing GmbH 21/12/2020 HM Unknown AU Concentrate for dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Bretovameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/028-29 EU/1/20/1528/028-29 Comirnaty JN.1 30 micrograms/dose dispersion for injection BioNTech Manufacturing GmbH 21/12/2020 HM Unknown AU Dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Bretovameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/040-041 EU/1/20/1528/040-041 COMIRNATY KP.2 10 micrograms/dose dispersion for injection children 5 to 11 years BioNTech Manufacturing GmbH 21/12/2020 HM Unknown AU Dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/042 EU/1/20/1528/042 COMIRNATY KP.2 3 micrograms/dose concentrate for dispersion for injection children 6 months to 4 years BioNTech Manufacturing GmbH 21/12/2020 HM Unknown AU Concentrate for dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/037-038 EU/1/20/1528/037-038 COMIRNATY KP.2 30 micrograms/dose dispersion for injection adults and adolescents from 12 year BioNTech Manufacturing GmbH 21/12/2020 HM Unknown AU Dispersion for injection J07BN01 Full application (Article 8(3) of Directive No 2001/83/EC) COVID-19 mRNA vaccine (nucleoside-modified) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/048-049 EU/1/20/1528/048-049 Comirnaty LP.8.1 10 micrograms/dose dispersion for injection BioNTech Manufacturing GmbH 21/12/2020 HM Unknown AU Dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. • Official batch release In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. EU/1/20/1528/045-046 EU/1/20/1528/045-046 COMIRNATY LP.8.1 30 micrograms/dose dispersion for injection BioNTech Manufacturing GmbH 21/12/2020 HM Unknown AU Dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. • Official batch release In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. EU/1/20/1528/051 EU/1/20/1528/051 Comirnaty LP.8.1 30 micrograms/dose dispersion for injection in pre-filled syringe BioNTech Manufacturing GmbH 21/12/2020 HM Unknown AU Dispersion for injection in pre-filled syringe J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. • Official batch release In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. EU/1/20/1528/047 EU/1/20/1528/047 Comirnaty LP8.1 30 micrograms/dose dispersion for injection in pre-filled syringe BioNTech Manufacturing GmbH 21/12/2020 HM Unknown AU Dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. • Official batch release In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. EU/1/20/1528/024 EU/1/20/1528/024 COMIRNATY Omicron XBB.1.5 10 mcg injection BioNTech Manufacturing GmbH 31/08/2023 HM Unknown AU Concentrate for dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Tozinameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/021 EU/1/20/1528/021 COMIRNATY Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection children 5 to 11 years BioNTech Manufacturing GmbH 31/08/2023 HM Unknown AU Concentrate for dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Tozinameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/022 EU/1/20/1528/022 COMIRNATY Omicron XBB.1.5 10 micrograms/dose dispersion for injection children 5 to 11 years BioNTech Manufacturing GmbH 31/08/2023 HM Unknown AU Dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Tozinameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/023 EU/1/20/1528/023 COMIRNATY Omicron XBB.1.5 10 micrograms/dose dispersion for injection children 5 to 11 years BioNTech Manufacturing GmbH 31/08/2023 HM Unknown AU Dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Tozinameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/026 EU/1/20/1528/026 COMIRNATY Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection children 6 months to 4 years BioNTech Manufacturing GmbH 15/05/2024 HM Unknown AU Concentrate for dispersion for injection J07BN01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Raxtozinameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/018 EU/1/20/1528/018 COMIRNATY Omicron XBB.1.5 30 micrograms/dose dispersion for injection adults and adolescents from 12 years BioNTech Manufacturing GmbH 31/08/2023 HM Unknown AU Dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Tozinameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/019 EU/1/20/1528/019 COMIRNATY Omicron XBB.1.5 30 micrograms/dose dispersion for injection adults and adolescents from 12 years BioNTech Manufacturing GmbH 31/08/2023 HM Unknown AU Dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Tozinameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/020 EU/1/20/1528/020 COMIRNATY Omicron XBB.1.5 30 micrograms/dose dispersion for injection adults and adolescents from 12 years BioNTech Manufacturing GmbH 31/08/2023 HM Unknown AU Dispersion for injection J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Tozinameran Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1528/052-055 EU/1/20/1528/052-055 COMIRNATY XFG 30 micrograms/dose dispersion for injection BioNTech Manufacturing GmbH HM Unknown AU Dispersion for injection in pre-filled syringe J07BN01 New active substance (Article 8(3) of Directive No 2001/83/EC) Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation *** AWAITING VALUE *** *** AWAITING VALUE *** EU/1/06/354/005-010 EU/1/06/354/005-010 Competact 15 mg/850 mg film-coated tablets CHEPLAPHARM Arzneimittel GmbH 28/07/2006 HM Unknown AU Film-coated tablet A10BD05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pioglitazone Metformin Hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0179/004/008 PA0179/004/008 Compound Sodium Lactate Intravenous Infusion BP, Ecobag (Hartmann’s Solution) B. Braun Medical Limited 30/03/2007 HM Marketed AU Solution for infusion B05BB B05BB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium chloride Potassium chloride Sodium lactate solution Calcium chloride dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0179/004/003 PA0179/004/003 Compound Sodium Lactate Intravenous Infusion BP, Solution for Infusion (Hartmann’s Solution) B. Braun Medical Limited 01/04/1983 HM Marketed AU Solution for infusion B05BB B05BB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium chloride Potassium chloride Sodium lactate solution Calcium chloride dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/012/001 PA2299/012/001 Compound Sodium Lactate Solution for Infusion BP Baxter Holding B.V. 17/04/2003 HM Marketed AU Solution for infusion B05BB B05BB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium chloride Potassium chloride Calcium chloride dihydrate Sodium lactate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/082/001 EU/1/98/082/001 COMTESS 200 mg Film-coated tablet Orion Corporation HM Unknown AU Tablet N04BX N04BX02 Full application (Article 8(3) of Directive No 2001/83/EC) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/082/002 EU/1/98/082/002 COMTESS 200 mg Film-coated tablet Orion Corporation HM Unknown AU Tablet N04BX N04BX02 Full application (Article 8(3) of Directive No 2001/83/EC) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/082/003 EU/1/98/082/003 COMTESS 200 mg Film-coated tablet Orion Corporation HM Unknown AU Tablet N04BX N04BX02 Full application (Article 8(3) of Directive No 2001/83/EC) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/511/1-4 EU/1/09/511/1-4 CONBRIZA 20 mg Film-coated tablet Pfizer Europe MA EEIG 17/04/2009 HM Unknown AU Film-coated tablet G03XC G03XC02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bazedoxifene Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22612/002/001 PA22612/002/001 Concerta XL 18 mg prolonged-release tablets Janssen Sciences Ireland Unlimited Company 22/11/2002 HM Marketed AU Prolonged-release tablet N06BA N06BA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Methylphenidate hydrochloride Methylphenidate hydrochloride Methylphenidate hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. PA22612/002/004 PA22612/002/004 Concerta XL 27 mg prolonged-release tablets Janssen Sciences Ireland Unlimited Company 01/08/2008 HM Marketed AU Prolonged-release tablet N06BA N06BA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Methylphenidate hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. PA22612/002/002 PA22612/002/002 Concerta XL 36 mg prolonged-release tablets Janssen Sciences Ireland Unlimited Company 22/11/2002 HM Marketed AU Prolonged-release tablet N06BA N06BA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Methylphenidate hydrochloride Methylphenidate hydrochloride Methylphenidate hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/25/1954/01 EU/1/25/1954/01 Conexxence 60 mg solution for injection in pre-filled syringe Fresenius Kabi Deutschland GmbH 18/07/2025 HM Unknown AU Solution for injection in pre-filled syringe M05BX04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Denosumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/801/001-004 EU/1/12/801/001-004 Constella 290 micrograms hard capsules AbbVie Deutschland GmbH & Co. KG 26/11/2012 HM Unknown AU Capsule, hard A06AX A06AX04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Linaclotide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/515/001-004 EU/1/09/515/001-004 CONTROLOC Control 20 mg Gastro-resistant tablet Takeda GmbH 12/06/2009 HM Unknown AU Gastro-resistant tablet A02BC A02BC02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Pantoprazole sodium sesquihydrate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/06/372/017-024 EU/1/06/372/017-024 IC0042-084-003 Copalia 10 mg/160 mg film-coated tablets Novartis Europharm Limited 16/01/2007 HM Unknown AU Film-coated tablet C09DB C09DB01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/372/009-016 EU/1/06/372/009-016 IC0042-086-003 Copalia 5 mg/160 mg film-coated tablets Novartis Europharm Limited HM Unknown AU Film-coated tablet C09DB C09DB01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/372/001-008 EU/1/06/372/001-008 IC0042-087-003 Copalia 5 mg/80 mg film-coated tablets Novartis Europharm Limited 16/01/2007 HM Unknown AU Film-coated tablet C09DB C09DB01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/575/13-24 EU/1/09/575/13-24 Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets Novartis Europharm Limited 04/11/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Hydrochlorothiazide Valsartan Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/575/37-48 EU/1/09/575/37-48 Copalia HCT 10 mg/160 mg/25 mg film-coated tablets Novartis Europharm Limited 04/11/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Hydrochlorothiazide Valsartan Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/575/49-60 EU/1/09/575/49-60 Copalia HCT 10 mg/320 mg/25 mg film-coated tablets Novartis Europharm Limited 04/11/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Valsartan Hydrochlorothiazide Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/575/1-12 EU/1/09/575/1-12 Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets Novartis Europharm Limited 04/11/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Amlodipine besilate Hydrochlorothiazide Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/575/25-36 EU/1/09/575/25-36 Copalia HCT 5 mg/160 mg/25 mg film-coated tablets Novartis Europharm Limited 04/11/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Amlodipine besilate Hydrochlorothiazide Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22579/001/001 PA22579/001/001 Copaxone 20 mg/ml solution for injection in pre-filled syringe TEVA GmbH 10/02/2004 HM Marketed AU Solution for injection in pre-filled syringe L03AX L03AX13 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Glatiramer acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/432/002 PPA0465/432/002 Copaxone 40 mg/ml solution for injection in pre-filled syringe PCO Manufacturing Ltd. 15/07/2022 HM Unknown AU Solution for injection in pre-filled syringe L03AX L03AX13 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Subcutaneous use Glatiramer acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22579/001/002 PA22579/001/002 Copaxone 40mg/ml solution for injection in pre-filled syringe TEVA GmbH 09/01/2015 HM Marketed AU Solution for injection in pre-filled syringe L03AX L03AX13 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Glatiramer acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/859/012-017 EU/1/13/859/012-017 Corbilta 100 mg/25mg/200 mg film coated tablets Orion Corporation 11/11/2013 HM Unknown AU Film-coated tablet N04BA N04BA03 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Carbidopa monohydrate Entacapone Levodopa Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/859/018-022 EU/1/13/859/018-022 Corbilta 125 mg/31.25 mg/200 mg film-coated tablets Orion Corporation 11/11/2013 HM Unknown AU Film-coated tablet N04BA N04BA03 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Entacapone Carbidopa monohydrate Levodopa Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/859/023-028 EU/1/13/859/023-028 Corbilta 150 mg/37.5 mg/200 mg film-coated tablets Orion Corporation 11/11/2013 HM Unknown AU Film-coated tablet N04BA N04BA03 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Levodopa Carbidopa monohydrate Entacapone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/859/029-033 EU/1/13/859/029-033 Corbilta 175 mg/43.75 mg/200 mg film-coated tablets Orion Corporation 11/11/2013 HM Unknown AU Film-coated tablet N04BA N04BA03 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Entacapone Carbidopa monohydrate Levodopa Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/859/034-038 EU/1/13/859/034-038 Corbilta 200 mg/50 mg/200 mg film-coated tablets Orion Corporation 11/11/2013 HM Unknown AU Film-coated tablet N04BA N04BA03 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Entacapone Carbidopa monohydrate Levodopa Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/859/001-006 EU/1/13/859/001-006 Corbilta 50 mg/12.5 mg/200 mg film-coated tablets Orion Corporation HM Unknown AU Film-coated tablet N04BA N04BA03 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Carbidopa monohydrate Entacapone Levodopa Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/859/007-011 EU/1/13/859/007-011 Corbilta 75 mg/18.75 mg/200 mg film-coated tablets Orion Corporation 11/11/2013 HM Unknown AU Film-coated tablet N04BA N04BA03 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Entacapone Carbidopa monohydrate Levodopa Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/142/001 PA0540/142/001 Cordarone X 100mg Tablets Sanofi-Aventis Ireland Limited T/A SANOFI 18/07/1984 HM Marketed AU Tablet C01BD C01BD01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Amiodarone hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/255/001 PPA1463/255/001 Cordarone X 200 mg Tablets IMED Healthcare Ltd., 05/12/2025 HM Unknown AU Tablet C01BD01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Amiodarone hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/142/002 PA0540/142/002 Cordarone X 200mg Tablets Sanofi-Aventis Ireland Limited T/A SANOFI 26/11/1984 HM Marketed AU Tablet C01BD C01BD01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Amiodarone hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/142/003 PA0540/142/003 Cordarone X Intravenous, 150mg/3ml, Concentrate for solution for infusion or slow injection Sanofi-Aventis Ireland Limited T/A SANOFI 20/02/1984 HM Marketed AU Concentrate for solution for infusion C01BD C01BD01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Amiodarone hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/05/317/1-7 EU/1/05/317/1-7 IC0145-001-003 Corlentor 5 mg film-coated tablets Les Laboratoires Servier HM Unknown AU Film-coated tablet C01EB C01EB17 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ivabradine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/05/317/8-14 EU/1/05/317/8-14 IC0145-041-003 Corlentor 7.5 mg film-coated tablets Les Laboratoires Servier HM Not marketed AU Film-coated tablet C01EB C01EB17 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ivabradine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0678/002/004 PA0678/002/004 Corsodyl 0.2% w/v Aniseed Mouthwash Haleon Ireland Limited 10/01/1995 HM Marketed AU Mouthwash A01AB A01AB03 Informed consent application (Article 10c of Directive No 2001/83/EC) Oromucosal use Chlorhexidine digluconate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA0678/002/001 PA0678/002/001 Corsodyl 1% w/w Dental Gel Haleon Ireland Limited 29/04/1975 HM Marketed AU Dental gel A01AB A01AB03 Informed consent application (Article 10c of Directive No 2001/83/EC) Dental use Chlorhexidine digluconate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0678/002/005 PA0678/002/005 Corsodyl Freshmint 0.2% w/v Mouthwash Haleon Ireland Limited 03/02/2012 HM Not marketed AU Mouthwash A01AB A01AB03 Informed consent application (Article 10c of Directive No 2001/83/EC) Oromucosal use Chlorhexidine digluconate (as chlorhexidine digluconate solution (20% w/v) ph.eur. Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA1009/026/001 PA1009/026/001 Cortiment 9 mg prolonged release tablets Ferring Ireland Ltd 05/12/2014 HM Marketed AU Prolonged-release tablet A07EA A07EA06 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Budesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/071/002 PA0281/071/002 Cortopin 1% w/w Cream Pinewood Laboratories Ltd 17/07/1989 HM Marketed AU Cream D07AA D07AA02 Well-established use application (Article 10a of Directive No 2001/83/EC) Topical Hydrocortisone Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only Product not subject to medical prescription for 15g tube only. EU/1/14/980/001 EU/1/14/980/001 Cosentyx 150 mg Powder for solution for injection Novartis Europharm Limited 15/01/2015 HM Unknown AU Powder for solution for injection L04AC L04AC10 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Secukinumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/14/980/004-005 EU/1/14/980/004-005 Cosentyx 150 mg Solution for injection pre-filled pen Novartis Europharm Limited 15/01/2015 HM Unknown AU Solution for injection in pre-filled pen L04AC L04AC10 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Secukinumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/14/980/002-003 EU/1/14/980/002-003 Cosentyx 150 mg Solution for injection pre-filled syringe Novartis Europharm Limited 15/01/2015 HM Unknown AU Solution for injection in pre-filled syringe L04AC L04AC10 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Secukinumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/14/980/10-011 EU/1/14/980/10-011 Cosentyx 300 mg Solution for injection in pre-filled pen Novartis Europharm Limited 20/11/2020 HM Unknown AU Solution for injection in pre-filled pen L04AC10 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Secukinumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/14/980/008-009 EU/1/14/980/008-009 Cosentyx 300 mg Solution for injection in pre-filled syringe Novartis Europharm Limited 14/01/2015 HM Unknown AU Solution for injection in pre-filled syringe L04AC10 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Secukinumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/14/980/012-013 EU/1/14/980/012-013 Cosentyx 75 mg Solution for injection pre-filled syringe Novartis Europharm Limited 16/07/2021 HM Unknown AU Solution for injection in pre-filled syringe L04AC10 Known active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Secukinumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0568/029/004 PA0568/029/004 Cosimprel 10mg/10mg Film-Coated Tablets Les Laboratoires Servier 04/03/2016 HM Not marketed AU Film-coated tablet C09BX C09BX02 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Perindopril arginine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/029/003 PA0568/029/003 Cosimprel 10mg/5mg Film-Coated Tablets Les Laboratoires Servier 04/03/2016 HM Not marketed AU Film-coated tablet C09BX C09BX02 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Perindopril arginine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/029/002 PA0568/029/002 Cosimprel 5mg/10mg Film-Coated Tablets Les Laboratoires Servier 04/03/2016 HM Not marketed AU Film-coated tablet C09BX C09BX02 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Perindopril arginine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/029/001 PA0568/029/001 Cosimprel 5mg/5mg Film-Coated Tablets Les Laboratoires Servier 04/03/2016 HM Not marketed AU Film-coated tablet C09BX C09BX02 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use BISOPROLOL FUMARATE Perindopril arginine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/021/001 PPA2306/021/001 CosmoFer 50 mg/ml solution for infusion and injection Originalis B.V. 18/10/2019 HM Unknown AU Solution for injection/infusion B03AC Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Intramuscular use Intravenous use IRON (III) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0982/001/001 PA0982/001/001 CosmoFer 50mg/ml solution for infusion and injection Pharmacosmos A/S 29/06/2001 HM Marketed AU Solution for injection/infusion B03AC Well-established use application (Article 10a of Directive No 2001/83/EC) Not Currently Available Iron (III) hydroxide dextran complex Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/296/001 PPA0465/296/001 COSOPT 20 mg/ml + 5 mg/ml eye drops, solution PCO Manufacturing Ltd. 05/10/2012 HM Unknown AU Eye drops, solution S01ED S01ED51 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Ocular use Dorzolamide Timolol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/060/001 PPA1463/060/001 COSOPT 20 mg/ml + 5 mg/ml eye drops, solution IMED Healthcare Ltd., 20/04/2012 HM Unknown AU Eye drops, solution S01ED51 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Ocular use Timolol Dorzolamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0879/005/001 PA0879/005/001 COSOPT 20mg/ml + 5mg/ml eye drops, solution Santen OY 14/08/1998 HM Marketed AU Eye drops, solution S01ED S01ED51 Full application (Article 8(3) of Directive No 2001/83/EC) Not Currently Available Dorzolamide hydrochloride Timolol Maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1048/001 EU/1/15/1048/001 Cotellic 20 mg film-coated tablets Roche Registration GmbH HM Unknown AU Film-coated tablet L01EE02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Cobimetinib hemifumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PPA0465/513/004 PPA0465/513/004 Coverdine 10 mg/2.5 mg/10 mg film-coated tablets PCO Manufacturing Ltd. 24/01/2025 HM Unknown AU Film-coated tablet C09BX Not Currently Available Perindopril arginine Indapamide Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/237/001 PPA1463/237/001 Coverdine 10 mg/2.5 mg/10 mg film-coated tablets IMED Healthcare Ltd., 04/04/2025 HM Unknown AU Film-coated tablet C09BX01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Perindopril arginine Indapamide Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/513/003 PPA0465/513/003 Coverdine 10 mg/2.5 mg/5 mg film-coated tablets PCO Manufacturing Ltd. 24/01/2025 HM Unknown AU Film-coated tablet C09BX C09BX01 Not Currently Available Perindopril arginine Indapamide Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/237/004 PPA1463/237/004 Coverdine 10 mg/2.5 mg/5 mg film-coated tablets IMED Healthcare Ltd., 14/11/2025 HM Unknown AU Film-coated tablet C09BX01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Perindopril arginine Indapamide Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/024/005 PA0568/024/005 Coverdine 10mg/2.5mg/10mg film-coated tablets Les Laboratoires Servier 16/04/2014 HM Marketed AU Film-coated tablet C09BX C09BX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Perindopril arginine Indapamide Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/028/001 PPA2306/028/001 Coverdine 10mg/2.5mg/10mg film-coated tablets Originalis B.V. 09/12/2022 HM Unknown AU Film-coated tablet C09BX C09BX01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Perindopril arginine Indapamide Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/024/004 PA0568/024/004 Coverdine 10mg/2.5mg/5mg film-coated tablets Les Laboratoires Servier 16/04/2014 HM Marketed AU Film-coated tablet C09BX C09BX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Perindopril arginine Indapamide Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/513/002 PPA0465/513/002 Coverdine 5 mg/1.25 mg/10 mg film-coated tablets PCO Manufacturing Ltd. 24/01/2025 HM Unknown AU Film-coated tablet C09BX C09BX01 Not Currently Available Perindopril arginine Indapamide Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/237/003 PPA1463/237/003 Coverdine 5 mg/1.25 mg/10 mg film-coated tablets IMED Healthcare Ltd., 14/11/2025 HM Unknown AU Film-coated tablet C09BX01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Perindopril arginine Indapamide Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/513/001 PPA0465/513/001 Coverdine 5 mg/1.25 mg/5 mg film-coated tablets PCO Manufacturing Ltd. 24/01/2025 HM Unknown AU Film-coated tablet C09BX C09BX01 Not Currently Available Perindopril arginine Indapamide Amlodipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/237/002 PPA1463/237/002 Coverdine 5 mg/1.25 mg/5 mg film-coated tablets IMED Healthcare Ltd., 14/11/2025 HM Unknown AU Film-coated tablet C09BX01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Perindopril arginine Indapamide Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/024/003 PA0568/024/003 Coverdine 5mg/1.25mg/10mg film-coated tablets Les Laboratoires Servier 16/04/2014 HM Marketed AU Film-coated tablet C09BX C09BX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Perindopril arginine Indapamide Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/024/002 PA0568/024/002 Coverdine 5mg/1.25mg/5mg film-coated tablets Les Laboratoires Servier 16/04/2014 HM Marketed AU Film-coated tablet C09BX C09BX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Perindopril arginine Indapamide Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/002/006 PA0568/002/006 IC0002-002-015 Coversyl Arginine 10 mg film coated tablets Les Laboratoires Servier 28/10/2005 HM Marketed AU Film-coated tablet C09AA C09AA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Perindopril arginine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/002/004 PA0568/002/004 Coversyl Arginine 2.5 mg film-coated tablets Les Laboratoires Servier 28/10/2005 HM Not marketed AU Film-coated tablet C09AA C09AA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Perindopril arginine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/002/005 PA0568/002/005 IC0002-001-015 Coversyl Arginine 5 mg film-coated tablets Les Laboratoires Servier 28/10/2005 HM Marketed AU Film-coated tablet C09AA C09AA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Perindopril arginine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/022/002 PA0568/022/002 Coversyl Arginine Plus 10mg/2.5mg film-coated tablets Les Laboratoires Servier 14/08/2009 HM Marketed AU Film-coated tablet C09BA C09BA04 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Perindopril arginine Indapamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/008/003 PA0568/008/003 IC0039-019-003 Coversyl Arginine Plus 2.5mg/0.625mg film-coated tablets Les Laboratoires Servier 11/05/2007 HM Marketed AU Film-coated tablet C09BA C09BA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Perindopril arginine Indapamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/016/002 PA0568/016/002 IC0039-020-003 Coversyl Arginine Plus 5mg/1.25mg film-coated tablets Les Laboratoires Servier 11/05/2007 HM Marketed AU Film-coated tablet C09BA C09BA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Perindopril arginine Indapamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/106/002 PPA0465/106/002 IC0003-024-003 Cozaar 100 mg film-coated tablets PCO Manufacturing Ltd. 08/02/2008 HM Unknown AU Film-coated tablet C09CA C09CA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Losartan potassium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/029/002 PPA1463/029/002 IC0003-024-003 Cozaar 100 mg film-coated tablets IMED Healthcare Ltd., 12/02/2010 HM Unknown AU Film-coated tablet C09CA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Losartan potassium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/002/003 PA23198/002/003 IC0003-024-003 Cozaar 100 mg Film-coated Tablets Organon Pharma (Ireland) Limited 16/11/2001 HM Marketed AU Film-coated tablet C09CA C09CA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Losartan potassium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only The development of this product has complied with all measures in the agreed paediatric investigation plan P/9/2008. For the purpose of the application of Article 45(3) of Regulation EC (No) 1901/2006, all studies in the agreed paediatric investigation pla PA23198/002/001 PA23198/002/001 Cozaar 12.5mg Film-coated Tablets Organon Pharma (Ireland) Limited 06/03/2009 HM Marketed AU Film-coated tablet C09CA C09CA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Losartan potassium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only The development of this product has complied with all measures in the agreed paediatric investigation plan P/9/2008. For the purpose of the application of Article 45(3) of Regulation EC (No) 1901/2006, all studies in the agreed paediatric investigation pla PPA0465/106/001 PPA0465/106/001 IC0003-023-003 Cozaar 50 mg film-coated tablets PCO Manufacturing Ltd. 06/02/2004 HM Unknown AU Film-coated tablet C09CA C09CA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Losartan potassium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/029/001 PPA1463/029/001 IC0003-023-003 Cozaar 50 mg film-coated tablets IMED Healthcare Ltd., 12/02/2010 HM Unknown AU Film-coated tablet C09CA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Losartan potassium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/002/002 PA23198/002/002 IC0003-023-003 Cozaar 50 mg Film-coated Tablets Organon Pharma (Ireland) Limited 06/06/1995 HM Marketed AU Film-coated tablet C09CA C09CA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Losartan potassium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only The development of this product has complied with all measures in the agreed paediatric investigation plan P/9/2008. For the purpose of the application of Article 45(3) of Regulation EC (No) 1901/2006, all studies in the agreed paediatric investigation pla PA23198/001/001 PA23198/001/001 IC0031-026-003 Cozaar Comp 100 mg/12.5 mg film-coated tablets Organon Pharma (Ireland) Limited 22/02/2008 HM Marketed AU Film-coated tablet C09DA C09DA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Losartan potassium Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/109/004 PPA0465/109/004 IC0031-026-003 Cozaar Comp 100 mg/12.5 mg film-coated tablets PCO Manufacturing Ltd. 16/04/2021 HM Unknown AU Film-coated tablet C09DA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Hydrochlorothiazide Losartan potassium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/109/002 PPA0465/109/002 IC0031-027-003 Cozaar Comp 100 mg/25 mg film-coated tablets PCO Manufacturing Ltd. 08/02/2008 HM Unknown AU Film-coated tablet C09CA C09CA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Losartan potassium Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/225/001 PPA1463/225/001 IC0031-026-003 Cozaar Comp 100mg/12.5mg film-coated tablets IMED Healthcare Ltd. 12/07/2024 HM Unknown AU Film-coated tablet C09DA C09DA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Losartan potassium Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/001/003 PA23198/001/003 IC0031-027-003 Cozaar Comp 100mg/25mg film-coated tablets Organon Pharma (Ireland) Limited 23/02/2001 HM Marketed AU Film-coated tablet C09DA C09DA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Losartan potassium Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/225/002 PPA1463/225/002 IC0031-027-003 Cozaar Comp 100mg/25mg film-coated tablets IMED Healthcare Ltd. 12/07/2024 HM Unknown AU Film-coated tablet C09DA C09DA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Losartan potassium Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/001/002 PA23198/001/002 IC0031-025-003 Cozaar Comp 50 mg/12.5 mg film-coated tablets Organon Pharma (Ireland) Limited 07/02/1997 HM Marketed AU Film-coated tablet C09DA C09DA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Losartan potassium Hydrochlorothiazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/109/001 PPA0465/109/001 IC0031-025-003 Cozaar Comp 50 mg/12.5 mg film-coated tablets PCO Manufacturing Ltd. 09/01/2004 HM Unknown AU Film-coated tablet C09DA C09DA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Hydrochlorothiazide Losartan potassium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/318/001 PA0126/318/001 Crampex TabletsCholecalciferol 0.02 mgCalcium Gluconate 200 mgNicotinic Acid 20 mg Clonmel Healthcare Ltd 23/04/1993 HM Not marketed AU Tablet A12AX Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cholecalciferol Calcium gluconate Nicotinic acid Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23355/006/001 PA23355/006/001 Creon 10000 Gastro-resistant Capsules Viatris Healthcare Limited 21/03/1997 HM Marketed AU Gastro-resistant capsule, hard A09AA A09AA02 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Pancreatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/125/001 PPA0465/125/001 Creon 10000 Gastro-resistant Capsules PCO Manufacturing Ltd. 25/06/2004 HM Unknown AU Gastro-resistant capsule, hard A09AA A09AA02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Pancreatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/145/001 PPA1463/145/001 Creon 10000 Gastro-Resistant Capsules IMED Healthcare Ltd., 22/02/2008 HM Unknown AU Gastro-resistant capsule, hard A09AA A09AA02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Pancreatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/006/004 PA23355/006/004 Creon 20000 Gastro-resistant Capsules, hard Viatris Healthcare Limited 01/02/2019 HM Not marketed AU Gastro-resistant capsule, hard A09AA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pancreatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/033/002 PPA1463/033/002 Creon 25000 Gastro-resistant capsules IMED Healthcare Ltd., 10/01/2013 HM Unknown AU Gastro-resistant capsule, hard A09AA A09AA02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Not Currently Available Oral use Pancreatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/006/002 PA23355/006/002 Creon 25000 Gastro-resistant Capsules Viatris Healthcare Limited 24/04/1997 HM Marketed AU Gastro-resistant capsule, hard A09AA A09AA02 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Pancreatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/125/002 PPA0465/125/002 Creon 25000 Gastro-resistant Capsules PCO Manufacturing Ltd. 25/06/2004 HM Unknown AU Gastro-resistant capsule, hard A09AA A09AA02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Pancreatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/006/005 PA23355/006/005 Creon 35000 Gastro-resistant Capsules, hard Viatris Healthcare Limited 01/02/2019 HM Not marketed AU Gastro-resistant capsule, hard A09AA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pancreatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/006/003 PA23355/006/003 Creon for Children 5000 Gastro-resistant Granules Viatris Healthcare Limited 23/06/2006 HM Marketed AU Gastro-resistant granules A09AA A09AA02 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Pancreatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1036/002 EU/1/15/1036/002 CRESEMBA 100 mg hard capsules Basilea Pharmaceutica Deutschland GmbH HM Unknown AU Powder for concentrate for solution for infusion J02AC J02AC05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Isavuconazonium sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1036/001 EU/1/15/1036/001 CRESEMBA 200 mg powder for concentrate for solution for infusion Basilea Pharmaceutica Deutschland GmbH 15/10/2015 HM Unknown AU Powder for concentrate for solution for infusion J02AC J02AC05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Isavuconazonium sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1036/003 EU/1/15/1036/003 CRESEMBA 40 mg hard capsules Basilea Pharmaceutica Deutschland GmbH 22/08/2024 HM Unknown AU Capsule, hard J02AC05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Isavuconazonium sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2242/016/002 PA2242/016/002 IC0006-002-003 Crestor 10 mg film-coated tablets Grunenthal Pharma Limited. 17/04/2003 HM Marketed AU Film-coated tablet C10AA C10AA07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/441/002 PPA0465/441/002 IC0006-002-003 Crestor 10 mg film-coated tablets PCO Manufacturing Ltd. 12/10/2018 HM Unknown AU Film-coated tablet C10AA07 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/119/002 PPA1463/119/002 IC0006-002-003 Crestor 10 mg film-coated tablets IMED Healthcare Ltd., 27/04/2018 HM Unknown AU Film-coated tablet C10AA C10AA07 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/038/002 PPA2306/038/002 IC0006-002-003 Crestor 10 mg film-coated tablets Originalis B.V. 03/01/2025 HM Unknown AU Film-coated tablet C10AA07 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2242/016/003 PA2242/016/003 IC0006-003-003 Crestor 20 mg film-coated tablets Grunenthal Pharma Limited. 17/04/2003 HM Marketed AU Film-coated tablet C10AA C10AA07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/441/003 PPA0465/441/003 IC0006-003-003 Crestor 20 mg film-coated tablets PCO Manufacturing Ltd. 12/10/2018 HM Unknown AU Film-coated tablet C10AA07 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/119/003 PPA1463/119/003 IC0006-003-003 Crestor 20 mg film-coated tablets IMED Healthcare Ltd., 27/04/2018 HM Unknown AU Film-coated tablet C10AA C10AA07 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/034/001 PPA2306/034/001 IC0006-003-003 Crestor 20 mg film-coated tablets Originalis B.V. 06/09/2024 HM Unknown AU Film-coated tablet C10AA07 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Rosuvastatin calcium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2242/016/004 PA2242/016/004 IC0006-004-003 Crestor 40 mg film-coated tablets Grunenthal Pharma Limited. 17/04/2003 HM Marketed AU Film-coated tablet C10AA C10AA07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/441/004 PPA0465/441/004 IC0006-004-003 Crestor 40 mg film-coated tablets PCO Manufacturing Ltd. 12/10/2018 HM Unknown AU Film-coated tablet C10AA C10AA07 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/119/004 PPA1463/119/004 IC0006-004-003 Crestor 40 mg film-coated tablets IMED Healthcare Ltd., 11/02/2022 HM Unknown AU Film-coated tablet C10AA C10AA07 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2242/016/001 PA2242/016/001 IC0006-001-003 Crestor 5 mg film-coated tablets Grunenthal Pharma Limited. 23/09/2005 HM Marketed AU Film-coated tablet C10AA C10AA07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/441/001 PPA0465/441/001 IC0006-001-003 Crestor 5 mg film-coated tablets PCO Manufacturing Ltd. 12/10/2018 HM Unknown AU Film-coated tablet C10AA07 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/119/001 PPA1463/119/001 IC0006-001-003 Crestor 5 mg film-coated tablets IMED Healthcare Ltd., 27/04/2018 HM Unknown AU Film-coated tablet C10AA07 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/038/001 PPA2306/038/001 IC0006-001-003 Crestor 5 mg film-coated tablets Originalis B.V. 03/01/2025 HM Unknown AU Film-coated tablet C10AA07 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Rosuvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2286/001/001 PA2286/001/001 Crinone 8% w/w progesterone vaginal gel Merck Serono (Ireland) Limited 25/07/1997 HM Marketed AU Vaginal gel G03DA G03DA04 Full application (Article 8(3) of Directive No 2001/83/EC) Vaginal use Progesterone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/301/001 PPA0465/301/001 Crinone 8% w/w progesterone vaginal gel PCO Manufacturing Ltd. 22/02/2013 HM Unknown AU Vaginal gel G03DA04 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Vaginal use Progesterone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/112/001 PPA1463/112/001 Crinone 8% w/w progesterone vaginal gel IMED Healthcare Ltd., 31/03/2017 HM Unknown AU Vaginal gel G03DA04 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Vaginal use Progesterone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/313/001 PA0126/313/001 Crystapen 600 mg Powder for Solution for Injection or Infusion Clonmel Healthcare Ltd 20/04/2001 HM Marketed AU Powder for solution for injection/infusion J01CE J01CE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Benzylpenicillin Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1262/001 EU/1/17/1262/001 CRYSVITA 10 mg solution for injection Kyowa Kirin Holdings B.V. HM Unknown AU Solution for injection M05BX M05BX05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Recombinant human igg1 monoclonal antibody to fibroblast growth factor 23 Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1262/002 EU/1/17/1262/002 CRYSVITA 20 mg solution for injection Kyowa Kirin Holdings B.V. 19/02/2018 HM Unknown AU Solution for injection M05BX M05BX05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Recombinant human igg1 monoclonal antibody to fibroblast growth factor 23 Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1262/003 EU/1/17/1262/003 CRYSVITA 30 mg solution for injection Kyowa Kirin Holdings B.V. 19/02/2018 HM Unknown AU Solution for injection M05BX M05BX05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Recombinant human igg1 monoclonal antibody to fibroblast growth factor 23 Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/05/328/001 EU/1/05/328/001 Cubicin 350 mg powder for solution for injection or infusion Merck Sharp & Dohme BV 19/01/2006 HM Unknown AU Powder for solution for injection/infusion J01XX J01XX09 Full application (Article 8(3) of Directive No 2001/83/EC) Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/05/328/002 EU/1/05/328/002 Cubicin 500 mg powder for solution for injection or infusion Merck Sharp & Dohme BV 19/01/2006 HM Unknown AU Powder for solution for injection/infusion J01XX J01XX09 Full application (Article 8(3) of Directive No 2001/83/EC) Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1365/002 EU/1/19/1365/002 Cufence Univar B.V 23/11/2023 HM Unknown AU Capsule, hard A16AX12 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Trientine tetrahydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/19/1365/001 EU/1/19/1365/001 Cufence 100 mg hard capsule Univar B.V 25/07/2019 HM Unknown AU Capsule, hard A16A A16AX12 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use TRIENTINE DIHYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1199/001 EU/1/17/1199/001 Cuprior 150 mg film-coated tablets gmp-orphan SA 05/09/2017 HM Unknown AU Film-coated tablet A16AX A16AX12 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Trientine tetrahydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/784/001 EU/1/12/784/001 Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution A.C.O.M. Advanced Center Oncology Macerata S.r.l. 23/08/2012 HM Unknown AU Radiopharmaceutical precursor, solution V New active substance (Article 8(3) of Directive No 2001/83/EC) Copper (64 cu) chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA22743/004/001 PA22743/004/001 Curanail 5% w/v medicated nail lacquer Galderma International 16/03/2012 HM Marketed AU Medicated nail lacquer D01AE D01AE16 Informed consent application (Article 10c of Directive No 2001/83/EC) Cutaneous use Amorolfine Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0584/005/001 PA0584/005/001 CUROSURF 120 mg/vial Endotracheopulmonary instillation, suspension Chiesi Farmaceutici S.p.A. 08/09/1994 HM Marketed AU Endotracheopulmonary instillation, suspension R07AA R07AA02 Full application (Article 8(3) of Directive No 2001/83/EC) Endotracheopulmonary use Porcine lung surfactant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0584/005/002 PA0584/005/002 CUROSURF 240 mg/vial Endotracheopulmonary instillation, suspension Chiesi Farmaceutici S.p.A. 08/09/1994 HM Marketed AU Endotracheopulmonary instillation, suspension R07AA R07AA02 Full application (Article 8(3) of Directive No 2001/83/EC) Endotracheopulmonary use Porcine lung surfactant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2219/001/001 PA2219/001/001 CUTAQUIG, 165 mg/ml, solution for injection Octapharma (IP) 01/05/2020 HM Not marketed AU Solution for injection J06BA J06BA01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Human normal immunoglobulin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2004/008/001 PA2004/008/001 Cuvitru 200 mg/ml solution for subcutaneous injection Baxalta Innovations GmbH 08/07/2016 HM Marketed AU Solvent for... J06BA01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Human normal immunoglobulin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/420/001 EU/1/07/420/001 Cyanokit 2.5 g Powder for solution for infusion SERB S.A. 23/11/2007 HM Unknown AU Powder for solution for infusion V03AB V03AB33 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Hydroxocobalamin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/420/002 EU/1/07/420/002 Cyanokit 5 g Powder for solution for infusion Merck Sante s.a.s. 07/10/2010 HM Unknown AU Powder for solution for infusion V03AB V03AB33 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Hydroxocobalamin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/003/001 PA1142/003/001 Cyclimorph 10 solution for injection Amdipharm Limited 01/04/1978 HM Not marketed AU Solution for injection N02AA N02AA51 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Subcutaneous use CYCLIZINE TARTRATE Morphine tartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1142/003/002 PA1142/003/002 Cyclimorph 15 Solution for Injection Amdipharm Limited 01/04/1978 HM Not marketed AU Solution for injection N02AA N02AA51 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Subcutaneous use Morphine Tartrate BPC 1959 CYCLIZINE TARTRATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA23317/001/001 PA23317/001/001 Cyclolux 0.5 mmol/ml solution for injection Sanochemia Pharmazeutika GmbH 16/12/2022 HM Not marketed AU Solution for injection V08CA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Gadoteric acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22766/013/003 PA22766/013/003 Cyclophosphamide Seacross 1000 mg powder for solution for injection/infusion Seacross Pharma (Europe) Limited 06/12/2024 HM Marketed AU Powder for solution for injection/infusion L01AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cyclophosphamide monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22766/013/001 PA22766/013/001 Cyclophosphamide Seacross 200 mg powder for solution for injection/infusion Seacross Pharma (Europe) Limited 06/12/2024 HM Not marketed AU Powder for solution for injection/infusion L01AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cyclophosphamide monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22766/013/004 PA22766/013/004 Cyclophosphamide Seacross 2000 mg powder for solution for injection/infusion Seacross Pharma (Europe) Limited 06/12/2024 HM Not marketed AU Powder for solution for injection/infusion L01AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cyclophosphamide monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22766/013/002 PA22766/013/002 Cyclophosphamide Seacross 500 mg powder for solution for injection/infusion Seacross Pharma (Europe) Limited 06/12/2024 HM Not marketed AU Powder for solution for injection/infusion L01AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cyclophosphamide monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/117/001 PA0822/117/001 Cyklokapron 100 mg/mL solution for injection/infusion Pfizer Healthcare Ireland Unlimited Company 01/04/1983 HM Marketed AU Solution for injection/infusion B02AA B02AA02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Tranexamic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23355/035/001 PA23355/035/001 Cyklokapron 500 mg Film-coated Tablets Viatris Healthcare Limited 18/08/2006 HM Marketed AU Film-coated tablet B02AA B02AA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use TRANEXAMIC ACID PH. EUR. Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/296/1-4 EU/1/04/296/1-4 IC0091-033-006 Cymbalta 30 mg hard gastro-resistant capsules Eli Lilly Nederland B.V. HM Unknown AU Gastro-resistant capsule, hard N06AX N06AX21 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Duloxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/296/002-005 EU/1/04/296/002-005 IC0091-127-006 Cymbalta 60 mg hard gastro-resistant capsules Eli Lilly Nederland B.V. 17/12/2004 HM Unknown AU Gastro-resistant capsule, hard N06AX N06AX21 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Duloxetine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2239/003/001 PA2239/003/001 Cymevene 500 mg powder for concentrate for solution for infusion CHEPLAPHARM Arzneimittel GmbH 17/08/2018 HM Marketed AU Powder for concentrate for solution for infusion J05AB J05AB06 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Ganciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2261/008/001 PA2261/008/001 Cymex Cream Dexcel Pharma GmbH 23/04/1997 HM Marketed AU Cream D08AJ D08AJ04 Generic application (Article 10(1) of Directive No 2001/83/EC) Topical use Cetrimide Chlorocresol Dimeticone Urea Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/14/957/001-003 EU/1/14/957/001-003 Cyramza 10 mg/ml Concentrate for solution for infusion Eli Lilly Nederland B.V. 19/12/2014 HM Unknown AU Concentrate for solution for infusion L01XC Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Ramucirumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/06/379/001 EU/1/06/379/001 Cystadane 1g oral powder Recordati Rare Diseases 15/02/2007 HM Unknown AU Oral powder A16AA A16AA06 Full application (Article 8(3) of Directive No 2001/83/EC) Betaine anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1049/001-002 EU/1/15/1049/001-002 Cystadrops 3.8 mg/mL eye drops solution Recordati Rare Diseases 19/01/2017 HM Unknown AU Eye drops, solution S01XA S01XA21 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Mercaptamine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/97/039/003 EU/1/97/039/003 CYSTAGON 150 mg hard capsules Recordati Rare Diseases HM Unknown AU Capsule, hard A16AA A16AA04 Full application (Article 8(3) of Directive No 2001/83/EC) Mercaptamine bitartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/97/039/004 EU/1/97/039/004 CYSTAGON 150 mg hard capsules Recordati Rare Diseases HM Unknown AU Capsule, hard A16AA A16AA04 Full application (Article 8(3) of Directive No 2001/83/EC) Mercaptamine bitartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/97/039/001 EU/1/97/039/001 CYSTAGON 50 mg hard capsules Recordati Rare Diseases HM Unknown AU Capsule, hard A16AA A16AA04 Full application (Article 8(3) of Directive No 2001/83/EC) Mercaptamine bitartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/97/039/002 EU/1/97/039/002 CYSTAGON 50 mg hard capsules Recordati Rare Diseases HM Unknown AU Capsule, hard A16AA A16AA04 Full application (Article 8(3) of Directive No 2001/83/EC) Mercaptamine bitartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA1410/042/001 PA1410/042/001 Cystopurin 3g Granules for oral solution Bayer Limited 19/09/1995 HM Marketed AU Granules for oral solution A12BA A12BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Potassium citrate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0822/200/002 PA0822/200/002 Cytarabine 100 mg/ml Solution for Injection Pfizer Healthcare Ireland Unlimited Company 21/05/1990 HM Marketed AU Solution for injection L01BC L01BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Cytarabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/082/001 PA2315/082/001 Cytarabine 100 mg/ml solution for injection or infusion Accord Healthcare Ireland Ltd. 15/02/2013 HM Marketed AU Solution for injection/infusion L01BC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Cytarabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/034/001 PA2059/034/001 Cytarabine 100 mg/ml Solution for Injection or Infusion Fresenius Kabi Deutschland GmbH 23/11/2012 HM Not marketed AU Solution for injection/infusion L01BC L01BC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Cytarabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA2315/082/002 PA2315/082/002 Cytarabine 20 mg/ml Solution for Injection/Infusion Accord Healthcare Ireland Ltd. 22/06/2018 HM Not marketed AU Solution for injection/infusion L01BC L01BC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Cytarabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0822/200/001 PA0822/200/001 Cytarabine 20 mg/ml Solution for Injection or Infusion Pfizer Healthcare Ireland Unlimited Company 20/11/1989 HM Marketed AU Solution for injection/infusion L01BC L01BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Cytarabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA23514/002/001 PA23514/002/001 Cytisinicline Adamed Pharma 1.5 mg film-coated tablets Adamed Pharma S.A. 14/04/2023 HM Not marketed AU Film-coated tablet N07BA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Cytisinicline Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0822/118/001 PA0822/118/001 Cytotec 200 microgram tablets Pfizer Healthcare Ireland Unlimited Company 11/04/1989 HM Marketed AU Tablet A02BB A02BB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Misoprostol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/386/002 PA0126/386/002 IC0173-208-001 Dabigatran Etexilate 110 mg hard capsules Clonmel Healthcare Ltd 19/07/2024 HM Marketed AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/386/003 PA0126/386/003 IC0173-062-001 Dabigatran Etexilate 150 mg hard capsules Clonmel Healthcare Ltd 19/07/2024 HM Marketed AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/386/001 PA0126/386/001 IC0173-028-001 Dabigatran Etexilate 75 mg hard capsules Clonmel Healthcare Ltd 19/07/2024 HM Not marketed AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1665/007-016 EU/1/22/1665/007-016 IC0173-208-001 Dabigatran etexilate Accord 110 mg hard capsules Accord Healthcare S.L.U. 26/05/2023 HM Unknown AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1665/017-024 EU/1/22/1665/017-024 IC0173-062-001 Dabigatran etexilate Accord 150 mg hard capsules Accord Healthcare S.L.U. 26/05/2023 HM Unknown AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1665/001-006 EU/1/22/1665/001-006 IC0173-028-001 Dabigatran etexilate Accord 75 mg hard capsules Accord Healthcare S.L.U. 26/05/2023 HM Unknown AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/340/002 PA0126/340/002 IC0173-208-001 Dabigatran etexilate Clonmel 110 mg hard capsules Clonmel Healthcare Ltd 10/11/2023 HM Not marketed AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/340/003 PA0126/340/003 IC0173-062-001 Dabigatran etexilate Clonmel 150 mg hard capsules Clonmel Healthcare Ltd 10/11/2023 HM Not marketed AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/340/001 PA0126/340/001 IC0173-028-001 Dabigatran etexilate Clonmel 75 mg hard capsules Clonmel Healthcare Ltd 10/11/2023 HM Not marketed AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1330/033/001 PA1330/033/001 Dabigatran etexilate Gedeon Richter 110 mg hard capsules Gedeon Richter Plc 09/04/2026 HM Not marketed AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1330/033/002 PA1330/033/002 Dabigatran etexilate Gedeon Richter 150 mg hard capsules Gedeon Richter Plc 09/04/2026 HM Not marketed AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/110/002 PA1347/110/002 IC0173-208-001 Dabigatran Etexilate Krka 110 mg hard capsules KRKA, d.d., Novo mesto 12/01/2024 HM Marketed AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/110/003 PA1347/110/003 IC0173-062-001 Dabigatran Etexilate Krka 150 mg hard capsules KRKA, d.d., Novo mesto 12/01/2024 HM Marketed AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/110/001 PA1347/110/001 IC0173-028-001 Dabigatran Etexilate Krka 75 mg hard capsules KRKA, d.d., Novo mesto 12/01/2024 HM Not marketed AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0074/095/001 PA0074/095/001 IC0173-208-001 Dabigatran etexilate Rowa 110 mg hard capsules Rowa Pharmaceuticals Limited, 24/01/2025 HM Not marketed AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0074/095/002 PA0074/095/002 IC0173-062-001 Dabigatran etexilate Rowa 150 mg hard capsules Rowa Pharmaceuticals Limited, 24/01/2025 HM Not marketed AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1769/007-015 EU/1/23/1769/007-015 IC0173-208-001 Dabigatran etexilate Teva 110 mg hard capsules TEVA GmbH 31/05/2024 HM Unknown AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1769/016-023 EU/1/23/1769/016-023 IC0173-062-001 Dabigatran etexilate Teva 150 mg hard capsules TEVA GmbH 31/05/2024 HM Unknown AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1769/001-006 EU/1/23/1769/001-006 IC0173-028-001 Dabigatran etexilate Teva 75 mg hard capsules TEVA GmbH 31/05/2024 HM Unknown AU Capsule, hard B01AE07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dabigatran etexilate mesilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1760/001/003 PA1760/001/003 Dacarbazine Lipomed 1000 mg powder for solution for infusion Lipomed GmbH 18/08/2017 HM Marketed AU Powder for solution for infusion L01AX L01AX04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Dacarbazine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1760/001/001 PA1760/001/001 Dacarbazine Lipomed 200 mg powder for solution for injection or infusion Lipomed GmbH 06/07/2012 HM Marketed AU Powder for solution for injection/infusion L01AX L01AX04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Dacarbazine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1760/001/002 PA1760/001/002 Dacarbazine Lipomed 500 mg powder for solution for infusion Lipomed GmbH 18/08/2017 HM Marketed AU Powder for solution for infusion L01AX L01AX04 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Dacarbazine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0623/003/004 PA0623/003/004 Dacarbazine medac 1000 mg, powder for solution for infusion medac Gesellschaft für klinische Spezialpräparate mbH 14/11/1997 HM Marketed AU Powder for solution for infusion L01AX L01AX04 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Dacarbazine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0623/003/002 PA0623/003/002 Dacarbazine medac 200 mg, powder for solution for injection/infusion medac Gesellschaft für klinische Spezialpräparate mbH 14/11/1997 HM Marketed AU Powder for solution for injection/infusion L01AX L01AX04 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Dacarbazine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0623/003/003 PA0623/003/003 Dacarbazine medac 500 mg, powder for solution for infusion medac Gesellschaft für klinische Spezialpräparate mbH 14/11/1997 HM Marketed AU Powder for solution for infusion L01AX L01AX04 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Dacarbazine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1774/001/003 PA1774/001/003 Dacepton 10 mg/ml solution for injection in cartridge EVER Valinject GmbH 16/06/2017 HM Not marketed AU Solution for injection in cartridge N04BC N04BC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Apomorphine hydrochloride hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA1774/001/002 PA1774/001/002 Dacepton 5 mg/ml solution for infusion EVER Valinject GmbH 09/05/2014 HM Not marketed AU Solution for infusion N04BC N04BC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Apomorphine hydrochloride hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/792/001 EU/1/12/792/001 Dacogen 50 mg powder for concentrate for solution for infusion Janssen-Cilag International NV HM Unknown AU Powder for concentrate for solution for infusion L01BC L01BC08 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Decitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/06/371/017-024 EU/1/06/371/017-024 IC0042-084-003 Dafiro 10 mg/160 mg film-coated tablets Novartis Europharm Limited 16/01/2007 HM Unknown AU Film-coated tablet C09DB C09DB01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Valsartan Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/371/009-016 EU/1/06/371/009-016 IC0042-086-003 Dafiro 5 mg/160 mg film-coated tablets Novartis Europharm Limited 16/01/2007 HM Unknown AU Film-coated tablet C09DB C09DB01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/371/001-008 EU/1/06/371/001-008 IC0042-087-003 Dafiro 5 mg/80 mg film-coated tablets Novartis Europharm Limited 16/01/2007 HM Unknown AU Film-coated tablet C09DB C09DB01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/574/13-24 EU/1/09/574/13-24 Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Novartis Europharm Limited 04/11/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Hydrochlorothiazide Valsartan Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/574/37-48 EU/1/09/574/37-48 Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Novartis Europharm Limited 04/11/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Hydrochlorothiazide Valsartan Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/574/49-60 EU/1/09/574/49-60 Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets Novartis Europharm Limited 04/11/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Valsartan Hydrochlorothiazide Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/574/1-12 EU/1/09/574/1-12 Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Novartis Europharm Limited 04/11/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Amlodipine besilate Hydrochlorothiazide Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/574/25-36 EU/1/09/574/25-36 Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Novartis Europharm Limited 04/11/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Amlodipine besilate Hydrochlorothiazide Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23490/028/001 PA23490/028/001 Daktarin 2% w/w Cream JNTL Consumer Health I (Ireland) Limited 31/03/1988 HM Marketed AU Cream D01AC D01AC02 Well-established use application (Article 10a of Directive No 2001/83/EC) Cutaneous use Miconazole nitrate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23490/028/002 PA23490/028/002 Daktarin 2% w/w Cutaneous Powder JNTL Consumer Health (Ireland) Limited 01/04/1977 HM Marketed AU Cutaneous powder D01AC D01AC02 Well-established use application (Article 10a of Directive No 2001/83/EC) Cutaneous use Miconazole nitrate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23490/028/003 PA23490/028/003 Daktarin 20 mg/g Oral Gel JNTL Consumer Health I (Ireland) Limited 10/07/1979 HM Marketed AU Oral gel A01AB A01AB09 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Miconazole Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0822/119/001 PA0822/119/001 Dalacin 100 mg Vaginal Ovule Pfizer Healthcare Ireland Unlimited Company 21/12/1998 HM Not marketed AU Pessary G01AA G01AA10 Full application (Article 8(3) of Directive No 2001/83/EC) Vaginal use Clindamycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/119/002 PA0822/119/002 Dalacin 2% vaginal cream Pfizer Healthcare Ireland Unlimited Company 15/10/1993 HM Marketed AU Vaginal cream G01AA G01AA10 Full application (Article 8(3) of Directive No 2001/83/EC) Vaginal use Clindamycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/416/001 PPA0465/416/001 Dalacin 2% Vaginal Cream PCO Manufacturing Ltd. 11/12/2015 HM Unknown AU Vaginal cream J01FF J01FF01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Vaginal use Clindamycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/120/001 PA0822/120/001 Dalacin C 150 mg Hard Capsules Pfizer Healthcare Ireland Unlimited Company 10/05/1977 HM Marketed AU Capsule, hard J01FF J01FF01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Clindamycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/205/001 PPA0465/205/001 Dalacin C 150 mg Hard Capsules PCO Manufacturing Ltd. 05/10/2007 HM Unknown AU Capsule, hard D10AF D10AF01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Clindamycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/150/001 PPA1463/150/001 Dalacin C 150 mg Hard Capsules IMED Healthcare Ltd., 29/08/2014 HM Unknown AU Capsule, hard J01FF J01FF01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Clindamycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA23080/008/001 PPA23080/008/001 Dalacin C 150 mg Hard Capsules Merit Pharmaceuticals Limited 28/06/2013 HM Unknown AU Capsule, hard J01FF01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Clindamycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/120/002 PA0822/120/002 Dalacin C Phosphate 150 mg/ml Concentrate for Solution for injection/infusion, 2ml Pfizer Healthcare Ireland Unlimited Company 09/09/1976 HM Marketed AU Concentrate for solution for injection/infusion J01FF J01FF01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Clindamycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/120/003 PA0822/120/003 Dalacin C Phosphate 150 mg/ml Concentrate for Solution for injection/infusion, 4ml Pfizer Healthcare Ireland Unlimited Company 09/09/1976 HM Marketed AU Concentrate for solution for injection/infusion J01FF J01FF01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Clindamycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/121/001 PA0822/121/001 Dalacin T Topical Lotion 10 mg/ml Cutaneous Emulsion Pfizer Healthcare Ireland Unlimited Company 03/01/1991 HM Marketed AU Cutaneous emulsion D10AF D10AF01 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Clindamycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23355/025/001 PA23355/025/001 Dalmane 15 mg Hard Capsules Viatris Healthcare Limited 01/04/1977 HM Marketed AU Capsule, hard N05CD N05CD01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Flurazepam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA23355/025/002 PA23355/025/002 Dalmane 30 mg Hard Capsules Viatris Healthcare Limited 01/04/1977 HM Marketed AU Capsule, hard N05CD N05CD01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Flurazepam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA1347/117/001 PA1347/117/001 Dalnecombi 7 mg/5 mg/2.5 mg tablets KRKA, d.d., Novo mesto 31/01/2025 HM Not marketed AU Tablet C09BX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Perindopril arginine Amlodipine besilate Indapamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/143/002 PA0711/143/002 IC0066-002-024 Dancex SR 10 mg Prolonged-Release Tablets Rowex Limited, 01/08/2008 HM Marketed AU Prolonged-release tablet N02AA N02AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use OXYCODONE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0711/143/003 PA0711/143/003 IC0066-003-024 Dancex SR 20 mg Prolonged-Release Tablets Rowex Limited, 01/08/2008 HM Marketed AU Prolonged-release tablet N02AA N02AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use OXYCODONE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0711/143/004 PA0711/143/004 IC0066-004-024 Dancex SR 40 mg Prolonged-Release Tablets Rowex Limited, 24/09/2012 HM Not marketed AU Prolonged-release tablet N02AA N02AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use OXYCODONE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0711/143/001 PA0711/143/001 IC0066-001-024 Dancex SR 5 mg Prolonged-Release Tablets Rowex Limited, 01/08/2008 HM Marketed AU Prolonged-release tablet N02AA N02AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use OXYCODONE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0711/143/006 PA0711/143/006 IC0066-005-024 Dancex SR 80 mg Prolonged-Release Tablets Rowex Limited, 24/09/2012 HM Not marketed AU Prolonged-release tablet N02AA N02AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use OXYCODONE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0711/250/002 PA0711/250/002 IC0102-016-024 Dancex SR Plus 10 mg/5 mg Prolonged-release tablets Rowex Limited, 15/04/2016 HM Not marketed AU Prolonged-release tablet N02AA N02AA55 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use OXYCODONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0711/250/003 PA0711/250/003 IC0102-061-024 Dancex SR Plus 20 mg/10 mg Prolonged-release tablets Rowex Limited, 15/04/2016 HM Not marketed AU Prolonged-release tablet N02AA N02AA55 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use OXYCODONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0711/250/004 PA0711/250/004 IC0102-160-024 Dancex SR Plus 40 mg/20 mg Prolonged-release tablets Rowex Limited, 15/04/2016 HM Not marketed AU Prolonged-release tablet N02AA N02AA55 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use OXYCODONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0711/250/001 PA0711/250/001 IC0102-159-024 Dancex SR Plus 5 mg/2.5 mg Prolonged-release tablets Rowex Limited, 15/04/2016 HM Not marketed AU Prolonged-release tablet N02AA N02AA55 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use OXYCODONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1336/004/002 PA1336/004/002 Dantrium 100 mg Capsules Norgine B.V. 19/03/1975 HM Not marketed AU Capsule, hard M03CA M03CA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Dantrolene sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1336/004/001 PA1336/004/001 Dantrium 25 mg Capsules Norgine B.V. 19/03/1975 HM Marketed AU Capsule, hard M03CA M03CA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Dantrolene sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/118/002 PA1347/118/002 IC0090-142-003 Dapagliflozin/Metformin Krka 5 mg/1000 mg film-coated tablets KRKA, d.d., Novo mesto 29/08/2025 HM Not marketed AU Film-coated tablet A10BD15 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dapagliflozin propanediol monohydrate Metformin Hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/118/001 PA1347/118/001 IC0090-143-003 Dapagliflozin/Metformin Krka 5 mg/850 mg film-coated tablets KRKA, d.d., Novo mesto 29/08/2025 HM Not marketed AU Film-coated tablet A10BD15 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dapagliflozin propanediol monohydrate Metformin Hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/390/002 PA0126/390/002 Dapagliflozin Clonmel 10 mg film-coated tablets Clonmel Healthcare Ltd 19/12/2025 HM Not marketed AU Film-coated tablet A10BK01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dapagliflozin propanediol monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/390/001 PA0126/390/001 Dapagliflozin Clonmel 5 mg film-coated tablets Clonmel Healthcare Ltd 19/12/2025 HM Not marketed AU Film-coated tablet A10BK01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dapagliflozin propanediol monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/111/002 PA1347/111/002 Dapagliflozin Krka 10 mg film-coated tablets KRKA, d.d., Novo mesto 01/12/2023 HM Not marketed AU Film-coated tablet A10BK01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dapagliflozin propanediol monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/111/001 PA1347/111/001 Dapagliflozin Krka 5 mg film-coated tablets KRKA, d.d., Novo mesto 01/12/2023 HM Not marketed AU Film-coated tablet A10BK01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dapagliflozin propanediol monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23250/020/002 PA23250/020/002 Dapagliflozin MSN 10 mg film-coated tablets MSN Labs Europe Limited 27/02/2026 HM Not marketed AU Film-coated tablet A10BK01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dapagliflozin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23250/020/001 PA23250/020/001 Dapagliflozin MSN 5 mg film-coated tablets MSN Labs Europe Limited 27/02/2026 HM Not marketed AU Film-coated tablet A10BK01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dapagliflozin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/342/002 PA0711/342/002 Dapagliflozin Rowex 10 mg film-coated tablets Rowex Limited, 13/03/2026 HM Not marketed AU Film-coated tablet A10BK01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dapagliflozin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/342/001 PA0711/342/001 Dapagliflozin Rowex 5 mg film-coated tablets Rowex Limited, 13/03/2026 HM Not marketed AU Film-coated tablet A10BK01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dapagliflozin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1721/013-024 EU/1/23/1721/013-024 Dapagliflozin Viatris 10 mg Film-coated tablet Viatris Limited 24/03/2023 HM Unknown AU Film-coated tablet A10BK01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dapagliflozin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1721/001-012 EU/1/23/1721/001-012 Dapagliflozin Viatris 5 mg Film-coated tablet Viatris Limited 24/03/2023 HM Unknown AU Film-coated tablet A10BK01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dapagliflozin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23092/004/001 PA23092/004/001 Daptomycin 350 mg powder for solution for injection/infusion Reddy Holding GmbH 22/03/2024 HM Marketed AU Powder for solution for injection/infusion J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2237/005/001 PA2237/005/001 Daptomycin 350 mg powder for solution for injection/infusion hameln pharma gmbh 09/12/2022 HM Not marketed AU Powder for solution for injection/infusion J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23092/004/002 PA23092/004/002 Daptomycin 500 mg powder for solution for injection/infusion Reddy Holding GmbH 22/03/2024 HM Marketed AU Powder for solution for injection/infusion J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2237/005/002 PA2237/005/002 Daptomycin 500 mg powder for solution for injection/infusion hameln pharma gmbh 09/12/2022 HM Not marketed AU Powder for solution for injection/infusion J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/258/001 PA2315/258/001 Daptomycin Accord Healthcare 350 mg powder for solution for injection/infusion Accord Healthcare Ireland Ltd. 28/07/2023 HM Not marketed AU Powder for solution for injection/infusion J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/258/002 PA2315/258/002 Daptomycin Accord Healthcare 500 mg powder for solution for injection/infusion Accord Healthcare Ireland Ltd. 28/07/2023 HM Not marketed AU Powder for solution for injection/infusion J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/237/001 PA2315/237/001 Daptomycin Accordpharma 350 mg powder for solution for injection/infusion Accord Healthcare Ireland Ltd. 17/01/2020 HM Marketed AU Powder for solution for injection/infusion J01XX J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/237/002 PA2315/237/002 Daptomycin Accordpharma 500 mg powder for solution for injection/infusion Accord Healthcare Ireland Ltd. 17/01/2020 HM Marketed AU Powder for solution for injection/infusion J01XX J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1175/001-002 EU/1/17/1175/001-002 Daptomycin Hospira 350 mg powder for solution for injection/infusion Pfizer Europe MA EEIG 22/03/2017 HM Unknown AU Powder for solution for injection/infusion J01XX J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1175/003-004 EU/1/17/1175/003-004 Daptomycin Hospira 500 mg powder for solution for injection/infusion Pfizer Europe MA EEIG 22/03/2017 HM Unknown AU Powder for solution for injection/infusion J01XX J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/021/001 PA1122/021/001 Daptomycin Noridem 350 mg Powder for solution for injection/infusion Noridem Enterprises Limited 25/08/2020 HM Marketed AU Powder for solution for injection/infusion J01XX J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/021/002 PA1122/021/002 Daptomycin Noridem 500 mg Powder for solution for injection/infusion Noridem Enterprises Limited 25/08/2020 HM Marketed AU Powder for solution for injection/infusion J01XX J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1982/003/001 PA1982/003/001 Daptomycin Xellia 350 mg powder for solution for injection/infusion Xellia Pharmaceuticals ApS 15/09/2017 HM Not marketed AU Powder for solution for injection/infusion J01XX J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1982/003/002 PA1982/003/002 Daptomycin Xellia 500 mg powder for solution for injection/infusion Xellia Pharmaceuticals ApS 15/09/2017 HM Not marketed AU Powder for solution for injection/infusion J01XX J01XX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Daptomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/299/002 PA0126/299/002 Darunavir Clonmel 600 mg film-coated tablets Clonmel Healthcare Ltd 02/06/2017 HM Marketed AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA0126/299/003 PA0126/299/003 Darunavir Clonmel 800 mg film-coated tablets Clonmel Healthcare Ltd 02/06/2017 HM Marketed AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) EU/1/17/1249/001-004 EU/1/17/1249/001-004 Darunavir Krka 400 mg Film-coated tablet KRKA, d.d., Novo mesto 26/01/2018 HM Unknown AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/17/1249/005-008 EU/1/17/1249/005-008 Darunavir Krka 600 mg Film-coated tablet KRKA, d.d., Novo mesto 26/01/2018 HM Unknown AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/17/1249/009-010 EU/1/17/1249/009-010 Darunavir Krka 800 mg Film-coated tablet KRKA, d.d., Novo mesto 26/01/2018 HM Unknown AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/17/1248/001-004 EU/1/17/1248/001-004 Darunavir Krka d.d. KRKA, d.d., Novo mesto 18/01/2018 HM Unknown AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/17/1248/005-008 EU/1/17/1248/005-008 Darunavir Krka d.d. KRKA, d.d., Novo mesto 18/01/2018 HM Unknown AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/17/1248/009-010 EU/1/17/1248/009-010 Darunavir Krka d.d. KRKA, d.d., Novo mesto 18/01/2018 HM Unknown AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0711/269/004 PA0711/269/004 Darunavir Rowex 800 mg Film-coated tablets Rowex Ltd 02/06/2017 HM Not marketed AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) EU/1/16/1140/006-011 EU/1/16/1140/006-011 Darunavir Viatris 150 mg film-coated tablets Viatris Limited 04/01/2017 HM Unknown AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1140/012-021 EU/1/16/1140/012-021 Darunavir Viatris 300 mg film-coated tablets Viatris Limited 04/01/2017 HM Unknown AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1140/022-029 EU/1/16/1140/022-029 Darunavir Viatris 400 mg film-coated tablets Viatris Limited 04/01/2017 HM Unknown AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1140/030-038 EU/1/16/1140/030-038 Darunavir Viatris 600mg film-coated tablets Viatris Limited 04/01/2017 HM Unknown AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1140/001-005 EU/1/16/1140/001-005 Darunavir Viatris 75 mg film-coated tablets Viatris Limited 04/01/2017 HM Unknown AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1140/039-045 EU/1/16/1140/039-045 Darunavir Viatris 800 mg film-coated tablets Viatris Limited 04/01/2017 HM Unknown AU Film-coated tablet J05AE J05AE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Darunavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1101/004 EU/1/16/1101/004 DARZALEX 1800 mg solution for injection Janssen-Cilag International NV 03/06/2020 HM Unknown AU Solution for injection L01XC Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Daratumumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1101/001-003 EU/1/16/1101/001-003 DARZALEX 20 mg/mL concentrate for solution for infusion Janssen-Cilag International NV 20/05/2016 HM Unknown AU Concentrate for solution for infusion L01XC24 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Daratumumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1839/017-020 EU/1/24/1839/017-020 IC0172-024-003 Dasatinib Accord Healthcare 100 mg film-coated tablets Accord Healthcare S.L.U. 26/07/2024 HM Unknown AU Film-coated tablet L01EA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1839/021-024 EU/1/24/1839/021-024 IC0172-134-003 Dasatinib Accord Healthcare 140 mg film-coated tablets Accord Healthcare S.L.U. 26/07/2024 HM Unknown AU Film-coated tablet L01EA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1839/001-004 EU/1/24/1839/001-004 IC0172-003-003 Dasatinib Accord Healthcare 20 mg film-coated tablets Accord Healthcare S.L.U. 26/07/2024 HM Unknown AU Film-coated tablet L01EA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1839/005-008 EU/1/24/1839/005-008 IC0172-023-003 Dasatinib Accord Healthcare 50 mg film-coated tablet Accord Healthcare S.L.U. 26/07/2024 HM Unknown AU Film-coated tablet L01EA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1839/009-012 EU/1/24/1839/009-012 IC0172-101-003 Dasatinib Accord Healthcare 70 mg film-coated tablets Accord Healthcare S.L.U. 26/07/2024 HM Unknown AU Film-coated tablet L01EA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1839/013-016 EU/1/24/1839/013-016 IC0172-005-003 Dasatinib Accord Healthcare 80 mg film-coated tablets Accord Healthcare S.L.U. 26/07/2024 HM Unknown AU Film-coated tablet L01EA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0126/310/004 PA0126/310/004 IC0172-024-003 Dasatinib Clonmel 100 mg film-coated tablets Clonmel Healthcare Ltd 06/03/2020 HM Marketed AU Film-coated tablet L01EA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA0126/310/001 PA0126/310/001 IC0172-003-003 Dasatinib Clonmel 20 mg film-coated tablets Clonmel Healthcare Ltd 06/03/2020 HM Marketed AU Film-coated tablet L01EA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA0126/310/002 PA0126/310/002 IC0172-023-003 Dasatinib Clonmel 50 mg film-coated tablets Clonmel Healthcare Ltd 06/03/2020 HM Marketed AU Film-coated tablet L01EA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA0126/310/003 PA0126/310/003 IC0172-101-003 Dasatinib Clonmel 70 mg film-coated tablets Clonmel Healthcare Ltd 06/03/2020 HM Marketed AU Film-coated tablet L01EA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA1347/093/005 PA1347/093/005 IC0172-024-003 Dasatinib Krka 100 mg film-coated tablets KRKA, d.d., Novo mesto 03/04/2020 HM Not marketed AU Film-coated tablet L01XE06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA1347/093/006 PA1347/093/006 IC0172-134-003 Dasatinib Krka 140 mg film-coated tablets KRKA, d.d., Novo mesto 03/04/2020 HM Not marketed AU Film-coated tablet L01XE06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA1347/093/001 PA1347/093/001 IC0172-003-003 Dasatinib Krka 20 mg film-coated tablets KRKA, d.d., Novo mesto 03/04/2020 HM Not marketed AU Film-coated tablet L01XE06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA1347/093/002 PA1347/093/002 IC0172-023-003 Dasatinib Krka 50 mg film-coated tablets KRKA, d.d., Novo mesto 03/04/2020 HM Not marketed AU Film-coated tablet L01XE06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA1347/093/003 PA1347/093/003 IC0172-101-003 Dasatinib Krka 70 mg film-coated tablets KRKA, d.d., Novo mesto 03/04/2020 HM Not marketed AU Film-coated tablet L01XE06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA1347/093/004 PA1347/093/004 IC0172-005-003 Dasatinib Krka 80 mg film-coated tablets KRKA, d.d., Novo mesto 03/04/2020 HM Not marketed AU Film-coated tablet L01XE06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA1986/066/004 PA1986/066/004 IC0172-024-003 Dasatinib Teva 100 mg Film-coated Tablets Teva B.V. 15/03/2019 HM Marketed AU Film-coated tablet L01XE06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA1986/066/001 PA1986/066/001 IC0172-003-003 Dasatinib Teva 20 mg Film-coated Tablets Teva B.V. 15/03/2019 HM Marketed AU Film-coated tablet L01XE06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA1986/066/002 PA1986/066/002 IC0172-023-003 Dasatinib Teva 50 mg Film-coated Tablets Teva B.V. 15/03/2019 HM Marketed AU Film-coated tablet L01XE06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA1986/066/003 PA1986/066/003 IC0172-101-003 Dasatinib Teva 70 mg Film-coated Tablets Teva B.V. 15/03/2019 HM Marketed AU Film-coated tablet L01XE06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dasatinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) EU/1/11/739/001-008 EU/1/11/739/001-008 IC0153-001-014 Dasselta 5 mg film-coated tablets KRKA, d.d., Novo mesto 28/11/2011 HM Unknown AU Film-coated tablet R06AX R06AX27 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Desloratadine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1915/001 EU/1/25/1915/001 Datroway 100 mg powder for concentrate for solution for infusion Daiichi Sankyo Europe GmbH 04/04/2025 HM Unknown AU Powder for concentrate for solution for infusion L01FX35 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Datopotamab deruxtecan Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription. (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/00/135/001-002 EU/1/00/135/001-002 DaTSCAN 74 MBq/ml solution for injection GE Healthcare B.V. 27/07/2000 HM Unknown AU Solution for injection V09AB V09AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Ioflupane Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1451/003-004 EU/1/20/1451/003-004 Daurismo 100 mg film-coated tablets Pfizer Europe MA EEIG 26/06/2020 HM Unknown AU Film-coated tablet L01XX63 Full application (Article 8(3) of Directive No 2001/83/EC) Glasdegib Maleate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1451/001-002 EU/1/20/1451/001-002 Daurismo 25 mg film-coated tablets Pfizer Europe MA EEIG 26/06/2020 HM Unknown AU Film-coated tablet L01XX63 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Glasdegib Maleate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/2001/001-002 EU/1/25/2001/001-002 Dawnzera 80mg solution for injection in pre-filled pen Otsuka Pharmaceutical Netherlands B.V. 19/01/2026 HM Unknown AU Solution for injection in pre-filled pen B06AC09 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Donidalorsen sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/10/636/008 EU/1/10/636/008 Daxas 250 micrograms tablets AstraZeneca AB HM Unknown AU Tablet R03DX R03DX07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Roflumilast Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/10/636/001-007 EU/1/10/636/001-007 Daxas 500 micrograms film-coated tablets AstraZeneca AB HM Unknown AU Film-coated tablet R03DX R03DX07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Roflumilast Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/26/2029/001-002 EU/1/26/2029/001-002 Dazparda 100 units/ml solution for injection in pre-filled pen Gan & Lee Pharmaceuticals Europe GmbH 27/04/2026 HM Unknown AU Solution for injection in pre-filled pen A10AB05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Insulin aspart Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. EU/1/25/1949/001 EU/1/25/1949/001 Dazublys 150 mg powder for concentrate for solution for infusion Curateq Biologics s.r.o. 30/06/2025 HM Unknown AU Powder for concentrate for solution for infusion L01FD01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Trastuzumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products are subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1009/001/002 PA1009/001/002 DDAVP/Desmopressin 4 micrograms/ml Solution for Injection Ferring Ireland Ltd 17/02/1977 HM Marketed AU Solution for injection H01BA H01BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Subcutaneous use DESMOPRESSIN ACETATE Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/261/001 PPA0465/261/001 Decapeptyl 3-month, 11.25 mg powder and solvent for suspension for injection PCO Manufacturing Ltd. 20/05/2011 HM Unknown AU Powder and solvent for suspension for injection L02AE04 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Intramuscular use Subcutaneous use Triptorelin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/126/001 PPA1463/126/001 Decapeptyl 3-month, 11.25 mg powder and solvent for suspension for injection IMED Healthcare Ltd., 06/09/2019 HM Unknown AU Powder and solvent for suspension for injection L02AE04 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Intramuscular use Triptorelin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/022/001 PPA2306/022/001 Decapeptyl 3-month, 11.25 mg Powder and solvent for suspension for injection Originalis B.V. 22/05/2020 HM Unknown AU Powder and solvent for suspension for injection L02AE04 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Intramuscular use Subcutaneous use Triptorelin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0869/003/002 PA0869/003/002 Decapeptyl 3-month, 11.25 mgPowder and solvent for suspension for injection Ipsen Pharmaceuticals Limited 02/10/1998 HM Marketed AU Powder and solvent for suspension for injection L02AE L02AE04 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Triptorelin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0869/003/003 PA0869/003/003 Decapeptyl 6-month 22.5 mg Powder and solvent for prolonged-release suspension for injection Ipsen Pharmaceuticals Limited 08/04/2011 HM Marketed AU Powder and solvent for prolonged-release suspension for injection L02AE L02AE04 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Triptorelin pamoate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/261/002 PPA0465/261/002 Decapeptyl 6-month 22.5 mg Powder and solvent for prolonged-release suspension for injection PCO Manufacturing Ltd. 22/05/2020 HM Unknown AU Powder and solvent for prolonged-release suspension for injection L02AE04 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Intramuscular use Triptorelin pamoate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/126/002 PPA1463/126/002 Decapeptyl 6-month 22.5 mg Powder and solvent for prolonged-release suspension for injection IMED Healthcare Ltd., 02/07/2021 HM Unknown AU Powder and solvent for prolonged-release suspension for injection L02AE04 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Intramuscular use Triptorelin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA25370/003/001 PPA25370/003/001 Decapeptyl 6-month 22.5 mg Powder and solvent for prolonged-release suspension for injection BModesto B.V. 04/07/2025 HM Unknown AU Powder and solvent for prolonged-release suspension for injection L02AE04 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Intramuscular use Triptorelin pamoate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0869/003/001 PA0869/003/001 Decapeptyl SR, 3 mg powder and solvent for suspension for injection Ipsen Pharmaceuticals Limited 05/12/1989 HM Marketed AU Powder and solvent for suspension for injection L02AE L02AE04 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Triptorelin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/282/001 PA2315/282/001 Decitabine Accord 40 mg powder for concentrate for solution for infusion Accord Healthcare Ireland Ltd. 27/02/2026 HM Not marketed AU Powder for concentrate for solution for infusion L01BC08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Decitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA2315/282/002 PA2315/282/002 Decitabine Accord 50 mg powder for concentrate for solution for infusion Accord Healthcare Ireland Ltd. 27/02/2026 HM Not marketed AU Powder for concentrate for solution for infusion L01BC08 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Decitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1774/011/001 PA1774/011/001 Decitabine EVER Pharma 50 mg powder for concentrate for solution for infusion EVER Valinject GmbH 13/03/2026 HM Not marketed AU Powder for concentrate for solution for infusion L01BC08 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Decitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/18/1349/001 EU/1/18/1349/001 Dectova 10 mg/mL solution for infusion GlaxoSmithKline Trading Services Limited 26/04/2019 HM Unknown AU Solution for infusion J05AH J05AH01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Zanamivir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1412/005-008 EU/1/19/1412/005-008 IC0133-135-003 Deferasirox Accord 180 mg film-coated tablets Accord Healthcare S.L.U. 09/01/2020 HM Unknown AU Film-coated tablet V03AC03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Deferasirox Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1412/009-012 EU/1/19/1412/009-012 IC0133-180-003 Deferasirox Accord 360 mg film-coated tablets Accord Healthcare S.L.U. 09/01/2020 HM Unknown AU Film-coated tablet V03AC03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Deferasirox Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1412/001-004 EU/1/19/1412/001-004 IC0133-166-003 Deferasirox Accord 90 mg film-coated tablets Accord Healthcare S.L.U. 09/01/2020 HM Unknown AU Film-coated tablet V03AC03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Deferasirox Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1386/006-010 EU/1/19/1386/006-010 IC0133-135-003 Deferasirox Mylan 180 mg film-coated tablets Mylan Pharmaceuticals Limited 26/09/2019 HM Unknown AU Film-coated tablet V03AC V03AC03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Deferasirox Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1386/011-016 EU/1/19/1386/011-016 IC0133-180-003 Deferasirox Mylan 360 mg film-coated tablets Mylan Pharmaceuticals Limited 26/09/2019 HM Unknown AU Film-coated tablet V03AC V03AC03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Deferasirox Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1386/001-005 EU/1/19/1386/001-005 IC0133-166-003 Deferasirox Mylan 90 mg film-coated tablets Mylan Pharmaceuticals Limited 26/09/2019 HM Unknown AU Film-coated tablet V03AC V03AC03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Deferasirox Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1310/001 EU/1/18/1310/001 Deferiprone Lipomed 500 mg Film-coated tablet Lipomed GmbH 20/09/2018 HM Unknown AU Film-coated tablet V03AC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Deferiprone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/01/13/878/001 EU/01/13/878/001 Defitelio 80 mg/mL concentrate for solution for infusion Gentium S.p.A. 18/10/2013 HM Unknown AU Concentrate for solution for infusion B01AX B01AX01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Defibrotide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/23/1753/003 EU/1/23/1753/003 Degarelix Accord 120 mg powder and solvent for solution for injection Accord Healthcare S.L.U. 29/09/2023 HM Unknown AU Powder and solvent for solution for injection L02BX02 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Degarelix Acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1753/001-002 EU/1/23/1753/001-002 Degarelix Accord 80 mg powder and solvent for solution for injection Accord Healthcare S.L.U. 29/09/2023 HM Unknown AU Powder and solvent for solution for injection L02BX02 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Degarelix Acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1985/001-002 EU/1/25/1985/001-002 Degevma 120 mg solution for injection TEVA GmbH 17/11/2025 HM Unknown AU Solution for injection M05BX04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Denosumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1333/001-002 EU/1/18/1333/001-002 Delstrigo 100 mg/300 mg/245 mg film-coated tablets Merck Sharp & Dohme BV, 22/11/2018 HM Unknown AU Film-coated tablet J05AR24 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Doravirine Lamivudine Tenofovir disoproxil fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1113/003/002 PA1113/003/002 DELTACORTRIL ENTERIC 2.5 mg gastro-resistant tablets Phoenix Labs 01/03/1977 HM Marketed AU Gastro-resistant tablet H02AB H02AB06 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Prednisolone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1113/003/001 PA1113/003/001 DELTACORTRIL ENTERIC 5 mg gastro-resistant tablets Phoenix Labs 01/03/1977 HM Marketed AU Gastro-resistant tablet H02AB H02AB06 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Prednisolone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/875/001-003 EU/1/13/875/001-003 Deltyba Otsuka Novel Products GmbH 28/04/2014 HM Unknown AU Film-coated tablet J04AK J04AK06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Delamanid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/13/875/005 EU/1/13/875/005 Deltyba 25 mg dispersible tablets Otsuka Novel Products GmbH 16/09/2021 HM Unknown AU Dispersible tablet J04AK06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Delamanid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1936/001 EU/1/25/1936/001 Denbrayce 120 mg solution for injection Mabxience Research, S.L. 26/06/2025 HM Unknown AU Solution for injection M05BX04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Denosumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/22/1699/001 EU/1/22/1699/001 Dengue Tetravalent Vaccine (Live, Attenuated) Takeda Takeda GmbH 05/12/2022 HM Unknown AU Powder and solvent for solution for injection J07BX04 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Dengue virus serotype 1# (live, attenuated) Dengue virus, serotype 2, live, attenuated Dengue virus serotype 3# (live, attenuated) Dengue virus serotype 4# (live, attenuated) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1699/002 EU/1/22/1699/002 Dengue Tetravalent Vaccine (Live, Attenuated) Takeda Takeda GmbH 05/12/2022 HM Unknown AU Powder and solvent for solution for injection J07BX04 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Dengue virus serotype 1# (live, attenuated) Dengue virus, serotype 2, live, attenuated Dengue virus serotype 3# (live, attenuated) Dengue virus serotype 4# (live, attenuated) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1699/003 EU/1/22/1699/003 Dengue Tetravalent Vaccine (Live, Attenuated) Takeda Takeda GmbH 05/12/2022 HM Unknown AU Powder and solvent for solution for injection J07BX04 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Dengue virus serotype 1# (live, attenuated) Dengue virus, serotype 2, live, attenuated Dengue virus serotype 3# (live, attenuated) Dengue virus serotype 4# (live, attenuated) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1699/004 EU/1/22/1699/004 Dengue Tetravalent Vaccine (Live, Attenuated) Takeda Takeda GmbH 05/12/2022 HM Unknown AU Powder and solvent for solution for injection J07BX04 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Dengue virus serotype 1# (live, attenuated) Dengue virus, serotype 2, live, attenuated Dengue virus serotype 3# (live, attenuated) Dengue virus serotype 4# (live, attenuated) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1113/020/001 PA1113/020/001 Dentinox Cradle Cap Treatment Shampoo, Sodium lauryl ether sulpho-succinate 6% w/w, Sodium lauryl ether sulphate 2.7% w/w Phoenix Labs Unlimited Company 09/01/1995 HM Marketed AU Shampoo D11AX Competence of personnel (Article 23 of Directive No 2010/63/EU) Topical Sodium laurylether sulfate Sodium lauryl ether sulfo succinate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA1113/021/001 PA1113/021/001 Dentinox Infant Colic Drops 21 mg/2.5 ml Oral Suspension Phoenix Labs 05/10/1983 HM Marketed AU Oral suspension A03AX A03AX13 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Dimeticone, activated Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA0126/235/002 PA0126/235/002 Denzapine ®100 mg Tablets Clonmel Healthcare Ltd 05/09/2008 HM Marketed AU Tablet N05AH N05AH02 Generic application (Article 10(1) of Directive No 2001/83/EC) Not Currently Available Oral use Clozapine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only DENZAPINE Official Recommendations: DENZAPINE is associated with a specific risk of agranulocytosis. Any adverse haematological effects should be notified to the Irish Medicines Board. Intrinsic to Denzapine therapy is enrolment with and monitoring by the DENZAPINE Monitoring Service (DMS), based at: Denzapine Monitoring Service Merz Pharma UK Ltd., 260 Centennial Park, Elstree South, Elstree, Hertfordshire WD6 3SR, UK. The DMS database embodies tightly controlled post-marketing surveillance and ensures the safe use of DENZAPINE in registered patients. Features of the DMS which are of fundamental importance to patient safety include the following: Psychiatrists who wish to prescribe DENZAPINE must be registered with the DMS. Pharmacists dispensing DENZAPINE must be registered with the DMS. Patients to receive DENZAPINE must be enrolled with the DMS. They must undergo pre-treatment screening, as well as subsequent haematological tests. These will be weekly initially, then may become fortnightly after a perio PA0126/235/004 PA0126/235/004 Denzapine ®200 mg Tablets Clonmel Healthcare Ltd 03/04/2009 HM Marketed AU Tablet N05AH N05AH02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Clozapine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only DENZAPINE Official Recommendations: DENZAPINE is associated with a specific risk of agranulocytosis. Any adverse haematological effects should be notified to the Irish Medicines Board. Intrinsic to Denzapine therapy is enrolment with and monitoring by the DENZAPINE Monitoring Service (DMS), based at: Denzapine Monitoring Service Merz Pharma UK Ltd., 260 Centennial Park, Elstree South, Elstree, Hertfordshire WD6 3SR, UK. The DMS database embodies tightly controlled post-marketing surveillance and ensures the safe use of DENZAPINE in registered patients. Features of the DMS which are of fundamental importance to patient safety include the following: Psychiatrists who wish to prescribe DENZAPINE must be registered with the DMS. Pharmacists dispensing DENZAPINE must be registered with the DMS. Patients to receive DENZAPINE must be enrolled with the DMS. They must undergo pre-treatment screening, as well as subsequent haematological tests. These will be weekly initially, then may become fortnightly after a perio PA0126/235/001 PA0126/235/001 Denzapine ®25 mg Tablets Clonmel Healthcare Ltd 05/09/2008 HM Marketed AU Tablet N05AH N05AH02 Generic application (Article 10(1) of Directive No 2001/83/EC) Not Currently Available Oral use Clozapine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only DENZAPINE Official Recommendations: DENZAPINE is associated with a specific risk of agranulocytosis. Any adverse haematological effects should be notified to the Irish Medicines Board. Intrinsic to Denzapine therapy is enrolment with and monitoring by the DENZAPINE Monitoring Service (DMS), based at: Denzapine Monitoring Service Merz Pharma UK Ltd., 260 Centennial Park, Elstree South, Elstree, Hertfordshire WD6 3SR, UK. The DMS database embodies tightly controlled post-marketing surveillance and ensures the safe use of DENZAPINE in registered patients. Features of the DMS which are of fundamental importance to patient safety include the following: Psychiatrists who wish to prescribe DENZAPINE must be registered with the DMS. Pharmacists dispensing DENZAPINE must be registered with the DMS. Patients to receive DENZAPINE must be enrolled with the DMS. They must undergo pre-treatment screening, as well as subsequent haematological tests. These will be weekly initially, then may become fortnightly after a perio PA0126/235/005 PA0126/235/005 Denzapine ®50 mg/ml Oral Suspension Clonmel Healthcare Ltd 06/03/2009 HM Marketed AU Oral suspension N05AH N05AH02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Clozapine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only DENZAPINE Official Recommendations: DENZAPINE is associated with a specific risk of agranulocytosis. Any adverse haematological effects should be notified to the Irish Medicines Board. Intrinsic to Denzapine therapy is enrolment with and monitoring by the DENZAPINE Monitoring Service (DMS), based at: Denzapine Monitoring Service Merz Pharma UK Ltd., 260 Centennial Park, Elstree South, Elstree, Hertfordshire WD6 3SR, UK. The DMS database embodies tightly controlled post-marketing surveillance and ensures the safe use of DENZAPINE in registered patients. Features of the DMS which are of fundamental importance to patient safety include the following: Psychiatrists who wish to prescribe DENZAPINE must be registered with the DMS. Pharmacists dispensing DENZAPINE must be registered with the DMS. Patients to receive DENZAPINE must be enrolled with the DMS. They must undergo pre-treatment screening, as well as subsequent haematological tests. These will be weekly initially, then may become fortnightly after a perio PA0126/235/003 PA0126/235/003 Denzapine ®50 mg Tablets Clonmel Healthcare Ltd 03/04/2009 HM Marketed AU Tablet N05AH N05AH02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Clozapine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only DENZAPINE Official Recommendations: DENZAPINE is associated with a specific risk of agranulocytosis. Any adverse haematological effects should be notified to the Irish Medicines Board. Intrinsic to Denzapine therapy is enrolment with and monitoring by the DENZAPINE Monitoring Service (DMS), based at: Denzapine Monitoring Service Merz Pharma UK Ltd., 260 Centennial Park, Elstree South, Elstree, Hertfordshire WD6 3SR, UK. The DMS database embodies tightly controlled post-marketing surveillance and ensures the safe use of DENZAPINE in registered patients. Features of the DMS which are of fundamental importance to patient safety include the following: Psychiatrists who wish to prescribe DENZAPINE must be registered with the DMS. Pharmacists dispensing DENZAPINE must be registered with the DMS. Patients to receive DENZAPINE must be enrolled with the DMS. They must undergo pre-treatment screening, as well as subsequent haematological tests. These will be weekly initially, then may become fortnightly after a perio PA0776/003/001 PA0776/003/001 Depixol 20mg/ml Solution for Injection Lundbeck ( Ireland ) Limited 21/06/1976 HM Marketed AU Solution for injection N05AF N05AF01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use FLUPENTIXOL DECANOATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0776/003/002 PA0776/003/002 Depixol Conc. 100mg/ml Solution for Injection Lundbeck ( Ireland ) Limited 25/01/1988 HM Marketed AU Solution for injection N05AF N05AF01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use FLUPENTIXOL DECANOATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/122/001 PA0822/122/001 Depo-Medrone 40 mg/ml Suspension for Injection 1 ml vial Pfizer Healthcare Ireland Unlimited Company 01/04/1978 HM Marketed AU Suspension for injection H02AB H02AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Not Currently Available Methylprednisolone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/122/002 PA0822/122/002 Depo-Medrone 40 mg/ml Suspension for Injection 2 ml vial Pfizer Healthcare Ireland Unlimited Company 01/04/1978 HM Marketed AU Suspension for injection H02AB H02AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Not Currently Available Methylprednisolone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/122/003 PA0822/122/003 Depo-Medrone 40 mg/ml Suspension for Injection 3 ml vial Pfizer Healthcare Ireland Unlimited Company 19/04/1991 HM Marketed AU Suspension for injection H02AB H02AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Not Currently Available Methylprednisolone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/123/002 PA0822/123/002 Depo-Medrone 40mg/ml with Lidocaine 10mg/ml Suspension for Injection, 2ml vial Pfizer Healthcare Ireland Unlimited Company 02/03/1981 HM Marketed AU Suspension for injection H02AB H02AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Not Currently Available Methylprednisolone acetate Lidocaine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/124/001 PA0822/124/001 Depo-Provera 150 mg/ml Suspension for Injection Pfizer Healthcare Ireland Unlimited Company 19/01/1996 HM Marketed AU Suspension for injection G03AC G03AC06 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Medroxyprogesterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/048/002 PA23266/048/002 IC0064-024-003 Depreger 100 mg film-coated tablet Viatris Limited 05/08/2005 HM Marketed AU Film-coated tablet N06AB N06AB06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Sertraline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/048/001 PA23266/048/001 IC0064-023-003 Depreger 50 mg film-coated tablets Viatris Limited 05/08/2005 HM Marketed AU Film-coated tablet N06AB N06AB06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Sertraline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1919/001-002 EU/1/25/1919/001-002 Deqsiga 100 mg/mL solution for infusion/human normal immunoglobulin (IVIg) Takeda Manufacturing Austria AG 02/05/2025 HM Unknown AU Solution for infusion J06BA02 Known active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Human Normal Immunoglobulin (IV) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Official batch release: In accordance with Article 114 Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. PA22702/001/001 PA22702/001/001 Derbac M Liquid 0.5% w/w cutaneous emulsion LanesHealth (Ireland) Limited 13/07/1993 HM Marketed AU Cutaneous emulsion P03AX P03AX03 Well-established use application (Article 10a of Directive No 2001/83/EC) Topical use Malathion Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0868/006/002 PA0868/006/002 DERMATRANS 10 mg/24 h transdermal patch Rottapharm Ltd 14/04/2000 HM Not marketed AU Transdermal patch C01DA C01DA02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Transdermal use Glyceryl trinitrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0868/006/003 PA0868/006/003 DERMATRANS 15 mg/24 h transdermal patch Rottapharm Ltd 14/04/2000 HM Not marketed AU Transdermal patch C01DA C01DA02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Transdermal use Glyceryl trinitrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0868/006/001 PA0868/006/001 DERMATRANS 5 mg/24 h transdermal patch Rottapharm Ltd 14/04/2000 HM Not marketed AU Transdermal patch C01DA C01DA02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Transdermal use Glyceryl trinitrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/005/001 PA1077/005/001 Dermovate 0.05% w/w Cream GlaxoSmithKline (Ireland) Limited 27/10/1983 HM Marketed AU Cream D07AD D07AD01 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Clobetasol propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/005/002 PA1077/005/002 Dermovate 0.05% w/w Ointment GlaxoSmithKline (Ireland) Limited 27/10/1983 HM Marketed AU Ointment D07AD D07AD01 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Clobetasol propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/005/003 PA1077/005/003 Dermovate Scalp Application 0.05% w/v Cutaneous Solution GlaxoSmithKline (Ireland) Limited 27/10/1983 HM Marketed AU Cutaneous solution D07AD D07AD01 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Clobetasol propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1099/001-002 EU/1/16/1099/001-002 Descovy 200 mg/10 mg film-coated tablets Gilead Sciences Ireland UC HM Unknown AU Film-coated tablet J05AR J05AR17 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Emtricitabine Tenofovir alafenamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1099/003-004 EU/1/16/1099/003-004 Descovy 200 mg/25 mg film-coated tablets Gilead Sciences Ireland UC HM Unknown AU Film-coated tablet J05AR J05AR17 Full application (Article 8(3) of Directive No 2001/83/EC) Emtricitabine Tenofovir alafenamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0126/154/001 PA0126/154/001 Desenex Ointment Zinc Undecylenate 20% w/w Undecylenic Acid 5% w/w Clonmel Healthcare Ltd 20/03/1998 HM Marketed AU Ointment D01AE D01AE04 Generic application (Article 10(1) of Directive No 2001/83/EC) Topical use Zinc undecylenate Undecylenic acid Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA0126/154/002 PA0126/154/002 Desenex Powder Zinc undecylenate 20% w/w Undecylenic Acid 2.0% w/w Clonmel Healthcare Ltd 20/03/1998 HM Marketed AU Cutaneous powder D01AE D01AE04 Generic application (Article 10(1) of Directive No 2001/83/EC) Topical use Zinc undecylenate Undecylenic acid Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA25414/001/001 PA25414/001/001 Desferal 500mg Vials Powder for Solution for Injection or Powder for Concentrate for Solution for Infusion Mitem Pharma 07/02/1980 HM Marketed AU Powder for solution for injection/infusion V03AC V03AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Deferoxamine mesilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/202/002 PA0711/202/002 IC0153-155-019 Deslor 0.5 mg/ml oral solution Rowex Limited, 22/06/2012 HM Marketed AU Oral solution R06AX R06AX27 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Desloratadine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/202/001 PA0711/202/001 IC0153-001-014 Deslor 5 mg film-coated tablets Rowex Ltd 22/06/2012 HM Marketed AU Film-coated tablet R06AX R06AX27 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Desloratadine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/745/001-009 EU/1/11/745/001-009 IC0153-001-014 Desloratadine Actavis 5 mg film-coated tablets Actavis Group hf 13/01/2012 HM Unknown AU Film-coated tablet R06AX R06AX27 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Desloratadine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22645/004/001 PA22645/004/001 IC0153-001-014 Desloratadine Glenmark 5 mg tablets Glenmark Arzneimittel GmbH 20/04/2012 HM Not marketed AU Tablet R06AX R06AX27 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Desloratadine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/746/001-006 EU/1/11/746/001-006 IC0153-001-014 Desloratadine ratiopharm 5 mg film-coated tablets Ratiopharm GmbH 13/01/2012 HM Unknown AU Film-coated tablet R06AX27 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Desloratadine Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/11/732/001-013 EU/1/11/732/001-013 IC0153-001-014 Desloratadine Teva 5 mg film-coated tablets Teva B.V. 24/11/2011 HM Unknown AU Film-coated tablet R06AX R06AX27 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Desloratadine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1009/007/003 PA1009/007/003 Desmotabs Melt 120 micrograms oral lyophilisate Ferring Ireland Ltd 30/09/2005 HM Marketed AU Oral lyophilisate H01BA H01BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Desmopressin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/260/001 PPA0465/260/001 Desmotabs Melt 120 micrograms oral lyophilisate PCO Manufacturing Ltd. 08/07/2011 HM Unknown AU Oral lyophilisate H01BA H01BA02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Sublingual use Desmopressin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/174/001 PPA1463/174/001 Desmotabs Melt 120 micrograms oral lyophilisate IMED Healthcare Ltd., 02/07/2021 HM Unknown AU Oral lyophilisate H01BA02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Sublingual use DESMOPRESSIN ACETATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1009/007/004 PA1009/007/004 Desmotabs Melt 240 micrograms oral lyophilisate Ferring Ireland Ltd 30/09/2005 HM Marketed AU Oral lyophilisate H01BA H01BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Desmopressin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1009/007/002 PA1009/007/002 Desmotabs Melt 60 micrograms oral lyophilisate Ferring Ireland Ltd 30/09/2005 HM Marketed AU Oral lyophilisate H01BA H01BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Desmopressin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/243/001 PA0711/243/001 IC0190-217-003 Desogestrel Rowex 75 microgram Film-coated Tablets Rowex Limited, 02/10/2015 HM Marketed AU Film-coated tablet G03AC G03AC09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Desogestrel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/005/001 PA23266/005/001 Desunin 10 000 IU soft capsules Viatris Limited 23/02/2024 HM Not marketed AU Capsule, soft A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/009/002 PA23355/009/002 Desunin 1000 IU Tablets Viatris Healthcare Limited 11/12/2015 HM Not marketed AU Tablet A11C Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/009/003 PA23355/009/003 Desunin 2000 IU Tablets Viatris Healthcare Limited 11/12/2015 HM Not marketed AU Tablet A11C Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/005/002 PA23266/005/002 Desunin 25,000 IU soft capsules Viatris Limited 23/02/2024 HM Marketed AU Capsule, soft A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Vitamin d3 Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/009/004 PA23355/009/004 Desunin 4000 IU Tablets Viatris Healthcare Limited 11/12/2015 HM Unknown AU Tablet A11C Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Colecalciferol concentrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/009/001 PA23355/009/001 Desunin 800 IU Tablets Viatris Healthcare Limited 08/06/2012 HM Marketed AU Tablet A11CC A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Colecalciferol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0803/004/001 PA0803/004/001 Detrunorm 15 mg Film-coated Tablets Apogepha Arzneimittel GmbH 12/12/2008 HM Not marketed AU Film-coated tablet G04BD G04BD06 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Propiverine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0803/006/001 PA0803/006/001 Detrunorm XL 30 mg Modified-Release Capsules APOGEPHA Arzneimittel GmbH 28/09/2007 HM Marketed AU Modified-release capsule, hard G04BD G04BD06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Propiverine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0803/006/002 PA0803/006/002 Detrunorm XL 45 mg Modified-Release Capsules APOGEPHA Arzneimittel GmbH 30/09/2011 HM Marketed AU Modified-release capsule, hard G04BD G04BD06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Propiverine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/061/001 PA23355/061/001 IC0025-039-003 Detrusitol 1 mg film-coated tablets Viatris Healthcare Limited 06/02/1998 HM Marketed AU Film-coated tablet G04BD G04BD07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tolterodine tartrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/061/002 PA23355/061/002 IC0025-006-003 Detrusitol 2 mg film-coated tablets Viatris Healthcare Limited 06/02/1998 HM Marketed AU Film-coated tablet G04BD G04BD07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tolterodine tartrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/054/001 PA23355/054/001 IC0025-006-032 Detrusitol SR 2 mg prolonged-release capsules, hard Viatris Healthcare Limited 27/07/2001 HM Marketed AU Prolonged-release capsule, hard G04BD07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tolterodine tartrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/054/002 PA23355/054/002 IC0025-008-032 Detrusitol SR 4 mg prolonged-release capsules, hard Viatris Healthcare Limited 27/07/2001 HM Marketed AU Prolonged-release capsule, hard G04BD07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tolterodine tartrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0979/004/002 PA0979/004/002 Dettol Antiseptic Disinfectant 4.8% w/v, concentrate for cutaneous solution Reckitt Benckiser Ireland Ltd 01/04/1983 HM Marketed AU Concentrate for cutaneous solution D08AE D08AE05 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Chloroxylenol Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PPA1463/193/001 PPA1463/193/001 Dexafree 1 mg/ml eye drops, solution in single dose container IMED Healthcare Ltd. 20/05/2022 HM Unknown AU Eye drops, solution S01BA S01BA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Ocular use DEXAMETHASONE PHOSPHATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1107/005/001 PA1107/005/001 Dexafree 1mg/ml eye drops, solution in single dose container Laboratoires Thea 24/08/2012 HM Marketed AU Eye drops, solution in single-dose container S01BA S01BA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Ocular use DEXAMETHASONE PHOSPHATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23081/007/001 PA23081/007/001 Dexamethasone 10 mg/5ml Oral Solution Taw Pharma (Ireland) Limited 20/12/2013 HM Not marketed AU Oral solution H02AB H02AB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dexamethasone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1691/014/001 PA1691/014/001 Dexamethasone 2mg Tablets Aspen Pharma Trading Limited 01/04/1978 HM Marketed AU Tablet H02AB H02AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Not Currently Available Dexamethasone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1567/002/001 PA1567/002/001 Dexamethasone Activase 0.5 mg Tablets Activase Pharmaceuticals Limited 03/06/2022 HM Not marketed AU Tablet H02AB02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Dexamethasone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1567/002/002 PA1567/002/002 Dexamethasone Activase 2 mg Tablets Activase Pharmaceuticals Limited 03/06/2022 HM Not marketed AU Tablet H02AB02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Dexamethasone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/077/001 PA2059/077/001 Dexamethasone phosphate 4 mg/ml solution for injection Fresenius Kabi Deutschland GmbH 22/07/2022 HM Not marketed AU Solution for injection H02AB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Infiltration Intraarticular use Intrabursal use Intramuscular use Intravenous use Dexamethasone sodium phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2237/004/001 PA2237/004/001 Dexamethasone Phosphate 4 mg/ml solution for injection hameln pharma gmbh 24/08/2021 HM Not marketed AU Solution for injection H02AB02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intraarticular use Intrabursal use Intralesional use Intramuscular use Intravenous use Subcutaneous use Dexamethasone sodium phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/201/001 PA0822/201/001 Dexamethasone Phosphate 4 mg/ml Solution for Injection Pfizer Healthcare Ireland Unlimited Company 28/07/1986 HM Marketed AU Solution for injection H02AB H02AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Dexamethasone sodium phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2165/014/001 PA2165/014/001 Dexamethasone phosphate 4 mg/ml solution for injection/infusion AS Kalceks 11/03/2022 HM Unknown AU Solution for injection/infusion H02AB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Infiltration Intraarticular use Intramuscular use Intravenous use Subconjunctival use Dexamethasone sodium phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/237/002 PA0281/237/002 Dexamethasone phosphate 4mg/ml Solution for Injection or Infusion Pinewood Laboratories Limited 09/01/2015 HM Not marketed AU Solution for injection/infusion H02AB H02AB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Dexamethasone sodium phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/091/001 PA1347/091/001 Dexamethasone Phosphate Krka 4 mg/ml solution for injection/infusion KRKA, d.d., Novo mesto 22/05/2020 HM Marketed AU Solution for injection/infusion H02AB H02AB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Dexamethasone sodium phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/020/001 PA1122/020/001 Dexamethasone phosphate Noridem 4 mg/mL Solution for injection Noridem Enterprises Limited 28/05/2021 HM Marketed AU Solution for injection H02AB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intraarticular use Intralesional use Intramuscular use Intravenous use Subcutaneous use Dexamethasone sodium phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/105/001 PA1986/105/001 Dexamethasone phosphate Teva 4 mg/ml solution for injection Teva B.V. 28/01/2022 HM Marketed AU Solution for injection H02AB02 Well-established use application (Article 10a of Directive No 2001/83/EC) Infiltration Intraarticular use Intramuscular use Intravenous use Subconjunctival use Dexamethasone sodium phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/718/001-006 EU/1/11/718/001-006 Dexdor 100 micrograms/ml concentrate for solution for infusion Orion Corporation 16/09/2011 HM Unknown AU Concentrate for solution for infusion N05CM N05CM18 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Dexmedetomidine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23335/001/001 PA23335/001/001 Dexeta 1.37 mg/ml eye drops, solution in single dose container SIFI S.p.A. 27/11/2020 HM Not marketed AU Eye drops, solution in single-dose container S01BA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Ocular use Dexamethasone sodium phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2261/001/003 PA2261/001/003 Deximune 100 mg Soft Capsules Dexcel Pharma GmbH 02/03/2007 HM Not marketed AU Capsule, soft L04AD L04AD01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ciclosporin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2261/001/001 PA2261/001/001 Deximune 25 mg Soft Capsules Dexcel Pharma GmbH 02/03/2007 HM Marketed AU Capsule, soft L04AD L04AD01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ciclosporin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2261/001/002 PA2261/001/002 Deximune 50 mg soft capsules Dexcel Pharma GmbH 02/03/2007 HM Not marketed AU Capsule, soft L04AD L04AD01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ciclosporin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2137/001/001 PA2137/001/001 Dexliq 4 mg/ml Oral Solution Laboratoires CTRS 30/06/2017 HM Not marketed AU Oral solution H02AB H02AB02 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Dexamethasone sodium phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/048/001 PA1122/048/001 Dexmedetomidine 100 microgram/ml concentrate for solution for infusion Noridem Enterprises Limited 01/05/2026 HM Not marketed AU Concentrate for solution for infusion N05CM18 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Dexmedetomidine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA2165/010/001 PA2165/010/001 Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion AS Kalceks 01/11/2019 HM Marketed AU Concentrate for solution for infusion N05CM18 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Dexmedetomidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA2299/050/001 PA2299/050/001 Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion Baxter Holding B.V. 12/03/2021 HM Not marketed AU Concentrate for solution for infusion N05CM18 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Dexmedetomidine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0736/042/001 PA0736/042/001 Dexmedetomidine B. Braun 100 micrograms/ml concentrate for solution for infusion B. Braun Melsungen AG 11/12/2020 HM Marketed AU Concentrate for solution for infusion N05CM18 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Dexmedetomidine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA1774/002/001 PA1774/002/001 Dexmedetomidine EVER Pharma 100 micrograms/ml concentrate for solution for infusion EVER Valinject GmbH 06/07/2018 HM Marketed AU Concentrate for solution for infusion N05CM N05CM18 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Dexmedetomidine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/076/001 PA2059/076/001 Dexmedetomidine Kabi 100 microgram/mL concentrate for solution for infusion Fresenius Kabi Deutschland GmbH 22/10/2021 HM Not marketed AU Concentrate for solution for infusion N05CM18 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Dexmedetomidine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23081/006/001 PA23081/006/001 Dexsol 2 mg/ 5 ml Oral Solution Taw Pharma (Ireland) Limited 03/02/2006 HM Marketed AU Oral solution H02AB H02AB02 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Dexamethasone sodium phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1913/004/001 PA1913/004/001 Diabact UBT 50 mg tablets Laboratoires Mayoly Spindler 11/10/2002 HM Marketed AU Tablet V04CX Full application (Article 8(3) of Directive No 2001/83/EC) Oral use 13c-urea Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/033/001 PA23266/033/001 IC0086-033-050 Diaclide MR 30 mg modified-release tablets Viatris Limited 24/07/2009 HM Marketed AU Modified-release tablet A10BB A10BB09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gliclazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/033/002 PA23266/033/002 IC0086-127-050 Diaclide MR 60 mg modified-release tablets Viatris Limited 13/02/2015 HM Marketed AU Modified-release tablet A10BB A10BB09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gliclazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/367/013 EU/1/06/367/013 Diacomit 100 mg Capsule, hard Biocodex 09/03/2021 HM Unknown AU Capsule, hard N03AX17 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Stiripentol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/06/367/001-3 EU/1/06/367/001-3 Diacomit 250 mg Capsule, hard Biocodex HM Unknown AU Capsule, hard N03AX N03AX17 Full application (Article 8(3) of Directive No 2001/83/EC) Stiripentol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/06/367/7-9 EU/1/06/367/7-9 Diacomit 250 mg Powder for oral suspension Biocodex HM Unknown AU Powder for oral suspension in sachet N03AX N03AX17 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Stiripentol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/06/367/4-6 EU/1/06/367/4-6 Diacomit 500 mg Capsule, hard Biocodex HM Unknown AU Capsule, hard N03AX N03AX17 Full application (Article 8(3) of Directive No 2001/83/EC) Stiripentol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/06/367/10-12 EU/1/06/367/10-12 Diacomit 500 mg Powder for oral suspension Biocodex HM Unknown AU Powder for oral suspension in sachet N03AX N03AX17 Full application (Article 8(3) of Directive No 2001/83/EC) Stiripentol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA1347/024/002 PA1347/024/002 IC0086-033-050 Diacronal MR 30 mg modified-release tablets KRKA, d.d., Novo mesto 04/07/2008 HM Marketed AU Modified-release tablet A10BB A10BB09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gliclazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/024/001 PA1347/024/001 IC0086-127-050 Diacronal MR 60 mg modified-release tablets KRKA, d.d., Novo mesto 22/02/2013 HM Marketed AU Modified-release tablet A10BB A10BB09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gliclazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0982/004/001 PA0982/004/001 Diafer 50 mg/ml solution for injection Pharmacosmos A/S 09/05/2014 HM Marketed AU Solution for injection B03AC Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use IRON (III) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/076/001 PA0749/076/001 IC0086-033-050 Diaglyc 30 mg modified-release tablets Teva Pharma B.V. 01/08/2008 HM Marketed AU Modified-release tablet A10BB A10BB09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gliclazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/013/001 PA0568/013/001 IC0086-033-050 Diamicron MR 30 mg modified-release tablets Les Laboratoires Servier 24/11/2000 HM Marketed AU Modified-release tablet A10BB A10BB09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Gliclazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0568/013/002 PA0568/013/002 IC0086-127-050 DIAMICRON MR 60 mg modified-release tablets Les Laboratoires Servier 18/12/2009 HM Marketed AU Modified-release tablet A10BB A10BB09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Gliclazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1142/020/003 PA1142/020/003 Diamox 250 mg Tablets Amdipharm Limited 01/04/1978 HM Marketed AU Tablet S01EC S01EC01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Acetazolamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1142/020/001 PA1142/020/001 Diamox SR 250mg Modified Release Hard Capsules Amdipharm Limited 20/03/1992 HM Not marketed AU Modified-release capsule, hard S01EC S01EC01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Acetazolamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA25288/001/001 PA25288/001/001 Dianeal PD4 Glucose 1.36 % w/v (13.6 mg/ml), Solution for peritoneal dialysis Vantive Belgium SRL 03/06/1993 HM Not marketed AU Solution for peritoneal dialysis B05DB Full application (Article 8(3) of Directive No 2001/83/EC) Intraperitoneal use Glucose anhydrous Glucose monohydrate Sodium chloride Sodium lactate Calcium chloride dihydrate ph. eur. Magnesium chloride hexahydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA25288/001/002 PA25288/001/002 Dianeal PD4 Glucose 2.27 % w/v (22.7 mg/ml), Solution for peritoneal dialysis Vantive Belgium SRL 03/06/1993 HM Not marketed AU Solution for peritoneal dialysis B05DB Full application (Article 8(3) of Directive No 2001/83/EC) Intraperitoneal use Glucose anhydrous Glucose monohydrate Sodium chloride Sodium lactate Calcium chloride dihydrate Magnesium chloride hexahydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA25288/001/003 PA25288/001/003 Dianeal PD4 Glucose 3.86 % w/v (38.6 mg/ml), Solution for peritoneal dialysis Vantive Belgium SRL 03/06/1993 HM Not marketed AU Solution for peritoneal dialysis B05DB Full application (Article 8(3) of Directive No 2001/83/EC) Intraperitoneal use Glucose anhydrous Glucose monohydrate Sodium chloride Sodium lactate Calcium chloride dihydrate Magnesium chloride hexahydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1410/003/001 PA1410/003/001 Dianette 2 mg/35 microgram coated tablets Bayer Limited 18/11/1988 HM Marketed AU Coated tablet G03HB G03HB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Cyproterone acetate Ethinylestradiol ph.eur. Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/050/001 PPA0465/050/001 Dianette 2 mg/35 microgram coated tablets PCO Manufacturing Ltd. 16/10/1998 HM Unknown AU Coated tablet G03HB G03HB01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Cyproterone acetate Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/164/001 PPA1463/164/001 Dianette 2 mg/35 microgram coated tablets IMED Healthcare Ltd., 18/06/2021 HM Unknown AU Coated tablet G03HB G03HB01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Cyproterone acetate Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22697/022/001 PA22697/022/001 Diazepam 0.4 mg/ml oral suspension Syri Pharma Limited t/a Thame Laboratories 28/11/2025 HM Not marketed AU Oral suspension N05BA01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Diazepam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA2315/199/002 PA2315/199/002 Diazepam 10mg Tablets Accord Healthcare Ireland Ltd. 29/03/2018 HM Not marketed AU Tablet N05BA N05BA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Diazepam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017 PA2315/199/001 PA2315/199/001 Diazepam 5mg Tablets Accord Healthcare Ireland Ltd. 29/03/2018 HM Not marketed AU Tablet N05BA N05BA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Diazepam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017. PA23199/003/001 PA23199/003/001 Diazepam Macure 5 mg/ml emulsion for injection Macure Pharma ApS 26/06/2026 HM Not marketed AU Emulsion for injection N05BA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intramuscular use Intravenous use Diazepam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA0711/009/002 PA0711/009/002 IC0056-115-043 Diclac 1% w/w Gel Rowex Limited, 23/08/1999 HM Marketed AU Gel M02AA M02AA15 Generic application (Article 10(1) of Directive No 2001/83/EC) Cutaneous use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/009/009 PA0711/009/009 IC0056-024-046 Diclac 100mg Suppositories Rowex Limited, 05/03/1992 HM Marketed AU Suppository M01AB M01AB05 Generic application (Article 10(1) of Directive No 2001/83/EC) Rectal use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/009/010 PA0711/009/010 Diclac 25 mg/ml Solution for Injection 3 ml Ampoule Rowex Limited, 26/08/1992 HM Not marketed AU Solution for injection M01AB M01AB05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/009/008 PA0711/009/008 IC0056-023-016 Diclac 50 mg Gastro-resistant Tablets Rowex Limited, 05/03/1992 HM Marketed AU Gastro-resistant tablet M01AB M01AB05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/009/003 PA0711/009/003 IC0056-028-024 Diclac 75 mg Prolonged-release Tablet Rowex Limited, 27/05/1999 HM Marketed AU Prolonged-release tablet M01AB M01AB05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/009/005 PA0711/009/005 Diclac Relief 1% w/w Gel Rowex Limited, 30/07/2004 HM Marketed AU Gel M02AA M02AA15 Generic application (Article 10(1) of Directive No 2001/83/EC) Topical Diclofenac sodium Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public Product not subject to medical prescription, supply through non-pharmacy outlets and pharmacies and promotion to the public subject to the following restrictions: maximum strength 1%, maximum pack size 100 g, maximum period of treatment 7 days, limited ind PA0711/331/001 PA0711/331/001 Diclac Relief Max 2% w/w gel Rowex Limited, 23/05/2025 HM Marketed AU Gel M02AA15 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Diclofenac Diethylamine Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Product not subject to medical prescription, supply through pharmacies only and promotion to the public subject to the following restrictions: maximum strength 2%, maximum pack size 100 g, maximum period of treatment 14 days, limited indications. PA0711/009/006 PA0711/009/006 IC0056-024-024 Diclac Retard 100 mg Prolonged-release Tablets Rowex Limited, 05/03/1992 HM Marketed AU Prolonged-release tablet M01AB M01AB05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1104/005/001 PA1104/005/001 Diclofenac 140 mg medicated plaster IBSA Farmaceutici Italia S.r.l 28/10/2022 HM Not marketed AU Medicated plaster M02AA15 Informed consent application (Article 10c of Directive No 2001/83/EC) Cutaneous use Diclofenac epolamine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2090/004/001 PA2090/004/001 Diclofenac Liderlens 40 mg/ml cutaneous spray solution Farmalider S.A. 02/12/2022 HM Not marketed AU Cutaneous spray, solution M02AA15 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/416/001 PA0126/416/001 Diclomel 140 mg medicated plaster Clonmel Healthcare Ltd 24/07/2026 HM Not marketed AU Medicated plaster M02AA15 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Diclofenac sodium Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0126/372/001 PA0126/372/001 Diclomel Max Strength 2% w/w gel Clonmel Healthcare Ltd 21/04/2023 HM Marketed AU Gel M02AA15 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Diclofenac Diethylamine Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Product not subject to medical prescription, supply through pharmacies only and promotion to the public subject to the following restrictions: maximum strength 2%, maximum pack size 100 g, maximum period of treatment 14 days, limited indications. PA23029/001/001 PA23029/001/001 Dienogest Stragen 2 mg film-coated tablets G&G Pharmaceutical (Netherlands) B.V. 28/06/2019 HM Unknown AU Film-coated tablet G03DB G03DB08 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dienogest Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2256/001/005 PA2256/001/005 IC0056-115-043 Difene 1% w/w Gel Glenwood GmbH 06/07/1995 HM Marketed AU Gel M02AA M02AA15 Generic application (Article 10(1) of Directive No 2001/83/EC) Cutaneous use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2256/001/004 PA2256/001/004 Difene 100 mg Dual Release Capsules Glenwood GmbH 30/05/1997 HM Marketed AU Modified-release capsule, hard M01AB M01AB05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2256/001/006 PA2256/001/006 IC0056-024-046 Difene 100mg Suppositories Glenwood GmbH 28/08/1990 HM Not marketed AU Suppository M01AB M01AB05 Generic application (Article 10(1) of Directive No 2001/83/EC) Rectal use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2256/001/001 PA2256/001/001 Difene 25mg Capsules Glenwood GmbH 28/08/1990 HM Marketed AU Gastro-resistant capsule, hard M01AB M01AB05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2256/001/002 PA2256/001/002 IC0056-023-016 Difene 50mg Capsules Glenwood GmbH 28/08/1990 HM Marketed AU Gastro-resistant capsule, hard M01AB M01AB05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2256/001/003 PA2256/001/003 Difene 75 mg Dual Release Capsules Glenwood GmbH 16/06/1994 HM Marketed AU Modified-release capsule, hard M01AB M01AB05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2256/001/007 PA2256/001/007 Difene Spray Gel 4% w/w Cutaneous Spray, Solution Glenwood GmbH 02/05/2003 HM Marketed AU Cutaneous spray, solution M02AA M02AA15 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Diclofenac sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/120/001 PPA1463/120/001 Differin 0.1% w/w cream IMED Healthcare Ltd., 01/02/2019 HM Unknown AU Cream D10AD D10AD03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Cutaneous use Adapalene Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22743/005/001 PA22743/005/001 Differin 0.1% w/w Cream Galderma International 18/02/2000 HM Not marketed AU Cream D10AD D10AD03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Topical Adapalene Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/437/002 PPA0465/437/002 Differin 0.1% w/w Cream PCO Manufacturing Ltd. 15/12/2017 HM Unknown AU Cream D10AD D10AD03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Cutaneous use Topical Adapalene Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/437/001 PPA0465/437/001 Differin 0.1% w/w gel PCO Manufacturing Ltd. 15/12/2017 HM Unknown AU Gel D10AD D10AD03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Cutaneous use Adapalene Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/120/002 PPA1463/120/002 Differin 0.1% w/w gel IMED Healthcare Ltd., 01/02/2019 HM Unknown AU Gel D10AD D10AD03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Cutaneous use Adapalene Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22743/005/002 PA22743/005/002 Differin 0.1% w/w Gel Galderma International 14/11/1994 HM Marketed AU Gel D10AD D10AD03 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Adapalene Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA25506/005/001 PA25506/005/001 Difflam Oral Rinse 0.15% w/v, gargle Cooper Consumer Health B.V. 18/04/2008 HM Marketed AU Gargle A01AD A01AD02 Not Currently Available Oral use BENZYDAMINE HYDROCHLORIDE Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA25506/005/002 PA25506/005/002 Difflam Spray, 0.15% w/v, Oromucosal Spray Cooper Consumer Health B.V. 20/06/2008 HM Marketed AU Oromucosal spray A01AD A01AD02 Not Currently Available Not Currently Available BENZYDAMINE HYDROCHLORIDE Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/11/733/001-004 EU/1/11/733/001-004 DIFICLIR 200 mg film-coated tablets Tillotts Pharma GmbH 05/12/2011 HM Unknown AU Film-coated tablet A07AA A07AA12 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fidaxomicin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/733/005 EU/1/11/733/005 DIFICLIR 40 mg/ml granules for oral suspension Tillotts Pharma GmbH 13/02/2020 HM Unknown AU Granules for oral suspension A07AA12 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fidaxomicin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/211/006 PA0822/211/006 Diflucan 10 mg/ml powder for oral suspension Pfizer Healthcare Ireland 12/11/1991 HM Marketed AU Powder for oral suspension J02AC J02AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fluconazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0822/211/002 PA0822/211/002 IC0151-062-001 Diflucan 150 mg hard capsules Pfizer Healthcare Ireland Unlimited Company 05/08/1988 HM Marketed AU Capsule, hard J02AC J02AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fluconazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0822/211/004 PA0822/211/004 Diflucan 2 mg/ml solution for infusion Pfizer Healthcare Ireland Unlimited Company 22/08/1989 HM Marketed AU Solution for infusion J02AC J02AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Oral use Fluconazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/211/003 PA0822/211/003 IC0151-067-001 Diflucan 200 mg hard capsules Pfizer Healthcare Ireland Unlimited Company 22/08/1989 HM Marketed AU Capsule, hard J02AC J02AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fluconazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0822/211/007 PA0822/211/007 Diflucan 40 mg/ml powder for oral suspension Pfizer Healthcare Ireland 12/11/1991 HM Marketed AU Powder for oral suspension J02AC J02AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fluconazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0822/211/001 PA0822/211/001 IC0151-023-001 Diflucan 50 mg hard capsules Pfizer Healthcare Ireland Unlimited Company 05/08/1988 HM Marketed AU Capsule, hard J02AC J02AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fluconazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0436/055/001 PA0436/055/001 IC0165-167-006 Dimethyl Fumarate 120 mg hard gastro-resistant capsules Norton Waterford 02/05/2025 HM Not marketed AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0436/055/002 PA0436/055/002 IC0165-203-006 Dimethyl Fumarate 240 mg hard gastro-resistant capsules Norton Waterford 02/05/2025 HM Not marketed AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/24/1811/001-002 EU/1/24/1811/001-002 IC0165-167-006 Dimethyl fumarate Accord 120 mg gastro-resistant hard capsules Accord Healthcare S.L.U. 22/04/2024 HM Unknown AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1811/003-006 EU/1/24/1811/003-006 IC0165-203-006 Dimethyl fumarate Accord 240 mg gastro-resistant hard capsules Accord Healthcare S.L.U. 22/04/2024 HM Unknown AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0126/391/001 PA0126/391/001 IC0165-167-006 Dimethyl fumarate Clonmel Healthcare 120 mg gastro-resistant hard capsules Clonmel Healthcare Ltd 06/06/2025 HM Marketed AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA0126/391/002 PA0126/391/002 IC0165-203-006 Dimethyl fumarate Clonmel Healthcare 240 mg gastro-resistant hard capsules Clonmel Healthcare Ltd 06/06/2025 HM Marketed AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA23250/010/001 PA23250/010/001 IC0165-167-006 Dimethyl fumarate MSN 120 mg gastro-resistant hard capsules MSN Labs Europe Limited 26/07/2024 HM Not marketed AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA23250/010/002 PA23250/010/002 IC0165-203-006 Dimethyl fumarate MSN 240 mg gastro-resistant hard capsules MSN Labs Europe Limited 26/07/2024 HM Not marketed AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/24/1814/001-004 EU/1/24/1814/001-004 IC0165-167-006 Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules Mylan Pharmaceuticals Limited 22/04/2024 HM Unknown AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1814/005-010 EU/1/24/1814/005-010 IC0165-203-006 Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules Mylan Pharmaceuticals Limited 22/04/2024 HM Unknown AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1810/001-003 EU/1/24/1810/001-003 IC0165-167-006 Dimethyl fumarate Neuraxpharm 120 mg gastro-resistant hard capsules Neuraxpharm Pharmaceuticals S.L. 22/04/2024 HM Unknown AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1810/004-008 EU/1/24/1810/004-008 IC0165-203-006 Dimethyl fumarate Neuraxpharm 240 mg gastro-resistant hard capsules Neuraxpharm Pharmaceuticals S.L. 22/04/2024 HM Unknown AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) PA0711/328/001 PA0711/328/001 IC0165-167-006 Dimethyl fumarate Rowex 120 mg hard gastro-resistant capsules Rowex Limited, 26/07/2024 HM Not marketed AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0711/322/001 PA0711/322/001 IC0165-203-006 Dimethyl fumarate Rowex 240 mg gastro-resistant hard capsules Rowex Limited, 26/07/2024 HM Not marketed AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0711/328/002 PA0711/328/002 IC0165-203-006 Dimethyl fumarate Rowex 240 mg hard gastro-resistant capsules Rowex Limited, 26/07/2024 HM Marketed AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0436/058/001 PA0436/058/001 IC0165-167-006 Dimethyl Fumarate Teva 120 mg gastro-resistant capsules, hard Norton Waterford 26/07/2024 HM Marketed AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0436/058/002 PA0436/058/002 IC0165-203-006 Dimethyl Fumarate Teva 240 mg gastro-resistant capsules, hard Norton Waterford 26/07/2024 HM Marketed AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1113/025/001 PA1113/025/001 Dioralyte Blackcurrant Powder for Oral Solution Phoenix Labs 03/06/1992 HM Marketed AU Powder for oral solution A07CA Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium chloride Potassium chloride Glucose Disodium hydrogen citrate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1113/025/002 PA1113/025/002 Dioralyte Citrus Powder for Oral Solution Phoenix Labs 03/06/1992 HM Marketed AU Powder for oral solution A07CA Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Glucose Sodium chloride Disodium hydrogen citrate Potassium chloride Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1113/026/001 PA1113/026/001 Dioralyte Natural, Powder for oral solution Phoenix Labs 13/07/1989 HM Marketed AU Powder for oral solution A07CA Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Glucose Sodium chloride Potassium chloride Disodium hydrogen citrate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1113/028/001 PA1113/028/001 Dioralyte Rebalance Blackcurrant Powder for Oral Solution Phoenix Labs 14/02/2020 HM Unknown AU Powder for oral solution A07CA Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Sodium chloride Potassium chloride Glucose Disodium hydrogen citrate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA1113/028/002 PA1113/028/002 Dioralyte Rebalance Citrus Powder for Oral Solution Phoenix Labs 14/02/2020 HM Unknown AU Powder for oral solution A07CA Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Sodium chloride Potassium chloride Glucose Disodium hydrogen citrate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA1113/028/003 PA1113/028/003 Dioralyte Rebalance Natural Powder for Oral Solution Phoenix Labs 14/02/2020 HM Unknown AU Powder for oral solution A07CA Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Sodium chloride Potassium chloride Glucose Disodium hydrogen citrate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA0896/009/002 PA0896/009/002 IC0038-082-003 Diovan 160 mg film-coated tablets Novartis Ireland Limited 14/12/2001 HM Marketed AU Film-coated tablet C09CA C09CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/461/001 PPA0465/461/001 IC0038-082-003 Diovan 160 mg film-coated tablets PCO Manufacturing Ltd. 21/05/2021 HM Unknown AU Film-coated tablet C09CA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/228/002 PPA1463/228/002 IC0038-082-003 Diovan 160 mg film-coated tablets IMED Healthcare Ltd., 20/09/2024 HM Unknown AU Film-coated tablet C09CA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0896/009/004 PA0896/009/004 IC0038-083-003 Diovan 320 mg film-coated tablets Novartis Ireland Limited 01/06/2007 HM Marketed AU Film-coated tablet C09CA C09CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0896/009/005 PA0896/009/005 Diovan 3mg/ml oral solution Novartis Ireland Limited 28/05/2010 HM Marketed AU Oral solution C09CA C09CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0896/009/003 PA0896/009/003 IC0038-004-003 Diovan 40 mg film-coated tablets Novartis Ireland Limited 29/07/2005 HM Marketed AU Film-coated tablet C09CA C09CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0896/009/001 PA0896/009/001 IC0038-005-003 Diovan 80 mg film-coated tablets Novartis Ireland Limited 14/12/2001 HM Marketed AU Film-coated tablet C09CA C09CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/461/002 PPA0465/461/002 IC0038-005-003 Diovan 80 mg film-coated tablets PCO Manufacturing Ltd. 21/05/2021 HM Unknown AU Film-coated tablet C09CA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/228/001 PPA1463/228/001 IC0038-005-003 Diovan 80 mg film-coated tablets IMED Healthcare Ltd., 20/09/2024 HM Unknown AU Film-coated tablet C09CA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22657/001/001 PA22657/001/001 Dipentum 250mg hard Capsules Atnahs Pharma Netherlands B.V. 12/07/1995 HM Marketed AU Capsule, hard A07EC A07EC03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Olsalazine sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22657/001/002 PA22657/001/002 Dipentum 500mg Tablets Atnahs Pharma Netherlands B.V. 18/05/1995 HM Marketed AU Tablet A07EC A07EC03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Olsalazine sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0697/002/001 PA0697/002/001 Dipeptiven, concentrate for solution for infusion Fresenius AG 20/05/1996 HM Not marketed AU Concentrate for solution for infusion B05XB B05XB02 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use L-alanyl-l glutamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1691/022/001 PA1691/022/001 Diprivan 1% w/v emulsion for injection or infusion, pre-filled syringe Aspen Pharma Trading Limited 19/10/1995 HM Marketed AU Emulsion for injection/infusion N01AX N01AX10 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Propofol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1113/030/001 PA1113/030/001 Diprobase Cream Phoenix Labs 05/10/1983 HM Not marketed AU Cream D02AC Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23198/009/001 PA23198/009/001 DiproSalic 0.05% w/w + 2% w/w scalp application Organon Pharma (Ireland) Limited 27/10/1983 HM Marketed AU Cutaneous solution D07XC D07XC01 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Betamethasone dipropionate Salicylic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/206/001 PPA1463/206/001 DiproSalic 0.05% w/w + 2% w/w scalp application IMED Healthcare Ltd. 25/08/2023 HM Unknown AU Cutaneous solution D07XC D07XC01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Cutaneous use Betamethasone dipropionate Salicylic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0979/007/001 PA0979/007/001 Disprin Direct 300 mg Orodispersible Tablets Reckitt Benckiser Ireland Ltd, 26/07/1983 HM Marketed AU Orodispersible tablet N02BA N02BA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Acetylsalicylic acid Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General sale in blister packs containing not more than 24 unit dosage forms. Retail sale through pharmacies only in blister packs containing not more than 50 unit dosage forms. The indications should be appropriate for self-diagnosis and self-treat PA0979/006/002 PA0979/006/002 Disprin Extra Strength 500 mg Effervescent tablets Reckitt Benckiser Ireland Ltd, 18/09/1998 HM Marketed AU Effervescent tablet N02BA N02BA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Acetylsalicylic acid Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General sale in blister packs containing not more than 16 unit dosage forms. Retail sale through pharmacies only in blister packs containing not more than 24 unit dosage forms The indications should be appropriate for self-diagnosis and self-tre PA0979/006/001 PA0979/006/001 Disprin Original 300 mg Dispersible Tablets Reckitt Benckiser Ireland Ltd, 01/04/1978 HM Marketed AU Dispersible tablet N02BA N02BA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Acetylsalicylic acid Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General sale in blister packs containing not more than 24 unit dosage forms. Retail sale through pharmacies only in blister packs containing not more than 50 unit dosage forms. The indications should be appropriate for self-diagnosis and self-treat PA1226/001/002 PA1226/001/002 Distaclor 125 mg/5 ml Granules for Oral Suspension Flynn Pharma Limited 16/11/1998 HM Marketed AU Granules for oral suspension J01DC J01DC04 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cefaclor Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1226/001/003 PA1226/001/003 Distaclor 250 mg/5 ml Granules for Oral Suspension Flynn Pharma Limited 16/11/1998 HM Marketed AU Granules for oral suspension J01DC J01DC04 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cefaclor Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1226/001/004 PA1226/001/004 Distaclor LA 375 mg Prolonged Release Tablets Flynn Pharma Limited 16/06/1994 HM Marketed AU Prolonged-release tablet J01DC J01DC04 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cefaclor monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1226/001/005 PA1226/001/005 Distaclor LA Forte 500 mg prolonged release tablets Flynn Pharma Limited 16/06/1994 HM Marketed AU Prolonged-release tablet J01DC J01DC04 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Cefaclor monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23289/002/001 PA23289/002/001 IC0165-167-006 Ditagfenda 120 mg hard gastro-resistant capsules Adalvo Limited 26/07/2024 HM Not marketed AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA23289/002/002 PA23289/002/002 IC0165-203-006 Ditagfenda 240 mg hard gastro-resistant capsules Adalvo Limited 26/07/2024 HM Not marketed AU Gastro-resistant capsule, hard L04AX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dimethyl Fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA2160/001/001 PA2160/001/001 diTeBooster, suspension for injection in pre-filled single-dose syringes.Diphtheria and tetanus vaccine (adsorbed, reduced antigen content). AJ Vaccines A/S 02/02/2007 HM Marketed AU Suspension for injection in pre-filled syringe J07AM J07AM51 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Diphtheria toxoid Tetanus toxoid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1327/002/001 PA1327/002/001 Divigel 0.1% w/w Gel, 1 mg/dose Orion Corporation 03/12/1996 HM Marketed AU Gel G03CA G03CA03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Transdermal use Estradiol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA23080/026/001 PPA23080/026/001 Divigel 0.1% w/w Gel, 1 mg/dose Merit Pharmaceuticals Limited 21/04/2023 HM Unknown AU Gel G03CA G03CA03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Transdermal use Estradiol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23343/001/001 PA23343/001/001 Dnord 255 microgram soft capsules Nordic Pharma Limited 19/08/2022 HM Marketed AU Capsule, soft A11CC06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Calcifediol monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0073/137/001 PA0073/137/001 Dobutamine 12.5mg/ml Concentrate for Solution for Infusion Mercury Pharmaceuticals (Ireland) Ltd 03/01/1996 HM Marketed AU Concentrate for solution for infusion C01CA07 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use DOBUTAMINE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22766/001/001 PA22766/001/001 Docetaxel 20 mg/ml concentrate for solution for infusion Seacross Pharma (Europe) Limited 26/08/2011 HM Marketed AU Concentrate for solution for infusion L01CD L01CD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Docetaxel (anhydrous) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/769/003 EU/1/12/769/003 Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion Accord Healthcare S.L.U. 27/06/2012 HM Unknown AU Concentrate for solution for infusion L01CD L01CD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Docetaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/769/001 EU/1/12/769/001 Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Accord Healthcare S.L.U. 22/05/2012 HM Unknown AU Concentrate for solution for infusion L01CD L01CD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Docetaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/769/002 EU/1/12/769/002 Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Accord Healthcare S.L.U. 27/06/2012 HM Unknown AU Concentrate for solution for infusion L01CD L01CD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Docetaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/770/002 EU/1/12/770/002 DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion Fresenius Kabi Deutschland GmbH 22/05/2012 HM Unknown AU Concentrate for solution for infusion L01CD L01CD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Docetaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/770/003 EU/1/12/770/003 DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion Fresenius Kabi Deutschland GmbH 22/05/2012 HM Unknown AU Concentrate for solution for infusion L01CD L01CD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Docetaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/770/004 EU/1/12/770/004 DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion Fresenius Kabi Deutschland GmbH 22/05/2012 HM Unknown AU Concentrate for solution for infusion L01CD L01CD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Docetaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/770/001 EU/1/12/770/001 DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion Fresenius Kabi Deutschland GmbH 22/05/2012 HM Unknown AU Concentrate for solution for infusion L01CD L01CD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Docetaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/11/748/001-006 EU/1/11/748/001-006 Docetaxel Mylan Mylan S.A.S. 31/01/2012 HM Unknown AU Concentrate for solution for infusion L01CD L01CD02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Anhydrous docetaxel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA1516/001/001 PA1516/001/001 Dolenio 1500mg Film-coated tablets Blue Bio Pharmaceuticals Limited 20/03/2009 HM Marketed AU Film-coated tablet M01AX M01AX05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Glucosamine sulfate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23229/010/001 PA23229/010/001 Dolmatil 200mg Tablets Neuraxpharm Ireland Limited 08/04/1987 HM Marketed AU Tablet N05AL N05AL01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sulpiride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22869/001/001 PA22869/001/001 Dolocopin 40mg/g Cream Ferndale Laboratories Limited 27/11/2015 HM Not marketed AU Cream N01BB02 Well-established use application (Article 10a of Directive No 2001/83/EC) Cutaneous use Lidocaine Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only Maximum pack size for non-prescription supply: 5 g. PA0711/046/001 PA0711/046/001 IC0085-002-014 Domerid 10mg tablets Rowex Limited, 04/04/2003 HM Marketed AU Tablet A03FA A03FA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Domperidone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/046/002 PA0711/046/002 Domerid Relief 10mg tablets Rowex Limited, 04/04/2003 HM Marketed AU Tablet A03FA A03FA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Domperidone Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only For non-prescription, pharmacy-only sale: MS 10 mg; MDD: 30 mg; MPS: 10: MQP: 100 mg. Pack sizes containing more than 10 tablets are subject to prescription. PA25506/004/002 PA25506/004/002 Dona 1500 mg Powder for oral solution Cooper Consumer Health B.V. 03/04/1998 HM Marketed AU Powder for oral solution M01AX M01AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium chloride Glucosamine sulfate sodium chloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA25506/004/001 PA25506/004/001 Dona 500mg Capsules Cooper Consumer Health B.V. 14/07/2006 HM Marketed AU Capsule, hard M01AX M01AX05 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Glucosamine sulfate sodium chloride GLUCOSAMINE SULPHATE Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA2315/033/002 PA2315/033/002 IC0062-002-015 Donepezil 10 mg film-coated tablets Accord Healthcare Ireland Ltd. 19/08/2011 HM Marketed AU Film-coated tablet N06DA N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/033/001 PA2315/033/001 IC0062-001-015 Donepezil 5 mg film-coated tablets Accord Healthcare Ireland Ltd. 19/08/2011 HM Marketed AU Film-coated tablet N06DA N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/004/002 PA22749/004/002 IC0062-002-015 Donepezil Hydrochloride 10mg Film-coated Tablets Brillpharma (Ireland) Limited 22/03/2013 HM Not marketed AU Film-coated tablet N06DA N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/004/001 PA22749/004/001 IC0062-001-015 Donepezil Hydrochloride 5mg Film-coated Tablets Brillpharma (Ireland) Limited 22/03/2013 HM Not marketed AU Film-coated tablet N06DA N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/014/004 PA1347/014/004 IC0062-002-015 Donepezil Krka 10 mg film-coated tablets KRKA, d.d., Novo mesto 28/10/2011 HM Marketed AU Film-coated tablet N06DA N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/014/003 PA1347/014/003 IC0062-001-015 Donepezil Krka 5 mg film-coated tablets KRKA, d.d., Novo mesto 28/10/2011 HM Marketed AU Film-coated tablet N06DA N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/194/002 PA0749/194/002 IC0062-002-015 Donepezil Teva 10 mg film-coated tablets Teva Pharma B.V. 27/11/2009 HM Marketed AU Film-coated tablet N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/194/001 PA0749/194/001 IC0062-001-015 Donepezil Teva 5 mg film-coated tablets Teva Pharma B.V. 27/11/2009 HM Marketed AU Film-coated tablet N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/183/002 PA0126/183/002 IC0062-002-015 Donesyn 10 mg film-coated tablets Clonmel Healthcare Ltd 16/05/2008 HM Marketed AU Film-coated tablet N06DA N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/183/001 PA0126/183/001 IC0062-001-015 Donesyn 5 mg film-coated tablets Clonmel Healthcare Ltd 16/05/2008 HM Marketed AU Film-coated tablet N06DA N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1848/003/001 PA1848/003/001 Donopa, 50 %/50 % v/v, medicinal gas, compressed SOL S.p.A. 15/07/2016 HM Unknown AU Medicinal gas, compressed N01AX N01AX63 Well-established use application (Article 10a of Directive No 2001/83/EC) Inhalation use Oxygen Nitrous oxide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0822/202/001 PA0822/202/001 Dopamine Hydrochloride 40 mg/ml Sterile Concentrate Pfizer Healthcare Ireland Unlimited Company 21/05/1986 HM Marketed AU Concentrate for solution for infusion C01CA C01CA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Not Currently Available DOPAMINE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1373/001-002 EU/1/19/1373/001-002 Doptelet 20 mg film-coated tablets Swedish Orphan Biovitrum AB(publ) 20/06/2019 HM Unknown AU Film-coated tablet B02BX B02BX08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Avatrombopag maleate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only TR2309/005/001 TR2309/005/001 Dormeasan Sleep Valerian-Hops oral drops A.Vogel Ireland Limited 02/05/2014 HM Marketed AU Oral drops, solution Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23148/008/001 PA23148/008/001 Dorzolamide/Timolol Brown & Burk 20 mg/ml + 5 mg/ml eye drops, solution in single-dose container Brown & Burk IR Limited 23/08/2024 HM Not marketed AU Eye drops, solution in single-dose container S01ED51 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Ocular use Dorzolamide hydrochloride Timolol Maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0822/126/001 PA0822/126/001 Dostinex 500 microgram tablets Pfizer Healthcare Ireland Unlimited Company 20/04/1995 HM Marketed AU Tablet G02CB G02CB03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Cabergoline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/162/001 PPA1463/162/001 Dostinex 500 microgram tablets IMED Healthcare Ltd., 01/04/2021 HM Unknown AU Tablet G02CB G02CB03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Cabergoline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/035/001 PPA2306/035/001 Dostinex 500 microgram tablets Originalis B.V. 26/07/2024 HM Unknown AU Tablet G02CB G02CB03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Cabergoline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/338/001 PPA0465/338/001 Dostinex 500 microgram Tablets PCO Manufacturing Ltd. 10/10/2014 HM Unknown AU Tablet G02CB G02CB03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Cabergoline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/013/001 PA22871/013/001 Dosulepin Hydrochloride 25 mg Hard Capsules Azure Pharmaceuticals Ltd. 05/08/2022 HM Not marketed AU Capsule, hard N06AA16 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dosulepin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/025/001 PA22871/025/001 Dosulepin Hydrochloride Azure 75 mg Coated Tablets Azure Pharmaceuticals Ltd. 14/04/2023 HM Not marketed AU Coated tablet N06AA16 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dosulepin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1410/082/001 PA1410/082/001 Dotagraf 279.32 mg/ml solution for injection Bayer Limited 16/12/2016 HM Not marketed AU Solution for injection V08CA V08CA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use DOTA ACID Meglumine Gadoteric acid Gadolinium oxide Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA1410/082/002 PA1410/082/002 Dotagraf 279.32 mg/ml solution for injection Bayer Limited 16/12/2016 HM Not marketed AU Solution for injection V08CA V08CA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Gadolinium oxide DOTA ACID Meglumine Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA0686/003/002 PA0686/003/002 Dotarem 279.32 mg/ml solution for injection Guerbet 10/06/1996 HM Marketed AU Solution for injection V08CA V08CA02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Gadoteric acid Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only PA0686/003/005 PA0686/003/005 Dotarem 279.32 mg/ml solution for injection in pre-filled syringe Guerbet 10/06/1996 HM Not marketed AU Solution for injection in pre-filled syringe V08CA V08CA02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Gadoteric acid Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1370/001-002 EU/1/19/1370/001-002 Dovato 50 mg/300 mg tablets ViiV Healthcare BV 01/07/2019 HM Unknown AU Film-coated tablet J05AR25 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Dolutegravir sodium Lamivudine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1025/001/002 PA1025/001/002 Dovobet 50 microgram/g + 0.5 mg/g gel LEO Pharma A/S 12/09/2008 HM Marketed AU Gel D05AX D05AX52 Fixed combination application (Article 10b of Directive No 2001/83/EC) Cutaneous use Calcipotriol Betamethasone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1025/001/001 PA1025/001/001 Dovobet® 50 microgram/g + 0.5 mg/g ointment LEO Pharma A/S 08/02/2002 HM Not marketed AU Ointment D05AX D05AX52 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Calcipotriol Betamethasone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0046/061/001 PA0046/061/001 Dovonex 50 microgram/g Ointment Leo Laboratories Limited 25/02/1991 HM Marketed AU Ointment D05AX D05AX02 New active substance (Article 8(3) of Directive No 2001/83/EC) Topical Calcipotriol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0046/061/002 PA0046/061/002 Dovonex 50 micrograms/g Cream Leo Laboratories Limited 14/03/1994 HM Marketed AU Cream D05AX D05AX02 Full application (Article 8(3) of Directive No 2001/83/EC) Topical Calcipotriol hydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1437/001-005 EU/1/20/1437/001-005 Dovprela 200 mg tablets Mylan IRE Healthcare Limited 31/07/2020 HM Unknown AU Tablet J04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pretomanid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0711/103/001 PA0711/103/001 IC0021-008-024 Doxane XL 4 mg prolonged-release tablets Rowex Ltd 12/01/2007 HM Marketed AU Prolonged-release tablet C02CA C02CA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Doxazosin mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0857/003/002 PA0857/003/002 Doxapram Hydrochloride 20mg/ml Solution for Injection MercuryPharm Ltd 01/04/1980 HM Marketed AU Solution for injection R07AB R07AB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Doxapram hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0857/003/001 PA0857/003/001 Doxapram Hydrochloride 2mg/ml Solution for Infusion MercuryPharm Ltd 01/04/1980 HM Not marketed AU Solution for infusion R07AB R07AB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Doxapram hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/202/001 PA0126/202/001 IC0021-039-002 Doxatan 1mg tablets Clonmel Healthcare Ltd 21/01/2000 HM Marketed AU Tablet C02CA C02CA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Doxazosin mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/202/002 PA0126/202/002 IC0021-006-002 Doxatan 2mg tablets Clonmel Healthcare Ltd 21/01/2000 HM Marketed AU Tablet C02CA C02CA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Doxazosin mesilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/202/003 PA0126/202/003 Doxatan 4mg tablets Clonmel Healthcare Ltd 21/01/2000 HM Marketed AU Tablet C02CA C02CA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Doxazosin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/202/004 PA0126/202/004 IC0021-008-024 Doxatan XL 4 mg Prolonged-release Tablets Clonmel Healthcare Ltd 29/07/2005 HM Marketed AU Prolonged-release tablet C02CA C02CA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Doxazosin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/083/001 PA2315/083/001 Doxorubicin 2 mg/ml Concentrate for Solution for Infusion Accord Healthcare Ireland Ltd. 09/07/2010 HM Not marketed AU Concentrate for solution for infusion L01DB L01DB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Intravesical use DOXORUBICIN HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22766/004/001 PA22766/004/001 Doxorubicin 2 mg/ml Concentrate for Solution for Infusion Seacross Pharma (Europe) Limited 29/01/2010 HM Not marketed AU Concentrate for solution for infusion L01DB L01DB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Intravesical use DOXORUBICIN HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2318/002/001 PA2318/002/001 Doxorubicin Rivopharm 2 mg/ml concentrate for solution for infusion Rivopharm Limited 09/12/2011 HM Marketed AU Concentrate for solution for infusion L01DB L01DB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Intravesical use DOXORUBICIN HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/083/001 PA0749/083/001 Doxorubicin Teva 2 mg/ml Concentrate for Solution for Infusion Teva Pharma B.V. 20/11/2009 HM Marketed AU Concentrate for solution for infusion L01DB L01DB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use DOXORUBICIN HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22998/004/001 PA22998/004/001 Doxpirexel 20 mg/ 20 mg modified-release tablets Exeltis Healthcare S.L. 30/06/2023 HM Not marketed AU Modified-release tablet R06AA59 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pyridoxine hydrochloride Doxylamine hydrogen succinate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1418/010/002 PA1418/010/002 IC0175-024-001 Doxycycline 100 mg hard capsules Athlone Pharmaceuticals Limited 23/08/2024 HM Marketed AU Capsule, hard J01AA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Doxycycline hyclate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1567/006/002 PA1567/006/002 IC0175-024-001 Doxycycline 100 mg hard capsules Activase Pharmaceuticals Limited 09/01/2026 HM Not marketed AU Capsule, hard J01AA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Doxycycline hyclate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1418/010/001 PA1418/010/001 Doxycycline 50 mg hard capsules Athlone Pharmaceuticals Limited 23/08/2024 HM Marketed AU Capsule, hard J01AA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Doxycycline hyclate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1436/030/001 PA1436/030/001 IC0175-024-001 Doxycycline Bluefish 100 mg Capsules Bluefish Pharmaceuticals AB 22/07/2010 HM Marketed AU Capsule, hard J01AA J01AA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Doxycycline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/161/001 PA0281/161/001 IC0175-024-001 Doxycycline Pinewood 100 mg Capsules Pinewood Laboratories Limited 22/07/2010 HM Marketed AU Capsule, hard J01AA J01AA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Doxycycline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/081/001 PA1986/081/001 IC0175-024-001 Doxycycline Teva 100mg Hard Capsules Teva B.V. 07/05/1985 HM Marketed AU Capsule, hard J01AA J01AA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Doxycycline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22998/001/001 PA22998/001/001 Doxylamine/Pyridoxine Exeltis 10 mg/10 mg gastro-resistant tablets Exeltis Healthcare S.L. 17/12/2021 HM Not marketed AU Gastro-resistant tablet R06AA59 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pyridoxine hydrochloride Doxylamine hydrogen succinate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22998/005/001 PA22998/005/001 Doxylamine/Pyridoxine Exeltis Healthcare 20mg/ 20mg modified-release tablets Exeltis Healthcare S.L. 30/06/2023 HM Not marketed AU Modified-release tablet R06AA59 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Doxylamine hydrogen succinate Pyridoxine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/141/002 PA0711/141/002 IC0062-002-015 Dozept 10 mg film-coated-tablets Rowex Limited, 10/10/2008 HM Marketed AU Film-coated tablet N06DA N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/141/001 PA0711/141/001 IC0062-001-015 Dozept 5 mg film-coated tablets Rowex Limited, 10/10/2008 HM Marketed AU Film-coated tablet N06DA N06DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Donepezil hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1721/005/001 PA1721/005/001 Dozol Oral Solution Paracetamol 120 mg/5 ml Diphenhydramine Hydrochloride 12.5 mg/5 ml Phoenix Healthcare Ltd 01/04/1978 HM Marketed AU Oral solution N02BE N02BE51 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Diphenhydramine hydrochloride Paracetamol Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA2034/001/001 PA2034/001/001 Drapolene Cream Benzalkonium chloride 0.01% w/w Cetrimide 0.2% w/w Ravira Limited 01/04/1983 HM Not marketed AU Cream D08AJ D08AJ01 D08AJ04 Well-established use application (Article 10a of Directive No 2001/83/EC) Topical Benzalkonium chloride solution Cetrimide Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA22668/007/001 PA22668/007/001 IC0191-215-003 Dretine 0.03 mg/3 mg Film-coated Tablets Theramex Ireland Limited 09/10/2009 HM Not marketed AU Film-coated tablet G03AA G03AA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ethinylestradiol Drospirenone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22668/006/001 PA22668/006/001 IC0191-216-003 Dretinelle 0.02 mg/3 mg Film-coated Tablets Theramex Ireland Limited 09/10/2009 HM Not marketed AU Film-coated tablet G03FA G03FA17 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ethinylestradiol Drospirenone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22835/005/001 PA22835/005/001 Droperidol 0.5 mg/ml solution for injection Sintetica GmbH 17/07/2023 HM Not marketed AU Solution for injection N05AD08 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Droperidol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1968/026/001 PA1968/026/001 Droperidol 1.25 mg/ml solution for injection Laboratoire Aguettant 20/12/2024 HM Not marketed AU Solution for injection N05AD08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Droperidol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1968/026/002 PA1968/026/002 Droperidol 2.5 mg/ml solution for injection Laboratoire Aguettant 20/12/2024 HM Not marketed AU Solution for injection N05AD08 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Droperidol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2245/001/001 PA2245/001/001 Dropizol 10 mg/ml Oral Drops Solution Atnahs Pharma Nordics A/S 22/06/2018 HM Not marketed AU Oral drops, solution A07DA A07DA02 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use OPIUM TINCTURE Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/21/1547/001-004 EU/1/21/1547/001-004 Drovelis 3 mg/14.2 mg film-coated tablets Chemical Works Of Gedeon Richter PLC 19/05/2021 HM Unknown AU Film-coated tablet G03AA G03AA18 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Drospirenone Estetrol Estetrol monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0865/018/002 PA0865/018/002 Drynol 10 mg orodispersible tablet Menarini International Operations Luxembourg S.A. 14/07/2017 HM Marketed AU Orodispersible tablet R06AX R06AX29 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bilastine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0865/018/003 PA0865/018/003 Drynol 2.5 mg/ml oral solution Menarini International Operations Luxembourg S.A. 14/07/2017 HM Marketed AU Oral solution R06AX R06AX29 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bilastine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0865/018/004 PA0865/018/004 Drynol 20 mg orodispersible tablets Menarini International Operations Luxembourg S.A. 03/03/2023 HM Not marketed AU Orodispersible tablet R06AX29 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bilastine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0865/018/001 PA0865/018/001 Drynol 20 mg Tablets Menarini International Operations Luxembourg S.A. 18/02/2011 HM Marketed AU Tablet R06AX R06AX29 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bilastine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0865/018/005 PA0865/018/005 Drynol 6 mg/mL eye drops, solution Menarini International Operations Luxembourg S.A. 22/07/2022 HM Not marketed AU Eye drops, solution S01GX13 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Bilastine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/517/001 PPA0465/517/001 Duac Once Daily 10 mg/g + 50 mg/g gel PCO Manufacturing Ltd. 22/08/2025 HM Unknown AU Gel D10AF51 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Cutaneous use Clindamycin Anhydrous Benzoyl Peroxide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1077/120/001 PA1077/120/001 Duac Once Daily 10mg/g + 50mg/g Gel GlaxoSmithKline (Ireland) Limited 22/07/2005 HM Marketed AU Gel D10AF D10AF51 Fixed combination application (Article 10b of Directive No 2001/83/EC) Topical CLINDAMYCIN PHOSPHATE Benzoyl peroxide hydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/964/001-003 EU/1/14/964/001-003 Duaklir Genuair 340 micrograms /12 micrograms inhalation powder Covis Pharma Europe B.V. HM Unknown AU Inhalation powder R03AL R03AL05 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Micronized aclidinium bromide Micronized formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/960/001 EU/1/14/960/001 DUAVIVE 0.45 mg/20 mg modified-release tablets Pfizer Europe MA EEIG 16/12/2014 HM Unknown AU Modified-release tablet G03CX Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Conjugated estrogens (ce) Bazedoxifene acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0879/009/001 PA0879/009/001 Ducressa 1 mg/ml + 5 mg/ml, eye drops, solution Santen OY 24/07/2020 HM Marketed AU Eye drops, solution S01CA01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Ocular use Levofloxacin Dexamethasone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1107/020/001 PA1107/020/001 Duelym 0.1 mg/g + 1 mg/g eye gel in single dose container Laboratoires Thea 07/11/2025 HM Not marketed AU Eye gel in single-dose container S01ED51 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Bimatoprost Timolol Maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/03/263/1-3 EU/1/03/263/1-3 DUKORAL Crucell Sweden AB 20/05/2004 HM Marketed AU Suspension and effervescent granules for oral suspension J07AE J07AE01 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Cholera vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23180/018/002 PA23180/018/002 Dulcolax 10 mg Suppositories Opella Healthcare France SAS T/A Sanofi 05/06/1986 HM Marketed AU Suppository A06AB A06AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Rectal use Bisacodyl Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23180/018/003 PA23180/018/003 Dulcolax 5mg Gastro-resistant Tablets Opella Healthcare France SAS T/A Sanofi 05/06/1986 HM Marketed AU Gastro-resistant tablet A06AB A06AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Bisacodyl Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23180/017/001 PA23180/017/001 Dulcolax Pico Liquid 5 mg/5 ml oral solution Opella Healthcare France SAS T/A Sanofi 31/08/1975 HM Marketed AU Oral solution A06AB A06AB08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium picosulfate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA2315/268/001 PA2315/268/001 IC0091-033-006 Duloxetine Accord 30 mg hard gastro-resistant capsules Accord Healthcare Ireland Ltd. 06/01/2023 HM Marketed AU Gastro-resistant capsule, hard N06AX21 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Duloxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/268/002 PA2315/268/002 IC0091-127-006 Duloxetine Accord 60 mg hard gastro-resistant capsules Accord Healthcare Ireland Ltd. 06/01/2023 HM Marketed AU Gastro-resistant capsule, hard N06AX21 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Duloxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/269/002 PA0126/269/002 IC0091-033-006 Duloxetine Clonmel 30 mg gastro resistant capsules, hard Clonmel Healthcare Ltd 25/09/2015 HM Marketed AU Gastro-resistant capsule, hard N06A Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Duloxetine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/269/004 PA0126/269/004 IC0091-127-006 Duloxetine Clonmel 60 mg gastro-resistant capsules, hard Clonmel Healthcare Ltd 25/09/2015 HM Marketed AU Gastro-resistant capsule, hard N06A Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Duloxetine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/051/002 PA1347/051/002 IC0091-033-006 Duloxetine Krka 30 mg hard gastro-resistant capsules KRKA, d.d., Novo mesto 13/03/2015 HM Marketed AU Gastro-resistant capsule, hard N06AX21 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Duloxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/051/004 PA1347/051/004 IC0091-127-006 Duloxetine Krka 60 mg hard gastro-resistant capsules KRKA, d.d., Novo mesto 13/03/2015 HM Marketed AU Gastro-resistant capsule, hard N06AX21 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Duloxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/972/001-003 EU/1/14/972/001-003 IC0091-033-006 Duloxetine Lilly 30 mg hard gastro-resistant capsules Eli Lilly Nederland B.V. HM Unknown AU Gastro-resistant capsule, hard N06AX N06AX21 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Duloxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/972/005-009 EU/1/14/972/005-009 IC0091-127-006 Duloxetine Lilly 60 mg hard gastro-resistant capsules Eli Lilly Nederland B.V. 08/12/2014 HM Unknown AU Gastro-resistant capsule, hard N06A Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Duloxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/270/001 PA0281/270/001 IC0091-033-006 Duloxetine Pinewood 30 mg hard gastro-resistant capsules Pinewood Laboratories Limited 15/09/2023 HM Marketed AU Gastro-resistant capsule, hard N06AX21 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Duloxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/270/002 PA0281/270/002 IC0091-127-006 Duloxetine Pinewood 60 mg hard gastro-resistant capsules Pinewood Laboratories Limited 15/09/2023 HM Marketed AU Gastro-resistant capsule, hard N06AX21 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Duloxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1010/01-010 EU/1/15/1010/01-010 IC0091-033-006 Duloxetine Viatris 30 mg hard gastro-resistant capsules Viatris Limited 19/06/2015 HM Unknown AU Gastro-resistant capsule, hard N06AX21 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Duloxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1010/011-020 EU/1/15/1010/011-020 IC0091-127-006 Duloxetine Viatris 60 mg hard gastro-resistant capsules Viatris Limited 19/06/2015 HM Unknown AU Gastro-resistant capsule, hard N06AX21 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Duloxetine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1028/001-003 EU/1/15/1028/001-003 IC0091-033-006 Duloxetine Zentiva 30 mg hard gastro-resistant capsules Zentiva k.s. 20/08/2015 HM Unknown AU Gastro-resistant capsule, hard N06A Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Duloxetine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1028/004-007 EU/1/15/1028/004-007 IC0091-127-006 Duloxetine Zentiva 60 mg hard gastro-resistant capsules Zentiva k.s. 20/08/2015 HM Unknown AU Gastro-resistant capsule, hard N06A Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Duloxetine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1824/002/001 PA1824/002/001 Duodopa 20 mg/ml + 5 mg/ml intestinal gel AbbVie Limited 18/11/2005 HM Marketed AU Intestinal gel N04BA N04BA02 Known active substance (Article 8(3) of Directive No 2001/83/EC) Topical Levodopa Carbidopa Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/10/619/008-014 EU/1/10/619/008-014 IC0043-031-003 DuoPlavin 75 mg/100 mg film-coated tablets Sanofi Winthrop Industrie 15/03/2010 HM Unknown AU Film-coated tablet B01AC B01AC30 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Acetylsalicylic acid Clopidogrel hydrogensulfate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/10/619/01-07 EU/1/10/619/01-07 IC0043-030-003 DuoPlavin 75 mg/75 mg film-coated tablets Sanofi Winthrop Industrie 15/03/2010 HM Unknown AU Film-coated tablet B01AC B01AC30 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Acetylsalicylic acid Clopidogrel hydrogensulfate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/920 /001-003 EU/1/14/920 /001-003 DuoResp Spiromax 160 micrograms/4.5 micrograms inhalation powder Teva Pharma B.V. 28/04/2014 HM Unknown AU Inhalation powder R03AK07 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Budesonide Formoterol fumatrate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/920 /004-006 EU/1/14/920 /004-006 DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder Teva Pharma B.V. 28/04/2014 HM Unknown AU Inhalation powder R03AK07 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Inhalation use Budesonide Formoterol fumatrate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/338/001-003 EU/1/06/338/001-003 Duotrav (Extravan) 40 micrograms/mL + 5 mg/mL eye drops, solution Novartis Europharm Limited 24/04/2006 HM Unknown AU Eye drops, solution S01ED S01ED51 Full application (Article 8(3) of Directive No 2001/83/EC) Travopost Timolol Timolol Maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22668/013/001 PA22668/013/001 Duphaston 10 mg film-coated tablets Theramex Ireland Limited 28/01/1985 HM Marketed AU Film-coated tablet G03DB G03DB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Dydrogesterone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1229/021-022 EU/1/17/1229/021-022 Dupixent Sanofi Winthrop Industrie 26/09/2017 HM Unknown AU Solution for injection D11AH05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Dupilumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1229/023-025 EU/1/17/1229/023-025 Dupixent 200 mg solution for injection in pre-filled pen Sanofi Winthrop Industrie 27/09/2017 HM Unknown AU Solution for injection D11AH05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Dupilumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/17/1229/009-0016 EU/1/17/1229/009-0016 Dupixent 200 mg solution for injection in pre-filled syringe Sanofi Winthrop Industrie 27/09/2017 HM Unknown AU Solution for injection D11AH05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Dupilumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/17/1229/026-028 EU/1/17/1229/026-028 Dupixent 300 mg solution for injection in pre-filled pen Sanofi Winthrop Industrie 27/09/2017 HM Unknown AU Solution for injection D11AH05 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Dupilumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/17/1229/001-008 EU/1/17/1229/001-008 Dupixent 300 mg solution for injection in pre-filled syringe Sanofi Winthrop Industrie 27/09/2017 HM Unknown AU Solution for injection in pre-filled syringe L04A Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Dupilumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA22581/001/001 PA22581/001/001 Duraphat 5000 ppm Fluoride Toothpaste Colgate-Palmolive A/S 25/07/2003 HM Marketed AU Toothpaste A01AA A01AA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Not Currently Available Sodium fluoride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22612/004/004 PA22612/004/004 Durogesic DTrans 100 micrograms/hour transdermal patch Janssen Sciences Ireland UC 31/10/1995 HM Marketed AU Transdermal patch N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PPA0465/314/004 PPA0465/314/004 Durogesic DTrans 100 micrograms/hour Transdermal Patch PCO Manufacturing Ltd. 25/07/2014 HM Unknown AU Transdermal patch N02AB03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA22612/004/005 PA22612/004/005 Durogesic DTrans 12 micrograms/hour Transdermal Patch Janssen Sciences Ireland UC 07/07/2006 HM Marketed AU Transdermal patch N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PPA0465/314/005 PPA0465/314/005 Durogesic DTrans 12 micrograms/hour Transdermal Patch PCO Manufacturing Ltd. 17/04/2015 HM Unknown AU Transdermal patch N02AB03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA22612/004/001 PA22612/004/001 Durogesic DTrans 25 micrograms/hour transdermal patch Janssen Sciences Ireland UC 31/10/1995 HM Marketed AU Transdermal patch N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PPA0465/314/001 PPA0465/314/001 Durogesic DTrans 25 micrograms/hour Transdermal Patch PCO Manufacturing Ltd. 25/07/2014 HM Unknown AU Transdermal patch N02AB03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA22612/004/002 PA22612/004/002 Durogesic DTrans 50 micrograms/hour Transdermal Patch Janssen Sciences Ireland UC 31/10/1995 HM Marketed AU Transdermal patch N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PPA0465/314/002 PPA0465/314/002 Durogesic DTrans 50 micrograms/hour Transdermal Patch PCO Manufacturing Ltd. 25/07/2014 HM Unknown AU Transdermal patch N02AB03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA22612/004/003 PA22612/004/003 Durogesic DTrans 75 micrograms/hour Transdermal Patch Janssen Sciences Ireland UC 31/10/1995 HM Marketed AU Transdermal patch N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PPA0465/314/003 PPA0465/314/003 Durogesic DTrans 75 micrograms/hour Transdermal Patch PCO Manufacturing Ltd. 25/07/2014 HM Unknown AU Transdermal patch N02AB03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA23266/045/001 PA23266/045/001 IC0036-065-001 Dutasteride/Tamsulosin hydrochloride 0.5 mg /0.4 mg hard capsules Viatris Limited 06/12/2019 HM Marketed AU Capsule, hard G04CA G04CA52 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dutasteride Tamsulosin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/222/001 PA2315/222/001 IC0036-065-001 Dutasteride/Tamsulosin Hydrochloride 0.5 mg/0.4 mg hard capsules Accord Healthcare Ireland Ltd. 22/11/2019 HM Marketed AU Capsule, hard G04CA G04CA52 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dutasteride Tamsulosin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/216/001 PA0281/216/001 IC0036-065-001 Dutasteride/Tamsulosin hydrochloride Pinewood 0.5 mg/0.4 mg hard capsules Pinewood Laboratories Ltd 09/10/2020 HM Marketed AU Capsule, hard G04CA52 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dutasteride Tamsulosin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0074/076/001 PA0074/076/001 IC0036-065-001 Dutasteride/Tamsulosin Rowa 0.5 mg/0.4 mg hard capsules. Rowa Pharmaceuticals Limited, 11/09/2020 HM Marketed AU Capsule, hard G04CA52 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Tamsulosin hydrochloride Dutasteride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/069/001 PA1347/069/001 IC0140-040-001 Dutasteride Krka 0.5 mg capsules, soft KRKA, d.d., Novo mesto 01/03/2017 HM Marketed AU Capsule, soft G04CB G04CB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dutasteride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0074/076/002 PA0074/076/002 IC0140-040-001 Dutasteride Rowa 0.5 mg soft capsules Rowa Pharmaceuticals Limited, 15/07/2019 HM Marketed AU Capsule, soft G04CB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dutasteride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/167/001 PA0749/167/001 IC0140-040-001 Dutasteride Teva 0.5 mg soft capsules Teva Pharma B.V. 01/02/2013 HM Marketed AU Capsule, soft G04CB G04CB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Dutasteride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1930/001 EU/1/25/1930/001 Duvyzat 8.86 mg/ml oral suspension Italfarmaco S.p.A. 06/06/2025 HM Unknown AU Oral suspension M09AX14 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Givinostat hydrochloride monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PPA0465/422/001 PPA0465/422/001 IC0166-204-070 Dymista 137 micrograms/50 micrograms per actuation nasal spray, suspension PCO Manufacturing Ltd. 23/12/2016 HM Unknown AU Nasal spray, suspension R01AD R01AD58 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Nasal use Azelastine hydrochloride Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/010/001 PA23355/010/001 IC0166-204-070 Dymista 137 micrograms/50 micrograms per actuation, Nasal Spray Suspension Viatris Healthcare Limited 22/02/2013 HM Marketed AU Nasal spray, suspension R01AD R01AD58 Fixed combination application (Article 10b of Directive No 2001/83/EC) Nasal use Azelastine hydrochloride Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA23080/018/001 PPA23080/018/001 IC0166-204-070 Dymista 137 micrograms/50 micrograms per actuation, Nasal Spray Suspension Merit Pharmaceuticals Limited 09/02/2018 HM Unknown AU Nasal spray, suspension R01AD R01AD58 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Nasal use Fluticasone propionate Azelastine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/209/006 EU/1/02/209/006 Dynastat 40 mg Powder and solvent for solution for injection Pfizer Europe MA EEIG 22/03/2002 HM Unknown AU Powder and solvent for solution for injection M01AH M01AH04 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Parecoxib Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/209/007 EU/1/02/209/007 Dynastat 40 mg Powder and solvent for solution for injection Pfizer Europe MA EEIG 22/03/2002 HM Unknown AU Powder and solvent for solution for injection M01AH M01AH04 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Parecoxib Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/209/008 EU/1/02/209/008 Dynastat 40 mg Powder and solvent for solution for injection Pfizer Europe MA EEIG 22/03/2002 HM Unknown AU Powder and solvent for solution for injection M01AH M01AH04 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Parecoxib Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/209/005 EU/1/02/209/005 Dynastat 40 mg Powder for solution for injection Pfizer Europe MA EEIG 22/03/2002 HM Unknown AU Powder for solution for injection M01AH M01AH04 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Parecoxib Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1914/001 EU/1/25/1914/001 Dyrupeg 6 mg solution for injection in pre-filled syringe Curateq Biologics s.r.o. 28/03/2025 HM Unknown AU Solution for injection in pre-filled syringe L03AA13 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Pegfilgrastim Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1613/002/002 PA1613/002/002 Dysport 300 units Powder for solution for injection Ipsen Pharma 18/07/2025 HM Marketed AU Powder for solution for injection M03AX01 Full application (Article 8(3) of Directive No 2001/83/EC) Intradermal use Intramuscular use Intravesical use Subcutaneous use Botulinum toxin type A - haemagglutinin complex Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Conditions of Licence: Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1613/002/001 PA1613/002/001 Dysport 500 units Powder for solution for injection Ipsen Pharma 20/04/1994 HM Marketed AU Powder for solution for injection J06AA J06AA04 Full application (Article 8(3) of Directive No 2001/83/EC) Not Currently Available Clostridium botulinum toxin type a haemagglutinin complex Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/18/1284/001-002 EU/1/18/1284/001-002 Dzuveo 30 micrograms sublingual tablet Laboratoire Aguettant 25/06/2018 HM Unknown AU Sublingual tablet N01AH N01AH03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Sublingual use SUFENTANIL CITRATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA22650/007/001 PA22650/007/001 E45 Cream White Soft Paraffin 14.5% w/w Light Liquid Paraffin 12.6% w/w Anhydrous Lanolin 1.0% w/w Karo Pharma AB 01/04/1977 HM Marketed AU Cream D02AX Well-established use application (Article 10a of Directive No 2001/83/EC) Topical use White soft paraffin Light liquid paraffin Lanolin anhydrous Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA0126/060/001 PA0126/060/001 Easofen 200mg Film-Coated Tablets Clonmel Healthcare Ltd 02/07/1986 HM Marketed AU Film-coated tablet M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Subject to the following restriction: maximum strength 200 mg, maximum pack size 50, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children over 12 years. PA0126/060/004 PA0126/060/004 Easofen for Children Six Plus Strawberry 200mg/5ml Oral Suspension Clonmel Healthcare Ltd 11/07/2014 HM Marketed AU Oral suspension M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0126/060/003 PA0126/060/003 Easofen for Children Strawberry 100mg/5ml Oral Suspension Clonmel Healthcare Ltd 11/07/2014 HM Marketed AU Oral suspension M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0126/060/002 PA0126/060/002 Easofen Max Strength 400 mg Film-coated Tablets Clonmel Healthcare Ltd 09/09/2011 HM Marketed AU Film-coated tablet M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0126/343/001 PA0126/343/001 Easofen Rapid Relief Max Strength 400 mg soft capsules Clonmel Healthcare Ltd 05/08/2022 HM Marketed AU Capsule, soft M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Subject to the following restrictions: maximum strength 400 mg, maximum pack size 25, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children over 12 years. PA0126/294/001 PA0126/294/001 Easolief Duo 500mg/150mg Film-coated Tablets Clonmel Healthcare Ltd 22/12/2017 HM Marketed AU Film-coated tablet N02BE N02BE51 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Paracetamol Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Pharmacy only: MAXIMUM PACK SIZE 24 in blister packs. Maximum two packs per retail transaction with pharmacist interview. Promotion to the public: Pack size not more than 24. Promotion to healthcare professionals: Pack size greater than 24. PA0126/407/001 PA0126/407/001 Easolief DUO Hot Drink 500 mg/150 mg powder for oral solution in sachet Clonmel Healthcare Ltd 24/10/2025 HM Unknown AU Powder for oral solution N02BE51 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Paracetamol Ibuprofen lysinate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Pharmacy only: MAXIMUM PACK SIZE 24. Maximum two packs per per retail transaction with pharmacist interview. Prescription only: Pack size greater than 24. Promotion to Public: Pack size not more than 24. Promotion to Healthcare professionals: Pack size greater than 24 PA0126/407/002 PA0126/407/002 Easolief DUO Hot Drink Max Strength 1000 mg/300 mg powder for oral solution in sachet Clonmel Healthcare Ltd 24/10/2025 HM Unknown AU Powder for oral solution N02BE51 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Paracetamol Ibuprofen lysinate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Pharmacy only: MAXIMUM PACK SIZE 12. Maximum two packs per per retail transaction with pharmacist interview. Prescription only: Pack size greater than 12. Promotion to Public: Pack size not more than 12. Promotion to Healthcare professionals: Pack size greater than 12 EU/1/23/1765/007-012 EU/1/23/1765/007-012 Ebglyss 250 mg solution for injection in pre-filled pen Almirall, S.A. 16/11/2023 HM Unknown AU Solution for injection in pre-filled pen D11AH10 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Lebrikizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/23/1765/001-006 EU/1/23/1765/001-006 Ebglyss 250 mg solution for injection in pre-filled syringe Almirall, S.A. 16/11/2023 HM Unknown AU Solution for injection in pre-filled syringe D11AH10 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Lebrikizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/14/915/001-002 EU/1/14/915/001-002 Ebilfumin 30 mg hard capsules Actavis Group hf 22/05/2014 HM Unknown AU Capsule, hard J05AH J05AH02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Oseltamivir phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/915/003-004 EU/1/14/915/003-004 Ebilfumin 45 mg hard capsules Actavis Group hf 22/05/2014 HM Unknown AU Capsule, hard J05AH J05AH02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Oseltamivir phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/915/005-006 EU/1/14/915/005-006 Ebilfumin 75 mg hard capsules Actavis Group hf 22/05/2014 HM Unknown AU Capsule, hard J05AH J05AH02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Oseltamivir phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/219/001-003 EU/1/02/219/001-003 IC0022-002-003 EBIXA 10 mg film-coated tablets H. Lundbeck A/S HM Unknown AU Film-coated tablet N06DX N06DX01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Memantine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/02/219/023-035 EU/1/02/219/023-035 IC0022-003-003 Ebixa 20 mg film-coated tablets H. Lundbeck A/S 08/05/2008 HM Unknown AU Film-coated tablet N06DX N06DX01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Memantine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/02/219/005-006 EU/1/02/219/005-006 IC0022-107-019 Ebixa 5 mg/pump actuation oral solution H. Lundbeck A/S 04/12/2001 HM Unknown AU Oral solution N06DX N06DX01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Memantine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/02/219/022 EU/1/02/219/022 IC0022-106-003 Ebixa 5 mg film-coated tabletsEbixa 10 mg film-coated tabletsEbixa 15 mg film-coated tabletsEbixa 20 mg film-coated tablets H. Lundbeck A/S 08/05/2008 HM Unknown AU Film-coated tablet N06DX N06DX01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Memantine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/22/1700/001 EU/1/22/1700/001 Ebvallo 2.8 × 10^7 – 7.3 × 10^7 cells/mL dispersion for injection Pierre Fabre Medicament 16/12/2022 HM Unknown AU Dispersion for injection L01XL09 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Tabelecleucel Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1051/007-012 EU/1/15/1051/007-012 IC0090-142-003 Ebymect 5 mg/1,000 mg film-coated tablets AstraZeneca AB 16/11/2015 HM Unknown AU Film-coated tablet A10BD A10BD15 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Metformin Hydrochloride Dapagliflozin propanediol monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1051/001-006 EU/1/15/1051/001-006 IC0090-143-003 Ebymect 5 mg/850 mg film-coated tablets AstraZeneca AB HM Unknown AU Film-coated tablet A10BD A10BD15 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Metformin Hydrochloride Dapagliflozin propanediol monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/416/002 EU/1/07/416/002 ECALTA 100 mg powder for concentrate for solution for infusion Pfizer Europe MA EEIG 23/07/2009 HM Unknown AU Powder for concentrate for solution for infusion J02AX J02AX06 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Anidulafungin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/763/001-006 EU/1/12/763/001-006 IC0079-062-003 Ecansya 150 mg film-coated tablets KRKA, d.d., Novo mesto HM Unknown AU Film-coated tablet L01BC L01BC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Capecitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/763/007-012 EU/1/12/763/007-012 IC0079-029-003 Ecansya 300 mg film-coated tablets KRKA, d.d., Novo mesto 20/04/2012 HM Unknown AU Film-coated tablet L01BC L01BC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Capecitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/763/013-018 EU/1/12/763/013-018 IC0079-117-003 Ecansya 500 mg film-coated tablets KRKA, d.d., Novo mesto 20/04/2012 HM Unknown AU Film-coated tablet L01BC L01BC06 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Capecitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). TR1725/001/001 TR1725/001/001 Echinace Tablets Sona Nutrition Ltd 04/07/2014 HM Not marketed AU Film-coated tablet Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public TR2309/009/004 TR2309/009/004 Echinaforce Cold & Flu tablets A.Vogel Ireland Limited 05/11/2012 HM Marketed AU Tablet Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public TR2309/009/002 TR2309/009/002 Echinaforce Cold and Flu Oral Drops A.Vogel Ireland Limited 19/07/2013 HM Marketed AU Oral drops, solution L03A Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public TR2309/009/001 TR2309/009/001 Echinaforce Forte Cold and Flu tablets A.Vogel Ireland Limited 05/11/2012 HM Marketed AU Tablet Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public TR2309/009/005 TR2309/009/005 Echinaforce Hot Drink Cold and Flu Echinacea concentrate for oral solution A.Vogel Ireland Limited 07/10/2016 HM Marketed AU Concentrate for oral solution Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public TR2309/013/001 TR2309/013/001 Echinaforce Sore Throat Spray A.Vogel Ireland Limited 24/04/2015 HM Marketed AU Oromucosal spray, solution R02A Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public EU/1/11/734/001-004 EU/1/11/734/001-004 Edarbi 20 mg tablets Takeda Pharma A/S HM Unknown AU Tablet C09CA C09CA09 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Azilsartan medoxomil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/734/005-008 EU/1/11/734/005-008 Edarbi 40 mg tablets Takeda Pharma A/S 07/12/2011 HM Unknown AU Tablet C09CA New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Azilsartan medoxomil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/734/009-011 EU/1/11/734/009-011 Edarbi 80 mg tablets Takeda Pharma A/S 07/12/2011 HM Unknown AU Tablet C09CA New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Azilsartan medoxomil Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1052/006-010 EU/1/15/1052/006-010 Edistride 10 mg film-coated tablets AstraZeneca AB 09/11/2015 HM Unknown AU Film-coated tablet A10BX A10BX09 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Dapagliflozin propanediol monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1052/001-005 EU/1/15/1052/001-005 Edistride 5 mg film-coated tablets AstraZeneca AB HM Unknown AU Film-coated tablet A10BX A10BX09 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Dapagliflozin propanediol monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/288/001 PA2315/288/001 Edoxaban Accord 15 mg film-coated tablets Accord Healthcare Ireland Ltd. 02/05/2025 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/288/002 PA2315/288/002 Edoxaban Accord 30 mg film-coated tablets Accord Healthcare Ireland Ltd. 02/05/2025 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/288/003 PA2315/288/003 Edoxaban Accord 60 mg film-coated tablets Accord Healthcare Ireland Ltd. 02/05/2025 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/115/001 PA1347/115/001 Edoxaban Krka 15 mg film-coated tablet KRKA, d.d., Novo mesto 08/11/2024 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/115/002 PA1347/115/002 Edoxaban Krka 30 mg film-coated tablet KRKA, d.d., Novo mesto 08/11/2024 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/115/003 PA1347/115/003 Edoxaban Krka 60 mg film-coated tablet KRKA, d.d., Novo mesto 08/11/2024 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0436/057/001 PA0436/057/001 Edoxaban Teva 15 mg film-coated tablets Norton Waterford 28/02/2025 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0436/057/002 PA0436/057/002 Edoxaban Teva 30 mg film-coated tablets Norton Waterford 28/02/2025 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0436/057/003 PA0436/057/003 Edoxaban Teva 60 mg film-coated tablets Norton Waterford 28/02/2025 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/337/001 PA0711/337/001 Edoxaban tosylate monohydrate 15 mg film-coated tablets Rowex Limited, 10/01/2025 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/337/002 PA0711/337/002 Edoxaban tosylate monohydrate 30 mg film-coated tablets Rowex Limited, 10/01/2025 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/012/001 PA1701/012/001 Edoxaban Zentiva 15 mg film-coated tablets Zentiva k.s. 07/03/2025 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/012/002 PA1701/012/002 Edoxaban Zentiva 30 mg film-coated tablets Zentiva k.s. 07/03/2025 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/012/003 PA1701/012/003 Edoxaban Zentiva 60 mg film-coated tablets Zentiva k.s. 07/03/2025 HM Not marketed AU Film-coated tablet B01AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Edoxaban tosylate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0822/127/001 PA0822/127/001 Edronax® 4 mg tablets Pfizer Healthcare Ireland Unlimited Company 28/11/1997 HM Marketed AU Tablet N06AX N06AX18 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Reboxetine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/736/002 EU/1/11/736/002 EDURANT 2.5 mg film-coated tablets Janssen-Cilag International NV 19/09/2024 HM Unknown AU Dispersible tablet J05AG05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rilpivirine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/11/736/001 EU/1/11/736/001 EDURANT 25 mg film-coated tablets Janssen-Cilag International NV 28/11/2011 HM Unknown AU Film-coated tablet J05AG J05AG05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Rilpivirine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1263/001-002 EU/1/17/1263/001-002 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 600 mg/200 mg/245 mg film-coated tablets KRKA, d.d., Novo mesto 08/02/2018 HM Unknown AU Film-coated tablet J05AR J05AR06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Tenofovir disoproxil succinate Efavirenz Emtricitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1222/001-002 EU/1/17/1222/001-002 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg film-coated tablets Mylan Pharmaceuticals Limited 05/09/2017 HM Unknown AU Film-coated tablet J05AR J05AR06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Efavirenz Tenofovir disoproxil maleate Emtricitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA1986/033/001 PA1986/033/001 Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 600 mg/200 mg/245 mg Film-coated Tablets Teva B.V. 24/03/2017 HM Marketed AU Film-coated tablet J05AR J05AR06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Efavirenz Emtricitabine Tenofovir disoproxil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1210/001 EU/1/17/1210/001 Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva 600 mg/200 mg/245 mg film-coated tablets Zentiva k.s. 17/07/2017 HM Unknown AU Film-coated tablet J05AR J05AR06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Tenofovir disoproxil phosphate Efavirenz Emtricitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/11/742/001-010 EU/1/11/742/001-010 Efavirenz Teva 600 mg film-coated tablets Teva B.V. HM Unknown AU Film-coated tablet J05AG J05AG03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Efavirenz Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA23355/002/003 PA23355/002/003 IC0026-062-030 Efexor XL 150 mg prolonged-release capsules, hard Viatris Healthcare Limited 26/07/1999 HM Marketed AU Prolonged-release capsule, hard N06AX N06AX16 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Venlafaxine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/085/005 PPA0465/085/005 IC0026-062-030 Efexor XL 150 mg prolonged-release capsules, hard PCO Manufacturing Ltd. 01/08/2025 HM Unknown AU Prolonged-release capsule, hard N06AX16 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Venlafaxine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23355/002/001 PA23355/002/001 IC0026-063-030 Efexor XL 37.5 mg prolonged-release capsules, hard Viatris Healthcare Limited 26/07/1999 HM Marketed AU Prolonged-release capsule, hard N06AX N06AX16 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Venlafaxine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23355/002/002 PA23355/002/002 IC0026-028-030 Efexor XL 75 mg prolonged-release capsules, hard Viatris Healthcare Limited 26/07/1999 HM Marketed AU Prolonged-release capsule, hard N06AX N06AX16 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Venlafaxine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/085/003 PPA0465/085/003 IC0026-028-030 Efexor XL 75 mg prolonged-release capsules, hard PCO Manufacturing Ltd. 03/06/2003 HM Unknown AU Prolonged-release capsule, hard N06AX N06AX16 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Venlafaxine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/441/1-2 EU/1/08/441/1-2 Effentora 100 micrograms buccal tablets Phoenix Labs 04/04/2008 HM Unknown AU Buccal tablet N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use FENTANYL CITRATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/08/441/3-4 EU/1/08/441/3-4 Effentora 200 micrograms buccal tablets Phoenix Labs 04/04/2008 HM Unknown AU Buccal tablet N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use FENTANYL CITRATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/08/441/5-6 EU/1/08/441/5-6 Effentora 400 micrograms buccal tablets Phoenix Labs 04/04/2008 HM Unknown AU Buccal tablet N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use FENTANYL CITRATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/08/441/7-8 EU/1/08/441/7-8 Effentora 600 micrograms buccal tablets Phoenix Labs 04/04/2008 HM Unknown AU Buccal tablet N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use FENTANYL CITRATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/08/441/9-10 EU/1/08/441/9-10 Effentora 800 micrograms buccal tablets Phoenix Labs 04/04/2008 HM Unknown AU Buccal tablet N02AB N02AB03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use FENTANYL CITRATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/08/457/8-14 EU/1/08/457/8-14 IC0070-122-003 Efficib 50 mg/1000 mg film-coated tablets Merck Sharp & Dohme BV 16/07/2008 HM Unknown AU Film-coated tablet A10BD A10BD07 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Sitagliptin phosphate Metformin Hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/457/1-7 EU/1/08/457/1-7 IC0070-121-003 Efficib 50 mg/850 mg film-coated tablets Merck Sharp & Dohme BV, 16/07/2008 HM Unknown AU Film-coated tablet A10BD A10BD07 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Sitagliptin phosphate Metformin Hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/503/8-14 EU/1/08/503/8-14 Efient 10 mg Film-coated tablet Substipharm HM Unknown AU Film-coated tablet B01AC B01AC22 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Prasugrel hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/503/1-7 EU/1/08/503/1-7 Efient 5 mg Film-coated tablet Substipharm 25/02/2009 HM Unknown AU Film-coated tablet B01AC B01AC22 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Prasugrel hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23458/001/001 PA23458/001/001 Efluelda suspension for injection in pre-filled syringe Trivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain Sanofi Winthrop Industrie 29/11/2024 HM Not marketed AU Suspension for injection in pre-filled syringe J07BB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Subcutaneous use Influenza Inactivated Split Virus Strain A (H1N1) Influenza Inactivated Split Virus Strain A (H3N2) Influenza Inactivated Split Virus Strain B Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23458/012/001 PA23458/012/001 Efluelda Tetra, suspension for injection in pre-filled syringe Sanofi Winthrop Industrie 24/04/2020 HM Not marketed AU Suspension for injection in pre-filled syringe J07BB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Influenza Inactivated Split Virus Strain B Influenza Inactivated Split Virus Strain A (H3N2) Influenza Inactivated Split Virus Strain B Influenza Inactivated Split Virus Strain A (H1N1) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1549/003 EU/1/21/1549/003 Efmody Diurnal Europe B.V. 27/05/2021 HM Unknown AU Modified-release capsule, hard H02AB09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1549/002 EU/1/21/1549/002 Efmody 10 mg modified-release hard capsules Immedica Pharma AB 27/05/2021 HM Unknown AU Modified-release capsule, hard H02AB09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1549/001 EU/1/21/1549/001 Efmody 5 mg modified-release hard capsules Immedica Pharma AB 27/05/2021 HM Unknown AU Modified-release capsule, hard H02AB09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA22743/006/001 PA22743/006/001 EFRACEA 40 mg modified-release hard capsules Galderma International 30/01/2009 HM Marketed AU Modified-release capsule, hard J01AA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Doxycycline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23355/026/001 PA23355/026/001 Efudix 5 % w/w Cream Viatris Healthcare Limited 01/04/1979 HM Marketed AU Cream L01BC L01BC02 Not Currently Available Topical Fluorouracil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23312/001/001 PA23312/001/001 Egostar 22400 IU film-coated tablets Jaba Recordati S.A. 08/04/2022 HM Marketed AU Film-coated tablet A11CC05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Vitamin d3 Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1963/002 EU/1/25/1963/002 Eiyzey 40 mg/mL solution for injection in a vial Zaklady Farmaceutyczne Polpharma S.A. 14/08/2025 HM Unknown AU Solution for injection in vial S01LA05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravitreal use Aflibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1963/001 EU/1/25/1963/001 Eiyzey 40 mg/mL solution for injection in pre-filled syringe Zaklady Farmaceutyczne Polpharma S.A. 14/08/2025 HM Unknown AU Solution for injection in pre-filled syringe S01LA05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravitreal use Aflibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23266/080/001 PA23266/080/001 Ejulir 6 mg/ml solution for injection in pre-filled pen Viatris Limited 06/02/2026 HM Not marketed AU Solution for injection in pre-filled pen A10BJ02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Subcutaneous use Liraglutide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/778/001-003 EU/1/12/778/001-003 Eklira Genuair 322 micrograms inhalation powder Covis Pharma Europe B.V. HM Unknown AU Inhalation powder R03BB R03BB05 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Micronized aclidinium bromide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1975/001-002 EU/1/25/1975/001-002 Ekterly 300 mg film-coated tablets Kalvista Pharmaceuticals (Ireland) Limited 17/09/2025 HM Unknown AU Film-coated tablet B06AC08 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Sebetralstat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1706/001 EU/1/22/1706/001 Eladynos 80 micrograms/dose solution for injection in pre-filled pen Theramex Ireland Limited 12/12/2022 HM Unknown AU Solution for injection in pre-filled syringe H05AA H05AA04 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Abaloparatide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1866/001 EU/1/24/1866/001 ELAHERE 5 mg/mL concentrate for solution for infusion Immunogen Biopharma (Ireland) Limited 14/11/2024 HM Unknown AU Concentrate for solution for infusion L01FX26 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Mirvetuximab soravtansine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) PA2118/002/003 PA2118/002/003 Elantan 20 mg Tablets Merus Labs Luxco II S.à.R.L. 21/04/1983 HM Marketed AU Tablet C01DA C01DA14 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Isosorbid-5-mononitrat Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2118/002/005 PA2118/002/005 Elantan LA 25mg Prolonged Release Capsules Merus Labs Luxco II S.à.R.L. 18/05/1995 HM Marketed AU Prolonged-release capsule, hard C01DA C01DA14 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use ISOSORBIDE MONONITRATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2118/002/004 PA2118/002/004 Elantan LA 50 mg Prolonged Release Capsules, hard Merus Labs Luxco II S.à.R.L. 24/07/1987 HM Marketed AU Prolonged-release capsule, hard C01DA C01DA14 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use ISOSORBIDE MONONITRATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/365/1-3 EU/1/06/365/1-3 Elaprase 2 mg/ml concentrate for solution for infusion Takeda Pharmaceuticals International AG Ireland Branch HM Unknown AU Concentrate for solution for infusion A16AB09 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Idursulfase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA1327/003/001 PA1327/003/001 Eldepryl 5 mg Tablets Orion Corporation 03/01/1996 HM Marketed AU Tablet N04BD N04BD01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Selegiline hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 2 to the Misuse of Drugs Regulations 2017. EU/1/17/1237/001-003 EU/1/17/1237/001-003 Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed GlaxoSmithKline Trading Services Limited 15/11/2017 HM Unknown AU Inhalation powder, pre-dispensed R03AL08 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Fluticasone furoate Umeclidinium bromide Vilanterol trifenatate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0688/048/001 PA0688/048/001 Eletriptan 20mg Film-coated tablet Chanelle Medical Unlimited Company 28/07/2017 HM Not marketed AU Film-coated tablet N02CC N02CC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use ELETRIPTAN Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0688/048/002 PA0688/048/002 Eletriptan 40mg Film-coated tablet Chanelle Medical Unlimited Company 28/07/2017 HM Not marketed AU Film-coated tablet N02CC N02CC06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use ELETRIPTAN Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1724/001-003 EU/1/23/1724/001-003 Elfabrio 2 mg/ml Concentrate for solution for infusion Chiesi Farmaceutici S.p.A. 04/05/2023 HM Unknown AU Concentrate for solution for infusion A16AB A16AB20 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Pegunigalsidase Alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA0812/005/002 PA0812/005/002 ELIGARD 22.5 mg powder and solvent for solution for injection Recordati Industria Chimica e Farmaceutica SpA 13/10/2005 HM Marketed AU Powder and solvent for solution for injection L02AE L02AE02 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Leuprorelin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/036/001 PPA2306/036/001 ELIGARD 22.5 mg powder and solvent for solution for injection Originalis B.V. 11/10/2024 HM Unknown AU Powder and solvent for solution for injection L02AE02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Subcutaneous use Leuprorelin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/511/001 PPA0465/511/001 ELIGARD 22.5 mg powder and solvent for solution for injection PCO Manufacturing Ltd. 03/01/2025 HM Unknown AU Powder for solution for injection L02AE02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Subcutaneous use Leuprorelin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA25370/004/001 PPA25370/004/001 ELIGARD 22.5 mg powder and solvent for solution for injection BModesto B.V. 27/06/2025 HM Unknown AU Powder and solvent for solution for injection L02AE02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Subcutaneous use Leuprorelin acetate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0812/005/003 PA0812/005/003 ELIGARD 45 mg powder and solvent for solution for injection Recordati Industria Chimica e Farmaceutica SpA 26/10/2007 HM Marketed AU Powder and solvent for solution for injection L02AE L02AE02 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Leuprorelin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/511/002 PPA0465/511/002 ELIGARD 45 mg powder and solvent for solution for injection PCO Manufacturing Ltd. 03/01/2025 HM Unknown AU Powder for solution for injection L02AE02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Subcutaneous use Leuprorelin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/037/001 PPA2306/037/001 ELIGARD 45 mg powder and solvent for solution for injection Originalis B.V. 16/05/2025 HM Unknown AU Powder and solvent for solution for injection L02AE02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Subcutaneous use Leuprorelin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA25370/001/002 PPA25370/001/002 ELIGARD 45 mg powder and solvent for solution for injection BModesto B.V. 20/06/2025 HM Unknown AU Powder and solvent for solution for injection L02AE02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Subcutaneous use Leuprorelin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0812/005/001 PA0812/005/001 ELIGARD 7.5 mg powder and solvent for solution for injection Recordati Industria Chimica e Farmaceutica SpA 13/10/2005 HM Not marketed AU Powder and solvent for solution for injection L02AE L02AE02 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Leuprorelin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/691/016 EU/1/11/691/016 Eliquis 0.15 mg granules in capsules for opening Bristol-Myers Squibb/Pfizer EEIG 26/07/2024 HM Unknown AU Granules in single-dose container B01AF02 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/691/017 EU/1/11/691/017 Eliquis 0.5 mg coated granule in sachet Bristol-Myers Squibb/Pfizer EEIG 26/07/2024 HM Unknown AU Coated granules in sachet B01AF02 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/691/018 EU/1/11/691/018 Eliquis 1.5 mg coated granule in sachet Bristol-Myers Squibb/Pfizer EEIG 26/07/2024 HM Unknown AU Coated granules in sachet B01AF02 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/691/019 EU/1/11/691/019 Eliquis 2 mg coated granule in sachet Bristol-Myers Squibb/Pfizer EEIG 26/07/2024 HM Unknown AU Coated granules in sachet B01AF02 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/691/001-005, 013 EU/1/11/691/001-005, 013 IC0124-018-003 Eliquis 2.5 mg film-coated tablets Bristol-Myers Squibb Pharma EEIG 18/05/2011 HM Unknown AU Film-coated tablet B01AF B01AF02 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/691/006-012 EU/1/11/691/006-012 IC0124-001-003 Eliquis 5 mg film-coated tablets Bristol-Myers Squibb Pharma EEIG HM Unknown AU Film-coated tablet B01AF B01AF02 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Apixaban Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/552/003 EU/1/09/552/003 IC0154-033-014 ellaOne 30 mg film-coated tablet Laboratoire HRA Pharma 10/11/2017 HM Unknown AU Film-coated tablet G03AD G03AD02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ulipristal acetate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/09/522/001 EU/1/09/522/001 IC0154-033-014 ellaOne 30 mg tablet Laboratoire HRA Pharma 15/05/2009 HM Unknown AU Tablet G03AD G03AD02 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use ULIPRISTAL (INN) Product not subject to medical prescription Supply through pharmacies only Advertising to the general public TR22953/001/001 TR22953/001/001 Ellura hard capsules Laboratoire Pharmaceutique Pharmatoka SAS 20/10/2023 HM Unknown AU Capsule, hard G04BX Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/17/1189/001-002 EU/1/17/1189/001-002 elmiron 100 mg capsules, hard bene-Arzneimittel GmbH 02/06/2017 HM Unknown AU Capsule, hard G04BX G04BX15 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Pentosan Polysulfate Sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/010/001 PA23198/010/001 Elocon 0.1% w/w Cream Organon Pharma (Ireland) Limited 20/12/1993 HM Marketed AU Cream D07AC13 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Mometasone furoate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/010/002 PA23198/010/002 Elocon 0.1% w/w Ointment Organon Pharma (Ireland) Limited 20/12/1993 HM Marketed AU Ointment D07AC D07AC13 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Mometasone furoate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/239/001 PPA1463/239/001 Elocon 0.1% w/w Ointment IMED Healthcare Ltd., 07/03/2025 HM Unknown AU Ointment D07AC13 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Cutaneous use Mometasone furoate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/010/003 PA23198/010/003 Elocon 0.1% w/w Scalp Lotion, Cutaneous Solution Organon Pharma (Ireland) Limited 20/12/1993 HM Not marketed AU Cutaneous solution D07AC D07AC13 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Mometasone furoate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1046/004 EU/1/15/1046/004 ELOCTA 1000 IU powder and solvent for solution for injection Swedish Orphan Biovitrum AB 19/11/2015 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efmoroctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1046/005 EU/1/15/1046/005 ELOCTA 1500 IU powder and solvent for solution for injection Swedish Orphan Biovitrum AB 19/11/2015 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efmoroctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1046/006 EU/1/15/1046/006 ELOCTA 2000 IU powder and solvent for solution for injection Swedish Orphan Biovitrum AB 19/11/2015 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efmoroctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1046/001 EU/1/15/1046/001 ELOCTA 250 IU powder and solvent for solution for injection Swedish Orphan Biovitrum AB 19/11/2015 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efmoroctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1046/007 EU/1/15/1046/007 ELOCTA 3000 IU powder and solvent for solution for injection Swedish Orphan Biovitrum AB 19/11/2015 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efmoroctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1046/008 EU/1/15/1046/008 ELOCTA 4000 IU powder and solvent for solution for injection Swedish Orphan Biovitrum AB(publ) 07/12/2018 HM Unknown AU Powder and solvent for solution for injection B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efmoroctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1046/002 EU/1/15/1046/002 ELOCTA 500 IU powder and solvent for solution for injection Swedish Orphan Biovitrum AB 19/11/2015 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efmoroctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1046/003 EU/1/15/1046/003 ELOCTA 750 IU powder and solvent for solution for injection Swedish Orphan Biovitrum AB 19/11/2015 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Efmoroctocog alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/609/001 EU/1/09/609/001 Elonva 100 micrograms solution for injection N.V. Organon 25/01/2010 HM Unknown AU Solution for injection G03GA G03GA09 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Corifollitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/609/002 EU/1/09/609/002 Elonva 150 micrograms solution for injection N.V. Organon 25/02/2010 HM Unknown AU Solution for injection G03GA G03GA09 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Corifollitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/23/1770/001-002 EU/1/23/1770/001-002 ELREXFIO 40 mg/mL solution for injection Pfizer Europe MA EEIG 07/12/2023 HM Unknown AU Solution for injection L01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Elranatamab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1903/001-004 EU/1/24/1903/001-004 IC0198-021-003 Eltrombopag Accord 12.5 mg film-coated tablets Accord Healthcare S.L.U. 28/03/2025 HM Unknown AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription. (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/24/1903/005-010 EU/1/24/1903/005-010 IC0198-022-003 Eltrombopag Accord 25 mg film-coated tablets Accord Healthcare S.L.U. 28/03/2025 HM Unknown AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription. (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/24/1903/011-016 EU/1/24/1903/011-016 IC0198-023-003 Eltrombopag Accord 50 mg film-coated tablets Accord Healthcare S.L.U. 28/03/2025 HM Unknown AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription. (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/24/1903/017-022 EU/1/24/1903/017-022 IC0198-028-003 Eltrombopag Accord 75 mg film-coated tablets Accord Healthcare S.L.U. 28/03/2025 HM Unknown AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription. (see Annex I: Summary of Product Characteristics, section 4.2) PA0126/377/001 PA0126/377/001 IC0198-022-003 Eltrombopag Clonmel 25 mg film-coated tablets Clonmel Healthcare Ltd 21/02/2025 HM Marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0126/377/002 PA0126/377/002 IC0198-023-003 Eltrombopag Clonmel 50 mg film-coated tablets Clonmel Healthcare Ltd 21/02/2025 HM Marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0126/377/003 PA0126/377/003 IC0198-028-003 Eltrombopag Clonmel 75 mg film-coated tablets Clonmel Healthcare Ltd 21/02/2025 HM Not marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1347/113/001 PA1347/113/001 IC0198-022-003 Eltrombopag Krka 25 mg film-coated tablets KRKA, d.d., Novo mesto 28/06/2024 HM Marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1347/113/002 PA1347/113/002 IC0198-023-003 Eltrombopag Krka 50 mg film-coated tablets KRKA, d.d., Novo mesto 28/06/2024 HM Marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1347/113/003 PA1347/113/003 IC0198-028-003 Eltrombopag Krka 75 mg film-coated tablets KRKA, d.d., Novo mesto 28/06/2024 HM Not marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA23250/011/001 PA23250/011/001 IC0198-022-003 Eltrombopag MSN 25 mg film-coated tablets MSN Labs Europe Limited 04/04/2025 HM Not marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA23250/011/002 PA23250/011/002 IC0198-023-003 Eltrombopag MSN 50 mg film-coated tablets MSN Labs Europe Limited 04/04/2025 HM Not marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0711/345/001 PA0711/345/001 IC0198-021-003 Eltrombopag Rowex 12.5 mg film-coated tablets Rowex Limited, 17/04/2025 HM Not marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/345/002 PA0711/345/002 IC0198-022-003 Eltrombopag Rowex 25 mg film-coated tablets Rowex Limited, 17/04/2025 HM Not marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/345/003 PA0711/345/003 IC0198-023-003 Eltrombopag Rowex 50 mg film-coated tablets Rowex Limited, 17/04/2025 HM Not marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/345/004 PA0711/345/004 IC0198-028-003 Eltrombopag Rowex 75 mg film-coated tablets Rowex Limited, 17/04/2025 HM Not marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22579/003/001 PA22579/003/001 IC0198-022-003 Eltrombopag Teva 25 mg Film-coated Tablets TEVA GmbH 14/02/2025 HM Marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA22579/003/002 PA22579/003/002 IC0198-023-003 Eltrombopag Teva 50 mg Film-coated Tablets TEVA GmbH 14/02/2025 HM Not marketed AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) EU/1/24/1869/001-004 EU/1/24/1869/001-004 IC0198-021-003 Eltrombopag Viatris 12.5 mg film-coated tablets Viatris Limited 12/12/2024 HM Unknown AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1869/005-008 EU/1/24/1869/005-008 IC0198-022-003 Eltrombopag Viatris 25 mg film-coated tablets Viatris Limited 12/12/2024 HM Unknown AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1869/009-012 EU/1/24/1869/009-012 IC0198-023-003 Eltrombopag Viatris 50 mg film-coated tablets Viatris Limited 12/12/2024 HM Unknown AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1869/013-016 EU/1/24/1869/013-016 IC0198-028-003 Eltrombopag Viatris 75 mg film-coated tablets Viatris Limited 12/12/2024 HM Unknown AU Film-coated tablet B02BX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eltrombopag olamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1142/028/002 PA1142/028/002 Eltroxin 100 microgram Tablets Amdipharm Limited 18/09/1995 HM Marketed AU Tablet H03AA H03AA01 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Levothyroxine sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1142/029/001 PA1142/029/001 Eltroxin 25 microgram Tablets Amdipharm Limited 02/07/2004 HM Marketed AU Tablet H03AA H03AA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Levothyroxine sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1142/028/001 PA1142/028/001 Eltroxin 50 microgram Tablets Amdipharm Limited 18/09/1995 HM Marketed AU Tablet H03AA H03AA01 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Levothyroxine sodium Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1772/001-010 EU/1/23/1772/001-010 Elucirem 0.5mmol/mL solution for injection Guerbet 07/12/2023 HM Unknown AU Solution for injection V08CA12 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Gadopiclenol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see annex I: Summary of Product Characteristics, section 4.2). PA1330/007/001 PA1330/007/001 IC0191-215-003 Elvina 0.03mg/3mg film-coated tablets Gedeon Richter Plc 20/08/2010 HM Marketed AU Film-coated tablet G03AA G03AA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Drospirenone Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only While you are receiving this medication, you should see your doctor regularly at least every six to twelve months. If you have any unusual symptoms such as unexplained pains in the chest, abdomen or legs, you must consult your doctor immediately. PA1330/008/001 PA1330/008/001 IC0191-216-003 Elvinette 0.02mg/3mg film-coated tablets Gedeon Richter Plc 03/06/2011 HM Marketed AU Film-coated tablet G03AA G03AA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Drospirenone Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1107/019/001 PA1107/019/001 Elymbus 0.1 mg/g eye gel in single-dose container Laboratoires Thea 23/06/2023 HM Marketed AU Eye gel in single-dose container S01EE03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Ocular use Bimatoprost Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1504/001 EU/1/20/1504/001 ELZONRIS 1 mg/mL concentrate for solution for infusion TMC Pharma (EU) Limited 07/01/2021 HM Unknown AU Concentrate for solution for infusion L01X L01XX67 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Tagraxofusp Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/98/095/001 EU/1/98/095/001 EMADINE 0.5 mg/ml, eye drops, solution Immedica Pharma AB 27/01/1999 HM Unknown AU Eye drops, solution S01GX S01GX06 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Emedastine difumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/095/003 EU/1/98/095/003 EMADINE 0.5 mg/ml, eye drops, solution Immedica Pharma AB 30/05/2002 HM Unknown AU Eye drops, solution S01GX Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Emedastine difumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/095/004 EU/1/98/095/004 EMADINE 0.5 mg/ml, eye drops, solution Immedica Pharma AB 30/05/2002 HM Unknown AU Eye drops, solution S01GX Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Emedastine difumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/158/001 PA0711/158/001 IC0004-003-016 Emazole 20 mg gastro-resistant tablets Rowex Limited, 08/04/2009 HM Marketed AU Gastro-resistant tablet A02BC A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Esomeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/158/002 PA0711/158/002 IC0004-004-016 Emazole 40 mg gastro-resistant tablets Rowex Limited, 08/04/2009 HM Marketed AU Gastro-resistant tablet A02BC A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Esomeprazole magnesium dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/355/001 PA0711/355/001 Emazole Control 20 mg gastro-resistant tablets Rowex Ltd 18/10/2019 HM Marketed AU Gastro-resistant tablet A02BC A02BC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Esomeprazole magnesium dihydrate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA1353/005/001 PA1353/005/001 Embesin 20 IU/ml concentrate for solution for infusion Orpha-Devel Handels und Vertriebs GmbH 23/03/2018 HM Marketed AU Concentrate for solution for infusion H01BA H01BA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Argipressin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1808/001 EU/1/24/1808/001 Emblaveo 1.5 g/0.5 g powder for concentrate for solution for infusion Pfizer Europe MA EEIG 22/04/2024 HM Unknown AU Powder for concentrate for solution for infusion J01DF51 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Avibactam sodium Aztreonam beta form Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1897/001 EU/1/24/1897/001 Emcitate 350 microgram dispersible tablets Rare Thyroid Therapeutics International AB 12/02/2025 HM Unknown AU Dispersible tablet H03AA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Tiratricol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/03/262/004-005 EU/1/03/262/004-005 IC0184-212-001 EMEND 125 mg hard capsules Merck Sharp & Dohme BV, 11/11/2003 HM Unknown AU Capsule, hard A04AD12 New active substance (Article 8(3) of Directive No 2001/83/EC) Aprepitant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/03/262/006 EU/1/03/262/006 IC0184-213-001 EMEND 125 mg hard capsules EMEND 80 mg hard capsules Merck Sharp & Dohme BV, 11/11/2003 HM Unknown AU Capsule, hard A04AD12 New active substance (Article 8(3) of Directive No 2001/83/EC) Aprepitant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/03/262/011 EU/1/03/262/011 Emend 125 mg powder for oral suspension Merck Sharp & Dohme BV, 16/12/2015 HM Unknown AU Powder for oral suspension A04AD A04AD12 New active substance (Article 8(3) of Directive No 2001/83/EC) Aprepitant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/03/262/001-003 EU/1/03/262/001-003 IC0184-005-001 EMEND 80 mg hard capsules Merck Sharp & Dohme BV, 11/11/2003 HM Unknown AU Capsule, hard A04AD12 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Aprepitant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/18/1330/001-004 EU/1/18/1330/001-004 Emgality Eli Lilly Nederland B.V. 14/11/2018 HM Unknown AU Solution for injection N02CX08 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use GALCANEZUMAB Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA23266/041/001 PA23266/041/001 IC0114-008-061 Emizof 4 mg film-coated tablets Viatris Limited 29/09/2006 HM Marketed AU Film-coated tablet A04AA A04AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ondansetron Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/041/002 PA23266/041/002 IC0114-009-061 Emizof 8 mg film-coated tablets Viatris Limited 29/09/2006 HM Marketed AU Film-coated tablet A04AA A04AA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ondansetron Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1691/023/001 PA1691/023/001 EMLA 5% w/w Cream Aspen Pharma Trading Limited 08/09/2017 HM Marketed AU Cream N01BB N01BB20 Full application (Article 8(3) of Directive No 2001/83/EC) Topical Lidocaine Prilocaine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/122/004 PA1347/122/004 Empagliflozin/Metformin Krka 12.5 mg/1000 mg film-coated tablets KRKA, d.d., Novo mesto 29/05/2026 HM Not marketed AU Film-coated tablet A10BD20 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Empagliflozin Metformin Hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/122/003 PA1347/122/003 Empagliflozin/Metformin Krka 12.5 mg/850 mg film-coated tablets KRKA, d.d., Novo mesto 29/05/2026 HM Not marketed AU Film-coated tablet A10BD20 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Empagliflozin Metformin Hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/122/002 PA1347/122/002 Empagliflozin/Metformin Krka 5 mg/1000 mg film-coated tablets KRKA, d.d., Novo mesto 29/05/2026 HM Not marketed AU Film-coated tablet A10BD20 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Empagliflozin Metformin Hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/122/001 PA1347/122/001 Empagliflozin/Metformin Krka 5 mg/850 mg film-coated tablets KRKA, d.d., Novo mesto 29/05/2026 HM Not marketed AU Film-coated tablet A10BD20 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Empagliflozin Metformin Hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1088/001 EU/1/16/1088/001 Empliciti 300 mg powder for concentrate for solution for infusion. Bristol-Myers Squibb Pharma EEIG 11/05/2016 HM Unknown AU Powder for concentrate for solution for infusion L01XC Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Elotuzumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1088/002 EU/1/16/1088/002 Empliciti 400 mg powder for concentrate for solution for infusion. Bristol-Myers Squibb Pharma EEIG HM Unknown AU Powder for concentrate for solution for infusion L01XC Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Elotuzumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/04/294/1-12 EU/1/04/294/1-12 EMSELEX pharmaand GmbH 22/10/2004 HM Unknown AU Prolonged-release tablet G04BD G04BD10 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Darifenacin hydrobromide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1966/001-006 EU/1/25/1966/001-006 Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris 200 mg/25 mg/25 mg film-coated tablets Viatris Limited 19/08/2025 HM Unknown AU Film-coated tablet J05AR19 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Emtricitabine Rilpivirine Tenofovir alafenamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1952/001-002 EU/1/25/1952/001-002 Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg film-coated tablets Viatris Limited 18/07/2025 HM Unknown AU Film-coated tablet J05AR17 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Emtricitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1952/003-008 EU/1/25/1952/003-008 Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 mg film-coated tablets Viatris Limited 18/07/2025 HM Unknown AU Film-coated tablet J05AR17 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Emtricitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2315/200/002 PA2315/200/002 IC0107-165-003 Emtricitabine/Tenofovir disoproxil Accordpharma 200 mg/245 mg film-coated tablets Accord Healthcare Ireland Ltd. 28/06/2019 HM Marketed AU Film-coated tablet J05AR J05AR03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Emtricitabine Tenofovir disoproxil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA0126/289/001 PA0126/289/001 IC0107-165-003 Emtricitabine/Tenofovir disoproxil Clonmel 200 mg/245 mg film-coated tablets Clonmel Healthcare Ltd 26/08/2016 HM Marketed AU Film-coated tablet J05AR J05AR03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Emtricitabine Tenofovir disoproxil succinate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1151/001-004 EU/1/16/1151/001-004 IC0107-165-003 Emtricitabine/Tenofovir disoproxil Krka 200 mg/245 mg film-coated tablets KRKA, d.d., Novo mesto HM Unknown AU Film-coated tablet J05AR J05AR03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Emtricitabine Tenofovir disoproxil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1182/001-004 EU/1/17/1182/001-004 IC0107-165-003 Emtricitabine/Tenofovir disoproxil Krka d.d 200 mg/245 mg film-coated tablets KRKA, d.d., Novo mesto 28/04/2017 HM Unknown AU Film-coated tablet J05AR J05AR03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Tenofovir disoproxil Emtricitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1133/001-006 EU/1/16/1133/001-006 IC0107-165-003 Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets Mylan Pharmaceuticals Limited HM Unknown AU Film-coated tablet J05AR J05AR03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Emtricitabine Tenofovir disoproxil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1986/016/001 PA1986/016/001 IC0107-165-003 Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg film-coated tablets Teva B.V. 06/05/2016 HM Marketed AU Film-coated tablet J05AR J05AR03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Emtricitabine Tenofovir disoproxil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22720/008/001 PA22720/008/001 IC0107-165-003 Emtricitabine/Tenofovir disoproxil Tillomed 200 mg/245 mg film-coated tablets Tillomed Pharma GmbH 02/10/2020 HM Not marketed AU Film-coated tablet J05AR J05AR03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Emtricitabine Tenofovir disoproxil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/16/1148/001-002 EU/1/16/1148/001-002 IC0107-165-003 Emtricitabine/Tenofovir disoproxil Zentiva 200 mg/245 mg film-coated tablets Zentiva k.s. 09/11/2016 HM Unknown AU Film-coated tablet J05AR J05AR03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Tenofovir disoproxil Emtricitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/03/261/1-3 EU/1/03/261/1-3 Emtriva 200 mg hard capsules Gilead Sciences Ireland UC 24/10/2003 HM Unknown AU Capsule, hard J05AF J05AF09 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Emtricitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA23128/005/001 PA23128/005/001 Emulsiderm Emollient Bath Additive/Cutaneous Emulsion liquid paraffin 25% w/w, isopropyl myristate 25% w/w, benzalkonium chloride 0.5% w/w Dermal Laboratories (Ireland) Limited 01/09/1982 HM Marketed AU Cutaneous emulsion D02AX Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Isopropyl myristate Liquid paraffin Benzalkonium chloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0206/019/001 PA0206/019/001 Emulsifying Ointment Ovelle Limited 18/11/1988 HM Marketed AU Ointment D02AX Well-established use application (Article 10a of Directive No 2001/83/EC) Topical Liquid paraffin White soft paraffin Emulsifying wax Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA1347/029/001 PA1347/029/001 IC0178-017-003 Enalapril/Lercanidipine Krka 10 mg/10 mg film-coated tablets KRKA, d.d., Novo mesto 09/08/2013 HM Marketed AU Film-coated tablet C09BB C09BB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enalapril maleate Lercanidipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/029/002 PA1347/029/002 IC0178-061-003 Enalapril/Lercanidipine Krka 20 mg/10 mg film-coated tablets KRKA, d.d., Novo mesto 09/08/2013 HM Marketed AU Film-coated tablet C09BB C09BB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enalapril maleate Lercanidipine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/241/002 PA2315/241/002 IC0179-002-002 Enalapril maleate Accord 10 mg tablets Accord Healthcare Ireland Ltd. 18/02/2022 HM Marketed AU Tablet C09AA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enalapril maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/241/003 PA2315/241/003 IC0179-003-002 Enalapril maleate Accord 20 mg tablets Accord Healthcare Ireland Ltd. 18/02/2022 HM Marketed AU Tablet C09AA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enalapril maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/241/001 PA2315/241/001 IC0179-001-002 Enalapril maleate Accord 5 mg tablets Accord Healthcare Ireland Ltd. 18/02/2022 HM Marketed AU Tablet C09AA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enalapril maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/028/002 PA0711/028/002 IC0179-002-002 ENAP 10 mg tablets Rowex Limited, 26/11/1999 HM Marketed AU Tablet C09AA C09AA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enalapril maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/028/003 PA0711/028/003 IC0179-003-002 ENAP 20 mg tablets Rowex Limited, 26/11/1999 HM Marketed AU Tablet C09AA C09AA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enalapril maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/028/001 PA0711/028/001 IC0179-001-002 ENAP 5 mg tablets Rowex Limited, 26/11/1999 HM Marketed AU Tablet C09AA C09AA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enalapril maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/99/126/022 EU/1/99/126/022 Enbrel 10 mg Powder and solvent for solution for injection Pfizer Europe MA EEIG HM Unknown AU Powder and solvent for solution for injection L04AB L04AB01 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/99/126/001-003 EU/1/99/126/001-003 Enbrel 25 mg Powder for solution for injection Pfizer Europe MA EEIG HM Unknown AU Powder for solution for injection L04AB L04AB01 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/99/126/002 EU/1/99/126/002 Enbrel 25 mg Powder for solution for injection Pfizer Europe MA EEIG 04/08/2006 HM Unknown AU Powder for solution for injection L04AB L04AB01 New active substance (Article 8(3) of Directive No 2001/83/EC) Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/99/126/013-015 EU/1/99/126/013-015 Enbrel 25 mg Solution for injection Pfizer Europe MA EEIG 26/09/2006 HM Unknown AU Solution for injection in pre-filled syringe L04AB L04AB01 New active substance (Article 8(3) of Directive No 2001/83/EC) Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/99/126/023-025 EU/1/99/126/023-025 Enbrel 25 mg Solution for injection Pfizer Europe MA EEIG 28/04/2005 HM Unknown AU Solution for injection in pre-filled pen L04AB L04AB01 New active substance (Article 8(3) of Directive No 2001/83/EC) Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/99/126/016-021 EU/1/99/126/016-021 Enbrel 50 mg Solution for injection Pfizer Europe MA EEIG 26/09/2006 HM Unknown AU Solution for injection in pre-filled syringe L04AB L04AB01 New active substance (Article 8(3) of Directive No 2001/83/EC) Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1105/001-002 EU/1/16/1105/001-002 EndolucinBeta 40 GBq/mL radiopharmaceutical precursor, solution ITM Medical Isotopes GmbH 07/07/2016 HM Unknown AU Radiopharmaceutical precursor, solution V10X Full application (Article 8(3) of Directive No 2001/83/EC) Intravitreal use Lutetium (177lu) chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2299/027/003 PA2299/027/003 Endoxana Coated Tablets 50 mg Baxter Holding B.V. 26/06/2008 HM Marketed AU Coated tablet L01AA L01AA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Cyclophosphamide monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/027/002 PA2299/027/002 Endoxana Injection 1000 mg Powder for Solution for Injection Baxter Holding B.V. 26/06/2008 HM Marketed AU Powder for solution for injection L01AA L01AA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Cyclophosphamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/027/001 PA2299/027/001 Endoxana Injection 500 mg Powder for Solution for Injection Baxter Holding B.V. 26/06/2008 HM Marketed AU Powder for solution for injection L01AA L01AA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Cyclophosphamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1438/001-005 EU/1/20/1438/001-005 Enerzair Breezhaler 114 micrograms/46 micrograms/136 micrograms inhalation powder, hard capsules Novartis Europharm Limited 03/07/2020 HM Unknown AU Inhalation powder, hard capsule R03AL12 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Indacaterol acetate Glycopyrronium bromide Mometasone furoate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1984/001-007 EU/1/25/1984/001-007 Enflonsia 105 mg solution for injection in pre-filled syringe Merck Sharp & Dohme BV, 15/04/2026 HM Unknown AU Solution for injection in pre-filled syringe J06BD10 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Clesrovimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1077/023/002 PA1077/023/002 Engerix B 20 micrograms/1 ml Suspension for injection in pre-filled syringe Hepatitis B (rDNA) vaccine (adsorbed) (HBV) GlaxoSmithKline (Ireland) Limited 26/06/1998 HM Marketed AU Suspension for injection in pre-filled syringe J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b surface antigen, recominant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1508/001 EU/1/20/1508/001 Enhertu 100 mg powder for concentrate for solution for infusion Daiichi Sankyo Europe GmbH 18/01/2021 HM Unknown AU Powder for concentrate for solution for infusion L01XC41 Known active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Trastuzumab Deruxtecan Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/22/1687/001-002 EU/1/22/1687/001-002 Enjaymo 50 mg/mL solution for infusion Recordati Rare Diseases 15/11/2022 HM Unknown AU Solution for infusion L04 L04AA55 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Sutimlimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23258/001/001 PA23258/001/001 Enoxaparin sodium Ledraxen 10,000 IU (100 mg)/1 mL, solution for injection in pre-filled syringe Venipharm 16/09/2022 HM Not marketed AU Solution for injection in pre-filled syringe B01AB05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23258/001/005 PA23258/001/005 Enoxaparin sodium Ledraxen 2,000 IU (20 mg)/0.2 mL, solution for injection in pre-filled syringe Venipharm 16/09/2022 HM Not marketed AU Solution for injection in pre-filled syringe B01AB05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23258/001/004 PA23258/001/004 Enoxaparin sodium Ledraxen 4,000 IU (40 mg)/0.4 mL, solution for injection in pre-filled syringe Venipharm 16/09/2022 HM Not marketed AU Solution for injection in pre-filled syringe B01AB05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23258/001/003 PA23258/001/003 Enoxaparin sodium Ledraxen 6,000 IU (60 mg)/0.6 mL, solution for injection in pre-filled syringe Venipharm 16/09/2022 HM Not marketed AU Solution for injection in pre-filled syringe B01AB05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23258/001/002 PA23258/001/002 Enoxaparin sodium Ledraxen 8,000 IU (80 mg)/0.8 mL, solution for injection in pre-filled syringe Venipharm 16/09/2022 HM Not marketed AU Solution for injection in pre-filled syringe B01AB05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1747/001 EU/1/23/1747/001 Enrylaze 10 mg/0.5 mL solution for injection/infusion. Jazz Pharmaceuticals Ireland Limited 15/09/2023 HM Unknown AU Solution for injection/infusion L01XX02 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Crisantaspase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/21/1559/001 EU/1/21/1559/001 Enspryng 120 mg solution for injection in pre-filled syringe Roche Registration GmbH 24/06/2021 HM Unknown AU Solution for injection in pre-filled syringe L04AA L04AC19 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Satralizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1025/005/001 PA1025/005/001 Enstilar 50 micrograms/g + 0.5 mg/g cutaneous foam LEO Pharma A/S 29/04/2016 HM Marketed AU Cutaneous foam D05AX D05AX52 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Calcipotriol Betamethasone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/708/001-004 EU/1/11/708/001-004 Entacapone Orion 200 mg film-coated tablets Orion Corporation 18/08/2011 HM Unknown AU Film-coated tablet N04BX N04BX02 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Entacapone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/10/665/001-004 EU/1/10/665/001-004 Entacapone Teva 200 mg film-coated tablets Teva Pharma B.V. 18/02/2011 HM Unknown AU Film-coated tablet N04BX N04BX02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Entacapone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1211/001-003 EU/1/17/1211/001-003 Entecavir Accord 0.5 mg film-coated tablets Accord Healthcare S.L.U. 26/09/2017 HM Unknown AU Film-coated tablet J05AF J05AF10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Entecavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1211/004-006 EU/1/17/1211/004-006 Entecavir Accord 1 mg film-coated tablets Accord Healthcare S.L.U. 26/09/2017 HM Unknown AU Film-coated tablet J05AF J05AF10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Entecavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0711/274/001 PA0711/274/001 Entecavir Rowex 0.5 mg Film-coated tablets Rowex Limited, 16/06/2017 HM Marketed AU Film-coated tablet J05AF J05AF10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use ENTECAVIR MONOHYDRATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). EU/1/17/1227/001-005 EU/1/17/1227/001-005 Entecavir Viatris 0.5 mg Film-coated tablet Viatris Limited 18/09/2017 HM Unknown AU Film-coated tablet J05AF J05AF10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Entecavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1227/006-010 EU/1/17/1227/006-010 Entecavir Viatris 1 mg film-coated tablets Viatris Limited 18/09/2017 HM Unknown AU Film-coated tablet J05AF J05AF10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Entecavir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2018/003/001 PA2018/003/001 Entocort CR 3 mg Gastro-resistant Capsule, Hard Tillotts Pharma GmbH 24/09/1996 HM Marketed AU Gastro-resistant capsule, hard A07EA A07EA06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Budesonide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0208/005/001 PA0208/005/001 Entonox BOC Gases Ireland Ltd 01/04/1980 HM Marketed AU Medicinal gas, compressed N01AX N01AX13 Well-established use application (Article 10a of Directive No 2001/83/EC) Inhalation use Oxygen Nitrous oxide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1058/001 EU/1/15/1058/001 Entresto 24 mg/26 mg film-coated tablets Novartis Europharm Limited 19/11/2015 HM Unknown AU Film-coated tablet C09DX C09DX04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sacubitril valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1058/002-004 EU/1/15/1058/002-004 Entresto 49 mg/51 mg film-coated tablets Novartis Europharm Limited 19/11/2015 HM Unknown AU Film-coated tablet C09DX C09DX04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sacubitril valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1058/023 EU/1/15/1058/023 Entresto 6 mg/6 mg granules in capsules for opening Novartis Europharm Limited 26/05/2023 HM Unknown AU Granules C09DX04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sacubitril Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1058/005-007 EU/1/15/1058/005-007 Entresto 97 mg/103 mg film-coated tablets Novartis Europharm Limited 19/11/2015 HM Unknown AU Film-coated tablet C09DX C09DX04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sacubitril valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/923/005-007 EU/1/14/923/005-007 Entyvio 108 mg solution for injection in pre-filled pen Takeda Pharma A/S 28/04/2020 HM Unknown AU Solution for injection in pre-filled pen L04AA33 Full application (Article 8(3) of Directive No 2001/83/EC) Vedolizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/14/923/002-004 EU/1/14/923/002-004 Entyvio 108 mg solution for injection in pre-filled syringe Takeda Pharma A/S 28/04/2020 HM Unknown AU Solution for injection in pre-filled syringe L04AA33 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Vedolizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/14/923/001 EU/1/14/923/001 Entyvio 300 mg powder for concentrate for solution for infusion Takeda Pharma A/S HM Unknown AU Powder for concentrate for solution for infusion L04AA33 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Vedolizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/789/001-006 EU/1/12/789/001-006 Enurev Breezhaler 44 micrograms inhalation powder, hard capsules Novartis Europharm Limited 28/09/2012 HM Unknown AU Inhalation powder, hard capsule R03BB06 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Glycopyrronium bromide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/35/001-003 EU/1/14/35/001-003 Envarsus 0.75 mg prolonged-release tablets Chiesi Farmaceutici S.p.A. 18/07/2014 HM Unknown AU Prolonged-release tablet L04AD L04AD02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Tacrolimus monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/35/004-006 EU/1/14/35/004-006 Envarsus 1 mg prolonged-release tablets Chiesi Farmaceutici S.p.A. 18/07/2014 HM Unknown AU Prolonged-release tablet L04AD L04AD02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Tacrolimus monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/35/007-009 EU/1/14/35/007-009 Envarsus 4 mg prolonged-release tablets Chiesi Farmaceutici S.p.A. 18/07/2014 HM Unknown AU Prolonged-release tablet L04AD L04AD02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Tacrolimus monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1944/001 EU/1/25/1944/001 Enwylma 120 mg solution for injection Zentiva k.s. 26/06/2025 HM Unknown AU Solution for injection M05BX04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Denosumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/09/580/1-6 EU/1/09/580/1-6 Enyglid 0.5 mg tablets KRKA, d.d., Novo mesto HM Unknown AU Tablet A10BX A10BX02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Repaglinide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/580/7-12 EU/1/09/580/7-12 Enyglid 1 mg tablets KRKA, d.d., Novo mesto 14/10/2009 HM Unknown AU Tablet A10BX A10BX02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Repaglinide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/580/13-18 EU/1/09/580/13-18 Enyglid 2 mg tablets KRKA, d.d., Novo mesto 14/10/2009 HM Unknown AU Tablet A10BX A10BX02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Repaglinide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/257/001 PA2315/257/001 Enzalutamide Accord 40 mg soft capsules Accord Healthcare Ireland Ltd. 02/08/2024 HM Not marketed AU Capsule, soft L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1990/009-017 EU/1/25/1990/009-017 Enzalutamide Accordpharma 160 mg film-coated tablets Accord Healthcare S.L.U. 09/01/2026 HM Unknown AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. EU/1/25/1990/001-003 EU/1/25/1990/001-003 Enzalutamide Accordpharma 40 mg film-coated tablets Accord Healthcare S.L.U. 09/01/2026 HM Unknown AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. EU/1/25/1990/004-008 EU/1/25/1990/004-008 Enzalutamide Accordpharma 80 mg film-coated tablets Accord Healthcare S.L.U. 09/01/2026 HM Unknown AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. PA0126/411/001 PA0126/411/001 Enzalutamide Clonmel 160 mg film-coated tablets Clonmel Healthcare Ltd 24/10/2025 HM Not marketed AU Film-coated tablet QL02BB04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/389/001 PA0126/389/001 Enzalutamide Clonmel 40 mg film-coated tablets Clonmel Healthcare Ltd 19/07/2024 HM Not marketed AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/389/002 PA0126/389/002 Enzalutamide Clonmel 80 mg film-coated tablets Clonmel Healthcare Ltd 19/07/2024 HM Not marketed AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/332/001 PA0711/332/001 Enzalutamide Rowex 40 mg film-coated tablets Rowex Limited, 24/11/2023 HM Not marketed AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/334/001 PA0711/334/001 Enzalutamide Rowex 40 mg film-coated tablets Rowex Limited, 19/07/2024 HM Not marketed AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/332/002 PA0711/332/002 Enzalutamide Rowex 80 mg film-coated tablets Rowex Limited, 24/11/2023 HM Not marketed AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/334/002 PA0711/334/002 Enzalutamide Rowex 80 mg film-coated tablets Rowex Limited, 19/07/2024 HM Not marketed AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22579/005/001 PA22579/005/001 Enzalutamide Teva 40 mg film-coated tablets TEVA GmbH 16/01/2026 HM Not marketed AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22579/005/002 PA22579/005/002 Enzalutamide Teva 80 mg film-coated tablets TEVA GmbH 16/01/2026 HM Not marketed AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1842/007-009 EU/1/24/1842/007-009 Enzalutamide Viatris 160 mg film-coated tablets Viatris Healthcare Limited 21/11/2025 HM Unknown AU Film-coated tablet L02BB04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription EU/1/24/1842/001-003 EU/1/24/1842/001-003 Enzalutamide Viatris 40 mg Film-coated tablet Viatris Limited 22/08/2024 HM Unknown AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1842/004-006 EU/1/24/1842/004-006 Enzalutamide Viatris 80 mg Film-coated tablet Viatris Limited 22/08/2024 HM Unknown AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1701/018/001 PA1701/018/001 Enzalutamide Zentiva 40 mg film-coated tablets Zentiva k.s. 20/02/2026 HM Not marketed AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1701/018/002 PA1701/018/002 Enzalutamide Zentiva 80 mg film-coated tablets Zentiva k.s. 20/02/2026 HM Not marketed AU Film-coated tablet L02BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Enzalutamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0549/026/001 PA0549/026/001 Epaclob 1 mg/ml Oral Suspension Ethypharm 25/11/2016 HM Marketed AU Oral suspension N05BA N05BA09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Clobazam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA0549/026/002 PA0549/026/002 Epaclob 2 mg/ml Oral Suspension Ethypharm 25/11/2016 HM Marketed AU Oral suspension N05BA N05BA09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Clobazam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017. PA23355/050/003 PA23355/050/003 Epanutin 100 mg Hard Capsules Viatris Healthcare Limited 01/04/1979 HM Marketed AU Capsule, hard N03AB N03AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use PHENYTOIN SODIUM Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/244/001 PPA0465/244/001 Epanutin 100 mg Hard Capsules PCO Manufacturing Ltd. 08/04/2011 HM Unknown AU Capsule, hard N03AB N03AB02 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use PHENYTOIN SODIUM Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/050/001 PA23355/050/001 Epanutin 25 mg Hard Capsules Viatris Healthcare Limited 29/10/1976 HM Marketed AU Capsule, hard N03AB N03AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use PHENYTOIN SODIUM Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/050/007 PA23355/050/007 Epanutin 30 mg/5ml Oral Suspension Viatris Healthcare Limited 01/04/1979 HM Marketed AU Oral suspension N03AB N03AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Phenytoin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/050/004 PA23355/050/004 Epanutin 300 mg Hard Capsules Viatris Healthcare Limited 26/03/1990 HM Marketed AU Capsule, hard N03AB N03AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use PHENYTOIN SODIUM Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/050/002 PA23355/050/002 Epanutin 50 mg Hard Capsules Viatris Healthcare Limited 01/04/1979 HM Marketed AU Capsule, hard N03AB N03AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use PHENYTOIN SODIUM Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/050/005 PA23355/050/005 Epanutin Infatabs 50mg Chewable Tablets Viatris Healthcare Limited 09/05/1975 HM Marketed AU Chewable tablet N03AB N03AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Phenytoin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/050/006 PA23355/050/006 Epanutin Ready Mixed Parenteral 250 mg/5 ml Solution for Injection or Infusion Viatris Healthcare Limited 09/05/1975 HM Marketed AU Solution for injection/infusion N03AB N03AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use PHENYTOIN SODIUM Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1116/003 EU/1/16/1116/003 Epclusa 150 mg/37.5 mg coated granules in sachet Gilead Sciences Ireland UC 07/01/2022 HM Unknown AU Coated granules J05AP55 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Sofosbuvir Velpatasvir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1116/004 EU/1/16/1116/004 Epclusa 200 mg/50 mg coated granules in sachet Gilead Sciences Ireland UC 07/01/2022 HM Unknown AU Coated granules J05AP55 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Sofosbuvir Velpatasvir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1116/002 EU/1/16/1116/002 Epclusa 200 mg/50 mg film-coated tablets Gilead Sciences Ireland UC 25/08/2020 HM Unknown AU Film-coated tablet J05A J05AP55 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Sofosbuvir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1116/001 EU/1/16/1116/001 Epclusa 400 mg/100 mg film-coated tablets Gilead Sciences Ireland UC HM Unknown AU Film-coated tablet J05A New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Sofosbuvir Velpatasvir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1968/011/002 PA1968/011/002 Ephedrine Hydrochloride 3 mg/ml solution for injection Laboratoire Aguettant 13/09/2024 HM Not marketed AU Solution for injection C01CA26 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Ephedrine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1968/011/001 PA1968/011/001 Ephedrine Hydrochloride 3 mg/ml solution for injection in pre-filled syringe Laboratoire Aguettant 21/12/2018 HM Marketed AU Solution for injection in pre-filled syringe C01CA26 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Ephedrine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1968/011/003 PA1968/011/003 Ephedrine Hydrochloride 30 mg/ ml solution for injection Laboratoire Aguettant 13/09/2024 HM Not marketed AU Solution for injection C01CA26 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Ephedrine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0549/027/001 PA0549/027/001 Ephedrine Hydrochloride 30mg in 1ml Solution for Injection Ethypharm 26/11/2004 HM Marketed AU Solution for injection C01CA26 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Ephedrine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/086/002 PA2059/086/002 Ephedrine Kabi 10 mg/mL solution for injection Fresenius Kabi Deutschland GmbH 02/08/2024 HM Not marketed AU Solution for injection C01CA26 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Ephedrine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/086/001 PA2059/086/001 Ephedrine Kabi 3 mg/mL solution for injection Fresenius Kabi Deutschland GmbH 02/08/2024 HM Not marketed AU Solution for injection C01CA26 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Ephedrine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/086/003 PA2059/086/003 Ephedrine Kabi 30 mg/mL solution for injection Fresenius Kabi Deutschland GmbH 02/08/2024 HM Not marketed AU Solution for injection C01CA26 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Ephedrine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22743/007/001 PA22743/007/001 Epiduo 0.1%/2.5% gel Galderma International 05/05/2017 HM Marketed AU Gel D10AD53 Fixed combination application (Article 10b of Directive No 2001/83/EC) Cutaneous use Adapalene Benzoyl Peroxide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/519/001 PPA0465/519/001 Epiduo 0.1%/2.5% gel PCO Manufacturing Ltd. 07/11/2025 HM Unknown AU Gel D10AD53 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Cutaneous use Adapalene Benzoyl Peroxide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22743/007/002 PA22743/007/002 Epiduo 0.3 %/2.5 % gel Galderma International 14/10/2022 HM Not marketed AU Gel D10AD53 Fixed combination application (Article 10b of Directive No 2001/83/EC) Cutaneous use Adapalene Anhydrous Benzoyl Peroxide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1389/001 EU/1/19/1389/001 Epidyolex 100 mg/ml oral solution Jazz Pharmaceuticals Ireland Limited 19/09/2019 HM Unknown AU Oral solution N03AX Full application (Article 8(3) of Directive No 2001/83/EC) Oral use CANNABIDIOL Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0540/150/001 PA0540/150/001 Epilim 100 mg Crushable Tablets Sanofi-Aventis Ireland Limited T/A SANOFI 25/06/1984 HM Marketed AU Tablet N03AG N03AG01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium valproate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/150/010 PA0540/150/010 Epilim Chrono 200mg Prolonged Release Tablets Sanofi-Aventis Ireland Limited T/A SANOFI 24/08/1992 HM Marketed AU Prolonged-release tablet N03AG N03AG01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium valproate Valproic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/150/011 PA0540/150/011 Epilim Chrono 300mg Prolonged Release Tablets Sanofi-Aventis Ireland Limited T/A SANOFI 24/08/1992 HM Marketed AU Prolonged-release tablet N03AG N03AG01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium valproate Valproic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/150/012 PA0540/150/012 Epilim Chrono 500mg Prolonged Release Tablets Sanofi-Aventis Ireland Limited T/A SANOFI 24/08/1992 HM Marketed AU Prolonged-release tablet N03AG N03AG01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium valproate Valproic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/150/005 PA0540/150/005 Epilim Chronosphere 100mg prolonged-release granules Sanofi-Aventis Ireland Limited T/A SANOFI 02/03/2007 HM Marketed AU Prolonged-release granules N03AG N03AG01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium valproate Valproic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/150/006 PA0540/150/006 Epilim Chronosphere 250mg prolonged-release granules Sanofi-Aventis Ireland Limited T/A SANOFI 02/03/2007 HM Marketed AU Prolonged-release granules N03AG N03AG01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium valproate Valproic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/150/007 PA0540/150/007 Epilim Chronosphere 500mg prolonged-release granules Sanofi-Aventis Ireland Limited T/A SANOFI 02/03/2007 HM Marketed AU Prolonged-release granules N03AG N03AG01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium valproate Valproic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/150/002 PA0540/150/002 Epilim Enteric 200 mg gastro-resistant coated tablets Sanofi-Aventis Ireland Limited T/A SANOFI 30/08/1983 HM Marketed AU Gastro-resistant tablet N03AG N03AG01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium valproate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/150/003 PA0540/150/003 Epilim Enteric 500mg Gastro-resistant Coated Tablets Sanofi-Aventis Ireland Limited T/A SANOFI 24/08/1983 HM Marketed AU Gastro-resistant tablet N03AG N03AG01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium valproate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/150/013 PA0540/150/013 Epilim Intravenous 400mg powder and solvent for solution for injection or infusion Sanofi-Aventis Ireland Limited T/A SANOFI 15/12/1998 HM Marketed AU Powder and solvent for solution for injection/infusion N03AG N03AG01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Sodium valproate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0540/150/014 PA0540/150/014 Epilim Liquid 200 mg/5ml Oral Solution Sanofi-Aventis Ireland Limited T/A SANOFI 30/03/1984 HM Marketed AU Oral solution N03AG N03AG01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium valproate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/150/015 PA0540/150/015 Epilim Syrup 200mg/5ml Oral Solution Sanofi-Aventis Ireland Limited T/A SANOFI 01/11/1983 HM Marketed AU Oral solution N03AG N03AG01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium valproate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0868/003/002 PA0868/003/002 EPINITRIL 10 mg/24 h transdermal patch Rottapharm Ltd 14/04/2000 HM Not marketed AU Transdermal patch C01DA C01DA02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Transdermal use Glyceryl trinitrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0868/003/003 PA0868/003/003 EPINITRIL 15 mg/24 h transdermal patch Rottapharm Ltd 14/04/2000 HM Not marketed AU Transdermal patch C01DA C01DA02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Transdermal use Glyceryl trinitrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0868/003/001 PA0868/003/001 EPINITRIL 5 mg/24 h transdermal patch Rottapharm Ltd 14/04/2000 HM Not marketed AU Transdermal patch C01DA C01DA02 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Transdermal use Glyceryl trinitrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/011/002 PA23355/011/002 EpiPen 300 micrograms solution for injection in pre-filled pen Viatris Healthcare Limited 29/08/2013 HM Marketed AU Solution for injection in pre-filled pen C01CA C01CA24 Well-established use application (Article 10a of Directive No 2001/83/EC) Intramuscular use Adrenaline Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/029/001 PA23355/029/001 Epipen Evo 300 microgram solution for injection in pre-filled pen Viatris Healthcare Limited 10/07/2026 HM Not marketed AU Solution for injection in pre-filled pen C01CA24 Well-established use application (Article 10a of Directive No 2001/83/EC) Intramuscular use Adrenaline tartrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/029/002 PA23355/029/002 Epipen Evo Junior 150 microgram solution for injection in pre-filled pen Viatris Healthcare Limited 10/07/2026 HM Not marketed AU Solution for injection in pre-filled pen C01CA24 Well-established use application (Article 10a of Directive No 2001/83/EC) Intramuscular use Adrenaline tartrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23355/011/001 PA23355/011/001 EpiPen Junior 150 micrograms solution for injection in pre-filled pen Viatris Healthcare Limited 29/08/2013 HM Marketed AU Solution for injection in pre-filled pen C01CA C01CA24 Well-established use application (Article 10a of Directive No 2001/83/EC) Intramuscular use Adrenaline Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22766/003/001 PA22766/003/001 Epirubicin 2 mg/ml Solution for Injection Seacross Pharma (Europe) Limited 03/04/2009 HM Not marketed AU Solution for injection L01DB L01DB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Epirubicin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/034/001 PA2315/034/001 Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion Accord Healthcare Ireland Ltd. 13/03/2009 HM Marketed AU Solution for injection/infusion L01DB L01DB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Intravesical use Epirubicin hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA20595/002/001 PA20595/002/001 Epistatus 10 mg oromucosal solution SERB S.A. 07/08/2020 HM Not marketed AU Oromucosal solution N05CD08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oromucosal use Midazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA20595/002/002 PA20595/002/002 Epistatus 2.5 mg oromucosal solution SERB S.A. 28/10/2022 HM Not marketed AU Oromucosal solution N05CD08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oromucosal use Midazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA20595/002/003 PA20595/002/003 Epistatus 5 mg oromucosal solution SERB S.A. 28/10/2022 HM Not marketed AU Oromucosal solution N05CD08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oromucosal use Midazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA20595/002/004 PA20595/002/004 Epistatus 7.5 mg oromucosal solution SERB S.A. 28/10/2022 HM Not marketed AU Oromucosal solution N05CD08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oromucosal use Midazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. EU/1/96/015/002 EU/1/96/015/002 Epivir 10 mg/ml oral solution ViiV Healthcare BV 08/08/1996 HM Unknown AU Oral solution J05A Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Lamivudine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/96/015/001 EU/1/96/015/001 Epivir 150 mg film-coated tablets ViiV Healthcare BV HM Unknown AU Coated tablet J05AF J05AF05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Lamivudine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/96/015/003 EU/1/96/015/003 Epivir 300 mg film-coated tablets ViiV Healthcare BV 15/11/2001 HM Unknown AU Film-coated tablet J05AF J05AF05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Lamivudine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA2315/085/001 PA2315/085/001 IC0115-022-003 Eplerenone 25 mg film-coated tablets Accord Healthcare Ireland Ltd. 23/10/2015 HM Marketed AU Film-coated tablet C03DA C03DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eplerenone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/085/002 PA2315/085/002 IC0115-023-003 Eplerenone 50 mg film-coated tablets Accord Healthcare Ireland Ltd. 23/10/2015 HM Marketed AU Film-coated tablet C03DA C03DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eplerenone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/078/001 PA1347/078/001 IC0115-022-003 Eplerenone Krka 25 mg film-coated tablets KRKA, d.d., Novo mesto 24/08/2018 HM Marketed AU Film-coated tablet C03DA C03DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eplerenone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/078/002 PA1347/078/002 IC0115-023-003 Eplerenone Krka 50 mg film-coated tablets KRKA, d.d., Novo mesto 24/08/2018 HM Marketed AU Film-coated tablet C03DA C03DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eplerenone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23250/014/001 PA23250/014/001 IC0115-022-003 Eplerenone MSN 25 mg film-coated tablets MSN Labs Europe Limited 19/07/2024 HM Not marketed AU Film-coated tablet C03DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eplerenone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23250/014/002 PA23250/014/002 IC0115-023-003 Eplerenone MSN 50 mg film-coated tablets MSN Labs Europe Limited 19/07/2024 HM Not marketed AU Film-coated tablet C03DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eplerenone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/235/001 PA0711/235/001 IC0115-022-003 Eplerenone Rowex 25 mg film-coated tablets Rowex Limited, 25/11/2011 HM Marketed AU Film-coated tablet C03DA C03DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eplerenone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/235/002 PA0711/235/002 IC0115-023-003 Eplerenone Rowex 50 mg film-coated tablets Rowex Limited, 25/11/2011 HM Marketed AU Film-coated tablet C03DA C03DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eplerenone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/032/001 PA23266/032/001 IC0115-022-003 Eplerenone Viatris 25 mg film-coated tablets Viatris Limited 08/11/2013 HM Marketed AU Film-coated tablet C03DA C03DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Eplerenone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/411/1-2 EU/1/07/411/1-2 Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Hexal AG 28/08/2007 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/411/15-16 EU/1/07/411/15-16 Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Hexal AG HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/411/3-4 EU/1/07/411/3-4 Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Hexal AG HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/411/21-22 EU/1/07/411/21-22 Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Hexal AG HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Epoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/411/5-6 EU/1/07/411/5-6 Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Hexal AG HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/411/23-24 EU/1/07/411/23-24 Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Hexal AG HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Epoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/411/7-8 EU/1/07/411/7-8 Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Hexal AG HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/411/25-26 EU/1/07/411/25-26 Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe Hexal AG HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Epoetin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/411/9-10 EU/1/07/411/9-10 Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Hexal AG HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/411/11-12 EU/1/07/411/11-12 Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Hexal AG HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/07/411/13-14 EU/1/07/411/13-14 Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Hexal AG HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Recombinant human erythropoietin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/573/1-2 EU/1/09/573/1-2 Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe Ratiopharm GmbH 29/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/573/11-16 EU/1/09/573/11-16 Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe Ratiopharm GmbH 29/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/573/3-4 EU/1/09/573/3-4 Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe Ratiopharm GmbH 29/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/573/17-22 EU/1/09/573/17-22 Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe Ratiopharm GmbH 29/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/573/5-6 EU/1/09/573/5-6 Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe Ratiopharm GmbH 29/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/573/23-28 EU/1/09/573/23-28 Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe Ratiopharm GmbH 29/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/573/7-8 EU/1/09/573/7-8 Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe Ratiopharm GmbH 29/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/09/573/9-10 EU/1/09/573/9-10 Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe Ratiopharm GmbH 29/10/2009 HM Unknown AU Solution for injection in pre-filled syringe B03XA B03XA01 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Xm01 drug substance epoetin theta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1860/001 EU/1/24/1860/001 Epruvy 10 mg/ml solution for injection (previously Ranibizumab Midas) Midas Pharma GmbH 19/09/2024 HM Unknown AU Solution for injection S01LA04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravitreal use Ranibizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1065/001 EU/1/15/1065/001 Eptifibatide Accord 0.75 mg/ml solution for infusion Accord Healthcare S.L.U. 11/01/2016 HM Unknown AU Solution for infusion B01AC B01AC16 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Eptifibatide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/15/1065/002 EU/1/15/1065/002 Eptifibatide Accord 2 mg/ml solution for injection Accord Healthcare S.L.U. 11/01/2016 HM Unknown AU Solution for injection B01AC B01AC16 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Eptifibatide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA23183/009/001 PA23183/009/001 Eptifibatide Jed 0.75 mg/ml solution for infusion Jed Pharma Limited 29/08/2025 HM Not marketed AU Solution for infusion B01AC16 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Eptifibatide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA23183/009/002 PA23183/009/002 Eptifibatide Jed 2 mg/ml solution for injection Jed Pharma Limited 29/08/2025 HM Not marketed AU Solution for injection B01AC16 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Eptifibatide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) EU/1/23/1735/001 EU/1/23/1735/001 Epysqli 300 mg concentrate for solution for infusion Samsung Bioepis NL B.V. 26/05/2023 HM Unknown AU Concentrate for solution for infusion L04AA25 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Eculizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA23211/001/001 PA23211/001/001 Equasym XL 10 mg modified-release capsules, hard Takeda Pharmaceuticals International AG Ireland Branch 28/07/2006 HM Marketed AU Modified-release capsule, hard N06BA04 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Methylphenidate hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, 4.2). This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA23211/001/002 PA23211/001/002 Equasym XL 20 mg modified-release capsules, hard Takeda Pharmaceuticals International AG Ireland Branch 28/07/2006 HM Marketed AU Modified-release capsule, hard N06BA N06BA04 Full application (Article 8(3) of Directive No 2001/83/EC) Not Currently Available Methylphenidate hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, 4.2). This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA23211/001/003 PA23211/001/003 Equasym XL 30 mg modified-release capsules, hard Takeda Pharmaceuticals International AG Ireland Branch 28/07/2006 HM Marketed AU Modified-release capsule, hard N06BA04 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Methylphenidate hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, 4.2). This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA23211/001/004 PA23211/001/004 Equasym XL 40 mg modified-release capsules, hard Takeda Pharmaceuticals International AG Ireland Branch 08/02/2013 HM Not marketed AU Modified-release capsule, hard N06BA N06BA04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Methylphenidate hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, 4.2). This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA23211/001/005 PA23211/001/005 Equasym XL 50 mg modified-release capsules, hard Takeda Pharmaceuticals International AG Ireland Branch 08/02/2013 HM Not marketed AU Modified-release capsule, hard N06BA N06BA04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Methylphenidate hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, 4.2). This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA23211/001/006 PA23211/001/006 Equasym XL 60 mg modified-release capsules, hard Takeda Pharmaceuticals International AG Ireland Branch 08/02/2013 HM Not marketed AU Modified-release capsule, hard N06BA N06BA04 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Methylphenidate hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, 4.2). This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/04/281/001 EU/1/04/281/001 Erbitux Merck Europe B.V. 29/06/2004 HM Unknown AU Solution for infusion L01XC L01XC06 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Cetuximab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/04/281/2-5 EU/1/04/281/2-5 Erbitux Merck Europe B.V. HM Unknown AU Solution for infusion L01XC L01XC06 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Cetuximab, chimeric antibody Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA22680/004/001 PA22680/004/001 Erdotin 300 mg capsules Galen Pharma Ireland Limited 13/10/2006 HM Marketed AU Capsule, hard R05CB R05CB15 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Erdosteine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1195/001-004 EU/1/17/1195/001-004 Erelzi 25 mg solution for injection in pre-filled syringe Sandoz GmbH 23/06/2017 HM Unknown AU Solution for injection in pre-filled syringe L04AB L04AB01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1195/009-012 EU/1/17/1195/009-012 Erelzi 50 mg solution for injection in pre-filled pen Sandoz GmbH 23/06/2017 HM Unknown AU Solution for injection in pre-filled pen L04AB01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Etanercept *** AWAITING VALUE *** *** AWAITING VALUE *** EU/1/17/1195/005-008 EU/1/17/1195/005-008 Erelzi 50 mg solution for injection in pre-filled syringe Sandoz GmbH 23/06/2017 HM Unknown AU Solution for injection in pre-filled syringe L04AB L04AB01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2315/276/001 PA2315/276/001 Eribulin Accord 0.44 mg/ml solution for injection Accord Healthcare Ireland Ltd. 06/07/2026 HM Not marketed AU Solution for injection L01XX41 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Eribulin Mesilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA23450/001/001 PA23450/001/001 Eribulin Advanz Pharma 0.44 mg/ml solution for injection Advanz Pharma Limited 22/09/2023 HM Not marketed AU Solution for injection L01XX41 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Eribulin mesylate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) EU/1/24/1819/001 EU/1/24/1819/001 Eribulin Baxter 0.44 mg/mL solution for injection Baxter Holding B.V. 27/06/2024 HM Unknown AU Solution for injection L01XX41 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Eribulin mesylate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1774/009/001 PA1774/009/001 Eribulin EVER Pharma 0.44 mg/ml solution for injection EVER Valinject GmbH 14/06/2024 HM Marketed AU Solution for injection L01XX41 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Eribulin Mesilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) PA25239/001/001 PA25239/001/001 Eribulin Tillomed 0.44 mg/ml solution for injection Tillomed Malta Limited 09/04/2026 HM Not marketed AU Solution for injection L01XX41 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Eribulin mesylate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2) EU/1/13/848/001 EU/1/13/848/001 Erivedge 150 mg hard capsules Roche Registration GmbH 12/07/2013 HM Unknown AU Capsule, hard L01XJ01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Vismodegib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products on restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1342/004-006 EU/1/18/1342/004-006 Erleada 240 mg film-coated tablets Janssen-Cilag International NV 25/08/2023 HM Unknown AU Film-coated tablet L02BB05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use APALUTAMIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1342/001-003 EU/1/18/1342/001-003 Erleada 60 mg film-coated tablets Janssen-Cilag International NV 14/01/2019 HM Unknown AU Film-coated tablet L02BB05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use APALUTAMIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/22/1656/001-002 EU/1/22/1656/001-002 Ertapenem SUN 1 g powder for concentrate for solution for infusion Sun Pharmaceutical Industries Europe B.V. 15/07/2022 HM Unknown AU Powder for concentrate for solution for infusion J01DH03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Ertapenem sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1125/002/001 PA1125/002/001 ERtracER Solution for Injection Curium Pharma Ireland Limited 27/02/2015 HM Marketed AU Solution for injection V09IX V09IX04 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Fludeoxyglucose [18F] Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1392/001 EU/1/19/1392/001 Ervebo solution for injection Merck Sharp & Dohme BV, 11/11/2019 HM Unknown AU Solution for injection J07BX J07BX02 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Recombinant Vesicular Stomatitis Virus - Zaire Ebolavirus Vaccine (Live Attenuated) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23208/001/001 PA23208/001/001 Erwinase 10 000 U powder for solution for injection/infusion Porton Biopharma Limited 18/06/2021 HM Marketed AU Powder for solution for injection/infusion L01XX02 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intramuscular use Intravenous use Crisantaspase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/008/002 PA1142/008/002 Erythrocin 250 mg tablets Amdipharm Limited 01/04/1977 HM Marketed AU Film-coated tablet J01FA J01FA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Erythromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/008/003 PA1142/008/003 Erythrocin 500 mg tablets Amdipharm Limited 01/04/1977 HM Marketed AU Film-coated tablet J01FA J01FA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Erythromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/008/001 PA1142/008/001 Erythrocin IV Lactobionate 1 g Powder for Concentrate for Solution for Infusion Amdipharm Limited 28/01/1980 HM Marketed AU Powder for concentrate for solution for infusion J01FA J01FA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Erythromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/006/004 PA1142/006/004 Erythroped Adult 500mg Film-coated Tablets Amdipharm Limited 27/01/1986 HM Not marketed AU Film-coated tablet J01FA J01FA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Erythromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/006/002 PA1142/006/002 Erythroped PI SF 125 mg/5 ml granules for oral suspension Amdipharm Limited 19/02/1999 HM Not marketed AU Granules for oral suspension J01FA J01FA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Erythromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/006/001 PA1142/006/001 Erythroped SF 250 mg/5 ml granules for oral suspension Amdipharm Limited 19/02/1999 HM Not marketed AU Granules for oral suspension J01FA J01FA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Erythromycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/667/007-008 EU/1/11/667/007-008 IC0127-173-003 Esbriet 267 mg film-coated tablets H.A.C Pharma HM Unknown AU Film-coated tablet L04AX L04AX05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Pirfenidone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/11/667/012-017 EU/1/11/667/012-017 Esbriet 267 mg film-coated tablets Roche Registration Limited 24/04/2017 HM Unknown AU Film-coated tablet L04AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pirfenidone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/11/667/001-003 EU/1/11/667/001-003 IC0127-173-003 Esbriet 267 mg hard capsules H.A.C Pharma 28/02/2011 HM Unknown AU Capsule, hard L04AX L04AX05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Pirfenidone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/11/667/009-010 EU/1/11/667/009-010 IC0127-174-003 Esbriet 534 mg film-coated tablets H.A.C Pharma HM Unknown AU Film-coated tablet L04AX L04AX05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Pirfenidone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/11/667/011 EU/1/11/667/011 IC0127-175-003 Esbriet 801 mg film-coated tablets H.A.C Pharma HM Unknown AU Film-coated tablet L04AX L04AX05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Pirfenidone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/11/667/018-019 EU/1/11/667/018-019 Esbriet 801 mg film-coated tablets Roche Registration Limited 24/04/2017 HM Unknown AU Film-coated tablet L04AX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Pirfenidone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA1347/123/001 PA1347/123/001 IC0004-003-016 ESCADRA 20 mg hard gastro-resistant capsules KRKA, d.d., Novo mesto 12/02/2010 HM Not marketed AU Gastro-resistant capsule, hard A02BC A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Esomeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/123/002 PA1347/123/002 IC0004-004-016 ESCADRA 40 mg hard gastro-resistant capsules KRKA, d.d., Novo mesto 12/02/2010 HM Not marketed AU Gastro-resistant capsule, hard A02BC A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Esomeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/194/002 PA0711/194/002 IC0071-002-003 Esciprex 10 mg film-coated tablets Rowex Limited, 12/08/2011 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/194/003 PA0711/194/003 IC0071-032-003 Esciprex 15 mg film-coated tablets Rowex Limited, 12/08/2011 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/194/004 PA0711/194/004 IC0071-003-003 Esciprex 20 mg film-coated tablets Rowex Limited, 12/08/2011 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/194/001 PA0711/194/001 IC0071-001-003 Esciprex 5 mg film-coated tablets Rowex Limited, 12/08/2011 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/008/002 PA22749/008/002 IC0071-002-003 Escitalopram 10 mg film-coated tablets Brillpharma (Ireland) Limited 05/12/2014 HM Not marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/086/002 PA2315/086/002 IC0071-002-003 Escitalopram 10 mg film-coated tablets Accord Healthcare Ireland Ltd. 13/01/2012 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/008/003 PA22749/008/003 IC0071-032-003 Escitalopram 15 mg film-coated tablets Brillpharma (Ireland) Limited 05/12/2014 HM Not marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/008/004 PA22749/008/004 IC0071-003-003 Escitalopram 20 mg film-coated tablets Brillpharma (Ireland) Limited 05/12/2014 HM Not marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/086/003 PA2315/086/003 IC0071-003-003 Escitalopram 20 mg film-coated tablets Accord Healthcare Ireland Ltd. 13/01/2012 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0688/041/001 PA0688/041/001 Escitalopram 20mg/ml Oral drops, solution Chanelle Medical Unlimited Company 23/03/2012 HM Not marketed AU Oral drops, solution N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/008/001 PA22749/008/001 IC0071-001-003 Escitalopram 5 mg film-coated tablets Brillpharma (Ireland) Limited 05/12/2014 HM Not marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/086/001 PA2315/086/001 IC0071-001-003 Escitalopram 5 mg film-coated tablets Accord Healthcare Ireland Ltd. 13/01/2012 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1436/023/002 PA1436/023/002 IC0071-002-003 Escitalopram Bluefish 10 mg film-coated tablets Bluefish Pharmaceuticals AB 28/03/2014 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1436/023/003 PA1436/023/003 IC0071-032-003 Escitalopram Bluefish 15 mg film-coated tablets Bluefish Pharmaceuticals AB 28/03/2014 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1436/023/004 PA1436/023/004 IC0071-003-003 Escitalopram Bluefish 20 mg film-coated tablets Bluefish Pharmaceuticals AB 28/03/2014 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1436/023/001 PA1436/023/001 IC0071-001-003 Escitalopram Bluefish 5 mg film-coated tablets Bluefish Pharmaceuticals AB 28/03/2014 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22645/005/002 PA22645/005/002 IC0071-002-003 Escitalopram Glenmark 10 mg film-coated tablets Glenmark Arzneimittel GmbH 24/02/2012 HM Not marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22645/005/003 PA22645/005/003 IC0071-032-003 Escitalopram Glenmark 15 mg film-coated tablets Glenmark Arzneimittel GmbH 24/02/2012 HM Not marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22645/005/004 PA22645/005/004 IC0071-003-003 Escitalopram Glenmark 20 mg film-coated tablets Glenmark Arzneimittel GmbH 24/02/2012 HM Not marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22645/005/001 PA22645/005/001 IC0071-001-003 Escitalopram Glenmark 5 mg film-coated tablets Glenmark Arzneimittel GmbH 24/02/2012 HM Not marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22992/007/002 PA22992/007/002 IC0071-002-003 Escitalopram Grindeks 10 mg film-coated tablets AS Grindeks 27/10/2023 HM Not marketed AU Film-coated tablet N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22992/007/003 PA22992/007/003 IC0071-003-003 Escitalopram Grindeks 20 mg film-coated tablets AS Grindeks 27/10/2023 HM Not marketed AU Film-coated tablet N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22992/007/001 PA22992/007/001 IC0071-001-003 Escitalopram Grindeks 5 mg film-coated tablets AS Grindeks 27/10/2023 HM Not marketed AU Film-coated tablet N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/046/002 PA1347/046/002 IC0071-002-003 Escitalopram Krka 10 mg film-coated tablets KRKA, d.d., Novo mesto 28/02/2014 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/046/003 PA1347/046/003 IC0071-032-003 Escitalopram Krka 15 mg film-coated tablets KRKA, d.d., Novo mesto 28/02/2014 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/046/004 PA1347/046/004 IC0071-003-003 Escitalopram Krka 20 mg film-coated tablets KRKA, d.d., Novo mesto 28/02/2014 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/046/001 PA1347/046/001 IC0071-001-003 Escitalopram Krka 5 mg film-coated tablets KRKA, d.d., Novo mesto 28/02/2014 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/262/002 PA0281/262/002 IC0071-002-003 Escitalopram Pinewood 10 mg film-coated tablets Pinewood Laboratories Ltd 23/06/2023 HM Not marketed AU Film-coated tablet N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/262/003 PA0281/262/003 IC0071-032-003 Escitalopram Pinewood 15 mg film-coated tablets Pinewood Laboratories Ltd 23/06/2023 HM Not marketed AU Film-coated tablet N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/262/004 PA0281/262/004 IC0071-003-003 Escitalopram Pinewood 20 mg film-coated tablets Pinewood Laboratories Ltd 23/06/2023 HM Not marketed AU Film-coated tablet N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/262/001 PA0281/262/001 IC0071-001-003 Escitalopram Pinewood 5 mg film-coated tablets Pinewood Laboratories Ltd 23/06/2023 HM Not marketed AU Film-coated tablet N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram oxalate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/111/002 PA0749/111/002 IC0071-002-003 Escitalopram Teva 10 mg film-coated tablets Teva Pharma B.V. 06/03/2009 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/111/003 PA0749/111/003 IC0071-032-003 Escitalopram Teva 15 mg film-coated tablets Teva Pharma B.V. 06/03/2009 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/111/004 PA0749/111/004 IC0071-003-003 Escitalopram Teva 20 mg film-coated tablets Teva Pharma B.V. 06/03/2009 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/111/001 PA0749/111/001 IC0071-001-003 Escitalopram Teva 5 mg film-coated tablets Teva Pharma B.V. 06/03/2009 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/042/002 PA23266/042/002 IC0071-002-003 Escitalpro 10 mg film-coated tablets Viatris Limited 22/12/2009 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/042/003 PA23266/042/003 IC0071-032-003 Escitalpro 15 mg film-coated tablets Viatris Limited 22/12/2009 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/042/004 PA23266/042/004 IC0071-003-003 Escitalpro 20 mg film-coated tablets Viatris Limited 22/12/2009 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/042/001 PA23266/042/001 IC0071-001-003 Escitalpro 5 mg film-coated tablets Viatris Limited 22/12/2009 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1286/058/001 PA1286/058/001 Esmeron 10 mg/ml solution for injection/infusion Merck Sharp & Dohme Ireland (Human Health) Limited 07/08/1996 HM Not marketed AU Solution for injection/infusion M03AC M03AC09 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Rocuronium bromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/007/001 PA22749/007/001 IC0004-003-016 Esomeprazole 20 mg gastro-resistant tablets Brillpharma (Ireland) Limited 12/12/2014 HM Not marketed AU Gastro-resistant tablet A02BC A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Esomeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22749/023/001 PA22749/023/001 IC0004-003-016 Esomeprazole 20 mg gastro-resistant tablets Brillpharma (Ireland) Limited 29/03/2018 HM Not marketed AU Gastro-resistant tablet A02BC A02BC05 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Esomeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1186/027/001 PA1186/027/001 Esomeprazole 20 mg hard gastro-resistant capsules Chefaro Ireland DAC 29/07/2022 HM Marketed AU Gastro-resistant capsule, hard A02BC05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Esomeprazole Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA22749/007/002 PA22749/007/002 IC0004-004-016 Esomeprazole 40 mg gastro-resistant tablets Brillpharma (Ireland) Limited 12/12/2014 HM Not marketed AU Gastro-resistant tablet A02BC A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Esomeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1989/002/001 PA1989/002/001 Esomeprazole 40 mg powder for solution for injection/infusion Demo S.A. 04/07/2025 HM Not marketed AU Powder for solution for injection/infusion A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Esomeprazole sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/132/005 PA2315/132/005 Esomeprazole 40 mg powder for solution injection/infusion Accord Healthcare Ireland Ltd. 08/08/2016 HM Marketed AU Powder for solution for injection/infusion A02BC A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Esomeprazole magnesium trihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1983/001/001 PA1983/001/001 IC0004-003-016 Esomeprazole Aristo 20 mg gastro-resistant capsules, hard Aristo Pharma GmbH 07/09/2012 HM Marketed AU Gastro-resistant capsule, hard A02BC A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Esomeprazole magnesium dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1983/001/002 PA1983/001/002 IC0004-004-016 Esomeprazole Aristo 40 mg gastro-resistant capsules, hard Aristo Pharma GmbH 07/09/2012 HM Marketed AU Gastro-resistant capsule, hard A02BC A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Esomeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/208/001 PA0126/208/001 IC0004-003-016 Esomeprazole Clonmel 20 mg gastro-resistant capsules, hard Clonmel Healthcare Ltd 12/11/2010 HM Marketed AU Gastro-resistant capsule, hard A02BC A02BC05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Esomeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/404/001 PA0126/404/001 Esomeprazole Clonmel 20 mg gastro-resistant tablets Clonmel Healthcare Ltd 26/09/2025 HM Not marketed AU Gastro-resistant tablet A02BC05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Esomeprazole magnesium trihydrate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0126/208/002 PA0126/208/002 IC0004-004-016 Esomeprazole Clonmel 40 mg gastro-resistant capsules, hard Clonmel Healthcare Ltd 12/11/2010 HM Marketed AU Gastro-resistant capsule, hard A02BC A02BC05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Esomeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1111/002/001 PA1111/002/001 IC0004-003-016 Esomeprazole Jubilant 20 mg gastro-resistant tablets Jubilant Pharmaceuticals nv 19/07/2024 HM Marketed AU Gastro-resistant tablet A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Esomeprazole magnesium (amorphous) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1111/002/002 PA1111/002/002 IC0004-004-016 Esomeprazole Jubilant 40 mg gastro-resistant tablets Jubilant Pharmaceuticals nv 19/07/2024 HM Marketed AU Gastro-resistant tablet A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Esomeprazole magnesium (amorphous) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/017/001 PA1347/017/001 IC0004-003-016 Esomeprazole Krka 20 mg hard gastro-resistant capsules KRKA, d.d., Novo mesto 01/10/2010 HM Marketed AU Gastro-resistant capsule, hard A02BC A02BC05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Esomeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/017/002 PA1347/017/002 IC0004-004-016 Esomeprazole Krka 40 mg hard gastro-resistant capsules KRKA, d.d., Novo mesto 01/10/2010 HM Marketed AU Gastro-resistant capsule, hard A02BC A02BC05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Esomeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/273/001 PA0281/273/001 IC0004-003-016 Esomeprazole Pinewood 20 mg gastro-resistant tablets Pinewood Laboratories Limited 28/02/2025 HM Marketed AU Gastro-resistant tablet A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Esomeprazole magnesium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/276/001 PA0281/276/001 IC0004-003-016 Esomeprazole Pinewood 20 mg hard gastro-resistant capsules Pinewood Laboratories Limited 16/01/2026 HM Not marketed AU Gastro-resistant capsule, hard A02BC05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Esomeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/273/002 PA0281/273/002 IC0004-004-016 Esomeprazole Pinewood 40 mg gastro-resistant tablets Pinewood Laboratories Limited 28/02/2025 HM Marketed AU Gastro-resistant tablet A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Esomeprazole magnesium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/276/002 PA0281/276/002 IC0004-004-016 Esomeprazole Pinewood 40 mg hard gastro-resistant capsules Pinewood Laboratories Limited 16/01/2026 HM Not marketed AU Gastro-resistant capsule, hard A02BC05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Esomeprazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1852/002/001 PA1852/002/001 Esomeprazole Ticerin 40 mg powder for solution for injection or infusion Laboratorios Azevedos Industria Farmaceutica S.A. 11/04/2014 HM Marketed AU Powder for solution for injection/infusion A02BC A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Esomeprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2321/002/001 PA2321/002/001 Esomeprazole Tillomed 40 mg powder for solution for injection/infusion Laboratorios Tillomed Spain, S.L.U. 21/02/2020 HM Marketed AU Powder for solution for injection/infusion A02BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Esomeprazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1374/002 EU/1/19/1374/002 Esperoct 1000 IU Powder and solvent for solution for injection Novo Nordisk A/S 20/06/2019 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use TUROCTOCOG ALFA PEGOL Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1374/003 EU/1/19/1374/003 Esperoct 1500 IU Powder and solvent for solution for injection Novo Nordisk A/S 20/06/2019 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use TUROCTOCOG ALFA PEGOL Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1374/004 EU/1/19/1374/004 Esperoct 2000 IU Powder and solvent for solution for injection Novo Nordisk A/S 20/06/2019 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use TUROCTOCOG ALFA PEGOL Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1374/005 EU/1/19/1374/005 Esperoct 3000 IU Powder and solvent for solution for injection Novo Nordisk A/S 20/06/2019 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use TUROCTOCOG ALFA PEGOL Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1374/006 EU/1/19/1374/006 Esperoct 4000 IU Powder and solvent for solution for injection Novo Nordisk A/S 15/09/2023 HM Unknown AU Powder and solvent for solution for injection B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use TUROCTOCOG ALFA PEGOL Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1374/001 EU/1/19/1374/001 Esperoct 500 IU Powder and solvent for solution for injection Novo Nordisk A/S 20/06/2019 HM Unknown AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use TUROCTOCOG ALFA PEGOL Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1374/007 EU/1/19/1374/007 Esperoct 5000 IU Powder and solvent for solution for injection Novo Nordisk A/S 15/09/2023 HM Unknown AU Powder and solvent for solution for injection B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use TUROCTOCOG ALFA PEGOL Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA25244/001/002 PA25244/001/002 Espestesin 40 mg/ml + 5 microgram/ml solution for injection Pierrel S.p.A. 21/02/2003 HM Not marketed AU Solution for injection N01BB N01BB58 Well-established use application (Article 10a of Directive No 2001/83/EC) Dental use Articaine hydrochloride Epinephrine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA25244/001/001 PA25244/001/001 Espestesin Forte 40 mg/ml + 10 microgram/ml solution for injection Pierrel S.p.A. 21/02/2003 HM Not marketed AU Solution for injection N01BB N01BB58 Well-established use application (Article 10a of Directive No 2001/83/EC) Dental use Articaine hydrochloride Epinephrine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0549/024/001 PA0549/024/001 Espranor 2 mg Oral Lyophilisate Ethypharm 14/07/2017 HM Not marketed AU Oral lyophilisate N07BC N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oromucosal use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0549/024/002 PA0549/024/002 Espranor 8 mg Oral Lyophilisate Ethypharm 14/07/2017 HM Not marketed AU Oral lyophilisate N07BC N07BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oromucosal use Buprenorphine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA2050/006/001 PA2050/006/001 Estradiol SUN 10 micrograms vaginal tablets Sun Pharmaceutical Industries Europe B.V. 13/08/2021 HM Marketed AU Vaginal tablet G03CA03 Well-established use application (Article 10a of Directive No 2001/83/EC) Vaginal use Estradiol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23311/004/004 PA23311/004/004 Estradot 100 micrograms/24 hours, transdermal patch Sandoz Pharmaceuticals d.d. 08/02/2002 HM Marketed AU Transdermal patch G03CA G03CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Estradiol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23311/004/005 PA23311/004/005 Estradot 25 micrograms/24 hours, transdermal patch Sandoz Pharmaceuticals d.d. 24/05/2005 HM Not marketed AU Transdermal patch G03CA G03CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Estradiol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23311/004/001 PA23311/004/001 Estradot 37.5 micrograms/24 hours, transdermal patch Sandoz Pharmaceuticals d.d. 08/02/2002 HM Marketed AU Transdermal patch G03CA G03CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Estradiol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23311/004/002 PA23311/004/002 Estradot 50 micrograms/24 hours, transdermal patch Sandoz Pharmaceuticals d.d. 08/02/2002 HM Marketed AU Transdermal patch G03CA G03CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Estradiol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23311/004/003 PA23311/004/003 Estradot 75 micrograms/24 hours, transdermal patch Sandoz Pharmaceuticals d.d. 08/02/2002 HM Marketed AU Transdermal patch G03CA G03CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Estradiol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0218/050/001 PA0218/050/001 Estrofem 2 mg film-coated tablets Novo Nordisk A/S 01/05/1996 HM Marketed AU Film-coated tablet G03CA G03CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Estradiol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/212/002 PA0126/212/002 IC0071-002-003 Etalopro 10 mg film-coated tablets Clonmel Healthcare Ltd 04/12/2009 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/212/003 PA0126/212/003 IC0071-032-003 Etalopro 15 mg film-coated tablets Clonmel Healthcare Ltd 04/12/2009 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/212/004 PA0126/212/004 IC0071-003-003 Etalopro 20 mg film-coated tablets Clonmel Healthcare Ltd 04/12/2009 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/212/001 PA0126/212/001 IC0071-001-003 Etalopro 5 mg film-coated tablets Clonmel Healthcare Ltd 04/12/2009 HM Marketed AU Film-coated tablet N06AB N06AB10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Escitalopram Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23142/004/001 PA23142/004/001 Ethambutol Hydrochloride 100mg film-coated tablets Aspire Pharma (Malta) Limited 01/10/2010 HM Not marketed AU Film-coated tablet J04AK J04AK02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ethambutol hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23142/004/002 PA23142/004/002 Ethambutol Hydrochloride 400mg film-coated tablets Aspire Pharma (Malta) Limited 01/10/2010 HM Not marketed AU Film-coated tablet J04AK J04AK02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ethambutol hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1474/008/001 PA1474/008/001 Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.02 mg/ 3 mg Film-coated Tablets Laboratorios Leon Farma, S.A. 09/10/2009 HM Not marketed AU Film-coated tablet G03AA G03AA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Drospirenone Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1474/008/002 PA1474/008/002 Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.03 mg/ 3 mg Film-coated Tablets Laboratorios Leon Farma, S.A. 09/10/2009 HM Not marketed AU Film-coated tablet G03AA G03AA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Drospirenone Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1474/004/001 PA1474/004/001 IC0191-216-003 Ethinylestradiol/Drospirenone Leon Farma 0.02mg/3 mg Film-coated Tablets Laboratorios Leon Farma, S.A. 09/10/2009 HM Not marketed AU Film-coated tablet G03AA G03AA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Drospirenone Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1474/004/002 PA1474/004/002 IC0191-215-003 Ethinylestradiol/Drospirenone Leon Farma 0.03mg/3 mg Film-coated Tablets Laboratorios Leon Farma, S.A. 09/10/2009 HM Not marketed AU Film-coated tablet G03AA G03AA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Drospirenone Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA25429/002/001 PA25429/002/001 Ethylex 50 mg film-coated tablets Walter Ritter GmbH & Co. KG 20/04/2004 HM Marketed AU Film-coated tablet N07BB N07BB04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Naltrexone hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA1113/034/001 PA1113/034/001 Etoflam 10% w/w gel Phoenix Labs 02/05/2025 HM Not marketed AU Gel M02AA06 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Etofenamate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1113/002/001 PA1113/002/001 Etoflam 5% w/w Gel Phoenix Labs 04/04/1990 HM Marketed AU Gel M02AA M02AA06 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Etofenamate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2059/036/001 PA2059/036/001 Etoposide 20 mg/ml concentrate for solution for infusion Fresenius Kabi Deutschland GmbH 16/05/2014 HM Marketed AU Concentrate for solution for infusion L01CB L01CB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Etoposide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/201/001 PA2315/201/001 Etoposide 20 mg/ml Concentrate for Solution for Infusion Accord Healthcare Ireland Ltd. 25/07/2014 HM Marketed AU Concentrate for solution for infusion L01CB L01CB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Etoposide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/002/001 PA0749/002/001 Etoposide-Teva 20 mg/ml Concentrate for Solution for Infusion Teva Pharma B.V. 27/07/1998 HM Marketed AU Concentrate for solution for infusion L01CB L01CB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Etoposide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/054/004 PA23266/054/004 IC0108-167-003 Etoricoxib 120 mg film-coated tablets Viatris Limited 11/09/2015 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/232/004 PA0711/232/004 IC0108-167-003 Etoricoxib 120 mg film-coated tablets Rowex Ltd 26/06/2015 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22749/018/004 PA22749/018/004 IC0108-167-003 Etoricoxib 120 mg film-coated tablets Brillpharma (Ireland) Limited 16/06/2017 HM Not marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/018/004 PA2315/018/004 IC0108-167-003 Etoricoxib 120 mg film-coated tablets Accord Healthcare Ireland Ltd. 01/02/2019 HM Not marketed AU Film-coated tablet M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/054/001 PA23266/054/001 IC0108-033-003 Etoricoxib 30 mg film-coated tablets Viatris Limited 11/09/2015 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/232/001 PA0711/232/001 IC0108-033-003 Etoricoxib 30 mg film-coated tablets Rowex Limited, 26/06/2015 HM Not marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22749/018/001 PA22749/018/001 IC0108-033-003 Etoricoxib 30 mg film-coated tablets Brillpharma (Ireland) Limited 16/06/2017 HM Not marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/018/001 PA2315/018/001 IC0108-033-003 Etoricoxib 30 mg film-coated tablets Accord Healthcare Ireland Ltd. 01/02/2019 HM Not marketed AU Film-coated tablet M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/054/002 PA23266/054/002 IC0108-127-003 Etoricoxib 60 mg film-coated tablets Viatris Limited 11/09/2015 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/232/002 PA0711/232/002 IC0108-127-003 Etoricoxib 60 mg film-coated tablets Rowex Limited, 26/06/2015 HM Not marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22749/018/002 PA22749/018/002 IC0108-127-003 Etoricoxib 60 mg film-coated tablets Brillpharma (Ireland) Limited 16/06/2017 HM Not marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/018/002 PA2315/018/002 IC0108-127-003 Etoricoxib 60 mg film-coated tablets Accord Healthcare Ireland Ltd. 01/02/2019 HM Not marketed AU Film-coated tablet M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/054/003 PA23266/054/003 IC0108-166-003 Etoricoxib 90 mg film-coated tablets Viatris Limited 11/09/2015 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/232/003 PA0711/232/003 IC0108-166-003 Etoricoxib 90 mg film-coated tablets Rowex Ltd 26/06/2015 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22749/018/003 PA22749/018/003 IC0108-166-003 Etoricoxib 90 mg film-coated tablets Brillpharma (Ireland) Limited 16/06/2017 HM Not marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/018/003 PA2315/018/003 IC0108-166-003 Etoricoxib 90 mg film-coated tablets Accord Healthcare Ireland Ltd. 01/02/2019 HM Not marketed AU Film-coated tablet M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/064/004 PA1347/064/004 IC0108-167-003 Etoricoxib Krka 120 mg film-coated tablets KRKA, d.d., Novo mesto 25/11/2016 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/064/001 PA1347/064/001 IC0108-033-003 Etoricoxib Krka 30 mg film-coated tablets KRKA, d.d., Novo mesto 25/11/2016 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/064/002 PA1347/064/002 IC0108-127-003 Etoricoxib Krka 60 mg film-coated tablets KRKA, d.d., Novo mesto 25/11/2016 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/064/003 PA1347/064/003 IC0108-166-003 Etoricoxib Krka 90 mg film-coated tablets KRKA, d.d., Novo mesto 25/11/2016 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/002/004 PA1986/002/004 IC0108-167-003 Etoricoxib Teva 120 mg film-coated tablets Teva B.V. 19/02/2016 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/002/001 PA1986/002/001 IC0108-033-003 Etoricoxib Teva 30 mg film-coated tablets Teva B.V. 19/02/2016 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/002/002 PA1986/002/002 IC0108-127-003 Etoricoxib Teva 60 mg film-coated tablets Teva B.V. 19/02/2016 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/002/003 PA1986/002/003 IC0108-166-003 Etoricoxib Teva 90 mg film-coated tablets Teva B.V. 19/02/2016 HM Marketed AU Film-coated tablet M01AH M01AH05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Etoricoxib Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22743/008/001 PA22743/008/001 Etrivex 500 micrograms/g shampoo Galderma International 20/04/2007 HM Not marketed AU Shampoo D07AD D07AD01 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Clobetasol propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/001/002 PA2239/001/002 Eucardic 12.5 mg Tablets CHEPLAPHARM Arzneimittel GmbH 19/01/1995 HM Marketed AU Tablet C07AG C07AG02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Carvedilol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/001/003 PA2239/001/003 Eucardic 25 mg Tablets CHEPLAPHARM Arzneimittel GmbH 19/01/1995 HM Marketed AU Tablet C07AG C07AG02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carvedilol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/001/001 PA2239/001/001 Eucardic 6.25 mg Tablets CHEPLAPHARM Arzneimittel GmbH 03/04/1998 HM Marketed AU Tablet C07AG C07AG02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carvedilol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/425/16-18 EU/1/07/425/16-18 Eucreas Novartis Europharm Limited 14/11/2007 HM Unknown AU Film-coated tablet Full application (Article 8(3) of Directive No 2001/83/EC) Vildagliptin Metformin hci Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/425/7-12 EU/1/07/425/7-12 Eucreas 50 mg/1000 mg film-coated tablets Novartis Europharm Limited 14/11/2007 HM Unknown AU Film-coated tablet A10BD08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Metformin hci Vildagliptin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/425/13-15 EU/1/07/425/13-15 Eucreas 50 mg/850 mg film-coated tablets Novartis Europharm Limited 14/11/2007 HM Unknown AU Film-coated tablet A10BD08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Vildagliptin Metformin hci Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/425/1-6 EU/1/07/425/1-6 Eucreas 50 mg/850 mg film-coated tablets Novartis Europharm Limited HM Unknown AU Film-coated tablet A10BD08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Metformin hci Vildagliptin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/006/001 PA1077/006/001 Eumovate Cream 0.05% w/w GlaxoSmithKline (Ireland) Limited 03/06/1976 HM Marketed AU Cream D07AB D07AB01 Full application (Article 8(3) of Directive No 2001/83/EC) Topical CLOBETASONE BUTYRATE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only HOR1149/011/001 HOR1149/011/001 Euphrasia A. Nelson & Company Limited 29/10/2010 HM Not marketed AU Pillules Not Currently Available Oral use Euphrasia officinalis Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public EU/1/11/716/005 EU/1/11/716/005 Eurartesim 160 mg/20 mg film-coated tablets Sigma-Tau Industrie Farmaceutiche Riunite SpA 27/10/2011 HM Unknown AU Film-coated tablet P01BA P01BE P01BE05 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Dihydroartemisinin Piperaquine phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/716/001-004 EU/1/11/716/001-004 Eurartesim 320 mg/40 mg film-coated tablets Alfasigma S.p.A HM Unknown AU Film-coated tablet P01BF P01BF05 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Piperaquine phosphate Dihydroartemisinin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/325/001 PA0126/325/001 Eurax 10% w/w Cream Clonmel Healthcare Ltd 01/04/1978 HM Marketed AU Cream D04AX Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Crotamiton Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/24/1846/003-004 EU/1/24/1846/003-004 EURneffy 1 mg nasal spray, solution in single-dose container ALK-Abello A/S 27/03/2026 HM Unknown AU Nasal spray, solution in single-dose container C01CA24 Known active substance (Article 8(3) of Directive No 2001/83/EC) Nasal use Epinephrine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1846/001-002 EU/1/24/1846/001-002 EURneffy 2 mg Nasal spray solution ALK-Abello A/S 22/08/2024 HM Unknown AU Nasal spray, solution in single-dose container C01CA24 Full application (Article 8(3) of Directive No 2001/83/EC) Nasal use Adrenaline Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1411/001-002 EU/1/19/1411/001-002 EVENITY 105 mg solution for injection in pre-filled pen UCB Pharma S.A. 09/12/2019 HM Unknown AU Solution for injection in pre-filled pen M05BX M05BX06 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use ROMOSOZUMAB Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1411/003-004 EU/1/19/1411/003-004 EVENITY 105 mg solution for injection in pre-filled syringe UCB Pharma S.A. 09/12/2019 HM Unknown AU Solution for injection in pre-filled syringe M05BX M05BX06 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use ROMOSOZUMAB Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0876/009/003 PA0876/009/003 Everolimus TAD 10 mg tablets TAD Pharma GmbH 01/11/2019 HM Not marketed AU Tablet L01XE L01XE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Everolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0876/009/001 PA0876/009/001 Everolimus TAD 2.5 mg tablets TAD Pharma GmbH 01/11/2019 HM Not marketed AU Tablet L01XE L01XE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Everolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0876/009/002 PA0876/009/002 Everolimus TAD 5 mg tablets TAD Pharma GmbH 01/11/2019 HM Not marketed AU Tablet L01XE L01XE10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Everolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/25/1946/001 EU/1/25/1946/001 Evfraxy 60 mg solution for injection in pre-filled syringe Biosimilar Collaborations Ireland Limited 30/06/2025 HM Unknown AU Solution for injection in pre-filled syringe M05BX04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Denosumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. EU/1/11/737/001-002 EU/1/11/737/001-002 Eviplera 200 mg/25 mg/245 mg film-coated tablets Gilead Sciences Ireland UC 28/11/2011 HM Unknown AU Film-coated tablet J05AR J05AR08 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Rilpivirine hydrochloride Tenofovir disoproxil fumarate (tdf) Emtricitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/98/073/001 EU/1/98/073/001 Evista 60 mg film coated tablets Substipharm 05/08/1998 HM Unknown AU Film-coated tablet G03X Full application (Article 8(3) of Directive No 2001/83/EC) Raloxifene Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/073/002 EU/1/98/073/002 Evista 60 mg film coated tablets Substipharm 05/08/1998 HM Unknown AU Film-coated tablet G03X Full application (Article 8(3) of Directive No 2001/83/EC) Raloxifene Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/073/003 EU/1/98/073/003 Evista 60 mg film coated tablets Substipharm 05/08/1998 HM Unknown AU Film-coated tablet G03X Full application (Article 8(3) of Directive No 2001/83/EC) Raloxifene Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/073/004 EU/1/98/073/004 Evista 60 mg film coated tablets Substipharm 05/08/1998 HM Unknown AU Film-coated tablet G03X Full application (Article 8(3) of Directive No 2001/83/EC) Raloxifene Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1551/001-002 EU/1/21/1551/001-002 Evkeeza 150 mg/ml concentrate for solution for infusion Ultragenyx Germany GmbH 17/06/2021 HM Unknown AU Concentrate for solution for infusion C10AX Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Evinacumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/06/334/01-05 EU/1/06/334/01-05 Evoltra 1 mg/ml concentrate for solution for infusion Sanofi B.V. 07/11/2006 HM Unknown AU Concentrate for solution for infusion L01BB L01BB06 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Clofarabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22668/008/001 PA22668/008/001 Evorel 50 micrograms per 24 hours Transdermal Patch Theramex Ireland Limited HM Marketed AU Transdermal patch G03CA G03CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Estradiol hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/489/001 PPA0465/489/001 Evorel Conti 50/170 micrograms per 24 hours transdermal patch PCO Manufacturing Ltd. 21/01/2022 HM Unknown AU Transdermal patch G03FA01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Transdermal use Estradiol Norethisterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22668/009/001 PA22668/009/001 Evorel Conti 50/170 micrograms per 24 hours Transdermal Patch Theramex Ireland Limited HM Marketed AU Transdermal patch G03CA G03CA53 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Estradiol hemihydrate Norethisterone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1025/001-002 EU/1/15/1025/001-002 EVOTAZ 300 mg/150 mg film-coated tablets Bristol-Myers Squibb Pharma EEIG 13/07/2015 HM Unknown AU Film-coated tablet J05AR J05AR15 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Atazanavir Cobicistat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/02/223/002 EU/1/02/223/002 Evra Gedeon Richter Plc 22/08/2002 HM Unknown AU Transdermal patch Full application (Article 8(3) of Directive No 2001/83/EC) Norelgestromin Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/223/003 EU/1/02/223/003 Evra Gedeon Richter Plc 22/08/2002 HM Unknown AU Transdermal patch Full application (Article 8(3) of Directive No 2001/83/EC) Norelgestromin Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/02/223/001 EU/1/02/223/001 Evra 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch Gedeon Richter Plc 22/08/2002 HM Unknown AU Transdermal patch G03AA Full application (Article 8(3) of Directive No 2001/83/EC) Norelgestromin Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1574/004 EU/1/21/1574/004 Evrenzo 100 mg Film-coated tablet Astellas Pharma Europe B.V. 18/08/2021 HM Unknown AU Film-coated tablet B03XA B03XA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Roxadustat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1574/005 EU/1/21/1574/005 Evrenzo 150 mg Film-coated tablet Astellas Pharma Europe B.V. 18/08/2021 HM Unknown AU Film-coated tablet B03XA B03XA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Roxadustat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1574/001 EU/1/21/1574/001 Evrenzo 20 mg Film-coated tablet Astellas Pharma Europe B.V. 18/08/2021 HM Unknown AU Film-coated tablet B03XA B03XA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Roxadustat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1574/002 EU/1/21/1574/002 Evrenzo 50 mg Film-coated tablet Astellas Pharma Europe B.V. 18/08/2021 HM Unknown AU Film-coated tablet B03XA B03XA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Roxadustat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1574/003 EU/1/21/1574/003 Evrenzo 70 mg Film-coated tablet Astellas Pharma Europe B.V. 18/08/2021 HM Unknown AU Film-coated tablet B03XA B03XA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Roxadustat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1531/001 EU/1/21/1531/001 Evrysdi 0.75 mg/mL powder for oral solution Roche Registration GmbH 26/03/2021 HM Unknown AU Powder for oral solution M09AX M09AX10 Full application (Article 8(3) of Directive No 2001/83/EC) Gastroenteral use Oral use Risdiplam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1531/002 EU/1/21/1531/002 Evrysdi 5 mg film-coated tablets Roche Registration GmbH 02/06/2025 HM Unknown AU Film-coated tablet M09AX10 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Risdiplam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/22/1651/001 EU/1/22/1651/001 EVUSHELD 150 mg + 150 mg solution for injection AstraZeneca AB 25/03/2022 HM Unknown AU Solution for injection J06B J06BD03 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Tixagevimab Cilgavimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1794/001 EU/1/24/1794/001 EXBLIFEP 2 g/0.5 g powder for concentrate for solution for infusion Advanz Pharma Limited 21/03/2024 HM Unknown AU Powder for concentrate for solution for infusion J01DE51 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Cefepime dihydrochloride monohydrate Enmetazobactam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0678/122/001 PA0678/122/001 Excedrin 250 mg/ 250 mg/ 65 mg film coated tablets Haleon Ireland Limited 04/06/2010 HM Marketed AU Film-coated tablet N02BE N02BE51 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Acetylsalicylic acid Paracetamol Caffeine Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Retail sale through pharmacies only in packs containing not more than 24 unit dosage forms. Not more than two such packs should be supplied in the course of any one retail transaction unless a valid prescription exists. Packs containing more than 24 unit EU/1/25/2007/001 EU/1/25/2007/001 EXDENSUR 100 mg solution for injection in pre-filled pen GlaxoSmithKline Trading Services Limited 12/02/2026 HM Unknown AU Solution for injection in pre-filled pen R03DX12 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Depemokimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/2007/002 EU/1/25/2007/002 EXDENSUR 100 mg solution for injection in pre-filled syringe GlaxoSmithKline Trading Services Limited 12/02/2026 HM Unknown AU Solution for injection in pre-filled syringe R03DX12 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Depemokimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/98/066/001-003 EU/1/98/066/001-003 IC0159-193-047 Exelon 1.5 mg hard capsules Novartis Europharm Limited HM Unknown AU Capsule, hard N06DA N06DA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rivastigmine hydrogen tartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/066/027-030 EU/1/98/066/027-030 IC0159-198-068 Exelon 13.3 mg/24 h transdermal patch Novartis Europharm Limited HM Unknown AU Transdermal patch N06DA N06DA03 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Rivastigmine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/066/013 EU/1/98/066/013 IC0159-195-019 Exelon 2 mg/ml oral solution Novartis Europharm Limited HM Unknown AU Oral solution N06DA N06DA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rivastigmine hydrogen tartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/066/004-006 EU/1/98/066/004-006 IC0159-045-047 Exelon 3.0 mg hard capsules Novartis Europharm Limited HM Unknown AU Capsule, hard N06DA N06DA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rivastigmine hydrogen tartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/066/007-009 EU/1/98/066/007-009 IC0159-194-047 Exelon 4.5 mg hard capsules Novartis Europharm Limited HM Unknown AU Capsule, hard N06DA N06DA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rivastigmine hydrogen tartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/066/19-22 EU/1/98/066/19-22 IC0159-196-068 Exelon 4.6 mg/24 h transdermal patch Novartis Europharm Limited HM Unknown AU Transdermal patch N06DA N06DA03 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Rivastigmine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/98/066/010-012 EU/1/98/066/010-012 IC0159-046-047 Exelon 6.0 mg hard capsules Novartis Europharm Limited HM Unknown AU Capsule, hard N06DA N06DA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rivastigmine hydrogen tartrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/98/066/23-26 EU/1/98/066/23-26 IC0159-197-068 Exelon 9.5 mg/24 h transdermal patch Novartis Europharm Limited HM Unknown AU Transdermal patch N06DA N06DA03 Full application (Article 8(3) of Directive No 2001/83/EC) Transdermal use Rivastigmine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/087/001 PA2315/087/001 IC0142-022-040 Exemestane 25 mg film-coated tablets Accord Healthcare Ireland Ltd. 25/06/2010 HM Marketed AU Film-coated tablet L02BG L02BG06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Exemestane Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/115/001 PA1986/115/001 IC0142-022-040 Exemestane Teva 25 mg film-coated tablets Teva B.V. 08/10/2010 HM Marketed AU Film-coated tablet L02BG L02BG06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Exemestane Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/370/017-024 EU/1/06/370/017-024 IC0042-084-003 Exforge 10 mg/160 mg film-coated tablets Novartis Europharm Limited 17/01/2007 HM Unknown AU Film-coated tablet C09DB C09DB01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Valsartan Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/370/009-016 EU/1/06/370/009-016 IC0042-086-003 Exforge 5 mg/160 mg film-coated tablets Novartis Europharm Limited 17/01/2007 HM Unknown AU Film-coated tablet C09DB C09DB01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/370/001-008 EU/1/06/370/001-008 IC0042-087-003 Exforge 5 mg/80 mg film-coated tablets Novartis Europharm Limited 17/01/2007 HM Unknown AU Film-coated tablet C09DB C09DB01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Amlodipine besilate Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/569/13-24 EU/1/09/569/13-24 Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets Novartis Europharm Limited 16/10/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Hydrochlorothiazide Valsartan Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/569/37-48 EU/1/09/569/37-48 Exforge HCT 10 mg/160 mg/25 mg film-coated tablets Novartis Europharm Limited 16/10/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Hydrochlorothiazide Valsartan Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/569/49-60 EU/1/09/569/49-60 Exforge HCT 10 mg/320 mg/25 mg film-coated tablets Novartis Europharm Limited 16/10/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Valsartan Hydrochlorothiazide Amlodipine besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/569/1-12 EU/1/09/569/1-12 Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets Novartis Europharm Limited 16/10/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Amlodipine besilate Hydrochlorothiazide Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/569/25-36 EU/1/09/569/25-36 Exforge HCT 5 mg/160 mg/25 mg film-coated tablets Novartis Europharm Limited 16/10/2009 HM Unknown AU Film-coated tablet C09DX C09DX01 Fixed combination application (Article 10b of Directive No 2001/83/EC) Oral use Amlodipine besilate Hydrochlorothiazide Valsartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/06/356/014-016 EU/1/06/356/014-016 IC0133-135-003 Exjade 180 mg film-coated tablets Novartis Europharm Limited HM Unknown AU Film-coated tablet V03AC V03AC03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Deferasirox Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/06/356/021 EU/1/06/356/021 Exjade 180 mg granules in sachet Novartis Europharm Limited 10/11/2017 HM Unknown AU Granules V03AC V03AC03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Deferasirox Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/06/356/017-019 EU/1/06/356/017-019 IC0133-180-003 Exjade 360 mg film-coated tablets Novartis Europharm Limited HM Unknown AU Film-coated tablet V03AC V03AC03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Deferasirox Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/06/356/022 EU/1/06/356/022 Exjade 360 mg granules in sachet Novartis Europharm Limited 10/11/2017 HM Unknown AU Granules V03AC V03AC03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Deferasirox Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/06/356/011-013 EU/1/06/356/011-013 IC0133-166-003 Exjade 90 mg film-coated tablets Novartis Europharm Limited HM Unknown AU Film-coated tablet V03AC V03AC03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Deferasirox Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/06/356/020 EU/1/06/356/020 Exjade 90 mg granules in sachet Novartis Europharm Limited 10/11/2017 HM Unknown AU Granules V03AC V03AC03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Deferasirox Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/06/356/001-009 EU/1/06/356/001-009 Exjade Dispersible Novartis Europharm Limited 28/08/2006 HM Unknown AU Dispersible tablet V03AC V03AC03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Deferasirox Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA1824/014/001 PA1824/014/001 EXOCIN (Ofloxacin) 0.3% w/v Eye Drops Solution AbbVie Limited 10/06/1991 HM Marketed AU Eye drops, solution S01AE S01AE01 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Ofloxacin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/078/001 PA1986/078/001 Exorex Lotion 5% v/w Cutaneous Emulsion Teva B.V. 16/10/2003 HM Not marketed AU Cutaneous emulsion D05AA Well-established use application (Article 10a of Directive No 2001/83/EC) Topical Coal tar solution Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/20/1489/001-004 EU/1/20/1489/001-004 EXPAREL liposomal Pacira Ireland Limited 16/11/2020 HM Unknown AU Prolonged-release dispersion for injection N01BB01 Full application (Article 8(3) of Directive No 2001/83/EC) Infiltration Perineural use Bupivacaine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23183/003/001 PA23183/003/001 Expudyne 250 mg/5 ml oral solution Jed Pharma Limited 10/03/2023 HM Marketed AU Oral solution R05CB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Carbocisteine Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA23183/005/001 PA23183/005/001 Expudyne Rx 750 mg/5 ml oral solution Jed Pharma Limited 31/03/2023 HM Not marketed AU Oral solution R05CB03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Carbocisteine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1113/010/001 PA1113/010/001 Exputex 250mg/5ml Oral Solution Phoenix Labs Unlimited Company 20/12/1985 HM Marketed AU Oral solution R05CB R05CB03 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Carbocisteine Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23128/006/001 PA23128/006/001 Exterol 5% w/w Ear Drops, Solution Dermal Laboratories (Ireland) Limited 26/02/1982 HM Marketed AU Ear drops, solution S02AA06 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Auricular use Urea hydrogen peroxide Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA25288/003/001 PA25288/003/001 EXTRANEAL Solution for peritoneal dialysis Vantive Belgium SRL 25/07/1997 HM Marketed AU Solution for peritoneal dialysis B05DA Not Currently Available Intraperitoneal use Icodextrin Sodium chloride Sodium (S) - lactate Calcium chloride Magnesium chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1895/002 EU/1/24/1895/002 Eydenzelt 40 mg/mL solution for injection in a vial Celltrion Healthcare Hungary Kft. 12/02/2025 HM Unknown AU Solution for injection in vial S01LA05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravitreal use Afibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1895/001 EU/1/24/1895/001 Eydenzelt 40 mg/mL solution for injection in pre-filled syringe Celltrion Healthcare Hungary Kft. 12/02/2025 HM Unknown AU Solution for injection in pre-filled syringe S01LA05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravitreal use Afibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/797/003 EU/1/12/797/003 Eylea 114.3 mg/ml solution for injection Bayer AG 05/01/2024 HM Unknown AU Solution for injection S01LA05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravitreal use Aflibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/797/004 EU/1/12/797/004 Eylea 114.3 mg/ml solution for injection in pre-filled syringe Bayer AG 22/11/2012 HM Unknown AU Solution for injection in pre-filled syringe S01LA05 Full application (Article 8(3) of Directive No 2001/83/EC) Aflibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/797/001-002 EU/1/12/797/001-002 Eylea 40 mg/mL solution for injection Bayer AG HM Unknown AU Solution for injection S01LA S01LA05 Full application (Article 8(3) of Directive No 2001/83/EC) Aflibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1972/001 EU/1/25/1972/001 Eyluxvi 40mg/ml Solution for injection in vial Biolitec Pharma Limited 15/09/2025 HM Unknown AU Solution for injection in vial S01LA05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravitreal use Aflibercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23142/014/001 PA23142/014/001 Eyreida 0.3 mg/ml eye drops, solution Aspire Pharma (Malta) Limited 08/11/2019 HM Not marketed AU Eye drops, solution S01EE03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Ocular use Bimatoprost Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23142/013/001 PA23142/013/001 Eyzeetan 0.3 mg/ml + 5 mg/ml eye drops, solution Aspire Pharma (Malta) Limited 01/11/2019 HM Not marketed AU Eye drops, solution S01ED51 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Ocular use Bimatoprost Timolol Maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22683/004/001 PA22683/004/001 IC0118-017-003 Ezetimibe/Atorvastatin 10 mg/10 mg film-coated tablets Althera Laboratories Limited 17/04/2025 HM Marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22683/004/002 PA22683/004/002 IC0118-051-003 Ezetimibe/Atorvastatin 10 mg/20 mg film-coated tablets Althera Laboratories Limited 17/04/2025 HM Marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22683/004/003 PA22683/004/003 IC0118-059-003 Ezetimibe/Atorvastatin 10 mg/40 mg film-coated tablets Althera Laboratories Limited 17/04/2025 HM Marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22683/004/004 PA22683/004/004 IC0118-060-003 Ezetimibe/Atorvastatin 10 mg/80 mg film-coated tablets Althera Laboratories Limited 17/04/2025 HM Not marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22683/002/001 PA22683/002/001 Ezetimibe/Atorvastatin Althera 10 mg/10 mg film-coated tablets Althera Laboratories Limited 27/02/2026 HM Not marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22683/002/002 PA22683/002/002 Ezetimibe/Atorvastatin Althera 10 mg/20 mg film-coated tablets Althera Laboratories Limited 27/02/2026 HM Not marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22683/002/003 PA22683/002/003 Ezetimibe/Atorvastatin Althera 10 mg/40 mg film-coated tablets Althera Laboratories Limited 27/02/2026 HM Not marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22683/002/004 PA22683/002/004 Ezetimibe/Atorvastatin Althera 10 mg/80 mg film-coated tablets Althera Laboratories Limited 27/02/2026 HM Not marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2244/003/001 PA2244/003/001 Ezetimibe/Atorvastatin DOC Generici 10 mg/ 10 mg film-coated tablet DOC Generici S.r.l. 05/06/2026 HM Not marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2244/003/002 PA2244/003/002 Ezetimibe/Atorvastatin DOC Generici 10 mg/ 20 mg film-coated tablet DOC Generici S.r.l. 05/06/2026 HM Not marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2244/003/003 PA2244/003/003 Ezetimibe/Atorvastatin DOC Generici 10 mg/ 40 mg film-coated tablet DOC Generici S.r.l. 05/06/2026 HM Not marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2244/003/004 PA2244/003/004 Ezetimibe/Atorvastatin DOC Generici 10 mg/ 80 mg film-coated tablets DOC Generici S.r.l. 05/06/2026 HM Not marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/116/001 PA1347/116/001 IC0118-017-003 Ezetimibe/Atorvastatin Krka 10 mg/10 mg film-coated tablets KRKA, d.d., Novo mesto 29/11/2024 HM Marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/116/002 PA1347/116/002 IC0118-051-003 Ezetimibe/Atorvastatin Krka 10 mg/20 mg film-coated tablets KRKA, d.d., Novo mesto 29/11/2024 HM Marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/116/003 PA1347/116/003 IC0118-059-003 Ezetimibe/Atorvastatin Krka 10 mg/40 mg film-coated tablets KRKA, d.d., Novo mesto 29/11/2024 HM Marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/116/004 PA1347/116/004 IC0118-060-003 Ezetimibe/Atorvastatin Krka 10 mg/80 mg film-coated tablets KRKA, d.d., Novo mesto 29/11/2024 HM Marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/009/001 PA1701/009/001 IC0118-017-003 Ezetimibe/Atorvastatin Zentiva 10 mg/10 mg film-coated tablets Zentiva k.s. 23/02/2024 HM Marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/009/002 PA1701/009/002 IC0118-051-003 Ezetimibe/Atorvastatin Zentiva 10 mg/20 mg film-coated tablets Zentiva k.s. 23/02/2024 HM Marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/009/003 PA1701/009/003 IC0118-059-003 Ezetimibe/Atorvastatin Zentiva 10 mg/40 mg film-coated tablets Zentiva k.s. 23/02/2024 HM Marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/009/004 PA1701/009/004 IC0118-060-003 Ezetimibe/Atorvastatin Zentiva 10 mg/80 mg film-coated tablets Zentiva k.s. 23/02/2024 HM Marketed AU Film-coated tablet C10BA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Atorvastatin calcium trihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/281/001 PA0126/281/001 IC0034-017-002 Ezetimibe/Simvastatin Clonmel 10 mg/10 mg tablets Clonmel Healthcare Ltd 07/04/2017 HM Marketed AU Tablet C10BA C10BA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Simvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/281/002 PA0126/281/002 IC0034-051-002 Ezetimibe/Simvastatin Clonmel 10 mg/20 mg tablets Clonmel Healthcare Ltd 07/04/2017 HM Marketed AU Tablet C10BA C10BA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Simvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/281/003 PA0126/281/003 IC0034-059-002 Ezetimibe/Simvastatin Clonmel 10 mg/40 mg tablets Clonmel Healthcare Ltd 07/04/2017 HM Marketed AU Tablet C10BA C10BA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Simvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/281/004 PA0126/281/004 IC0034-060-002 Ezetimibe/Simvastatin Clonmel 10 mg/80 mg tablets Clonmel Healthcare Ltd 07/04/2017 HM Marketed AU Tablet C10BA C10BA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Simvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/067/001 PA1347/067/001 IC0034-017-002 Ezetimibe/Simvastatin Krka 10 mg/10 mg tablets KRKA, d.d., Novo mesto 01/03/2017 HM Not marketed AU Tablet C10BA C10BA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Simvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/067/002 PA1347/067/002 IC0034-051-002 Ezetimibe/Simvastatin Krka 10 mg/20 mg tablets KRKA, d.d., Novo mesto 01/03/2017 HM Marketed AU Tablet C10BA C10BA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Simvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/067/003 PA1347/067/003 IC0034-059-002 Ezetimibe/Simvastatin Krka 10 mg/40 mg tablets KRKA, d.d., Novo mesto 01/03/2017 HM Marketed AU Tablet C10BA C10BA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Simvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/067/001 PA1986/067/001 IC0034-051-002 Ezetimibe/Simvastatin Teva Pharma 10 mg/20 mg tablets Teva B.V. 16/12/2016 HM Marketed AU Tablet H01CB H01CB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Simvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/067/002 PA1986/067/002 IC0034-059-002 Ezetimibe/Simvastatin Teva Pharma 10 mg/40 mg tablets Teva B.V. 16/12/2016 HM Marketed AU Tablet C10BA C10BA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Simvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/067/003 PA1986/067/003 IC0034-060-002 Ezetimibe/Simvastatin Teva Pharma 10 mg/80 mg tablets Teva B.V. 16/12/2016 HM Marketed AU Tablet H01CB H01CB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Simvastatin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/050/001 PA23266/050/001 IC0104-002-002 Ezetimibe 10 mg tablets Viatris Limited 25/07/2014 HM Marketed AU Tablet C10AX C10AX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/088/001 PA2315/088/001 IC0104-002-002 Ezetimibe 10 mg tablets Accord Healthcare Ireland Ltd. 15/04/2016 HM Marketed AU Tablet C10AX C10AX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1347/066/001 PA1347/066/001 IC0104-002-002 Ezetimibe Krka 10 mg tablets KRKA, d.d., Novo mesto 02/12/2016 HM Marketed AU Tablet C10AX C10AX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0074/074/001 PA0074/074/001 IC0104-002-002 Ezetimibe Rowa 10 mg tablets Rowa Pharmaceuticals Limited, 28/07/2017 HM Marketed AU Tablet C10AX C10AX09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ezetimibe Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/023/001 PA23198/023/001 IC0104-002-002 Ezetrol 10 mg tablets Organon Pharma (Ireland) Limited 25/07/2003 HM Marketed AU Tablet C10AX C10AX09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ezetimibe Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/227/001 PPA0465/227/001 IC0104-002-002 Ezetrol 10 mg tablets PCO Manufacturing Ltd. 31/07/2009 HM Unknown AU Tablet C10AX C10AX09 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Ezetimibe Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/187/001 PPA1463/187/001 IC0104-002-002 Ezetrol 10 mg tablets IMED Healthcare Ltd. 18/02/2022 HM Unknown AU Tablet C10AX C10AX09 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Ezetimibe Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1950/001-002 EU/1/25/1950/001-002 Ezmekly 1 mg dispersible tablets Merck Europe B.V. 17/07/2025 HM Unknown AU Dispersible tablet L01EE05 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Mirdametinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex 1: Summary of Product Characteristics, section 4.2. EU/1/25/1950/003 EU/1/25/1950/003 Ezmekly 1 mg hard capsules Merck Europe B.V. 17/07/2025 HM Unknown AU Capsule, hard L01EE05 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Mirdametinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex 1: Summary of Product Characteristics, section 4.2. EU/1/25/1950/004-005 EU/1/25/1950/004-005 Ezmekly 2 mg hard capsules Merck Europe B.V. 17/07/2025 HM Unknown AU Capsule, hard L01EE05 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Mirdametinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex 1: Summary of Product Characteristics, section 4.2. EU/1/24/1802/001-003 EU/1/24/1802/001-003 FABHALTA 200 mg hard capsules Novartis Europharm Limited 17/05/2024 HM Unknown AU Capsule, hard L04AJ08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Iptacopan Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/188/001-003 EU/1/01/188/001-003 Fabrazyme 35 mg powder for concentrate for solution for infusion Sanofi B.V. 17/06/2021 HM Unknown AU Powder for concentrate for solution for infusion A16AB04 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Agalsidase Beta Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/01/188/004-006 EU/1/01/188/004-006 Fabrazyme 5 mg powder for concentrate for solution for infusion Sanofi B.V. HM Unknown AU Powder for concentrate for solution for infusion A16AB A16AB04 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Protein c agalsidase beta (recombinant human-a-galactoside a) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA2030/001/001 PA2030/001/001 Famciclovir 500 mg Film-Coated Tablets Medinutrix Ltd. 09/09/2011 HM Not marketed AU Film-coated tablet J05AB J05AB09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Famciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0749/025/002 PA0749/025/002 Famciclovir Teva 250 mg Film-coated Tablets Teva Pharma B.V. 15/02/2008 HM Marketed AU Film-coated tablet J05AB J05AB09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Famciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/043/001 PA1142/043/001 Famotidine 20 mg film-coated tablets Amdipharm Limited 06/07/2026 HM Unknown AU Film-coated tablet A02BA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Famotidine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only N/A PA1142/043/002 PA1142/043/002 Famotidine 40 mg film-coated tablets Amdipharm Limited 06/07/2026 HM Unknown AU Film-coated tablet A02BA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Famotidine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only N/A PA0126/344/001 PA0126/344/001 Famotidine Clonmel 20 mg film-coated tablets Clonmel Healthcare Ltd 30/07/2021 HM Marketed AU Film-coated tablet A02BA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Famotidine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/344/002 PA0126/344/002 Famotidine Clonmel 40 mg film-coated tablets Clonmel Healthcare Ltd 30/07/2021 HM Marketed AU Film-coated tablet A02BA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Famotidine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/392/001 PA0126/392/001 Famotidine Clonmel Healthcare 20 mg film-coated tablets Clonmel Healthcare Ltd 31/10/2025 HM Not marketed AU Film-coated tablet A02BA03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Famotidine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/392/002 PA0126/392/002 Famotidine Clonmel Healthcare 40 mg film-coated tablets Clonmel Healthcare Ltd 31/10/2025 HM Not marketed AU Film-coated tablet A02BA03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Famotidine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1477/001-002 EU/1/20/1477/001-002 Fampridine Accord 10 mg prolonged-release tablets Accord Healthcare S.L.U. 24/09/2020 HM Unknown AU Prolonged-release tablet N07XX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fampridine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) PA0074/087/001 PA0074/087/001 Fampridine Rowa 10 mg prolonged-release tablets Rowa Pharmaceuticals Limited, 01/07/2022 HM Not marketed AU Prolonged-release tablet N07XX07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fampridine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). EU/1/11/699/001-002 EU/1/11/699/001-002 Fampyra 10 mg prolonged-release tablets Merz Pharmaceuticals GmbH 20/07/2011 HM Unknown AU Prolonged-release tablet N07XX N07XX07 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Fampridine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA1113/018/001 PA1113/018/001 Famvir 125 mg film-coated tablets Phoenix Labs 23/11/1995 HM Marketed AU Film-coated tablet J05AB J05AB09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Famciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1113/018/002 PA1113/018/002 Famvir 250 mg film-coated tablets Phoenix Labs 23/11/1995 HM Marketed AU Film-coated tablet J05AB J05AB09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Famciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/212/001 PPA0465/212/001 Famvir 250 mg film-coated tablets PCO Manufacturing Ltd. 26/09/2008 HM Unknown AU Film-coated tablet J05AB J05AB09 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Famciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/166/001 PPA1463/166/001 Famvir 250 mg Film-Coated Tablets IMED Healthcare Ltd., 01/04/2021 HM Unknown AU Film-coated tablet J05AB J05AB09 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Famciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1113/018/003 PA1113/018/003 Famvir 500 mg film-coated tablets Phoenix Labs 17/05/2013 HM Marketed AU Film-coated tablet J05AB J05AB09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Famciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/212/002 PPA0465/212/002 Famvir 500 mg film-coated tablets PCO Manufacturing Ltd. 18/07/2014 HM Unknown AU Film-coated tablet J05AB J05AB09 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Famciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/166/002 PPA1463/166/002 Famvir 500 mg film-coated tablets IMED Healthcare Ltd., 01/04/2021 HM Unknown AU Film-coated tablet J05AB J05AB09 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Famciclovir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0849/001/003 PA0849/001/003 Fanhdi 1000 IU powder and solvent for solution for injection Instituto Grifols S.A. 07/07/2000 HM Not marketed AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Human coagulation factor viii Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches of finished product marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC. Batches of human albumin used in manufacture shall be subject to control authority batch r PA0849/001/001 PA0849/001/001 Fanhdi 250 IU powder and solvent for solution for injection Instituto Grifols S.A. 07/07/2000 HM Not marketed AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Human coagulation factor viii Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches of finished product marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC. Batches of human albumin used in manufacture shall be subject to control authority batch r PA0849/001/002 PA0849/001/002 Fanhdi 500 IU powder and solvent for solution for injection Instituto Grifols S.A. 07/07/2000 HM Not marketed AU Powder and solvent for solution for injection B02BD B02BD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Human coagulation factor viii Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches of finished product marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC. Batches of human albumin used in manufacture shall be subject to control authority batch r EU/1/96/004/001 EU/1/96/004/001 Fareston 60 mg Tablets Orion Corporation 14/02/1996 HM Unknown AU Tablet L02BA L02BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Toremifene citrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/96/004/002 EU/1/96/004/002 Fareston 60 mg Tablets Orion Corporation 14/02/1996 HM Unknown AU Tablet L02BA L02BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Toremifene Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1023/001-003 EU/1/15/1023/001-003 Farydak 10 mg hard capsules pharmaand GmbH 28/08/2015 HM Unknown AU Capsule, hard L01X Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Panobinostat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1023/004-006 EU/1/15/1023/004-006 Farydak 15 mg hard capsules pharmaand GmbH HM Unknown AU Capsule, hard L01X Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Panobinostat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1023/007-009 EU/1/15/1023/007-009 Farydak 20 mg hard capsules pharmaand GmbH HM Unknown AU Capsule, hard L01X Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Panobinostat Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1252/001-002 EU/1/17/1252/001-002 Fasenra 30 mg solution for injection AstraZeneca AB HM Unknown AU Solution for injection in pre-filled syringe R03DX R03DX10 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Benralizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/03/269/001-002 EU/1/03/269/001-002 IC0129-130-063 Faslodex 250 mg Solution for injection AstraZeneca AB HM Unknown AU Solution for injection in pre-filled syringe L02BA L02BA03 New active substance (Article 8(3) of Directive No 2001/83/EC) Fulvestrant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0512/001/001 PA0512/001/001 Fastum 2.5% w/w Gel A. Menarini Industrie Farmaceutische Riunite S.r.l. 19/08/1992 HM Marketed AU Gel M02AA M02AA10 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Ketoprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/170/001-002 EU/1/00/170/001-002 Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion Sanofi Winthrop Industrie 23/02/2001 HM Unknown AU Powder and solvent for concentrate for solution for infusion V03AF V03AF07 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Rasburicase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA23355/024/002 PA23355/024/002 Faverin 100 mg film-coated tablets Viatris Healthcare Limited 11/10/1989 HM Marketed AU Film-coated tablet N06AB N06AB08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fluvoxamine maleate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23355/024/001 PA23355/024/001 Faverin 50 mg film-coated tablets Viatris Healthcare Limited 11/10/1989 HM Marketed AU Film-coated tablet N06AB N06AB08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fluvoxamine maleate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/295/002 PA0126/295/002 Febuxostat Clonmel 120 mg Film-coated tablets Clonmel Healthcare Ltd 27/04/2018 HM Marketed AU Film-coated tablet M04AA M04AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Febuxostat Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/295/001 PA0126/295/001 Febuxostat Clonmel 80 mg Film-coated tablets Clonmel Healthcare Ltd 27/04/2018 HM Marketed AU Film-coated tablet M04AA M04AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Febuxostat Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/18/1347/005-008 EU/1/18/1347/005-008 Febuxostat Krka 120 mg film-coated tablets KRKA, d.d., Novo mesto 28/03/2019 HM Unknown AU Film-coated tablet M04AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Febuxostat Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/18/1347/001-004 EU/1/18/1347/001-004 Febuxostat Krka 80 mg film-coated tablets KRKA, d.d., Novo mesto 28/03/2019 HM Unknown AU Film-coated tablet M04AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Febuxostat Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0074/085/002 PA0074/085/002 Febuxostat Rowa 120 mg film-coated tablets Rowa Pharmaceuticals Limited, 30/04/2021 HM Unknown AU Film-coated tablet M04AA M04AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Febuxostat Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0074/085/001 PA0074/085/001 Febuxostat Rowa 80 mg film-coated tablets Rowa Pharmaceuticals Limited, 30/04/2021 HM Unknown AU Film-coated tablet M04AA M04AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Febuxostat Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/273/002 PA0711/273/002 Febuxostat Rowex 120 mg Film-coated Tablets Rowex Limited, 14/07/2017 HM Marketed AU Film-coated tablet M04AA M04AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Febuxostat Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/273/001 PA0711/273/001 Febuxostat Rowex 80 mg Film-coated Tablets Rowex Limited, 14/07/2017 HM Marketed AU Film-coated tablet M04AA M04AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Febuxostat Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1194/009-016 EU/1/17/1194/009-016 Febuxostat Viatris 120 mg film-coated tablets Viatris Limited 15/06/2017 HM Unknown AU Film-coated tablet M04AA M04AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Febuxostat Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1194/001-008 EU/1/17/1194/001-008 Febuxostat Viatris 80 mg film-coated tablets Viatris Limited 15/06/2017 HM Unknown AU Film-coated tablet M04AA M04AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Febuxostat Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23101/001/001 PA23101/001/001 Fefol Spansule 150 mg/0.5 mg Modified Release Capsules Intapharm Labs Ltd 01/04/1980 HM Not marketed AU Modified-release capsule, hard B03AD B03AD03 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Dried ferrous sulphate Folic acid Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA2004/001/003 PA2004/001/003 FEIBA 100 U/ml powder and solvent for solution for infusion Baxalta Innovations GmbH 19/07/2024 HM Marketed AU Powder and solvent for solution for infusion B02BD03 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Factor VIII inhibitor bypassing fraction Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2004/001/002 PA2004/001/002 FEIBA 50 U/ml powder and solvent for solution for infusion Baxalta Innovations GmbH 28/05/2010 HM Not marketed AU Powder and solvent for solution for infusion B02BD B02BD03 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Feiba Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0896/012/001 PA0896/012/001 IC0117-018-003 Femara 2.5 mg film-coated tablets Novartis Ireland Limited 10/01/1997 HM Not marketed AU Film-coated tablet L02BG L02BG04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Letrozole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA2306/001/001 PPA2306/001/001 IC0117-018-003 Femara 2.5 mg film-coated tablets Originalis B.V. 14/09/2018 HM Unknown AU Film-coated tablet L02BG04 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Letrozole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22668/015/001 PA22668/015/001 Fematab 1mg film-coated tablet Theramex Ireland Limited 16/04/1999 HM Marketed AU Film-coated tablet G03CA G03CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Estradiol hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23355/038/001 PA23355/038/001 Fematab 2mg Film-coated tablet Viatris Healthcare Limited 12/12/1994 HM Marketed AU Film-coated tablet G03CA G03CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Estradiol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22668/014/001 PA22668/014/001 Femoston 1/10mg film-coated tablets Theramex Ireland Limited 23/01/1998 HM Marketed AU Film-coated tablet G03FB G03FB08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Dydrogesterone Estradiol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22668/014/002 PA22668/014/002 Femoston 2/10mg film-coated tablets Theramex Ireland Limited 31/10/1997 HM Marketed AU Film-coated tablet G03FB G03FB08 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Dydrogesterone Estradiol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22668/014/003 PA22668/014/003 Femoston-conti 0.5 mg/2.5 mg film-coated tablets Theramex Ireland Limited 01/10/2010 HM Marketed AU Film-coated tablet G03FA G03FA14 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Estradiol Dydrogesterone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/464/002 PPA0465/464/002 Femoston-conti 0.5 mg/2.5 mg film-coated tablets PCO Manufacturing Ltd. 18/02/2022 HM Unknown AU Film-coated tablet G03FA G03FA14 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Estradiol Dydrogesterone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22668/014/004 PA22668/014/004 Femoston-conti 1 mg/5 mg film-coated tablets Theramex Ireland Limited 08/12/2000 HM Marketed AU Film-coated tablet G03FA G03FA14 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Estradiol Dydrogesterone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/464/001 PPA0465/464/001 Femoston-conti 1 mg/5 mg film-coated tablets PCO Manufacturing Ltd. 05/03/2021 HM Unknown AU Film-coated tablet G03FA G03FA14 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Dydrogesterone Estradiol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/189/001 PPA1463/189/001 Femoston-conti 1 mg/5 mg film-coated tablets IMED Healthcare Ltd., 02/12/2022 HM Unknown AU Film-coated tablet G03FA14 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Estradiol Dydrogesterone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/04/0299/001-003 EU/1/04/0299/001-003 Fendrix suspension for injection GlaxoSmithKline Biologicals S.A. 02/02/2005 HM Unknown AU Suspension for injection J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/088/004 PA0281/088/004 Fenopine 100mg/5ml Oral Suspension Pinewood Laboratories Ltd 03/09/2010 HM Marketed AU Oral suspension M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0281/088/005 PA0281/088/005 Fenopine 200 mg/5 ml Oral Suspension Pinewood Laboratories Limited 01/02/2019 HM Not marketed AU Oral suspension M01AE01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Ibuprofen ph. eur. Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/088/006 PA0281/088/006 Fenopine for Children Six Plus Strawberry 200mg/5ml Oral Suspension Pinewood Laboratories Ltd 18/12/2020 HM Marketed AU Oral suspension M01AE01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA1676/002/004 PA1676/002/004 Fentadur 100 micrograms/hour Transdermal Patch Lavipharm S.A. 06/01/2012 HM Marketed AU Transdermal patch N02AB N02AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1676/002/005 PA1676/002/005 Fentadur 12 micrograms/hour transdermal patch Lavipharm S.A. 18/05/2012 HM Marketed AU Transdermal patch N02AB N02AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1676/002/001 PA1676/002/001 Fentadur 25 micrograms/hour Transdermal Patch Lavipharm S.A. 06/01/2012 HM Marketed AU Transdermal patch N02AB N02AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1676/002/002 PA1676/002/002 Fentadur 50 micrograms/hour Transdermal Patch Lavipharm S.A. 06/01/2012 HM Marketed AU Transdermal patch N02AB N02AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1676/002/003 PA1676/002/003 Fentadur 75 micrograms/hour Transdermal Patch Lavipharm S.A. 06/01/2012 HM Marketed AU Transdermal patch N02AB N02AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0711/146/004 PA0711/146/004 Fental Matrix 100 micrograms/hour transdermal patch Rowex Limited, 27/04/2007 HM Marketed AU Transdermal patch N02AB N02AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0711/146/001 PA0711/146/001 Fental Matrix 25 micrograms/hour transdermal patch Rowex Limited, 27/04/2007 HM Marketed AU Transdermal patch N02AB N02AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0711/146/002 PA0711/146/002 Fental Matrix 50 micrograms/hour transdermal patch Rowex Limited, 27/04/2007 HM Marketed AU Transdermal patch N02AB N02AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0711/146/003 PA0711/146/003 Fental Matrix 75 micrograms/hour transdermal patch Rowex Limited, 27/04/2007 HM Marketed AU Transdermal patch N02AB N02AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Transdermal use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0073/122/001 PA0073/122/001 Fentanyl 100 micrograms in 2 ml Solution for Injection Mercury Pharmaceuticals (Ireland) Ltd 04/07/1990 HM Marketed AU Solution for injection N01AH N01AH01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use FENTANYL CITRATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA2165/011/001 PA2165/011/001 Fentanyl 50 micrograms/ml solution for injection AS Kalceks 28/08/2020 HM Marketed AU Solution for injection N01AH01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Fentanyl Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0073/122/002 PA0073/122/002 Fentanyl 500 micrograms in 10 ml Solution for Injection Mercury Pharmaceuticals (Ireland) Ltd 04/07/1990 HM Marketed AU Solution for injection N01AH N01AH01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use FENTANYL CITRATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. EU/1/15/1075/001-004 EU/1/15/1075/001-004 Feraccru 30 mg hard capsules Norgine B.V. 18/02/2016 HM Unknown AU Capsule, hard B03AB B03AB10 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Ferric maltol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0949/004/001 PA0949/004/001 Ferinject 50 mg iron/mL dispersion for injection/infusion Vifor France 11/04/2008 HM Marketed AU Dispersion for injection/infusion B03AC Known active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use IRON CARBOXYMALTOSE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/315/001 PA0711/315/001 Ferric carboxymaltose 50 mg iron/ml dispersion for injection/infusion Rowex Limited, 02/12/2022 HM Marketed AU Dispersion for injection/infusion B03AC Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Ferric carboxymaltose Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/124/001 PA1986/124/001 Ferric carboxymaltose Teva 50 mg iron/ml dispersion for injection/infusion Teva B.V. 24/05/2024 HM Marketed AU Dispersion for injection/infusion B03AC Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Ferric carboxymaltose Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/99/108/004-006 EU/1/99/108/004-006 Ferriprox 1 000 mg film-coated tablets Chiesi Farmaceutici S.p.A. 28/07/2010 HM Unknown AU Film-coated tablet V03AC V03AC02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Deferiprone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/99/108/002-003 EU/1/99/108/002-003 Ferriprox 100 mg/ml oral solution Chiesi Farmaceutici S.p.A. 19/11/2007 HM Unknown AU Oral solution V03AC V03AC02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Deferiprone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/99/108/001 EU/1/99/108/001 Ferriprox 500 mg film-coated tablets Chiesi Farmaceutici S.p.A. 25/08/1999 HM Unknown AU Film-coated tablet V03AC V03AC02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Deferiprone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA1235/001/001 PA1235/001/001 Ferrograd 325mg Prolonged release Tablets Teofarma S.R.L. 01/04/1980 HM Marketed AU Prolonged-release tablet B03AA B03AA07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ferrous sulfate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1235/002/001 PA1235/002/001 Ferrograd C 325mg/500mg Prolonged release Tablets Teofarma S.R.L. 01/04/1980 HM Marketed AU Prolonged-release tablet B03AA B03AA07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ferrous sulfate Sodium ascorbate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1235/003/001 PA1235/003/001 Ferrograd Folic 325mg/0.35mg Prolonged release Tablets Teofarma S.R.L. 01/04/1980 HM Marketed AU Prolonged-release tablet B03AD B03AD03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ferrous sulfate Folic acid Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA2315/243/001 PA2315/243/001 IC0139-009-024 Fesoterodine Accord 8 mg prolonged-release tablets Accord Healthcare Ireland Ltd. 10/12/2021 HM Marketed AU Prolonged-release tablet G04BD11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fesoterodine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1983/007/001 PA1983/007/001 IC0139-008-024 Fesoterodine Aristo 4 mg prolonged-release tablets Aristo Pharma GmbH 26/11/2021 HM Marketed AU Prolonged-release tablet G04BD11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fesoterodine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1983/007/002 PA1983/007/002 IC0139-009-024 Fesoterodine Aristo 8 mg prolonged-release tablets Aristo Pharma GmbH 26/11/2021 HM Marketed AU Prolonged-release tablet G04BD11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fesoterodine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/335/001 PA0126/335/001 IC0139-008-024 Fesoterodine Clonmel 4 mg prolonged-release tablets Clonmel Healthcare Ltd 25/06/2021 HM Marketed AU Prolonged-release tablet G04BD11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fesoterodine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/335/002 PA0126/335/002 IC0139-009-024 Fesoterodine Clonmel 8 mg prolonged-release tablets Clonmel Healthcare Ltd 25/06/2021 HM Marketed AU Prolonged-release tablet G04BD11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fesoterodine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2244/002/001 PA2244/002/001 IC0139-008-024 Fesoterodine Doc 4 mg prolonged-release tablets DOC Generici S.r.l. 12/08/2022 HM Not marketed AU Prolonged-release tablet G04BD11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fesoterodine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2244/002/002 PA2244/002/002 IC0139-009-024 Fesoterodine Doc 8 mg prolonged-release tablets DOC Generici S.r.l. 12/08/2022 HM Not marketed AU Prolonged-release tablet G04BD11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fesoterodine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/215/001 PA0281/215/001 IC0139-008-024 Fesoterodine Pinewood 4 mg prolonged-release tablets Pinewood Laboratories Limited 15/07/2022 HM Marketed AU Prolonged-release tablet G04BD11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fesoterodine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/215/002 PA0281/215/002 IC0139-009-024 Fesoterodine Pinewood 8 mg prolonged-release tablets Pinewood Laboratories Ltd 15/07/2022 HM Marketed AU Prolonged-release tablet G04BD11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fesoterodine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0074/091/001 PA0074/091/001 IC0139-008-024 Fesoterodine Rowa 4 mg prolonged-release tablets Rowa Pharmaceuticals Limited, 22/07/2022 HM Not marketed AU Prolonged-release tablet G04BD11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fesoterodine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0074/091/002 PA0074/091/002 IC0139-009-024 Fesoterodine Rowa 8 mg prolonged-release tablets Rowa Pharmaceuticals Limited, 22/07/2022 HM Not marketed AU Prolonged-release tablet G04BD11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fesoterodine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1434/001 EU/1/20/1434/001 Fetcroja 1 g powder for concentrate for solution for infusion Shionogi B.V. 23/04/2020 HM Unknown AU Powder for concentrate for solution for infusion J01DI04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Cefiderocol Sulfate Tosilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/15/1039/001 EU/1/15/1039/001 Fexeric Akebia Europe Limited 23/09/2015 HM Unknown AU Film-coated tablet V03AE Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ferric citrate coordination complex Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0074/096/001 PA0074/096/001 Fexo Allergy Relief 120 mg film-coated tablets Rowa Pharmaceuticals Limited, 13/10/2023 HM Marketed AU Film-coated tablet R06AX26 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fexofenadine hydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public The applicant has committed to a maximum pack size restriction of 30 tablets. PA1963/014/001 PA1963/014/001 Fexofast 120 mg Film-coated Tablets Cipla Europe NV 22/07/2011 HM Not marketed AU Film-coated tablet R06AX R06AX26 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fexofenadine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1963/014/002 PA1963/014/002 IC0189-135-003 Fexofast 180 mg Film-coated Tablets Cipla Europe NV 22/07/2011 HM Not marketed AU Film-coated tablet R06AX R06AX26 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fexofenadine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0688/017/001 PA0688/017/001 Fexofenadine hydrochloride 120 mg Film-coated tablets Chanelle Medical Unlimited Company 14/09/2007 HM Not marketed AU Film-coated tablet R06AX R06AX26 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fexofenadine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22871/004/002 PA22871/004/002 Fexofenadine Hydrochloride 120 mg Film-coated tablets Azure Pharmaceuticals Ltd. 26/06/2020 HM Marketed AU Film-coated tablet R06AX26 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fexofenadine hydrochloride Product not subject to medical prescription Supply through pharmacies only Advertising to the general public The applicant has committed to a maximum pack size restriction of 30 tablets. PA0688/017/002 PA0688/017/002 IC0189-135-003 Fexofenadine hydrochloride 180 mg Film-coated Tablets Chanelle Medical Unlimited Company 14/09/2007 HM Not marketed AU Film-coated tablet R06AX R06AX26 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fexofenadine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22871/004/003 PA22871/004/003 IC0189-135-003 Fexofenadine Hydrochloride 180 mg Film-coated tablets Azure Pharmaceuticals Ltd. 26/06/2020 HM Marketed AU Film-coated tablet R06AX26 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fexofenadine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1160/001-006 EU/1/16/1160/001-006 Fiasp 100 units/mL FlexTouch solution for injection in pre-filled pen Novo Nordisk A/S 09/01/2017 HM Unknown AU Solution for injection in pre-filled pen A10AB A10AB05 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Insulin aspart Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22778/002/001 PA22778/002/001 Fibrovein 0.2% Solution for Injection STD Pharmaceutical (Ireland) Limited 19/05/2023 HM Not marketed AU Solution for injection C05BB04 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium tetradecyl sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22778/002/002 PA22778/002/002 Fibrovein 0.5% Solution for Injection STD Pharmaceutical (Ireland) Limited 19/05/2023 HM Not marketed AU Solution for injection C05BB04 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium tetradecyl sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22778/002/003 PA22778/002/003 Fibrovein 1% Solution for Injection STD Pharmaceutical (Ireland) Limited 19/05/2023 HM Not marketed AU Solution for injection C05BB04 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium tetradecyl sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22778/002/004 PA22778/002/004 Fibrovein 3% Solution for Injection STD Pharmaceutical (Ireland) Limited 19/05/2023 HM Not marketed AU Solution for injection C05BB04 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium tetradecyl sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2219/011/002 PA2219/011/002 FIBRYGA 2 g powder and solvent for solution for injection/infusion Octapharma (IP) 12/06/2026 HM Not marketed AU Powder and solvent for solution for injection/infusion B02BB01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Human fibrinogen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2219/011/001 PA2219/011/001 FIBRYGA, 1 g, powder and solvent for solution for injection/infusion Octapharma (IP) 04/09/2020 HM Marketed AU Powder and solvent for solution for injection/infusion B02BB01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Human fibrinogen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/496/1-4 EU/1/08/496/1-4 Filgrastim Hexal 30 MU (60 MU/ml) Solution for injection or infusion Hexal AG HM Unknown AU Solution for injection in pre-filled syringe L03AA L03AA02 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Ep2006 (recombinant human granulocyte-colony stimulating factor) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/08/496/5-8 EU/1/08/496/5-8 Filgrastim Hexal 48 MU (96 MU/ml) Solution for injection or infusion Hexal AG 06/02/2009 HM Unknown AU Solution for injection in pre-filled syringe L03AA L03AA02 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Ep2006 (recombinant human granulocyte-colony stimulating factor) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/23/1788/001 EU/1/23/1788/001 Filspari 200 mg film-coated tablets Vifor France 19/04/2024 HM Unknown AU Film-coated tablet C09XX01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sparsentan Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1788/002-003 EU/1/23/1788/002-003 Filspari 400 mg film-coated tablets Vifor France 19/04/2024 HM Unknown AU Film-coated tablet C09XX01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sparsentan Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1652/001-002 EU/1/22/1652/001-002 Filsuvez Chiesi Farmaceutici S.p.A. 21/06/2022 HM Unknown AU Gel D03AX D03AX13 Full application (Article 8(3) of Directive No 2001/83/EC) BETULAE CORTEX DRY EXTRACT (5-10 : 1); EXTRACTION SOLVENT: N-HEPTANE 95% (W/W) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22753/002/001 PA22753/002/001 Finasteride 1mg film-coated tablets Careforsons Ireland Limited 16/10/2020 HM Marketed AU Film-coated tablet D11AX10 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Finasteride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/089/001 PA2315/089/001 Finasteride 5 mg Film-coated Tablets Accord Healthcare Ireland Ltd. 13/11/2008 HM Marketed AU Film-coated tablet G04CB G04CB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Finasteride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1226/017/001 PA1226/017/001 IC0161-145-001 Fingolimod 0.25 mg hard capsules Flynn Pharma Limited 09/08/2024 HM Not marketed AU Capsule, hard L04AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use FINGOLIMOD HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA0074/086/001 PA0074/086/001 IC0161-040-001 Fingolimod 0.5 mg hard capsules Rowa Pharmaceuticals Limited, 14/08/2020 HM Not marketed AU Capsule, hard L04AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fingolimod Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA1226/017/002 PA1226/017/002 IC0161-040-001 Fingolimod 0.5 mg hard capsules Flynn Pharma Limited 09/08/2024 HM Marketed AU Capsule, hard L04AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use FINGOLIMOD HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) EU/1/20/1450/001-006 EU/1/20/1450/001-006 IC0161-040-001 Fingolimod Accord 0.5 mg hard capsules Accord Healthcare S.L.U. 25/06/2020 HM Unknown AU Capsule, hard L04AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use FINGOLIMOD HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA0126/319/001 PA0126/319/001 IC0161-040-001 Fingolimod Clonmel 0.5 mg hard capsules Clonmel Healthcare Ltd 29/01/2021 HM Marketed AU Capsule, hard L04AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fingolimod Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA1347/101/001 PA1347/101/001 IC0161-040-001 Fingolimod Krka 0.5 mg hard capsules KRKA, d.d., Novo mesto 12/02/2021 HM Marketed AU Capsule, hard L04AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use FINGOLIMOD HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2) PA23250/007/001 PA23250/007/001 IC0161-040-001 Fingolimod MSN 0.5 mg hard capsules MSN Labs Europe Limited 27/11/2020 HM Marketed AU Capsule, hard L04AA27 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fingolimod Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). EU/1/21/1573/001-024 EU/1/21/1573/001-024 IC0161-040-001 Fingolimod Mylan 0.5 mg hard capsules Mylan Pharmaceuticals Limited 18/08/2021 HM Unknown AU Capsule, hard L04AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use FINGOLIMOD HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA0711/346/001 PA0711/346/001 IC0161-040-001 Fingolimod Rowex 0.5 mg hard capsules Rowex Limited, 20/02/2026 HM Not marketed AU Capsule, hard L04AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use FINGOLIMOD HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0436/047/001 PA0436/047/001 IC0161-040-001 Fingolimod Teva 0.5 mg hard capsules Norton Waterford 20/11/2020 HM Marketed AU Capsule, hard L04AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fingolimod Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA23169/001/001 PA23169/001/001 IC0161-040-001 Fingolimod Tillomed 0.5 mg hard capsules Tillomed Pharma GmbH 01/04/2021 HM Marketed AU Capsule, hard L04AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fingolimod Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). EU/1/23/1767/001-002 EU/1/23/1767/001-002 Finlee 10 mg dispersible tablets Novartis Europharm Limited 15/11/2023 HM Unknown AU Dispersible tablet L01EC02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Dabrafenib Mesylate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA2299/044/002 PA2299/044/002 Finomel Emulsion for Infusion Baxter Holding B.V. 19/07/2019 HM Marketed AU Emulsion for infusion B05BA B05BA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Glycine Alanine Arginine Histidine Isoleucine Leucine Lysine hydrochloride Methionine Phenylalanine Proline Serine Threonine Tryptophan Tyrosine Valine Sodium acetate trihydrate Potassium chloride Calcium chloride dihydrate Magnesium sulphate heptahydrate Sodium Glycerophosphate Hydrate Zinc sulphate heptahydrate Glucose monohydrate Soya Bean Oil, Refined Ph.Eur Olive oil, refined Medium chain triglycerides saturated Fish oil, rich in omega-3 acids Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/044/001 PA2299/044/001 Finomel Peri Emulsion for Infusion Baxter Holding B.V. 19/07/2019 HM Marketed AU Emulsion for infusion B05BA B05BA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Alanine Arginine Glycine Histidine Isoleucine Leucine Lysine hydrochloride Methionine Phenylalanine Proline Serine Threonine Tryptophan Tyrosine Valine Sodium acetate trihydrate Potassium chloride Calcium chloride dihydrate Magnesium sulphate heptahydrate Sodium Glycerophosphate Hydrate Zinc sulphate heptahydrate Glucose monohydrate Soya Bean Oil, Refined Ph.Eur Olive oil, refined Medium chain triglycerides saturated Fish oil, rich in omega-3 acids Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23214/001/001 PA23214/001/001 Finovare 20 mg/g Cream Citrine Healthcare Limited 31/03/2023 HM Marketed AU Cream D06AX01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Fusidic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1491/001-004 EU/1/20/1491/001-004 Fintepla 2.2 mg/ml oral solution UCB Pharma S.A. 18/12/2020 HM Unknown AU Oral solution N03AX N03AX26 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fenfluramine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1445/019/001 PA1445/019/001 Fintrid 5 mg film-coated tablets Aurobindo Pharma (Malta) Limited 20/06/2008 HM Not marketed AU Film-coated tablet G04CB G04CB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Finasteride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/461/001-002 EU/1/08/461/001-002 IC0148-033-063 Firazyr 30 mg solution for injection in pre-filled syringe Takeda Pharmaceuticals International AG Ireland Branch 11/07/2008 HM Unknown AU Solution for injection in pre-filled syringe B06AC B06AC02 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Icatibant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/09/601/001 EU/1/09/601/001 FIRDAPSE 10 mg tablets SERB S.A. 23/12/2009 HM Unknown AU Tablet N07XX05 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use 3,4-diaminopyridine phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/08/504/001 EU/1/08/504/001 Firmagon 80 mg powder and solvent for solution for injection Ferring Pharmaceuticals A/S HM Unknown AU Powder and solvent for solution for injection L02BX L02BX02 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Degarelix (as acetate) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/504/002 EU/1/08/504/002 Firmagon 120 mg powder and solvent for solution for injection Ferring Pharmaceuticals A/S HM Unknown AU Powder and solvent for solution for injection L02BX L02BX02 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Degarelix (as acetate) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1107/014/001 PA1107/014/001 Fixapost 50 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container Laboratoires Thea 22/06/2018 HM Marketed AU Eye drops, solution in single-dose container S01ED S01ED51 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Ocular use Timolol Latanoprost Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0814/003/002 PA0814/003/002 Flagyl 400mg Tablets Fidia Farmaceutici S.p.A. 01/04/1977 HM Marketed AU Film-coated tablet P01AB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Metronidazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0814/003/001 PA0814/003/001 Flagyl-S 200mg/5ml Oral Suspension Fidia Farmaceutici S.p.A. 01/04/1977 HM Marketed AU Oral suspension P01AB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Metronidazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/404/006-008 EU/1/07/404/006-008 Flebogamma DIF 100 mg/ml solution for infusion Instituto Grifols S.A. HM Unknown AU Solution for infusion J06BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Human normal immunoglobulin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/404/1-5 EU/1/07/404/1-5 Flebogamma DIF 50 mg/ml solution for infusion Instituto Grifols S.A. 23/08/2007 HM Unknown AU Solution for infusion J06BA J06BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Human normal immunoglobulin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/050/002 PA1986/050/002 Flecainide 100mg Tablets Teva B.V. 13/06/2006 HM Marketed AU Tablet C01BC C01BC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Flecainide acetate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1986/050/001 PA1986/050/001 Flecainide 50mg Tablets Teva B.V. 13/06/2006 HM Marketed AU Tablet C01BC C01BC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Flecainide acetate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1104/004/001 PA1104/004/001 Flector Tissugel 140 mg medicated plaster IBSA Farmaceutici Italia S.r.l 04/11/2003 HM Marketed AU Medicated plaster M02AA M02AA15 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Diclofenac epolamine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2004/002/001 PA2004/002/001 Flexbumin 200 g/l solution for infusion Baxalta Innovations GmbH 24/08/2007 HM Marketed AU Solution for infusion B05AA B05AA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Human plasma protein Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EEC. EU/1/16/1106/001 EU/1/16/1106/001 Flixabi 100 mg powder for concentrate for solution for infusion Samsung Bioepis NL B.V. 26/05/2016 HM Unknown AU Powder for concentrate for solution for infusion L04AB L04AB02 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Infliximab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0678/095/001 PA0678/095/001 Flixonase Allergy Relief 50 micrograms per dose Nasal Spray Haleon Ireland Limited 02/05/2003 HM Marketed AU Nasal spray, suspension R01AD R01AD08 Informed consent application (Article 10c of Directive No 2001/83/EC) Intranasal use Fluticasone propionate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Product not subject to medical prescription if compliant with the following restrictions: pack containing not more than 3,000 mcg fluticasone proprionate, maximum period of treatment: 6 months, maximum dose: 100 mcg per nostril, maximum daily dose: 200 mcg per nostril, limited indications, pharmaceutical form: non-pressurised nasal spray, for use in adults and children not under 12 years. PA1077/044/010 PA1077/044/010 Flixotide Diskus 100 micrograms, Inhalation Powder, pre-dispensed GlaxoSmithKline (Ireland) Limited 02/12/1996 HM Marketed AU Inhalation powder, pre-dispensed R03BA R03BA05 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/044/011 PA1077/044/011 Flixotide Diskus 250 micrograms, Inhalation Powder, pre-dispensed GlaxoSmithKline (Ireland) Limited 02/12/1996 HM Marketed AU Inhalation powder, pre-dispensed R03BA R03BA05 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/044/009 PA1077/044/009 Flixotide Diskus 50 micrograms, Inhalation Powder, pre-dispensed GlaxoSmithKline (Ireland) Limited 02/12/1996 HM Marketed AU Inhalation powder, pre-dispensed R03BA R03BA05 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/044/012 PA1077/044/012 Flixotide Diskus 500 micrograms, Inhalation Powder, pre-dispensed GlaxoSmithKline (Ireland) Limited 02/12/1996 HM Marketed AU Inhalation powder, pre-dispensed R03BA R03BA05 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/044/014 PA1077/044/014 Flixotide Evohaler 125 micrograms per metered dose Pressurised Inhalation Suspension GlaxoSmithKline (Ireland) Limited 08/01/1999 HM Marketed AU Pressurised inhalation, suspension R03BA R03BA05 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/260/001 PPA1463/260/001 Flixotide Evohaler 125 micrograms per metered dose Pressurised Inhalation Suspension IMED Healthcare Ltd., 06/03/2026 HM Unknown AU Pressurised inhalation, suspension R03BA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/073/001 PPA0465/073/001 Flixotide Evohaler 125 micrograms per metered dose pressurised inhalation, suspension PCO Manufacturing Ltd. 07/07/2001 HM Unknown AU Pressurised inhalation, suspension R03BA R03BA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/260/002 PPA1463/260/002 Flixotide Evohaler 250 micrograms per metered dose Pressurised Inhalation Suspension IMED Healthcare Ltd., 06/03/2026 HM Unknown AU Pressurised inhalation, suspension R03BA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/073/002 PPA0465/073/002 Flixotide Evohaler 250 micrograms per metered dose pressurised inhalation, suspension PCO Manufacturing Ltd. 07/09/2001 HM Unknown AU Pressurised inhalation, suspension R03BA R03BA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/044/015 PA1077/044/015 Flixotide Evohaler 250 micrograms per metered dose Pressurised Inhalation, Suspension GlaxoSmithKline (Ireland) Limited 08/01/1999 HM Marketed AU Pressurised inhalation, suspension R03BA R03BA05 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/073/005 PPA0465/073/005 Flixotide Evohaler 50 micrograms per metered dose pressurised inhalation, suspension PCO Manufacturing Ltd. 17/05/2019 HM Unknown AU Pressurised inhalation, suspension R03BA R03BA05 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/044/013 PA1077/044/013 Flixotide Evohaler 50 micrograms per metered dose, Pressurised Inhalation Suspension GlaxoSmithKline (Ireland) Limited 20/12/2000 HM Marketed AU Pressurised inhalation, suspension R03BA R03BA05 Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use Fluticasone propionate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1077/058/002 PA1077/058/002 Flolan 0.5 mg powder and solvent for solution for infusion GlaxoSmithKline (Ireland) Limited 17/12/1992 HM Marketed AU Powder and solvent for solution for infusion B01AC B01AC09 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Epoprostenol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1077/058/001 PA1077/058/001 Flolan 1.5 mg powder and solvent for solution for infusion GlaxoSmithKline (Ireland) Limited 20/12/2000 HM Marketed AU Powder and solvent for solution for infusion B01AC B01AC09 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Epoprostenol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/111/003 PA1986/111/003 Floxapen 1000 mg powder for solution for injection or infusion Teva B.V. 03/08/2012 HM Marketed AU Powder for solution for injection/infusion J01CF J01CF05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/111/004 PA1986/111/004 Floxapen 2000 mg powder for solution for injection or infusion Teva B.V. 03/08/2012 HM Marketed AU Powder for solution for injection/infusion J01CF J01CF05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/111/001 PA1986/111/001 Floxapen 250mg Powder for solution for Injection or Infusion Teva B.V. 18/01/1979 HM Marketed AU Powder for solution for injection/infusion J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intraarticular use Intramuscular use Intrapleural use Intravenous use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/111/002 PA1986/111/002 Floxapen 500 mg Powder for Solution for Injection or Infusion Teva B.V. 18/01/1979 HM Marketed AU Powder for solution for injection/infusion J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intraarticular use Intramuscular use Intrapleural use Intravenous use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1878/001-004 EU/1/24/1878/001-004 Fluad suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, adjuvanted) Seqirus Netherlands B.V. 15/11/2024 HM Unknown AU Solution for injection in pre-filled syringe J07BB02 Known active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use A/(H1N1)-LIKE VIRUS ANTIGEN A/(H3N2)-LIKE VIRUS ANTIGEN B (Victoria lineage)-like virus antigen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. • Official batch release In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. PA1077/134/001 PA1077/134/001 Fluarix Tetra suspension for injection in pre-filled syringe Influenza vaccine (split virion, inactivated) GlaxoSmithKline (Ireland) Limited 01/06/2018 HM Not marketed AU Suspension for injection in pre-filled syringe J07BB J07BB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238 A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/6/2021, IVR-227) B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, BVR-26) [Victoria lineage] B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches of vaccine marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.1 of Directive 2001/83/EC as amended. EU/1/24/1879/001-004 EU/1/24/1879/001-004 Flucelvax suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) Seqirus Netherlands B.V. 15/11/2024 HM Unknown AU Suspension for injection in pre-filled syringe J07BB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use A/(H1N1)-LIKE VIRUS ANTIGEN A/(H3N2)-LIKE VIRUS ANTIGEN B (Victoria lineage)-like virus antigen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to medical prescription. • Official batch release In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. PA0281/031/004 PA0281/031/004 IC0089-130-001 Flucillin – Flucloxacillin Capsules 250 mg Pinewood Laboratories Ltd 03/05/1995 HM Marketed AU Capsule, hard J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/031/005 PA0281/031/005 IC0089-117-009 Flucillin – Flucloxacillin capsules 500 mg Pinewood Laboratories Ltd 03/05/1995 HM Marketed AU Capsule, hard J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/026/002 PA22871/026/002 Flucloxacillin 1000 mg Film-coated Tablets Azure Pharmaceuticals Ltd. 24/03/2023 HM Not marketed AU Film-coated tablet J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use FLUCLOXACILLIN SODIUM Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/069/002 PA2059/069/002 Flucloxacillin 1000 mg powder for solution for injection/infusion Fresenius Kabi Deutschland GmbH 13/11/2020 HM Marketed AU Powder for solution for injection/infusion J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intraarticular use Intramuscular use Intrapleural use Intravenous use FLUCLOXACILLIN SODIUM Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/036/002 PA1122/036/002 Flucloxacillin 1000 mg powder for solution for injection/infusion Noridem Enterprises Limited 15/11/2024 HM Not marketed AU Powder for solution for injection/infusion J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Flucloxacillin sodium monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1862/003/003 PA1862/003/003 Flucloxacillin 1000 mg Powder for solution for injection/infusion Ibigen Srl 26/08/2016 HM Marketed AU Powder for solution for injection/infusion J01CF J01CF05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA25636/001/002 PA25636/001/002 Flucloxacillin 1000 mg powder for solution for injection or infusion Antibiotice S.A. 13/08/2019 HM Not marketed AU Powder for solution for injection/infusion J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use FLUCLOXACILLIN SODIUM Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/024/001 PA22749/024/001 IC0089-129-060 Flucloxacillin 125 mg/5 ml Powder for Oral Solution, Sugar Free Brillpharma (Ireland) Limited 24/07/2020 HM Not marketed AU Powder for oral solution J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use FLUCLOXACILLIN SODIUM Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1418/016/003 PA1418/016/003 IC0089-129-060 Flucloxacillin 125mg/5ml Oral Solution Athlone Pharmaceuticals Limited 14/10/2011 HM Marketed AU Powder for oral solution J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1418/015/001 PA1418/015/001 IC0089-129-060 Flucloxacillin 125mg/5ml Oral Solution BP Athlone Pharmaceuticals Limited 14/10/2011 HM Not marketed AU Powder for oral solution J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/228/003 PA0281/228/003 Flucloxacillin 1g Powder for Solution for Injection or Infusion Pinewood Laboratories Limited 19/09/2003 HM Not marketed AU Powder for solution for injection/infusion J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Flucloxacillin sodium monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1862/003/004 PA1862/003/004 Flucloxacillin 2000 mg powder for solution for injection/infusion Ibigen Srl 26/08/2016 HM Marketed AU Powder for solution for injection/infusion J01CF J01CF05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/069/003 PA2059/069/003 Flucloxacillin 2000 mg powder for solution for injection/infusion Fresenius Kabi Deutschland GmbH 13/11/2020 HM Marketed AU Powder for solution for injection/infusion J01CF05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intraarticular use Intramuscular use Intrapleural use Intravenous use FLUCLOXACILLIN SODIUM Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/036/003 PA1122/036/003 Flucloxacillin 2000 mg powder for solution for injection/infusion Noridem Enterprises Limited 15/11/2024 HM Not marketed AU Powder for solution for injection/infusion J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Flucloxacillin sodium monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/024/002 PA22749/024/002 IC0089-131-060 Flucloxacillin 250 mg/5 ml Powder for Oral Solution, Sugar Free Brillpharma (Ireland) Limited 24/07/2020 HM Not marketed AU Powder for oral solution J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use FLUCLOXACILLIN SODIUM Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0298/016/001 PA0298/016/001 IC0089-130-001 Flucloxacillin 250 mg Capsules Athlone Laboratories Limited 14/10/2011 HM Not marketed AU Capsule, hard J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1418/016/001 PA1418/016/001 IC0089-130-001 Flucloxacillin 250 mg Capsules Athlone Pharmaceuticals Limited 14/10/2011 HM Marketed AU Capsule, hard J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1862/003/001 PA1862/003/001 Flucloxacillin 250 mg Powder for solution for injection/infusion Ibigen Srl 26/08/2016 HM Marketed AU Powder for solution for injection/infusion J01CF J01CF05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1418/016/004 PA1418/016/004 IC0089-131-060 Flucloxacillin 250mg/5ml Oral Solution Athlone Pharmaceuticals Limited 08/10/2010 HM Marketed AU Oral solution J01CF J01CF05 Complete application (stand-alone) - Council Directive 81/851/EEC Oral use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/228/001 PA0281/228/001 Flucloxacillin 250mg Powder for Solution for Injection or Infusion Pinewood Laboratories Limited 19/09/2008 HM Not marketed AU Powder for solution for injection/infusion J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Flucloxacillin sodium monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0298/016/002 PA0298/016/002 IC0089-117-009 Flucloxacillin 500 mg capsules Athlone Laboratories Limited 14/10/2011 HM Marketed AU Capsule, hard J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1418/016/002 PA1418/016/002 IC0089-117-009 Flucloxacillin 500 mg capsules Athlone Pharmaceuticals Limited 14/10/2011 HM Marketed AU Capsule, hard J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22871/026/001 PA22871/026/001 IC0089-117-009 Flucloxacillin 500 mg film-coated tablets Azure Pharmaceuticals Ltd. 24/03/2023 HM Marketed AU Film-coated tablet J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use FLUCLOXACILLIN SODIUM Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/069/001 PA2059/069/001 Flucloxacillin 500 mg powder for solution for injection/infusion Fresenius Kabi Deutschland GmbH 13/11/2020 HM Marketed AU Powder for solution for injection/infusion J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intraarticular use Intramuscular use Intrapleural use Intravenous use FLUCLOXACILLIN SODIUM Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/036/001 PA1122/036/001 Flucloxacillin 500 mg powder for solution for injection/infusion Noridem Enterprises Limited 15/11/2024 HM Not marketed AU Powder for solution for injection/infusion J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Flucloxacillin sodium monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1862/003/002 PA1862/003/002 Flucloxacillin 500 mg Powder for solution for injection/infusion Ibigen Srl 26/08/2016 HM Marketed AU Powder for solution for injection/infusion J01CF J01CF05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA25636/001/001 PA25636/001/001 Flucloxacillin 500 mg powder for solution for injection or infusion Antibiotice S.A. 13/08/2019 HM Not marketed AU Powder for solution for injection/infusion J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Flucloxacillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/228/002 PA0281/228/002 Flucloxacillin 500mg Powder for Solution for Injection or Infusion Pinewood Laboratories Limited 19/09/2003 HM Not marketed AU Powder for solution for injection/infusion J01CF J01CF05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Flucloxacillin sodium monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/057/003 PA0711/057/003 IC0151-062-001 Flucol 150 mg hard capsules Rowex Limited, 30/07/2004 HM Marketed AU Capsule, hard J02AC J02AC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fluconazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/057/004 PA0711/057/004 IC0151-067-001 Flucol 200 mg hard capsules Rowex Limited, 30/07/2004 HM Marketed AU Capsule, hard J02AC J02AC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fluconazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/057/001 PA0711/057/001 IC0151-023-001 Flucol 50 mg hard capsules Rowex Limited, 30/07/2004 HM Marketed AU Capsule, hard J02AC J02AC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fluconazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/090/002 PA2315/090/002 IC0151-062-001 Fluconazole 150 mg hard capsule Accord Healthcare Ireland Ltd. 17/08/2012 HM Marketed AU Capsule, hard J02AC J02AC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fluconazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0736/030/001 PA0736/030/001 Fluconazole 2 mg/ml solution for infusion B. Braun Melsungen AG 28/11/2008 HM Marketed AU Solution for infusion J02AC J02AC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Fluconazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/033/001 PA2299/033/001 Fluconazole 2 mg/ml solution for infusion Baxter Holding B.V. 04/07/2008 HM Marketed AU Solution for infusion J02AC J02AC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Fluconazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/006/001 PA1122/006/001 Fluconazole 2 mg/mL Solution for infusion Noridem Enterprises Limited 05/02/2010 HM Marketed AU Solution for infusion J02AC J02AC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Fluconazole Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/090/003 PA2315/090/003 IC0151-067-001 Fluconazole 200 mg hard capsule Accord Healthcare Ireland Ltd. 17/08/2012 HM Marketed AU Capsule, hard J02AC J02AC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fluconazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/090/001 PA2315/090/001 IC0151-023-001 Fluconazole 50 mg hard capsules Accord Healthcare Ireland Ltd. 17/08/2012 HM Marketed AU Capsule, hard J02AC J02AC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fluconazole Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0611/004/002 PA0611/004/002 Fludara 10 mg film-coated tablets Sanofi B.V. 08/03/2002 HM Not marketed AU Film-coated tablet L01BB L01BB05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fludarabine phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/035/001 PA2315/035/001 Fludarabine Phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion Accord Healthcare Ireland Ltd. 19/09/2014 HM Marketed AU Concentrate for solution for injection/infusion L01BB L01BB05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Fludarabine phosphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23355/036/001 PA23355/036/001 Fludrocortisone acetate 0.1 mg tablets Viatris Healthcare Limited 01/04/1978 HM Marketed AU Tablet H02AA H02AA02 Full application (Article 8(3) of Directive No 2001/83/EC) Not Currently Available Fludrocortisone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22865/007/001 PA22865/007/001 Fludrocortisone Acetate Renata 0.1 mg tablets Renata Pharmaceuticals (Ireland) Limited 15/12/2023 HM Marketed AU Tablet H02AA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fludrocortisone acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1816/001-002 EU/1/24/1816/001-002 Fluenz nasal spray suspension Influenza vaccine (live, nasal) AstraZeneca AB 03/06/2024 HM Unknown AU Nasal spray, suspension J07BB03 Full application (Article 8(3) of Directive No 2001/83/EC) Nasal use REASSORTANT INFLUENZA VIRUS (LIVE ATTENUATED) B/<OFFICIAL STRAIN> LIKE STRAIN (<ACTUAL STRAIN>) 10^7.0±0.5 FLUORESCENT FOCUS UNITS PER 0.2 ML REASSORTANT INFLUENZA VIRUS (LIVE ATTENUATED) A/<OFFICIAL STRAIN> (H3N2) LIKE STRAIN (<ACTUAL STRAIN>) 10^7.0±0.5 FLUORESCENT FOCUS UNITS PER 0.2 ML REASSORTANT INFLUENZA VIRUS (LIVE ATTENUATED) A/<OFFICIAL STRAIN> (H1N1) LIKE STRAIN (<ACTUAL STRAIN>) 10^7.0±0.5 FLUORESCENT FOCUS UNITS PER 0.2 ML Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2273/001/001 PA2273/001/001 Fluorescein 100 mg/ml solution for injection Pharmargus Limited 27/08/2021 HM Not marketed AU Solution for injection S01JA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Fluorescein sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA0822/223/001 PA0822/223/001 Fluorouracil 25 mg/ml Solution for Injection or Infusion Pfizer Healthcare Ireland Unlimited Company 22/05/1986 HM Marketed AU Solution for injection/infusion L01BC L01BC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Fluorouracil sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/091/001 PA2315/091/001 Fluorouracil 50 mg/ml Solution for Injection or Infusion Accord Healthcare Ireland Ltd. 26/02/2010 HM Marketed AU Solution for injection/infusion L01BC L01BC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Fluorouracil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1567/007/001 PA1567/007/001 Fluoxetine 10 mg hard capsule Activase Pharmaceuticals Limited 23/01/2026 HM Not marketed AU Capsule, hard N06AB03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use FLUOXETINE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22697/010/001 PA22697/010/001 Fluoxetine 20 mg/ 5 ml Oral Solution Syri Pharma Limited t/a Thame Laboratories 20/05/2016 HM Marketed AU Oral solution N06AB N06AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use FLUOXETINE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1567/007/002 PA1567/007/002 IC0075-003-001 Fluoxetine 20 mg hard capsule Activase Pharmaceuticals Limited 23/01/2026 HM Not marketed AU Capsule, hard N06AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use FLUOXETINE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/002/001 PA22749/002/001 IC0075-003-001 Fluoxetine 20mg Hard Capsules Brillpharma (Ireland) Limited 13/07/2012 HM Not marketed AU Capsule, hard N06AB N06AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fluoxetine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1567/007/003 PA1567/007/003 Fluoxetine 30 mg hard capsule Activase Pharmaceuticals Limited 23/01/2026 HM Not marketed AU Capsule, hard N06AB03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use FLUOXETINE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1567/007/004 PA1567/007/004 Fluoxetine 40 mg hard capsule Activase Pharmaceuticals Limited 23/01/2026 HM Not marketed AU Capsule, hard N06AB03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use FLUOXETINE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1567/007/005 PA1567/007/005 IC0075-127-001 Fluoxetine 60 mg hard capsule Activase Pharmaceuticals Limited 23/01/2026 HM Not marketed AU Capsule, hard N06AB03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use FLUOXETINE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/002/002 PA22749/002/002 IC0075-127-001 Fluoxetine 60 mg Hard Capsules Brillpharma (Ireland) Limited 13/07/2012 HM Not marketed AU Capsule, hard N06AB N06AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fluoxetine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/126/001 PA1986/126/001 IC0188-214-070 Fluticasone Furoate Teva 27.5 micrograms/spray, nasal spray, suspension Teva B.V. 31/05/2024 HM Marketed AU Nasal spray, suspension R01AD12 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intranasal use Fluticasone furoate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0678/118/001 PA0678/118/001 Fluticasone propionate 50 micrograms/actuation, nasal spray, suspension Haleon Ireland Limited 12/06/2015 HM Not marketed AU Nasal spray, suspension R01AD R01AD08 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Nasal use Fluticasone propionate (micronised) Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Retail through pharmacies and promotion to the public if compliant with the following restrictions: pack containing not more than 3,000 mcg fluticasone proprionate, maximum period of treatment: 6 months, maxiumum dose: 100 mcg per nostril, maximum daily dose: 200 mcg per nostril, limited indications, pharmaceutical form: non-pressurised nasal spray, for use in adults only. PA1688/013/002 PA1688/013/002 Flutiform 125 microgram/5 microgram per metered dose pressurised inhalation, suspension Mundipharma Pharmaceuticals Limited 19/10/2012 HM Marketed AU Pressurised inhalation, suspension R03AK R03AK11 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Fluticasone propionate Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/138/002 PPA1463/138/002 Flutiform 125 microgram/5 microgram per metered dose pressurised inhalation, suspension IMED Healthcare Ltd., 23/04/2021 HM Unknown AU Pressurised inhalation, suspension R03AK R03AK11 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Inhalation use Fluticasone propionate Formoterol fumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/508/001 PPA0465/508/001 Flutiform 125 microgram/5 microgram per metered dose pressurised inhalation, suspension PCO Manufacturing Ltd. 20/09/2024 HM Unknown AU Pressurised inhalation, suspension R03AK11 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Inhalation use Fluticasone propionate Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1688/013/003 PA1688/013/003 Flutiform 250 microgram/10 microgram per metered dose pressurised inhalation, suspension Mundipharma Pharmaceuticals Limited 19/10/2012 HM Marketed AU Pressurised inhalation, suspension R03AK R03AK11 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Fluticasone propionate Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/138/001 PPA1463/138/001 Flutiform 250 microgram/10 microgram per metered dose pressurised inhalation, suspension IMED Healthcare Ltd., 02/10/2020 HM Unknown AU Pressurised inhalation, suspension R03AK R03AK11 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Inhalation use Fluticasone propionate Formoterol fumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/508/002 PPA0465/508/002 Flutiform 250 microgram/10 microgram per metered dose pressurised inhalation, suspension PCO Manufacturing Ltd. 20/09/2024 HM Unknown AU Pressurised inhalation, suspension R03AK11 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Inhalation use Fluticasone propionate Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1688/013/001 PA1688/013/001 Flutiform 50 microgram/5 microgram per metered dose pressurised inhalation, suspension Mundipharma Pharmaceuticals Limited 19/10/2012 HM Marketed AU Pressurised inhalation, suspension R03AK R03AK11 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Fluticasone propionate Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/110/001 PA0711/110/001 IC0075-003-001 Fluzac 20mg Capsules Rowex Limited, 10/03/2006 HM Marketed AU Capsule, hard N06AB N06AB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use FLUOXETINE HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1824/008/001 PA1824/008/001 FML 0.1% w/v Eye Drops Suspension AbbVie Limited 01/04/1978 HM Not marketed AU Eye drops, suspension S01BA S01BA07 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Fluorometholone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/577/1-4 EU/1/09/577/1-4 Foclivia Seqirus S.r.l. HM Unknown AU Suspension for injection J07BB J07BB02 Informed consent application (Article 10c of Directive No 2001/83/EC) Intramuscular use A/vietnam/1194/2004 (h5n1) virus surface inactivated antigen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23155/001/001 PA23155/001/001 Folic Acid 400 microgram Tablets Generic Pharma International (G.P.I) Limited 14/06/2018 HM Not marketed AU Tablet B03BB B03BB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Folic acid Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA0126/057/001 PA0126/057/001 Folic Acid 5mg Tablets Clonmel Healthcare Ltd 11/05/1988 HM Marketed AU Tablet B03BB B03BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Folic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2165/024/001 PA2165/024/001 Folinic acid (as calcium folinate) 10 mg/ml solution for injection/infusion AS Kalceks 07/12/2023 HM Marketed AU Solution for injection/infusion V03AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Calcium folinate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/001/001 PA2059/001/001 Folinic acid (as calcium folinate) 10 mg/ml solution for injection or infusion Fresenius Kabi Deutschland GmbH 22/01/2016 HM Marketed AU Solution for injection/infusion V03AF V03AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Folinic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0822/198/001 PA0822/198/001 Folinic Acid (as Calcium Folinate) 15mg Tablets Pfizer Healthcare Ireland Unlimited Company 28/07/1986 HM Marketed AU Tablet V03AF V03AF03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Calcium folinate hydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA20595/001/001 PA20595/001/001 Fomepizole SERB 5 mg/mL, concentrate for solution for infusion. SERB S.A. 11/10/2002 HM Marketed AU Concentrate for solution for infusion V03AB V03AB34 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Fomepizole sulphate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1972/001/001 PA1972/001/001 Fomicyt 40 mg/ml Powder for solution for infusion InfectoPharm Arzneimittel und Consilium GmbH 31/07/2015 HM Marketed AU Powder for solution for infusion J01XX J01XX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Fosfomycin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to the general public PA1691/034/001 PA1691/034/001 Fondaparinux Sodium Aspen 1.5 mg/0.3 ml solution for injection, pre-filled syringe Aspen Pharma Trading Limited 29/07/2022 HM Not marketed AU Solution for injection B01AX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Fondaparinux sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1691/034/005 PA1691/034/005 Fondaparinux sodium Aspen 10 mg/0.8 ml solution for injection, pre-filled syringe. Aspen Pharma Trading Limited 29/07/2022 HM Not marketed AU Solution for injection B01AX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Fondaparinux sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1691/034/002 PA1691/034/002 Fondaparinux sodium Aspen 2.5 mg/0.5 ml solution for injection, pre-filled syringe. Aspen Pharma Trading Limited 29/07/2022 HM Not marketed AU Solution for injection B01AX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Fondaparinux sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1691/034/003 PA1691/034/003 Fondaparinux sodium Aspen 5 mg/0.4 ml solution for injection, pre-filled syringe. Aspen Pharma Trading Limited 29/07/2022 HM Not marketed AU Solution for injection B01AX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Fondaparinux sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1691/034/004 PA1691/034/004 Fondaparinux sodium Aspen 7.5 mg/0.6 ml solution for injection, pre-filled syringe. Aspen Pharma Trading Limited 29/07/2022 HM Not marketed AU Solution for injection B01AX05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Fondaparinux sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1239/001/001 PA1239/001/001 Formoterol 12 micrograms inhalation powder, hard capsule Laboratorios LICONSA, S.A. 14/03/2008 HM Not marketed AU Inhalation powder, hard capsule R03AC R03AC13 Well-established use application (Article 10a of Directive No 2001/83/EC) Inhalation use Formoterol fumarate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/03/247/01-2 EU/1/03/247/01-2 Forsteo 20 micrograms/80 microliters solution for injection in pre-filled pen Eli Lilly Nederland B.V. 10/06/2003 HM Unknown AU Solution for injection H05AA H05AA02 New active substance (Article 8(3) of Directive No 2001/83/EC) Teriparatide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/381/001 EU/1/13/381/001 Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution Recordati Ireland Limited 15/11/2013 HM Unknown AU Cutaneous spray, solution N01BB N01BB20 Fixed combination application (Article 10b of Directive No 2001/83/EC) Cutaneous use Lidocaine Prilocaine Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA23311/001/002 PA23311/001/002 Fortum 1 g powder for solution for injection or infusion Sandoz Pharmaceuticals d.d. 24/09/1984 HM Marketed AU Powder for solution for injection/infusion J01DD J01DD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Subcutaneous use Ceftazidime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23311/001/003 PA23311/001/003 Fortum 2 g powder for solution for injection or infusion Sandoz Pharmaceuticals d.d. 24/09/1984 HM Marketed AU Powder for solution for injection/infusion J01DD J01DD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Ceftazidime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23311/001/001 PA23311/001/001 Fortum 500 mg powder for solution for injection Sandoz Pharmaceuticals d.d. 24/09/1984 HM Marketed AU Powder for solution for injection J01DD J01DD02 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Ceftazidime Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/795/006-010 EU/1/12/795/006-010 Forxiga 10 mg film-coated tablets AstraZeneca AB 09/05/2012 HM Unknown AU Film-coated tablet A10BK A10BK01 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Dapagliflozin propanediol monohydrate equivalent to 10mg dapagliflozin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/795/001-005 EU/1/12/795/001-005 Forxiga 5 mg film-coated tablets AstraZeneca AB HM Unknown AU Film-coated tablet A10BK A10BK01 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Dapagliflozin propanediol monohydrate equivalent to 5mg dapagliflozin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/003/001 PA23198/003/001 IC0051-101-002 FOSAMAX Once Weekly 70 mg tablets Organon Pharma (Ireland) Limited 17/05/2001 HM Marketed AU Tablet M05BA M05BA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Alendronic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/05/310/1-4 EU/1/05/310/1-4 IC0052-102-002 Fosavance 70 mg/2800 IU tablets N.V. Organon 24/08/2005 HM Unknown AU Tablet M05BB M05BB03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Vitamin d3 Alendronic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/05/310/6-8 EU/1/05/310/6-8 IC0052-103-002 Fosavance 70 mg/5600 IU tablets N.V. Organon 04/10/2007 HM Unknown AU Tablet M05BB M05BB03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Vitamin d3 Alendronic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22720/009/001 PA22720/009/001 Foscarnet sodium hexahydrate Tillomed 24 mg/ml solution for infusion Tillomed Pharma GmbH 12/08/2022 HM Marketed AU Solution for infusion J05AD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Foscarnet Sodium Hexahydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23429/008/001 PA23429/008/001 Fosfomycin Ascend 3 g granules for oral solution Ascend GmbH 04/04/2025 HM Not marketed AU Granules for oral solution J01XX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Fosfomycin trometamol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0584/008/001 PA0584/008/001 Fostair 100 microgram/6 microgram per actuation pressurised inhalation solution Chiesi Farmaceutici S.p.A. 01/09/2017 HM Not marketed AU Pressurised inhalation, solution R03AK08 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0584/008/003 PA0584/008/003 Fostair 200 microgram/6 microgram per actuation pressurised inhalation solution Chiesi Farmaceutici S.p.A. 13/04/2018 HM Not marketed AU Pressurised inhalation, solution R03AK R03AK08 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0584/008/002 PA0584/008/002 Fostair Nexthaler 100 micrograms/6 micrograms per metered dose inhalation powder Chiesi Farmaceutici S.p.A. 19/01/2018 HM Not marketed AU Inhalation powder R03AK R03AK08 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Beclometasone dipropionate Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0584/008/004 PA0584/008/004 Fostair Nexthaler 200 micrograms/6 micrograms per metered dose inhalation powder Chiesi Farmaceutici S.p.A. 13/04/2018 HM Not marketed AU Inhalation powder R03AK R03AK08 Fixed combination application (Article 10b of Directive No 2001/83/EC) Inhalation use Formoterol fumarate dihydrate Beclometasone dipropionate anhydrous Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/018/001 PA23266/018/001 IC0051-101-002 Fostepor Once Weekly 70mg tablets Viatris Limited 13/10/2006 HM Marketed AU Tablet M05BA M05BA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Alendronic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1104/002/002 PA1104/002/002 Fostimon 150 IU, powder and solvent for solution for injection IBSA Farmaceutici Italia S.r.l 23/11/2007 HM Not marketed AU Powder and solvent for solution for injection G03GA G03GA04 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Subcutaneous use Urofollitropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1104/002/001 PA1104/002/001 Fostimon 75 IU, powder and solvent for solution for injection IBSA Farmaceutici Italia S.r.l 23/11/2007 HM Not marketed AU Powder and solvent for solution for injection G03GA G03GA04 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Subcutaneous use Urofollitropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1104/002/004 PA1104/002/004 Fostimon PFS 150 IU Powder and Solvent for Solution for Injection IBSA Farmaceutici Italia S.r.l 23/11/2007 HM Not marketed AU Powder and solvent for solution for injection G03GA G03GA04 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Subcutaneous use Urofollitropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1104/002/005 PA1104/002/005 Fostimon PFS 225 IU Powder and Solvent for Solution for Injection IBSA Farmaceutici Italia S.r.l 22/02/2013 HM Not marketed AU Powder and solvent for solution for injection G03GA G03GA04 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Subcutaneous use Urofollitropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1104/002/006 PA1104/002/006 Fostimon PFS 300 IU Powder and Solvent for Solution for Injection IBSA Farmaceutici Italia S.r.l 22/02/2013 HM Not marketed AU Powder and solvent for solution for injection G03GA G03GA04 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Subcutaneous use Urofollitropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1104/002/003 PA1104/002/003 Fostimon PFS 75 IU Powder and Solvent for Solution for Injection IBSA Farmaceutici Italia S.r.l 23/11/2007 HM Not marketed AU Powder and solvent for solution for injection G03GA G03GA04 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Subcutaneous use Urofollitropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1215/002 EU/1/17/1215/002 Fotivda 1340 microgram hard capsules EUSA Pharma (Netherlands) B.V. 24/08/2017 HM Unknown AU Capsule, hard Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tivozanib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1215/001 EU/1/17/1215/001 Fotivda 890 microgram hard capsules EUSA Pharma (Netherlands) B.V. 24/08/2017 HM Unknown AU Capsule, hard L01XE L01XE34 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tivozanib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23211/002/004 PA23211/002/004 Foznol 1000 mg Chewable Tablets Takeda Pharmaceuticals International AG Ireland Branch 17/06/2005 HM Marketed AU Chewable tablet V03AE V03AE03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Lanthanum Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/495/001 PPA0465/495/001 Foznol 1000 mg Chewable Tablets PCO Manufacturing Ltd. 30/09/2022 HM Unknown AU Chewable tablet V03AE V03AE03 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Lanthanum Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23211/002/006 PA23211/002/006 Foznol 1000 mg Oral Powder Takeda Pharmaceuticals International AG Ireland Branch 11/05/2012 HM Not marketed AU Oral powder V03AE V03AE03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Lanthanum carbonate hydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23211/002/001 PA23211/002/001 Foznol 250 mg Chewable Tablets Takeda Pharmaceuticals International AG Ireland Branch 17/06/2005 HM Not marketed AU Chewable tablet V03AE V03AE03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Lanthanum carbonate hydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23211/002/002 PA23211/002/002 Foznol 500 mg Chewable Tablets Takeda Pharmaceuticals International AG Ireland Branch 17/06/2005 HM Marketed AU Chewable tablet V03AE V03AE03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Lanthanum Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23211/002/003 PA23211/002/003 Foznol 750 mg Chewable Tablets Takeda Pharmaceuticals International AG Ireland Branch 17/06/2005 HM Marketed AU Chewable tablet V03AE V03AE03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Lanthanum Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23211/002/005 PA23211/002/005 Foznol 750 mg Oral Powder Takeda Pharmaceuticals International AG Ireland Branch 11/05/2012 HM Not marketed AU Oral powder V03AE V03AE03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Lanthanum carbonate hydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/218/001 PA0711/218/001 IC0191-215-003 Freedo 0.03mg/3mg film-coated tablets Rowex Limited, 09/10/2009 HM Marketed AU Film-coated tablet G03AA G03AA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Drospirenone Ethinylestradiol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0711/208/001 PA0711/208/001 IC0191-216-003 Freedonel 0.02 mg/3 mg film-coated tablets Rowex Limited, 09/10/2009 HM Marketed AU Film-coated tablet G03AA G03AA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ethinylestradiol Drospirenone Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22657/004/001 PA22657/004/001 Frisium 10mg Tablets Atnahs Pharma Netherlands B.V. 25/08/1980 HM Marketed AU Tablet N05BA N05BA09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Clobazam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA0688/027/001 PA0688/027/001 Frovatriptan 2.5mg Film-coated Tablets Chanelle Medical Unlimited Company 19/07/2013 HM Not marketed AU Film-coated tablet N02CC N02CC07 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Frovatriptan succinate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0865/009/001 PA0865/009/001 FROVEX 2.5 mg film-coated tablets Menarini International Operations Luxembourg S.A. 17/05/2002 HM Marketed AU Film-coated tablet N02CC N02CC07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use FROVATRIPTAN Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/321/001 PPA0465/321/001 FROVEX 2.5 mg film-coated tablets PCO Manufacturing Ltd. 23/08/2013 HM Unknown AU Film-coated tablet N02CC N02CC07 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Frovatriptan succinate monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/262/001 PPA1463/262/001 FROVEX 2.5 mg film-coated tablets IMED Healthcare Ltd., 06/07/2026 HM Unknown AU Film-coated tablet N02CC07 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Oral use Frovatriptan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0540/101/002 PA0540/101/002 Frumil 40mg/5mg Tablets Sanofi-Aventis Ireland Limited T/A SANOFI 29/01/1991 HM Marketed AU Tablet C03EB C03EB01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Furosemide AMILORIDE HYDROCHLORIDE Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1827/001 EU/1/24/1827/001 FRUZAQLA 1 mg hard capsules Hutchmed Europe B.V. 20/06/2024 HM Unknown AU Capsule, hard L01EK04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fruquintinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1827/002 EU/1/24/1827/002 FRUZAQLA 5 mg hard capsules Hutchmed Europe B.V. 20/06/2024 HM Unknown AU Capsule, hard L01EK04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fruquintinib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/26/2023/001-003 EU/1/26/2023/001-003 Fubelv 25 mg solution for injection in pre-filled syringe Biocon Biologics Ireland Limited 23/04/2026 HM Unknown AU Solution for injection in pre-filled syringe L04AB01 Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC) Subcutaneous use Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/26/2023/006-007 EU/1/26/2023/006-007 Fubelv 50 mg solution for injection in pre-filled pen Biocon Biologics Ireland Limited 23/04/2026 HM Unknown AU Solution for injection in pre-filled pen L04AB01 Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC) Subcutaneous use Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/26/2023/004-005 EU/1/26/2023/004-005 Fubelv 50 mg solution for injection in pre-filled syringe Biocon Biologics Ireland Limited 23/04/2026 HM Unknown AU Solution for injection in pre-filled syringe L04AB01 Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC) Subcutaneous use Etanercept Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0046/040/001 PA0046/040/001 Fucibet 20 mg/g + 1 mg/g cream Leo Laboratories Limited 23/05/1984 HM Marketed AU Cream D07CC D07CC01 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Fusidic acid Betamethasone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/231/002 PPA0465/231/002 Fucibet Lipid 20 mg/g + 1 mg/g cream PCO Manufacturing Ltd. 27/07/2012 HM Unknown AU Cream D07CC01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Cutaneous use Betamethasone Fusidic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0046/040/002 PA0046/040/002 Fucibet Lipid 20mg/g + 1mg/g cream Leo Laboratories Limited 12/05/2006 HM Marketed AU Cream D07CC D07CC01 Full application (Article 8(3) of Directive No 2001/83/EC) Topical use Fusidic acid Betamethasone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PPA1463/197/001 PPA1463/197/001 Fucibet Lipid 20mg/g + 1mg/g cream IMED Healthcare Ltd. 03/02/2023 HM Unknown AU Cream D07CC D07CC01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Topical use Fusidic acid Betamethasone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0046/004/012 PA0046/004/012 Fucidin 20 mg/g cream Leo Laboratories Limited 13/10/1980 HM Marketed AU Cream D06AX D06AX01 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Fusidic acid hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0046/004/008 PA0046/004/008 Fucidin 20 mg/g ointment Leo Laboratories Limited 01/04/1977 HM Marketed AU Ointment D06AX D06AX01 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Sodium fusidate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0046/004/014 PA0046/004/014 Fucidin 250mg Tablets Leo Laboratories Limited 13/03/1990 HM Not marketed AU Tablet J01XC J01XC01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium fusidate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0046/005/005 PA0046/005/005 Fucidin H 20mg/g + 10mg/g Cream Leo Laboratories Limited 29/03/1985 HM Marketed AU Cream D07CA D07CA01 Full application (Article 8(3) of Directive No 2001/83/EC) Cutaneous use Fusidic acid HYDROCORTISONE ACETATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/016/001 PA1142/016/001 Fucithalmic 10 mg/g Viscous Eye Drops, suspension Amdipharm Limited 06/04/1988 HM Marketed AU Eye drops, suspension S01AA S01AA13 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Fusidic acid hemihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/18/1329/001-002 EU/1/18/1329/001-002 Fulphila 6 mg solution for injection in pre-filled syringe Biosimilar Collaborations Ireland Limited 20/11/2018 HM Unknown AU Solution for injection in pre-filled syringe L03AA13 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Pegfilgrastim Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23092/001/001 PA23092/001/001 IC0129-130-063 Fulvestrant 250 mg solution for injection in pre-filled syringe Reddy Holding GmbH 05/08/2022 HM Not marketed AU Solution for injection in pre-filled syringe L02BA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Fulvestrant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/046/001 PA2315/046/001 IC0129-130-063 Fulvestrant 250 mg Solution for injection in pre-filled syringe Accord Healthcare Ireland Ltd. 20/10/2017 HM Marketed AU Solution for injection in pre-filled syringe L02BA L02BA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Fulvestrant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1774/006/001 PA1774/006/001 IC0129-130-063 Fulvestrant EVER Pharma 250 mg solution for injection in pre-filled syringe EVER Valinject GmbH HM Marketed AU Solution for injection in pre-filled syringe L02BA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Fulvestrant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/17/1253/001-002 EU/1/17/1253/001-002 IC0129-130-063 Fulvestrant Mylan 250 mg solution for injection in pre-filled syringe Mylan Pharmaceuticals Limited 08/01/2018 HM Unknown AU Solution for injection in pre-filled syringe L02BA L02BA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Fulvestrant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0711/245/001 PA0711/245/001 IC0129-130-063 Fulvestrant Rowex 250 mg/5 ml solution for injection in pre-filled syringe Rowex Limited, 28/08/2015 HM Marketed AU Solution for injection in pre-filled syringe L02BA L02BA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Fulvestrant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/011/001 PA1986/011/001 IC0129-130-063 Fulvestrant Teva 250 mg Solution for Injection in Pre-filled Syringe Teva B.V. 04/03/2016 HM Marketed AU Solution for injection in pre-filled syringe L02BA L02BA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Fulvestrant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/141/001 PA0126/141/001 IC0150-130-002 Fungasil 250 mg tablets Clonmel Healthcare Ltd 12/08/2009 HM Marketed AU Tablet D01BA D01BA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Terbinafine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2239/004/001 PA2239/004/001 Fungizone 50 mg Powder for sterile concentrate CHEPLAPHARM Arzneimittel GmbH 01/04/1977 HM Marketed AU Powder for concentrate for solution for infusion J02AA J02AA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Amphotericin b Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/036/001 PA2299/036/001 Furosemide 10 mg/ml Solution for Injection Baxter Holding B.V. 03/04/2009 HM Not marketed AU Solution for injection C03CA C03CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Furosemide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2237/002/001 PA2237/002/001 Furosemide 10 mg/ml solution for injection/infusion hameln pharma gmbh 25/09/2020 HM Not marketed AU Solution for injection C03CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Furosemide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/163/001 PA2315/163/001 Furosemide 10 mg/ml Solution for Injection or Infusion Accord Healthcare Ireland Ltd. 22/07/2005 HM Marketed AU Solution for injection/infusion C03CA C03CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Furosemide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/038/001 PA2059/038/001 Furosemide 20 mg/2 ml solution for injection/infusion Fresenius Kabi Deutschland GmbH 01/02/2008 HM Not marketed AU Solution for injection C03CA C03CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Furosemide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/008/001 PA0126/008/001 Furosemide 20 mg Tablets Clonmel Healthcare Ltd 03/11/1978 HM Marketed AU Tablet C03CA C03CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Furosemide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0073/059/004 PA0073/059/004 Furosemide 20mg in 2ml Solution for Injection Mercury Pharmaceuticals (Ireland) Ltd 15/03/1982 HM Marketed AU Solution for injection C03CA C03CA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Furosemide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0073/059/006 PA0073/059/006 Furosemide 250mg in 25ml Solution for Injection/Infusion Mercury Pharmaceuticals (Ireland) Ltd 28/05/1990 HM Not marketed AU Solution for injection/infusion C03CA C03CA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Furosemide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0126/008/002 PA0126/008/002 Furosemide 40 mg Tablets Clonmel Healthcare Ltd 03/11/1978 HM Marketed AU Tablet C03CA C03CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Furosemide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0073/059/005 PA0073/059/005 Furosemide 50mg in 5ml Solution for Injection Mercury Pharmaceuticals (Ireland) Ltd 28/05/1990 HM Marketed AU Solution for injection C03CA C03CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Furosemide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/001/001 PA22749/001/001 Furosemide Bristol 20 mg Tablets Brillpharma (Ireland) Limited 26/05/2006 HM Marketed AU Tablet C03CA C03CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Furosemide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22749/001/002 PA22749/001/002 Furosemide Bristol 40 mg Tablets Brillpharma (Ireland) Limited 26/05/2006 HM Marketed AU Tablet C03CA C03CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Furosemide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/421/001 PA0126/421/001 Furosemide Clonmel 20 mg tablets Clonmel Healthcare Ltd 29/05/2026 HM Not marketed AU Tablet C03CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Furosemide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/421/002 PA0126/421/002 Furosemide Clonmel 40 mg tablets Clonmel Healthcare Ltd 29/05/2026 HM Not marketed AU Tablet C03CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Furosemide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/263/001 PA0281/263/001 Furosemide Pinewood 20 mg Tablets Pinewood Laboratories Ltd 20/10/2023 HM Marketed AU Tablet C03CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Furosemide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/263/002 PA0281/263/002 Furosemide Pinewood 40 mg Tablets Pinewood Laboratories Ltd 20/10/2023 HM Marketed AU Tablet C03CA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Furosemide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA25477/001/001 PA25477/001/001 Fusidic acid/Betamethasone Bailleul 20 mg/g + 1 mg/g Cream Laboratoires Bailleul S.A. 05/09/2025 HM Not marketed AU Cream D07CC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Fusidic acid Betamethasone valerate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23425/001/001 PA23425/001/001 Fusidic acid/Betamethasone Galenpharma 20+1mg/gram(s) Cream GALENpharma GmbH 19/07/2024 HM Not marketed AU Cream D07CC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Fusidic acid Betamethasone valerate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA25250/001/001 PA25250/001/001 Fusidic acid/Betamethasone Laboratoires Medgen 20 mg/g + 1 mg/g Cream Laboratoires Medgen 12/09/2025 HM Not marketed AU Cream D07CC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Fusidic acid Betamethasone valerate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/03/252/001 EU/1/03/252/001 Fuzeon Roche Registration GmbH 27/05/2003 HM Not marketed AU Powder and solvent for solution for injection J05AX J05AX07 New active substance (Article 8(3) of Directive No 2001/83/EC) Enfuvirtide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA0979/009/001 PA0979/009/001 Fybogel Citrus 3.5 g Granules Reckitt Benckiser Ireland Limited 27/01/1975 HM Not marketed AU Granules A06AC A06AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ispaghula husks Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0979/010/001 PA0979/010/001 Fybogel Mebeverine Granules for Oral Suspension Ispaghula Husk 3.5g Mebeverine Hydrochloride 135mg Reckitt Benckiser Ireland Limited 14/03/1986 HM Not marketed AU Granules for oral suspension A06AC A06AC51 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Mebeverine hydrochloride Ispaghula husks Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0979/009/002 PA0979/009/002 Fybogel Orange 3.5 g granules Reckitt Benckiser Ireland Ltd, 08/04/1993 HM Marketed AU Granules A06AC A06AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ispaghula husks Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public EU/1/12/776/024 EU/1/12/776/024 Fycompa 0.5 mg film-coated tablets Eisai GmbH 19/06/2016 HM Unknown AU Oral suspension N03AX N03AX22 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Perampanel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/776/011-013 EU/1/12/776/011-013 Fycompa 10 mg film-coated tablets Eisai GmbH HM Unknown AU Film-coated tablet N03AX N03AX22 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Perampanel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/776/014-016 EU/1/12/776/014-016 Fycompa 12 mg film-coated tablets Eisai GmbH HM Unknown AU Film-coated tablet N03AX N03AX22 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Perampanel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/776/001 EU/1/12/776/001 Fycompa 2 mg film-coated tablets Eisai GmbH HM Unknown AU Film-coated tablet N03AX N03AX22 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Perampanel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/776/002-004 EU/1/12/776/002-004 Fycompa 4 mg film-coated tablets Eisai GmbH HM Unknown AU Film-coated tablet N03AX N03AX22 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Perampanel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/776/005-007 EU/1/12/776/005-007 Fycompa 6 mg film-coated tablets Eisai GmbH HM Unknown AU Film-coated tablet N03AX N03AX22 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Perampanel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/776/008-010 EU/1/12/776/008-010 Fycompa 8 mg film-coated tablets Eisai GmbH HM Unknown AU Film-coated tablet N03AX N03AX22 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Perampanel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1107/012/001 PA1107/012/001 Fydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml, solution for injection Laboratoires Thea 28/08/2015 HM Marketed AU Solution for injection S01FA S01FA56 Fixed combination application (Article 10b of Directive No 2001/83/EC) Intraocular use Tropicamide Phenylephrine hydrochloride Lidocaine Hydrochloride Monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/26/2020/001-003 EU/1/26/2020/001-003 FYLREVY 14.2 mg film-coated tablets Gedeon Richter Plc 26/03/2026 HM Unknown AU Film-coated tablet G03CA10 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Estetrol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/26/2020/004-006 EU/1/26/2020/004-006 FYLREVY 18.9 mg film-coated tablets Gedeon Richter Plc 26/03/2026 HM Unknown AU Film-coated tablet G03CA10 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Estetrol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1862/003 EU/1/24/1862/003 Fymskina 130 mg Concentrate for solution for infusion Formycon AG 25/09/2024 HM Unknown AU Concentrate for solution for infusion L04AC05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Ustekinumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1862/001 EU/1/24/1862/001 Fymskina 45 mg Solution for injection Formycon AG 25/09/2024 HM Unknown AU Solution for injection in pre-filled syringe L04AC05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Ustekinumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1862/002 EU/1/24/1862/002 Fymskina 90 mg Solution for injection Formycon AG 25/09/2024 HM Unknown AU Solution for injection in pre-filled syringe L04AC05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Ustekinumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2315/164/003 PA2315/164/003 IC0109-024-001 Gabapentin 100 mg hard capsules Accord Healthcare Ireland Ltd. 14/10/2016 HM Not marketed AU Capsule, hard N02BF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gabapentin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/164/004 PA2315/164/004 IC0109-029-001 Gabapentin 300 mg hard capsules Accord Healthcare Ireland Ltd. 14/10/2016 HM Not marketed AU Capsule, hard N02BF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gabapentin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/164/005 PA2315/164/005 IC0109-068-001 Gabapentin 400 mg hard capsules Accord Healthcare Ireland Ltd. 14/10/2016 HM Not marketed AU Capsule, hard N02BF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gabapentin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/164/001 PA2315/164/001 IC0109-168-003 Gabapentin 600 mg film-coated tablets Accord Healthcare Ireland Ltd. 05/12/2011 HM Not marketed AU Film-coated tablet N02BF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gabapentin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/164/002 PA2315/164/002 IC0109-169-003 Gabapentin 800 mg film-coated tablets Accord Healthcare Ireland Ltd. 05/12/2011 HM Not marketed AU Film-coated tablet N02BF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gabapentin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1445/026/001 PA1445/026/001 IC0109-024-001 Gabapentin Auro 100 mg hard capsules Aurobindo Pharma (Malta) Limited 21/10/2022 HM Unknown AU Capsule, hard N02BF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gabapentin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1445/026/002 PA1445/026/002 IC0109-029-001 Gabapentin Auro 300 mg hard capsules Aurobindo Pharma (Malta) Limited 21/10/2022 HM Unknown AU Capsule, hard N02BF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gabapentin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1445/026/003 PA1445/026/003 IC0109-068-001 Gabapentin Auro 400 mg hard capsules Aurobindo Pharma (Malta) Limited 21/10/2022 HM Unknown AU Capsule, hard N02BF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gabapentin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23081/010/001 PA23081/010/001 IC0109-126-019 Gabapentin Rosemont 50 mg/ml Oral Solution Taw Pharma (Ireland) Limited 26/10/2012 HM Marketed AU Oral solution N02BF01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Gabapentin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22697/025/001 PA22697/025/001 IC0109-126-019 Gabapentin Thame 50 mg/ml oral solution Syri Pharma Limited t/a Thame Laboratories 27/06/2025 HM Marketed AU Oral solution N02BF01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Gabapentin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1445/020/001 PA1445/020/001 IC0109-024-001 Gabin 100 mg capsules, hard Aurobindo Pharma (Malta) Limited 03/06/2011 HM Marketed AU Capsule, hard N02BF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gabapentin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1445/020/002 PA1445/020/002 IC0109-029-001 Gabin 300 mg capsules, hard Aurobindo Pharma (Malta) Limited 03/06/2011 HM Marketed AU Capsule, hard N02BF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gabapentin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1445/020/003 PA1445/020/003 IC0109-068-001 Gabin 400 mg capsules, hard Aurobindo Pharma (Malta) Limited 03/06/2011 HM Marketed AU Capsule, hard N02BF01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gabapentin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/199/002 PA0749/199/002 Gabitril 10 mg film-coated tablets Teva Pharma B.V. 07/03/1997 HM Marketed AU Film-coated tablet N03AG N03AG06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tiagabine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/199/003 PA0749/199/003 Gabitril 15 mg film-coated tablets Teva Pharma B.V. 07/03/1997 HM Marketed AU Film-coated tablet N03AG N03AG06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tiagabine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0749/199/001 PA0749/199/001 Gabitril 5 mg, film-coated tablet Teva Pharma B.V. 07/03/1997 HM Marketed AU Film-coated tablet N03AG N03AG06 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tiagabine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1410/018/003 PA1410/018/003 Gadovist 1.0 mmol/ml solution for injection Bayer Limited 08/12/2000 HM Not marketed AU Solution for injection V08CA V08CA09 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Gadobutrol Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only Restricted to hospital dispensing. PA1410/018/001 PA1410/018/001 Gadovist 1.0 mmol/ml solution for injection Bayer Limited 08/12/2000 HM Not marketed AU Solution for injection V08CA V08CA09 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Gadobutrol Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only PA1410/018/004 PA1410/018/004 Gadovist 1.0 mmol/ml solution for injection in prefilled cartridge Bayer Limited 08/04/2009 HM Not marketed AU Solution for injection in cartridge V08CA V08CA09 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Gadobutrol Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only Restricted to hospital dispensing. PA1410/018/002 PA1410/018/002 Gadovist 1.0 mmol/ml solution for injection in prefilled syringe Bayer Limited 20/04/2001 HM Marketed AU Solution for injection in pre-filled syringe V08CA V08CA09 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Gadobutrol Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only Restricted to hospital dispensing. EU/1/15/1082/001 EU/1/15/1082/001 Galafold 123 mg hard capsules Amicus Therapeutics Europe Limited 26/05/2016 HM Unknown AU Capsule, hard Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Migalastat hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/2004/001 EU/1/25/2004/001 GalenVita 0.74 GBq radionuclide generator Monrol Europe S.R.L. 08/01/2026 HM Unknown AU Radionuclide generator V09X Well-established use application (Article 10a of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/2004/002 EU/1/25/2004/002 GalenVita 1.11 GBq radionuclide generator Monrol Europe S.R.L. 08/01/2026 HM Unknown AU Radionuclide generator V09X Well-established use application (Article 10a of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/2004/003 EU/1/25/2004/003 GalenVita 1.48 GBq radionuclide generator Monrol Europe S.R.L. 08/01/2026 HM Unknown AU Radionuclide generator V09X Well-established use application (Article 10a of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/2004/004 EU/1/25/2004/004 GalenVita 1.85 GBq radionuclide generator Monrol Europe S.R.L. 08/01/2026 HM Unknown AU Radionuclide generator V09X Well-established use application (Article 10a of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/2004/005 EU/1/25/2004/005 GalenVita 2.22 GBq radionuclide generator Monrol Europe S.R.L. 08/01/2026 HM Unknown AU Radionuclide generator V09X Well-established use application (Article 10a of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/2004/006 EU/1/25/2004/006 GalenVita 2.59 GBq radionuclide generator Monrol Europe S.R.L. 08/01/2026 HM Unknown AU Radionuclide generator V09X Well-established use application (Article 10a of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/2004/007 EU/1/25/2004/007 GalenVita 2.96 GBq radionuclide generator Monrol Europe S.R.L. 08/01/2026 HM Unknown AU Radionuclide generator V09X Well-established use application (Article 10a of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/2004/008 EU/1/25/2004/008 GalenVita 3.33 GBq radionuclide generator Monrol Europe S.R.L. 08/01/2026 HM Unknown AU Radionuclide generator V09X Well-established use application (Article 10a of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/2004/009 EU/1/25/2004/009 GalenVita 3.70 GBq radionuclide generator Monrol Europe S.R.L. 08/01/2026 HM Unknown AU Radionuclide generator V09X Well-established use application (Article 10a of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0126/314/002 PA0126/314/002 Galfer 140 mg/5ml Oral Suspension Clonmel Healthcare Ltd 25/07/1988 HM Marketed AU Oral suspension B03AA B03AA02 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Ferrous fumarate Ph.Eur. Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0126/314/001 PA0126/314/001 Galfer 305 mg hard capsules Clonmel Healthcare Ltd 04/06/1976 HM Marketed AU Capsule, hard B03AA B03AA02 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Ferrous fumarate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0126/317/001 PA0126/317/001 Galfer FA 305 mg/0.35 mg Hard Capsules Clonmel Healthcare Ltd 04/06/1976 HM Not marketed AU Capsule, hard B03AD B03AD02 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Ferrous fumarate Folic acid Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA25393/001/001 PA25393/001/001 Galliad 0.74 to 1.85 GBq Radionuclide generator IRE Elit 09/01/2026 HM Marketed AU Radionuclide generator V09X Full application (Article 8(3) of Directive No 2001/83/EC) GERMANIUM (68GE) CHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1836/001 EU/1/24/1836/001 GalliaPharm 1.11 GBq Radionuclide generator Eckert & Ziegler Radiopharma GmbH 01/08/2024 HM Unknown AU Radionuclide generator V09X Full application (Article 8(3) of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1836/002 EU/1/24/1836/002 GalliaPharm 1.48 GBq Radionuclide generator Eckert & Ziegler Radiopharma GmbH 01/08/2024 HM Unknown AU Radionuclide generator V09X Full application (Article 8(3) of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1836/003 EU/1/24/1836/003 GalliaPharm 1.85 GBq Radionuclide generator Eckert & Ziegler Radiopharma GmbH 01/08/2024 HM Unknown AU Radionuclide generator V09X Full application (Article 8(3) of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1836/004 EU/1/24/1836/004 GalliaPharm 2.22 GBq Radionuclide generator Eckert & Ziegler Radiopharma GmbH 01/08/2024 HM Unknown AU Radionuclide generator V09X Full application (Article 8(3) of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1836/005 EU/1/24/1836/005 GalliaPharm 2.59 GBq Radionuclide generator Eckert & Ziegler Radiopharma GmbH 01/08/2024 HM Unknown AU Radionuclide generator V09X Full application (Article 8(3) of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1836/006 EU/1/24/1836/006 GalliaPharm 2.96 GBq Radionuclide generator Eckert & Ziegler Radiopharma GmbH 01/08/2024 HM Unknown AU Radionuclide generator V09X Full application (Article 8(3) of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1836/007 EU/1/24/1836/007 GalliaPharm 3.33 GBq Radionuclide generator Eckert & Ziegler Radiopharma GmbH 01/08/2024 HM Unknown AU Radionuclide generator V09X Full application (Article 8(3) of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1836/008 EU/1/24/1836/008 GalliaPharm 3.70 GBq Radionuclide generator Eckert & Ziegler Radiopharma GmbH 01/08/2024 HM Unknown AU Radionuclide generator V09X Full application (Article 8(3) of Directive No 2001/83/EC) Route of administration not applicable GERMANIUM (68GE) CHLORIDE Gallium (68Ga) Chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0690/003/001 PA0690/003/001 Gallium (Ga67) Citrate injection Curium Netherlands B.V. 31/03/2000 HM Marketed AU Solution for injection V09HX V09HX01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Gallium (67 ga) citrate Product subject to Restricted Prescription (C) Supply through pharmacies only Advertising to healthcare professionals only Restricted to hospital dispensing PA1347/015/002 PA1347/015/002 Galsya SR 16 mg prolonged-release capsules, hard KRKA, d.d., Novo mesto 03/06/2011 HM Marketed AU Prolonged-release capsule, hard N06DA N06DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Galantamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/015/003 PA1347/015/003 Galsya SR 24 mg prolonged-release capsules, hard KRKA, d.d., Novo mesto 03/06/2011 HM Marketed AU Prolonged-release capsule, hard N06DA N06DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Galantamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/015/001 PA1347/015/001 Galsya SR 8 mg prolonged-release capsules, hard KRKA, d.d., Novo mesto 03/06/2011 HM Marketed AU Prolonged-release capsule, hard N06DA N06DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Galantamine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0864/001/003 PA0864/001/003 Galtasa 1000 mg gastro-resistant tablets Faes Farma S.A. 12/08/2022 HM Not marketed AU Gastro-resistant tablet A07EC02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Mesalazine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0864/001/001 PA0864/001/001 Galtasa 500 mg gastro-resistant tablets Faes Farma S.A. 02/10/2020 HM Not marketed AU Gastro-resistant tablet A07EC02 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Mesalazine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0864/001/002 PA0864/001/002 Galtasa 500 mg suppositories Faes Farma S.A. 28/10/2022 HM Not marketed AU Suppository A07EC02 Full application (Article 8(3) of Directive No 2001/83/EC) Rectal use Mesalazine Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/414/1-10 EU/1/07/414/1-10 Galvus 50 mg Tablet Novartis Europharm Limited HM Unknown AU Tablet A10BH A10BH02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Vildagliptin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1701/004/001 PA1701/004/001 Gamanil 70mg film-coated tablets Zentiva k.s. 14/05/1984 HM Marketed AU Film-coated tablet N06AA N06AA07 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Lofepramine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1405/001/001 PA1405/001/001 Gamunex 10%, 100 mg/ml, solution for infusion Grifols Deutschland GmbH 11/08/2006 HM Marketed AU Solution for infusion J06BA J06BA02 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Immunoglobulin human normal Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.1 of Directive 2001/83/EC, as amended. EU/1/06/340/001-002 EU/1/06/340/001-002 Ganfort 0.3 mg/ml + 5 mg/ml eye drops, solution AbbVie Deutschland GmbH & Co. KG HM Unknown AU Eye drops, solution S01ED S01ED51 Full application (Article 8(3) of Directive No 2001/83/EC) Bimatoprost Timolol Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/22/1658/001-002 EU/1/22/1658/001-002 Ganirelix Gedeon Richter 0.25 mg/0.5 mL solution for injection in pre-filled syringe Chemical Works Of Gedeon Richter PLC 15/07/2022 HM Unknown AU Solution for injection in pre-filled syringe H01CC01 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Ganirelix Acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/06/357/01-21 EU/1/06/357/01-21 Gardasil Merck Sharp & Dohme BV, HM Unknown AU Suspension for injection J07BM01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Quadrivalent human papillomavirus type 11 recombinant vaccine (in) Quadrivalent human papillomavirus type 16 recombinant vaccine (in) Quadrivalent human papillomavirus type 18 recombinant vaccine (in) Quadrivalent human papillomavirus type 6 recombinant vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1007/001-004 EU/1/15/1007/001-004 Gardasil 9 suspension for injection. Gardasil 9 suspension for injection in a pre-filled syringe. Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed) Merck Sharp & Dohme BV, 10/06/2015 HM Unknown AU Suspension for injection J07B New active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hpv type 6 l1 protein Hpv type 11 l1 protein Hpv 16 l1 protein Hpv 18 l1 protein Hpv type 31 l1 protein Hpv type 33 l1 protein Hpv type 45 l1 protein Hpv type 52 l1 protein Hpv type 58 l1 protein Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1410/004/001 PA1410/004/001 Gastrografin, 660mg/ml and 100mg/ml Oral and Rectal Solution Bayer Limited 01/04/1983 HM Marketed AU Oral/rectal solution V08AA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rectal use Sodium amidotrizoate Amidotrizoate meglumine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1826/005/001 PA1826/005/001 Gastromiro 612.4 mg/ml oral or rectal solution Bracco Imaging spa 10/04/1990 HM Marketed AU Oral/rectal solution V08AB V08AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Rectal use Iopamidol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0979/011/008 PA0979/011/008 Gaviscon Advance Chewable Tablets Sodium alginate 500 mg, Potassium hydrogen carbonate 100 mg. Reckitt Benckiser Ireland Ltd 10/02/2006 HM Marketed AU Chewable tablet A02BX A02BX13 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium alginate Potassium hydrogen carbonate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0979/011/001 PA0979/011/001 Gaviscon Advance Oral Suspension Sodium alginate 500 mg, Potassium hydrogen carbonate 100 mg. Reckitt Benckiser Ireland Limited 14/08/1998 HM Marketed AU Oral suspension A02BX Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium alginate Potassium hydrogen carbonate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0979/011/006 PA0979/011/006 Gaviscon Advance Peppermint Oral Suspension Sachets Sodium Alginate 500mg, Potassium hydrogen carbonate 100 mg Oral suspension. Reckitt Benckiser Ireland Limited 05/03/2004 HM Not marketed AU Oral suspension A02BX A02BX13 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium alginate Potassium hydrogen carbonate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0979/011/007 PA0979/011/007 Gaviscon Advance Peppermint Oral Suspension Sodium alginate 500 mg, Potassium hydrogen carbonate 100 mg. Reckitt Benckiser Ireland Limited 05/03/2004 HM Not marketed AU Oral suspension A02BX A02BX13 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium alginate Potassium hydrogen carbonate Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA0979/015/012 PA0979/015/012 Gaviscon Extra Chewable TabletsSodium alginate 250mgSodium bicarbonate 106.5mgCalcium carbonate 187.5mg Reckitt Benckiser Ireland Ltd 01/10/2010 HM Marketed AU Chewable tablet A02BX A02BX13 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium alginate Sodium bicarbonate Calcium carbonate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General Sale: maximum pack size 32 tablets PA0979/015/013 PA0979/015/013 Gaviscon Extra Liquid Sachets Peppermint Flavour Oral SuspensionSodium Alginate 500 mg/10 ml Sodium Bicarbonate 213 mg/10 ml Calcium Carbonate 325 mg/10 ml Reckitt Benckiser Ireland Ltd 14/12/2012 HM Not marketed AU Oral suspension in sachet A02BX A02BX13 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium alginate Sodium bicarbonate Calcium carbonate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public Maximum pack size 24 sachets PA0979/082/001 PA0979/082/001 Gaviscon Extra Mixed Berries Flavour Chewable Tablets Sodium alginate 250 mg Sodium hydrogen carbonate 106.5 mg Calcium carbonate 187.5 mg Reckitt Benckiser Ireland Ltd, 27/10/2023 HM Not marketed AU Chewable tablet A02BX A02BX13 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium alginate Sodium hydrogen carbonate Calcium carbonate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General Sale: Maximum pack size 32 tablets PA0979/083/001 PA0979/083/001 Gaviscon Extra Mixed Berries Flavour Oral Suspension in Sachet Sodium alginate 500 mg/10ml Sodium hydrogen carbonate 213 mg/ 10ml Calcium carbonate 325 mg/ 10ml Reckitt Benckiser Ireland Limited 02/08/2024 HM Unknown AU Oral suspension A02BX Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium alginate Sodium hydrogen carbonate Calcium carbonate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public Maximum pack size 24 sachets PA0979/084/001 PA0979/084/001 Gaviscon Extra Mixed Berries Oral Suspension Sodium alginate 500 mg/ 10 ml sodium hydrogen carbonate 213 mg/ 10 ml Calcium carbonate 325 mg/ 10 ml Reckitt Benckiser Ireland Limited 02/08/2024 HM Not marketed AU Oral suspension A02BX Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium alginate Sodium hydrogen carbonate Calcium carbonate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General Sale: Maximum pack size 600ml PA0979/015/011 PA0979/015/011 Gaviscon Extra Oral Suspension Sodium alginate 500 mg Sodium bicarbonate 213 mg Calcium carbonate 325 mg Reckitt Benckiser Ireland Ltd 01/10/2010 HM Marketed AU Oral suspension A02BX A02BX13 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium alginate Sodium bicarbonate Calcium carbonate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General Sale: Maximum pack size 600ml PA0979/012/001 PA0979/012/001 Gaviscon Infant, Powder for Oral Suspension Reckitt Benckiser Ireland Ltd 12/07/1991 HM Marketed AU Powder for oral suspension A02BX A02BX13 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium alginate Magnesium alginate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0979/015/002 PA0979/015/002 Gaviscon Liquid Peppermint Flavour, Oral Suspension Sodium alginate 500 mg Sodium bicarbonate 267 mg Calcium carbonate 160 mg Reckitt Benckiser Ireland Ltd 03/01/1996 HM Marketed AU Oral suspension A02AX Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium alginate Calcium carbonate Sodium bicarbonate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public As an item for retail sale through pharmacies only. General sale: Maximum pack size 300 ml. PA0979/015/010 PA0979/015/010 Gaviscon Liquid Sachets Oral Suspension Sodium alginate 500mg, Sodium bicarbonate 267mg, Calcium carbonate 160mg Reckitt Benckiser Ireland Ltd 01/10/2010 HM Not marketed AU Oral suspension in sachet A02BX A02BX13 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium alginate Sodium bicarbonate Calcium carbonate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public General Sale maximum pack size 30. PA0979/015/003 PA0979/015/003 Gaviscon Liquid-Aniseed Flavour, Oral Suspension Each 10 ml contains: Sodium alginate 500 mg Sodium bicarbonate 267 mg Calcium carbonate 160 mg Reckitt Benckiser Ireland Ltd 29/06/2001 HM Marketed AU Oral suspension A02BX Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium bicarbonate Calcium carbonate Sodium alginate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public Retail sale through pharmacies only. General sale: Maximum pack size 300 ml. PA0979/015/001 PA0979/015/001 Gaviscon Oral Suspension 500mg/10ml Sodium Alginate 267mg/10ml Sodium Bicarbonate 160mg/10ml Calcium Carbonate Reckitt Benckiser Ireland Limited 03/05/1978 HM Not marketed AU Oral suspension A02BX Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sodium bicarbonate Calcium carbonate Sodium alginate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0979/015/004 PA0979/015/004 Gaviscon Peppermint Chewable Tablets Sodium alginate 250 mg Sodium hydrogen Carbonate 133.5 mg Calcium Carbonate 80 mg Reckitt Benckiser Ireland Limited 22/12/2004 HM Marketed AU Chewable tablet A02BX A02BX13 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium alginate Sodium hydrogen carbonate Calcium carbonate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA0979/015/005 PA0979/015/005 Gaviscon Strawberry Chewable Tablets Sodium alginate 250mg Sodium hydrogen Carbonate 133.5mg Calcium Carbonate 80mg Reckitt Benckiser Ireland Ltd 22/12/2004 HM Not marketed AU Chewable tablet A02BX A02BX13 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Sodium alginate Sodium hydrogen carbonate Calcium carbonate Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public EU/1/14/937/001 EU/1/14/937/001 Gazyvaro 1,000 mg concentrate for solution for infusion Roche Registration GmbH HM Unknown AU Concentrate for solution for infusion L01XC L01XC15 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Obinutuzumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1330/006/001 PA1330/006/001 Gedarel 20/150 microgram film-coated tablets Gedeon Richter Plc 23/01/2009 HM Not marketed AU Film-coated tablet G03AA G03AA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ethinyloestradiol Desogestrel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1330/005/001 PA1330/005/001 Gedarel extra 30/150 micrograms Film Coated Tablets Gedeon Richter Plc 23/01/2009 HM Not marketed AU Film-coated tablet G03AA G03AA09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ethinylestradiol Desogestrel Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0736/034/001 PA0736/034/001 Gelaspan Solution for Infusion B. Braun Melsungen AG 09/09/2011 HM Marketed AU Solution for infusion B05AA B05AA06 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Succinylated gelatine (= modified fluid gelatine) Sodium chloride Sodium acetate trihydrate Potassium chloride Calcium chloride dihydrate Magnesium chloride hexahydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0736/011/001 PA0736/011/001 Gelofusine 40mg/ml Solution for Infusion B. Braun Melsungen AG 03/03/2000 HM Marketed AU Solution for infusion B05AA B05AA06 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Succinylated gelatine (= modified fluid gelatine) Sodium chloride Sodium hydroxide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/008/002 PA2059/008/002 Geloplasma Solution for Infusion (Polyolefine/Freeflex Bag) Fresenius Kabi Deutschland GmbH 10/09/2010 HM Marketed AU Solution for infusion B05AA Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Modified liquid gelatine Sodium chloride Magnesium chloride hexahydrate Potassium chloride Sodium (s)-lactate solution Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/008/001 PA2059/008/001 Geloplasma, Solution for Infusion Fresenius Kabi Deutschland GmbH 20/04/2007 HM Not marketed AU Solution for infusion B05AA Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Modified liquid gelatine Sodium chloride Magnesium chloride hexahydrate Potassium chloride Sodium lactate solution Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only HOR1149/012/001 HOR1149/012/001 Gelsemium A. Nelson & Company Limited 11/03/2011 HM Not marketed AU Not assigned Not Currently Available Oral use Gelsemium sempervirens Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA23259/006/001 PA23259/006/001 Geltears 0.2 % w/w carbomer eye gel Bausch + Lomb Ireland Limited 07/02/1997 HM Marketed AU Eye gel S01XA S01XA20 Full application (Article 8(3) of Directive No 2001/83/EC) Ocular use Carbomer Product not subject to medical prescription Supply through pharmacies only Advertising to the general public PA2059/039/002 PA2059/039/002 Gemcitabine 1 g powder for solution for infusion Fresenius Kabi Deutschland GmbH 23/04/2010 HM Not marketed AU Powder for solution for infusion L01BC L01BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Gemcitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA2315/092/002 PA2315/092/002 Gemcitabine 1 g Powder for Solution for Infusion Accord Healthcare Ireland Ltd. 24/07/2009 HM Not marketed AU Powder for solution for infusion L01BC L01BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Gemcitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/092/004 PA2315/092/004 Gemcitabine 100 mg/ml Concentrate for Solution for Infusion Accord Healthcare Ireland Ltd. 09/03/2012 HM Not marketed AU Concentrate for solution for infusion L01BC L01BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Gemcitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/039/003 PA2059/039/003 Gemcitabine 2 g powder for solution for infusion Fresenius Kabi Deutschland GmbH 23/04/2010 HM Not marketed AU Powder for solution for infusion L01BC L01BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Gemcitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA2059/039/001 PA2059/039/001 Gemcitabine 200 mg powder for solution for infusion Fresenius Kabi Deutschland GmbH 23/04/2010 HM Not marketed AU Powder for solution for infusion L01BC L01BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Gemcitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). PA2315/092/001 PA2315/092/001 Gemcitabine 200 mg Powder for Solution for Infusion Accord Healthcare Ireland Ltd. 24/07/2009 HM Not marketed AU Powder for solution for infusion L01BC L01BC05 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Gemcitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2315/092/003 PA2315/092/003 Gemcitabine 2g Powder for Solution for Infusion Accord Healthcare Ireland Ltd. 23/09/2011 HM Not marketed AU Powder for solution for infusion L01BC L01BC05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Gemcitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/039/005 PA2059/039/005 Gemcitabine 38 mg/ml Concentrate for Solution for Infusion Fresenius Kabi Deutschland GmbH 16/01/2015 HM Marketed AU Concentrate for solution for infusion L01BC L01BC05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Gemcitabine hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/122/001 PA1986/122/001 Gemcitabine Teva 40 mg/ml Concentrate for Solution for Infusion Teva B.V. 04/03/2016 HM Marketed AU Concentrate for solution for infusion L01BC L01BC05 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Gemcitabine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/20/1465/001 EU/1/20/1465/001 Gencebok 10 mg/ml solution for infusion Gennisium Pharma 19/08/2020 HM Unknown AU Solution for infusion N06BC01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Caffeine Caffeine citrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0822/128/002 PA0822/128/002 GENOTROPIN 12 mg powder and solvent for solution for injection Pfizer Healthcare Ireland Unlimited Company 01/09/1992 HM Marketed AU Powder and solvent for solution for injection H01AC H01AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Somatropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0822/128/001 PA0822/128/001 GENOTROPIN 5.3 mg powder and solvent for solution for injection, with preservative Pfizer Healthcare Ireland Unlimited Company 20/02/1991 HM Marketed AU Powder and solvent for solution for injection H01AC H01AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Somatropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0822/128/005 PA0822/128/005 GENOTROPIN MINIQUICK 0.6 mg powder and solvent for solution for injection Pfizer Healthcare Ireland Unlimited Company 10/12/1998 HM Marketed AU Powder and solvent for solution for injection H01AC H01AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Somatropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0822/128/003 PA0822/128/003 GENOTROPIN MINIQUICK 0.2 mg powder and solvent for solution for injection Pfizer Healthcare Ireland Unlimited Company 10/12/1998 HM Marketed AU Powder and solvent for solution for injection H01AC H01AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Somatropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0822/128/004 PA0822/128/004 GENOTROPIN MINIQUICK 0.4 mg powder and solvent for solution for injection Pfizer Healthcare Ireland Unlimited Company 10/12/1998 HM Marketed AU Powder and solvent for solution for injection H01AC H01AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Somatropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0822/128/006 PA0822/128/006 GENOTROPIN MINIQUICK 0.8 mg powder and solvent for solution for injection Pfizer Healthcare Ireland Unlimited Company 10/12/1998 HM Marketed AU Powder and solvent for solution for injection H01AC H01AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Somatropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0822/128/007 PA0822/128/007 GENOTROPIN MINIQUICK 1.0 mg powder and solvent for solution for injection Pfizer Healthcare Ireland Unlimited Company 10/12/1998 HM Marketed AU Powder and solvent for solution for injection H01AC H01AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Somatropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0822/128/008 PA0822/128/008 GENOTROPIN MINIQUICK 1.2 mg powder and solvent for solution for injection Pfizer Healthcare Ireland Unlimited Company 10/12/1998 HM Marketed AU Powder and solvent for solution for injection H01AC H01AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Somatropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0822/128/009 PA0822/128/009 GENOTROPIN MINIQUICK 1.4 mg powder and solvent for solution for injection Pfizer Healthcare Ireland Unlimited Company 10/12/1998 HM Marketed AU Powder and solvent for solution for injection H01AC H01AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Somatropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0822/128/010 PA0822/128/010 GENOTROPIN MINIQUICK 1.6 mg powder and solvent for solution for injection Pfizer Healthcare Ireland Unlimited Company 10/12/1998 HM Marketed AU Powder and solvent for solution for injection H01AC H01AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Somatropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0822/128/011 PA0822/128/011 GENOTROPIN MINIQUICK 1.8 mg powder and solvent for solution for injection Pfizer Healthcare Ireland Unlimited Company 10/12/1998 HM Marketed AU Powder and solvent for solution for injection H01AC H01AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Somatropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0822/128/012 PA0822/128/012 GENOTROPIN MINIQUICK 2.0 mg powder and solvent for solution for injection Pfizer Healthcare Ireland Unlimited Company 10/12/1998 HM Marketed AU Powder and solvent for solution for injection H01AC H01AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Somatropin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (Summary of Product Characteristics, section 4.2). PA0281/242/001 PA0281/242/001 Gentamicin 10 mg/ml solution for injection or infusion Pinewood Laboratories Ltd 13/03/2015 HM Not marketed AU Solution for injection/infusion J01GB J01GB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Gentamicin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/023/001 PA1122/023/001 Gentamicin 20 mg/mL Solution for injection/infusion Noridem Enterprises Limited 12/11/2021 HM Not marketed AU Solution for injection/infusion J01GB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Gentamicin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/023/002 PA1122/023/002 Gentamicin 40 mg/mL Solution for injection/infusion Noridem Enterprises Limited 12/11/2021 HM Marketed AU Solution for injection/infusion J01GB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Gentamicin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/242/002 PA0281/242/002 Gentamicin 40 mg/ml solution for injection or infusion Pinewood Laboratories Ltd 13/03/2015 HM Not marketed AU Solution for injection/infusion J01GB J01GB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Gentamicin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1122/023/003 PA1122/023/003 Gentamicin 80 mg/mL Solution for injection/infusion Noridem Enterprises Limited 12/11/2021 HM Not marketed AU Solution for injection/infusion J01GB03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Gentamicin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/013/002 PA1142/013/002 Genticin 0.3% w/v Eye/Ear Drops, Solution Amdipharm Limited 20/04/1995 HM Marketed AU Ear/eye drops, solution S02AA S02AA14 Full application (Article 8(3) of Directive No 2001/83/EC) Auricular use Ocular use Gentamicin sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/013/001 PA1142/013/001 Genticin 80 mg/2ml Solution for Injection Amdipharm Limited 20/04/1995 HM Marketed AU Solution for injection J01GB J01GB03 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Gentamicin sulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1142/014/001 PA1142/014/001 Gentisone HC 0.3% w/v & 1.0% w/v Ear Drops, Suspension Amdipharm Limited 18/05/1995 HM Marketed AU Ear drops, suspension S02CA S02CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Auricular use Gentamicin sulfate HYDROCORTISONE ACETATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/1061/001-002 EU/1/15/1061/001-002 Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets Gilead Sciences Ireland UC HM Unknown AU Film-coated tablet J05AR J05AR18 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Elvitegravir Cobicistat Emtricitabine Tenofovir alafenamide fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1061/003-004 EU/1/15/1061/003-004 Genvoya 90 mg/90 mg/120 mg/6 mg film-coated tablets Gilead Sciences Ireland UC 03/10/2022 HM Unknown AU Film-coated tablet J05AR J05AR18 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Elvitegravir Cobicistat Emtricitabine Tenofovir alafenamide Tenofovir alafenamide fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23355/062/001 PA23355/062/001 Geodon 20mg capsules, hard Viatris Healthcare Limited 08/03/2002 HM Marketed AU Capsule, hard N05AE N05AE04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ziprasidone hydrochloride monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23355/062/002 PA23355/062/002 Geodon 40mg capsules, hard Viatris Healthcare Limited 08/03/2002 HM Marketed AU Capsule, hard N05AE N05AE04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ziprasidone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23355/062/003 PA23355/062/003 Geodon 60mg capsules, hard Viatris Healthcare Limited 08/03/2002 HM Not marketed AU Capsule, hard N05AE N05AE04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ziprasidone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23355/062/004 PA23355/062/004 Geodon 80mg capsules, hard Viatris Healthcare Limited 08/03/2002 HM Marketed AU Capsule, hard N05AE N05AE04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ziprasidone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1445/024/003 PA1445/024/003 IC0094-039-002 Gerax 1 mg Tablets Aurobindo Pharma (Malta) Limited 08/01/1996 HM Marketed AU Tablet N05BA N05BA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alprazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017. PA1445/024/001 PA1445/024/001 IC0094-145-002 Gerax 250 microgram Tablets Aurobindo Pharma (Malta) Limited 08/01/1996 HM Marketed AU Tablet N05BA N05BA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alprazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017. PA1445/024/002 PA1445/024/002 IC0094-040-002 Gerax 500 microgram Tablets Aurobindo Pharma (Malta) Limited 08/01/1996 HM Marketed AU Tablet N05BA N05BA12 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Alprazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017. PA23266/015/002 PA23266/015/002 IC0037-071-034 Germentin 125 mg/31.25 mg per 5 ml Powder for Oral Suspension Viatris Limited 05/03/2004 HM Marketed AU Powder for oral suspension J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clavulanic acid Amoxicillin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/015/003 PA23266/015/003 IC0037-074-003 Germentin 250 mg/125 mg Film-coated Tablets Viatris Limited 05/03/2004 HM Marketed AU Film-coated tablet J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amoxicillin Clavulanic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/015/001 PA23266/015/001 IC0037-073-003 Germentin 500 mg/125 mg film coated tablets Viatris Limited 18/08/2000 HM Marketed AU Film-coated tablet J01CR J01CR02 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Amoxicillin trihydrate potassium clavulanate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/076/002 PA23266/076/002 IC0019-024-003 Geroquel 100 mg film-coated tablets Viatris Limited 19/10/2007 HM Marketed AU Film-coated tablet N05AH N05AH04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Quetiapine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/076/003 PA23266/076/003 IC0019-067-003 Geroquel 200 mg film-coated tablets Viatris Limited 19/10/2007 HM Marketed AU Film-coated tablet N05AH N05AH04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Quetiapine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23266/076/001 PA23266/076/001 IC0019-022-003 Geroquel 25 mg film-coated tablets Viatris Limited 19/10/2007 HM Marketed AU Film-coated tablet N05AH N05AH04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Quetiapine fumarate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22937/001/005 PA22937/001/005 Ghemaxan 10,000 IU (100 mg)/1 mL solution for injection in pre-filled syringes Chemi S.p.A. 19/06/2020 HM Not marketed AU Solution for injection in pre-filled syringe B01AB05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Extracorporeal use Intravenous use Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22937/001/006 PA22937/001/006 Ghemaxan 12,000 IU (120 mg)/0.8 mL solution for injection in pre-filled syringes Chemi S.p.A. 19/06/2020 HM Not marketed AU Solution for injection in pre-filled syringe B01AB05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Extracorporeal use Intravenous use Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22937/001/007 PA22937/001/007 Ghemaxan 15,000 IU (150 mg)/1 mL solution for injection in pre-filled syringes Chemi S.p.A. 19/06/2020 HM Not marketed AU Solution for injection in pre-filled syringe B01AB05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Extracorporeal use Intravenous use Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22937/001/001 PA22937/001/001 Ghemaxan 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringes Chemi S.p.A. 19/06/2020 HM Not marketed AU Solution for injection in pre-filled syringe B01AB05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Extracorporeal use Intravenous use Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22937/001/002 PA22937/001/002 Ghemaxan 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringes Chemi S.p.A. 19/06/2020 HM Not marketed AU Solution for injection in pre-filled syringe B01AB05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Extracorporeal use Intravenous use Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22937/001/003 PA22937/001/003 Ghemaxan 6,000 IU (60 mg)/0.6 mL solution for injection in pre-filled syringes Chemi S.p.A. 19/06/2020 HM Not marketed AU Solution for injection in pre-filled syringe B01AB05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Extracorporeal use Intravenous use Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22937/001/004 PA22937/001/004 Ghemaxan 8,000 IU (80 mg)/0.8 mL solution for injection in pre-filled syringes Chemi S.p.A. 19/06/2020 HM Not marketed AU Solution for injection in pre-filled syringe B01AB05 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Extracorporeal use Intravenous use Subcutaneous use Enoxaparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/18/1337/001 EU/1/18/1337/001 GHRYVELIN 60 mg granules for oral suspension in sachet Atnahs Pharma Netherlands B.V. 11/01/2019 HM Unknown AU Granules for oral suspension in sachet V04CD06 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use MACIMORELIN ACETATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1384/001-002 EU/1/19/1384/001-002 Giapreza 2.5 mg/ml Concentrate for solution for infusion Paion Pharma GmbH 23/08/2019 HM Unknown AU Concentrate for solution for infusion C01CX09 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/11/677/007-008 EU/1/11/677/007-008 IC0161-145-001 Gilenya 0.25 mg hard capsules Novartis Europharm Limited 22/11/2018 HM Unknown AU Capsule, hard L04AE01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use FINGOLIMOD HYDROCHLORIDE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/11/677/001-004 EU/1/11/677/001-004 IC0161-040-001 Gilenya 0.5 mg hard capsules Novartis Europharm Limited HM Unknown AU Capsule, hard L04AE01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Fingolimod Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). TR1242/001/001 TR1242/001/001 Ginkgo-Biloba Pharma Nord film-coated tablets Pharma Nord ApS 16/03/2018 HM Unknown AU Film-coated tablet Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) Oral use Product not subject to medical prescription Supply through pharmacies only Advertising to the general public EU/1/13/879/001-003 EU/1/13/879/001-003 GIOTRIF 20 mg film-coated tablets Boehringer Ingelheim International GmbH 25/09/2013 HM Unknown AU Film-coated tablet L01XE L01XE13 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Afatinib-dimaleate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/13/879/004-006 EU/1/13/879/004-006 GIOTRIF 30 mg film-coated tablets Boehringer Ingelheim International GmbH HM Unknown AU Film-coated tablet L01XE L01XE13 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Afatinib-dimaleate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/13/879/007-009 EU/1/13/879/007-009 GIOTRIF 40 mg film-coated tablets Boehringer Ingelheim International GmbH HM Unknown AU Film-coated tablet L01XE L01XE13 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Afatinib-dimaleate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/13/879/010-012 EU/1/13/879/010-012 GIOTRIF 50 mg film-coated tablets Boehringer Ingelheim International GmbH HM Unknown AU Film-coated tablet L01XE L01XE13 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Afatinib-dimaleate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/20/1428/001 EU/1/20/1428/001 Givlaari 189 mg/mL solution for injection Alnylam Netherlands B.V. 02/03/2020 HM Unknown AU Solution for injection A16AX16 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Givosiran Sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA22701/003/001 PA22701/003/001 Gliadel 7.7 mg Implant Clinigen Healthcare B.V. 07/07/1999 HM Marketed AU Implant L01AD L01AD01 Full application (Article 8(3) of Directive No 2001/83/EC) Intralesional use Carmustine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/006/001 PA22749/006/001 IC0086-033-050 Gliclazide MR 30 mg prolonged-release tablets Brillpharma (Ireland) Limited 12/09/2014 HM Not marketed AU Prolonged-release tablet A10BB A10BB09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Gliclazide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/07/413/1-3 EU/1/07/413/1-3 Gliolan 30 mg/ml powder for oral solution Photonamic GmbH & Co. KG 07/09/2007 HM Unknown AU Powder for oral solution L01XD L01XD04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use 5-aminolevulinic acid hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/01/198/007-008 EU/1/01/198/007-008 IC0171-024-009 Glivec 100 mg film-coated tablets Novartis Europharm Limited 11/11/2003 HM Unknown AU Film-coated tablet L01XE L01XE01 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Imatinib mesilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/01/198/002-006 EU/1/01/198/002-006 IC0171-024-009 Glivec 100 mg hard capsules Novartis Europharm Limited 07/11/2001 HM Unknown AU Capsule, hard L01XE L01XE01 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Imatinib mesilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) . EU/1/01/198/009-010 EU/1/01/198/009-010 IC0171-068-009 Glivec 400 mg film-coated tablets Novartis Europharm Limited 11/11/2003 HM Unknown AU Film-coated tablet L01XE L01XE01 New active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Imatinib mesilate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) PA0218/031/002 PA0218/031/002 GlucaGen HypoKit 1 mg powder and solvent for solution for injection Novo Nordisk A/S 17/12/1991 HM Marketed AU Powder and solvent for solution for injection H04AA H04AA01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Subcutaneous use GLUCAGON Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2286/005/003 PA2286/005/003 IC0067-119-003 Glucophage 1000 mg film-coated tablets Merck Serono (Ireland) Limited 16/11/2001 HM Marketed AU Film-coated tablet A10BA A10BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Metformin Hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2286/005/001 PA2286/005/001 IC0067-117-003 Glucophage 500 mg film-coated tablets Merck Serono (Ireland) Limited 16/05/1983 HM Marketed AU Film-coated tablet A10BA A10BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Metformin Hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2286/005/002 PA2286/005/002 IC0067-118-003 Glucophage 850 mg film-coated tablets Merck Serono (Ireland) Limited 16/05/1983 HM Marketed AU Film-coated tablet A10BA A10BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Metformin Hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1242/001/001 PA1242/001/001 Glucosamine Pharma Nord 400 mg hard capsules Pharma Nord ApS 28/10/2005 HM Marketed AU Capsule, hard M01AX M01AX05 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use GLUCOSAMINE HEMISULPHATE:POTASSIUM CHLORIDE COMPLEX (1:1) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2059/040/005 PA2059/040/005 Glucose 10% w/v Solution for Infusion Fresenius Kabi Deutschland GmbH 09/01/2004 HM Not marketed AU Solution for infusion B05BA B05BA03 Not Currently Available Intravenous use Glucose anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/040/006 PA2059/040/006 Glucose 10% w/v Solution for Infusion Fresenius Kabi Deutschland GmbH 09/01/2004 HM Not marketed AU Solution for infusion B05BA B05BA03 Not Currently Available Intravenous use Glucose anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/040/007 PA2059/040/007 Glucose 10% w/v Solution for Infusion Fresenius Kabi Deutschland GmbH 09/01/2004 HM Not marketed AU Solution for infusion B05BA B05BA03 Not Currently Available Intravenous use Glucose anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/040/008 PA2059/040/008 Glucose 10% w/v Solution for Infusion Fresenius Kabi Deutschland GmbH 09/01/2004 HM Marketed AU Solution for infusion B05BA B05BA03 Not Currently Available Intravenous use Glucose anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/040/010 PA2059/040/010 Glucose 10% w/v Solution for Infusion Fresenius Kabi Deutschland GmbH 31/07/2009 HM Marketed AU Solution for infusion B05BA B05BA03 Not Currently Available Intravenous use Glucose anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/003/002 PA2299/003/002 Glucose 10% w/v Solution for Infusion Baxter Holding B.V. 11/06/2010 HM Marketed AU Solution for infusion B05BA B05BA03 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Glucose Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/003/001 PA2299/003/001 Glucose 5% w/v Intravenous Infusion BP, polyolefin/polyamide bag Baxter Holding B.V. 16/05/2003 HM Marketed AU Solution for infusion B05BA B05BA03 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Glucose Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/040/001 PA2059/040/001 Glucose 5% w/v Solution for Infusion Fresenius Kabi Deutschland GmbH 09/01/2004 HM Not marketed AU Solution for infusion B05BA B05BA03 Not Currently Available Intravenous use Glucose anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/040/003 PA2059/040/003 Glucose 5% w/v Solution for Infusion Fresenius Kabi Deutschland GmbH 09/01/2004 HM Not marketed AU Solution for infusion B05BA B05BA03 Not Currently Available Intravenous use Glucose anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/040/004 PA2059/040/004 Glucose 5% w/v Solution for Infusion Fresenius Kabi Deutschland GmbH 09/01/2004 HM Marketed AU Solution for infusion B05BA B05BA03 Not Currently Available Intravenous use Glucose anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/040/009 PA2059/040/009 Glucose 5% w/v Solution for Infusion Fresenius Kabi Deutschland GmbH 31/07/2009 HM Marketed AU Solution for infusion B05BA B05BA03 Not Currently Available Intravenous use Glucose anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/040/002 PA2059/040/002 Glucose 5% w/v, Solution for Infusion Fresenius Kabi Deutschland GmbH 09/01/2004 HM Not marketed AU Solution for infusion B05BA B05BA03 Not Currently Available Intravenous use Glucose anhydrous Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0179/001/039 PA0179/001/039 Glucose 50% w/v sterile concentrate, concentrate solution for infusion B. Braun Medical Limited 17/08/1992 HM Marketed AU Concentrate for solution for infusion B05BA B05BA03 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Anhydrous glucose Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0179/001/028 PA0179/001/028 Glucose Intravenous Infusion BP 10% w/v, solution for infusion B. Braun Medical Limited 17/08/1992 HM Marketed AU Solution for infusion B05BA B05BA03 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Anhydrous glucose Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0179/001/003 PA0179/001/003 Glucose Intravenous Infusion BP 5% w/v solution for infusion B. Braun Medical Limited 01/04/1983 HM Marketed AU Solution for infusion B05 B05BA B05BA03 V07AB Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Glucose Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0549/028/001 PA0549/028/001 Glycerol 1g Suppositories Ethypharm 25/02/1993 HM Not marketed AU Suppository A06AX A06AX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Rectal use Glycerol Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0549/028/003 PA0549/028/003 Glycerol 4g Suppositories Ethypharm 18/10/1991 HM Marketed AU Suppository A06AX A06AX01 Generic application (Article 10(1) of Directive No 2001/83/EC) Rectal use Glycerol Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0822/204/001 PA0822/204/001 Glyceryl Trinitrate 5 mg/ml Sterile Concentrate Pfizer Healthcare Ireland Unlimited Company 01/10/1987 HM Marketed AU Concentrate for solution for infusion C01DA C01DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Glyceryl trinitrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0549/029/001 PA0549/029/001 Glycopyrronium bromide 200 micrograms/ml Solution for injection Ethypharm 18/05/2018 HM Not marketed AU Solution for injection A03AB A03AB02 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Intravenous use Glycopyrronium bromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0857/001/001 PA0857/001/001 Glycopyrronium Bromide 200 micrograms/ml Solution for Injection MercuryPharm Ltd 09/03/1981 HM Marketed AU Solution for injection A03AB A03AB02 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Glycopyrronium bromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0857/002/001 PA0857/002/001 Glycopyrronium Bromide and Neostigmine Metilsulfate 0.5mg/2.5mg per ml Solution for Injection MercuryPharm Ltd 07/11/1986 HM Marketed AU Solution for injection N07AA N07AA51 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Glycopyrronium bromide Neostigmine Metilsulfate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1009/004/002 PA1009/004/002 Glypressin 1 mg/ 8.5 ml solution for injection Ferring Ireland Ltd 25/09/2009 HM Marketed AU Solution for injection H01BA H01BA04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Terlipressin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1009/004/001 PA1009/004/001 GLYPRESSIN 1 mg Powder and Solvent for Solution for Injection Ferring Ireland Ltd 09/04/1987 HM Marketed AU Powder and solvent for solution for injection H01BA H01BA04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Terlipressin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2262/004/001 PA2262/004/001 Glytrin 400 micrograms per metered dose Sublingual Spray Evolan Pharma AB 29/11/1990 HM Not marketed AU Sublingual spray, solution C01DA C01DA02 Generic application (Article 10(1) of Directive No 2001/83/EC) Sublingual use Glyceryl trinitrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1146/001-009 EU/1/16/1146/001-009 Glyxambi 10 mg/5 mg film-coated tablets Boehringer Ingelheim International GmbH HM Unknown AU Film-coated tablet A10BD A10BD19 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Empagliflozin Linagliptin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1146/010-018 EU/1/16/1146/010-018 Glyxambi 25 mg/5 mg film-coated tablets Boehringer Ingelheim International GmbH 11/11/2016 HM Unknown AU Film-coated tablet A10BD A10BD19 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Empagliflozin Linagliptin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/1988/005-006 EU/1/25/1988/005-006 GOBIVAZ 100 mg solution for injection in pre-filled pen Advanz Pharma Limited 17/11/2025 HM Unknown AU Solution for injection in pre-filled pen L04AB06 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Golimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1988/007-008 EU/1/25/1988/007-008 GOBIVAZ 100 mg solution for injection in pre-filled syringe Advanz Pharma Limited 17/11/2025 HM Unknown AU Solution for injection in pre-filled syringe L04AB06 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Golimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1988/001-002 EU/1/25/1988/001-002 GOBIVAZ 50 mg solution for injection in pre-filled pen Advanz Pharma Limited 17/11/2025 HM Unknown AU Solution for injection in pre-filled pen L04AB06 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Golimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/1988/003-004 EU/1/25/1988/003-004 GOBIVAZ 50 mg solution for injection in pre-filled syringe Advanz Pharma Limited 17/11/2025 HM Unknown AU Solution for injection in pre-filled syringe L04AB06 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Golimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1884/001 EU/1/24/1884/001 Gohibic 200 mg Concentrate for solution for infusion InflaRx GmbH 13/01/2025 HM Unknown AU Concentrate for solution for infusion L04AA L04AJ10 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Vilobelimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22695/001/001 PA22695/001/001 Golden Eye 0.1% w/v Eye drops, solution Cambridge Healthcare Ireland Limited 02/03/1993 HM Marketed AU Eye drops, solution S01AX S01AX15 Informed consent application (Article 10c of Directive No 2001/83/EC) Ocular use Propamidine isetionate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA22695/001/002 PA22695/001/002 Golden Eye 0.15% w/w Eye Ointment Cambridge Healthcare Ireland Limited 02/03/1993 HM Marketed AU Eye ointment S01AX S01AX14 Informed consent application (Article 10c of Directive No 2001/83/EC) Ocular use Dibromopropamidine isethionate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only EU/1/95/001/023 EU/1/95/001/023 Gonal-F Serono Limited 07/06/2002 HM Unknown AU Powder and solvent for solution for injection G03GA G03GA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Follitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/95/001/024 EU/1/95/001/024 Gonal-F Serono Limited 07/06/2002 HM Unknown AU Powder and solvent for solution for injection G03GA G03GA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Follitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/95/001/025 EU/1/95/001/025 Gonal-F Merck Europe B.V. 07/06/2002 HM Unknown AU Powder and solvent for solution for injection G03GA G03GA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Follitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/95/001/026 EU/1/95/001/026 Gonal-F Merck Europe B.V. 07/06/2002 HM Unknown AU Powder and solvent for solution for injection G03GA G03GA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Follitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/95/001/027 EU/1/95/001/027 Gonal-F Merck Europe B.V. 07/06/2002 HM Unknown AU Powder and solvent for solution for injection G03GA G03GA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Follitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/95/001/028 EU/1/95/001/028 Gonal-F Serono Limited 07/06/2002 HM Unknown AU Powder and solvent for solution for injection G03GA G03GA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Follitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/95/001/029 EU/1/95/001/029 Gonal-F Serono Limited 07/06/2002 HM Unknown AU Powder and solvent for solution for injection G03GA G03GA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Follitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/95/001/031 EU/1/95/001/031 Gonal-F Merck Europe B.V. 07/06/2002 HM Unknown AU Powder and solvent for solution for injection G03GA G03GA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Follitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/95/001/021 EU/1/95/001/021 Gonal-F 1050 IU/1.75 mL powder and solvent for solution for injection Merck Europe B.V. 29/01/2001 HM Unknown AU Powder and solvent for solution for injection G03GA G03GA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Follitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/95/001/033 EU/1/95/001/033 Gonal-F 300 IU/0.48 mL solution for injection in pre-filled pen Merck Europe B.V. 31/03/2004 HM Unknown AU Solution for injection in pre-filled pen G03GA G03GA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Follitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/95/001/034 EU/1/95/001/034 Gonal-F 450 IU/0.72 mL solution for injection in pre-filled pen Merck Europe B.V. 20/10/1995 HM Unknown AU Solution for injection in pre-filled pen G03GA G03GA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Follitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/95/001/035 EU/1/95/001/035 GONAL-f 900 IU/1.44 mL solution for injection in pre-filled pen Merck Europe B.V. 20/10/1995 HM Unknown AU Solution for injection in pre-filled pen G03GA05 New active substance (Article 8(3) of Directive No 2001/83/EC) Follitropin alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1403/001-003 EU/1/19/1403/001-003 GoResp Digihaler 160 microgram/4.5 microgram inhalation powder Teva Pharma B.V. 07/04/2020 HM Unknown AU Inhalation powder R03AK07 Informed consent application (Article 10c of Directive No 2001/83/EC) Inhalation use Budesonide Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1403/004-005 EU/1/19/1403/004-005 GoResp Digihaler 320 microgram/9 microgram inhalation powder Teva Pharma B.V. 03/04/2020 HM Unknown AU Inhalation powder R03AK07 Informed consent application (Article 10c of Directive No 2001/83/EC) Inhalation use Budesonide Formoterol fumarate dihydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/25/2009/003-004 EU/1/25/2009/003-004 Gotenfia 100 mg solution for injection in pre-filled syringe Stada Arzneimittel AG 10/02/2026 HM Unknown AU Solution for injection in pre-filled syringe L04AB06 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Golimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/25/2009/001-002 EU/1/25/2009/001-002 Gotenfia 50 mg solution for injection in pre-filled syringe Stada Arzneimittel AG 10/02/2026 HM Unknown AU Solution for injection in pre-filled syringe L04AB06 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Golimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1015/001/001 PA1015/001/001 Grafalon 20 mg/ml concentrate for solution for infusion Neovii Biotech GmbH 05/06/2001 HM Marketed AU Concentrate for solution for infusion L04AA L04AA04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Anti-human t-lymphocyte immunoglobulin from rabbits Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Conditions Batches marketed in Ireland shall be subject to control authority batch release by the Paul Ehrlich Institute, Germany. Part of Package leaflet information( It wouldn't fit into the box below) It is strongly recommended that every time that Grafalon is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product. PA22641/002/002 PA22641/002/002 GRANOCYTE 13 million IU/mL, powder and solvent for solution for injection/infusion, in a pre-filled syringe Chugai Pharma France 01/09/2009 HM Marketed AU Powder and solvent for solution for injection/infusion L03AA L03AA10 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Lenograstim Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22641/002/001 PA22641/002/001 GRANOCYTE 34 million IU/mL, powder and solvent for solution for injection/infusion, in a pre-filled syringe Chugai Pharma France 01/09/2009 HM Marketed AU Powder and solvent for solution for injection/infusion L03AA L03AA10 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Lenograstim Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1137/001-005 EU/1/16/1137/001-005 IC0063-003-003 Granpidam 20 mg film-coated tablets Accord Healthcare S.L.U. 14/11/2016 HM Unknown AU Film-coated tablet G04BE G04BE03 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Sildenafil Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). HOR1149/013/001 HOR1149/013/001 GRAPHITES A. Nelson & Company Limited 21/04/2011 HM Not marketed AU Not assigned Not Currently Available Oral use Graphites Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public EU/1/19/1375/001 EU/1/19/1375/001 Grasustek 6 mg Solution for injection Juta Pharma GmbH 20/06/2019 HM Unknown AU Solution for injection L03AA L03AA13 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1255/004/001 PA1255/004/001 GRAZAX 75,000 SQ-T sublingual lyophilisate ALK-Abello A/S 27/11/2006 HM Marketed AU Sublingual lyophilisate V01AA V01AA02 New active substance (Article 8(3) of Directive No 2001/83/EC) Oromucosal use Grass pollen allergen extract Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/535/1-16 EU/1/09/535/1-16 IC0005-028-003 Grepid 75 mg film-coated tablets Pharmathen S.A. 28/07/2009 HM Unknown AU Film-coated tablet B01AC B01AC04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Clopidogrel besilate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23148/006/001 PA23148/006/001 Griseofulvin 500 mg film-coated tablets Brown & Burk IR Limited 25/03/2011 HM Marketed AU Film-coated tablet D01BA D01BA01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Griseofulvin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22650/006/001 PA22650/006/001 Gyno-Pevaryl Once 150 mg Vaginal Pessary Karo Pharma AB HM Not marketed AU Pessary G01AF G01AF05 Full application (Article 8(3) of Directive No 2001/83/EC) Vaginal use ECONAZOLE NITRATE Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0812/004/001 PA0812/004/001 Gynoxin 200 mg Vaginal Capsules Recordati Industria Chimica e Farmaceutica SpA 24/02/1992 HM Not marketed AU Vaginal capsule, soft G01AF G01AF12 Full application (Article 8(3) of Directive No 2001/83/EC) Vaginal use Fenticonazole nitrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0812/004/002 PA0812/004/002 Gynoxin 600 mg Vaginal Capsules Recordati Industria Chimica e Farmaceutica SpA 24/02/1992 HM Not marketed AU Vaginal capsule, soft G01AF G01AF12 Full application (Article 8(3) of Directive No 2001/83/EC) Vaginal use Fenticonazole nitrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/678/001-002 EU/1/11/678/001-002 HALAVEN 0.44 mg/ml solution for injection Eisai GmbH 17/03/2011 HM Unknown AU Solution for injection L01XX L01XX41 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Eribulin mesylate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA0822/129/002 PA0822/129/002 Halcion 125 micrograms Tablets Pfizer Healthcare Ireland Unlimited Company 13/11/1984 HM Marketed AU Tablet N05CD N05CD05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Triazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017. PA0822/129/001 PA0822/129/001 Halcion 250 microgram Tablets Pfizer Healthcare Ireland Unlimited Company 30/09/1977 HM Marketed AU Tablet N05CD N05CD05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Triazolam Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017. PA22587/003/002 PA22587/003/002 Haldol Decanoate 100 mg/ml Solution for Injection Essential Pharma Limited 03/08/1994 HM Marketed AU Solution for injection N05AD N05AD01 Not Currently Available Intramuscular use HALOPERIDOL DECANOATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22587/003/001 PA22587/003/001 Haldol Decanoate 50 mg/ml Solution for Injection Essential Pharma Limited 10/10/1993 HM Marketed AU Solution for injection N05AD N05AD01 Not Currently Available Intramuscular use HALOPERIDOL DECANOATE Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22720/002/002 PA22720/002/002 Half Beta-Prograne 80 mg Prolonged-Release Capsules Tillomed Pharma GmbH 25/06/1999 HM Marketed AU Prolonged-release capsule, hard C07AA C07AA05 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Propranolol hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23198/004/006 PA23198/004/006 Half Sinemet CR 25mg/100mg Prolonged-Release Tablets Organon Pharma (Ireland) Limited 22/02/1993 HM Marketed AU Prolonged-release tablet N04BA N04BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Levodopa Carbidopa Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0073/101/001 PA0073/101/001 Haloperidol 5mg/ml Solution for Injection Mercury Pharmaceuticals (Ireland) Ltd 12/10/1988 HM Not marketed AU Solution for injection N05AD N05AD01 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Haloperidol Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1968/020/001 PA1968/020/001 Hartmann's Solution Compound Sodium Lactate Intravenous Infusion BP Laboratoire Aguettant 18/05/2007 HM Not marketed AU Solution for infusion B05BB B05BB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium chloride Calcium chloride dihydrate Potassium chloride Sodium lactate solution 60% Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/057/005 PA2059/057/005 Hartmann's Solution for Infusion, PE bottle Fresenius Kabi Deutschland GmbH 24/07/2009 HM Not marketed AU Solution for infusion B05BB B05BB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium chloride Potassium chloride Calcium chloride dihydrate Sodium lactate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/057/004 PA2059/057/004 Hartmann’s Solution for Infusion, glass bottle Fresenius Kabi Deutschland GmbH 20/05/2005 HM Not marketed AU Solution for infusion B05BB B05BB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium chloride Potassium chloride Calciumchloride dihydrate Sodium lactate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/057/003 PA2059/057/003 Hartmann’s Solution for Infusion, PPC PSEB bag Fresenius Kabi Deutschland GmbH 20/05/2005 HM Marketed AU Solution for infusion B05BB B05BB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium chloride Potassium chloride Calcium chloride dihydrate Sodium lactate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/057/002 PA2059/057/002 Hartmann’s Solution for Infusion, PSEB bag Fresenius Kabi Deutschland GmbH 20/05/2005 HM Not marketed AU Solution for infusion B05BB B05BB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium chloride Potassium chloride Calcium chloride dihydrate Sodium lactate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2059/057/001 PA2059/057/001 Hartmann’s Solution for Infusion, PVC bag Fresenius Kabi Deutschland GmbH 20/05/2005 HM Not marketed AU Solution for infusion B05BB B05BB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Sodium chloride Potassium chloride Calcium chloride dihydrate Sodium lactate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/958/004 EU/1/14/958/004 Harvoni 33.75 mg/150 mg Coated granules Gilead Sciences Ireland UC 03/07/2020 HM Unknown AU Granules J05AP51 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ledipasvir Sofosbuvir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/14/958/005 EU/1/14/958/005 Harvoni 45 mg/200 mg Coated granules Gilead Sciences Ireland UC 03/07/2020 HM Unknown AU Granules J05AP51 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ledipasvir Sofosbuvir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/958/003 EU/1/14/958/003 Harvoni 45 mg/200 mg Film-coated tablet Gilead Sciences Ireland UC 03/07/2020 HM Unknown AU Film-coated tablet J05AP51 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ledipasvir Sofosbuvir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/14/958/001-002 EU/1/14/958/001-002 Harvoni 90 mg/400 mg Film-coated tablet Gilead Sciences Ireland UC HM Unknown AU Film-coated tablet J05AX J05AX65 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Sofosbuvir Ledipasvir Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1077/026/001 PA1077/026/001 Havrix Junior Monodose Vaccine. Hepatitis A Vaccine (Inactivated, Adsorbed). 720 ELISA units/ 0.5ml Suspension for injection in a pre-filled syringe GlaxoSmithKline (Ireland) Limited 02/10/1998 HM Marketed AU Suspension for injection in pre-filled syringe J07BC J07BC02 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intramuscular use Subcutaneous use Hepatitis A antigen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1077/026/002 PA1077/026/002 Havrix Monodose Vaccine. Hepatitis A Vaccine (inactivated, adsorbed), 1440 ELISA units/ 1ml Suspension for injection in a pre-filled syringe GlaxoSmithKline (Ireland) Limited 13/12/1994 HM Not marketed AU Suspension for injection in pre-filled syringe J07BC J07BC02 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intramuscular use Subcutaneous use Aluminium Hepatitis A antigen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches marketed in Ireland shall be subjected to control authority batch release in accordance with article 114.1 of Directive 2001/83/EC. EU/1/01/183/002 EU/1/01/183/002 HBVAXPRO Merck Sharp & Dohme BV, 27/04/2001 HM Unknown AU Suspension for injection J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/003 EU/1/01/183/003 HBVAXPRO Merck Sharp & Dohme BV, 27/04/2001 HM Unknown AU Suspension for injection J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/004 EU/1/01/183/004 HBVAXPRO Merck Sharp & Dohme BV, HM Unknown AU Suspension for injection in pre-filled syringe J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/005 EU/1/01/183/005 HBVAXPRO Merck Sharp & Dohme BV, HM Unknown AU Suspension for injection in pre-filled syringe J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/006 EU/1/01/183/006 HBVAXPRO Merck Sharp & Dohme BV, 27/04/2001 HM Unknown AU Suspension for injection J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/007 EU/1/01/183/007 HBVAXPRO Merck Sharp & Dohme BV, HM Unknown AU Suspension for injection J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/008 EU/1/01/183/008 HBVAXPRO Merck Sharp & Dohme BV, HM Unknown AU Suspension for injection J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/009 EU/1/01/183/009 HBVAXPRO Merck Sharp & Dohme BV, 27/04/2001 HM Unknown AU Suspension for injection J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/010 EU/1/01/183/010 HBVAXPRO Merck Sharp & Dohme BV, 27/04/2001 HM Unknown AU Suspension for injection J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/011 EU/1/01/183/011 HBVAXPRO Merck Sharp & Dohme BV, HM Unknown AU Suspension for injection in pre-filled syringe J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/012 EU/1/01/183/012 HBVAXPRO Merck Sharp & Dohme BV, 27/04/2001 HM Unknown AU Suspension for injection J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/013 EU/1/01/183/013 HBVAXPRO Merck Sharp & Dohme BV, HM Unknown AU Suspension for injection in pre-filled syringe J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/014 EU/1/01/183/014 HBVAXPRO Merck Sharp & Dohme BV, 27/04/2001 HM Unknown AU Suspension for injection J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/015 EU/1/01/183/015 HBVAXPRO Merck Sharp & Dohme BV, 27/04/2001 HM Marketed AU Suspension for injection J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/018-025 EU/1/01/183/018-025 HBVAXPRO Merck Sharp & Dohme BV, 27/04/2001 HM Unknown AU Suspension for injection J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/026-029 EU/1/01/183/026-029 HBVAXPRO Merck Sharp & Dohme BV, 27/04/2001 HM Unknown AU Suspension for injection in pre-filled syringe J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/01/183/001 EU/1/01/183/001 HBVAXPRO 5 micrograms, suspension for injection Merck Sharp & Dohme BV, 27/04/2001 HM Unknown AU Suspension for injection J07BC J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b vaccine Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22650/008/001 PA22650/008/001 HC45 Hydrocortisone Acetate Cream (Hydrocortisone Acetate 1% w/w) Karo Pharma AB 24/09/1996 HM Marketed AU Cream D07AA D07AA02 Well-established use application (Article 10a of Directive No 2001/83/EC) Topical use HYDROCORTISONE ACETATE Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only EU/1/18/1287/007 EU/1/18/1287/007 Hefiya 20 mg solution for injection in pre-filled syringe Sandoz GmbH 27/03/2020 HM Unknown AU Solution for injection in pre-filled syringe L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1287/004-006 EU/1/18/1287/004-006 Hefiya 40 mg solution for injection in pre-filled pen Sandoz GmbH 26/07/2018 HM Unknown AU Solution for injection in pre-filled pen L04AB L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1287/001-003 EU/1/18/1287/001-003 Hefiya 40 mg solution for injection in pre-filled syringe Sandoz GmbH 26/07/2018 HM Unknown AU Solution for injection in pre-filled syringe L04AB L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1287/010-011 EU/1/18/1287/010-011 Hefiya 80 mg solution for injection in pre-filled pen Sandoz GmbH 26/07/2018 HM Unknown AU Solution for injection in pre-filled pen L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1287/008-009 EU/1/18/1287/008-009 Hefiya 80 mg solution for injection in pre-filled syringe Sandoz GmbH 26/07/2018 HM Unknown AU Solution for injection in pre-filled syringe L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/97/045/001 EU/1/97/045/001 Helicobacter Test INFAI 75 mg powder for oral solution INFAI Institut fur biomedizinish 14/08/1997 HM Unknown AU Powder for oral solution V04CX Full application (Article 8(3) of Directive No 2001/83/EC) Inhalation use 13c-urea Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/97/045/003 EU/1/97/045/003 Helicobacter Test INFAI for children of the age 3-11 INFAI Institut fur biomedizinish 10/10/2002 HM Unknown AU Powder for oral solution Full application (Article 8(3) of Directive No 2001/83/EC) 13c-urea Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/14/919/001 EU/1/14/919/001 HEMANGIOL 3.75 mg/mL oral solution Pierre Fabre Dermatologie HM Unknown AU Oral solution C07AA C07AA05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Propranolol hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/22/1715/001 EU/1/22/1715/001 Hemgenix 1 x 10^13 genome copies/mL concentrate for solution for infusion CSL Behring GmbH 20/02/2023 HM Unknown AU Concentrate for solution for infusion B02BD Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Etranacogene dezaparvovec Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1271/002-005 EU/1/18/1271/002-005 Hemlibra 150 mg/mL solution for injection Roche Registration GmbH 23/02/2018 HM Unknown AU Solution for injection B02BX B02BX06 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Emicizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1271/001 EU/1/18/1271/001 Hemlibra 30 mg/mL solution for injection Roche Registration GmbH HM Unknown AU Solution for injection B02BX B02BX06 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Emicizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1271/006 EU/1/18/1271/006 Hemlibra 30 mg/mL solution for injection Roche Registration GmbH 23/02/2018 HM Unknown AU Solution for injection B02BX06 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Emicizumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA25288/005/002 PA25288/005/002 Hemosol B0 solution for haemodialysis/haemofiltration Vantive Belgium SRL 11/06/1999 HM Marketed AU Solution for haemodialysis/haemofiltration B05Z Well-established use application (Article 10a of Directive No 2001/83/EC) Haemodialysis Intravenous use Magnesium chloride hexahydrate Calcium chloride dihydrate Lactic acid Sodium hydrogen carbonate Sodium chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA25288/005/001 PA25288/005/001 Hemosol B0 solution for haemodialysis/haemofiltration Vantive Belgium SRL 11/06/1999 HM Marketed AU Solution for haemodialysis/haemofiltration B05ZB Well-established use application (Article 10a of Directive No 2001/83/EC) Haemodialysis Intravenous use Magnesium chloride hexahydrate Calcium chloride dihydrate Lactic acid Sodium hydrogen carbonate Sodium chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/229/002 PA0281/229/002 Heparin sodium 1,000 IU/ml Solution for injection or concentrate for solution for infusion, 10ml ampoules Pinewood Laboratories Ltd 30/04/1999 HM Marketed AU Solution for injection/infusion B01AB B01AB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Heparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/229/001 PA0281/229/001 Heparin sodium 1,000 IU/ml Solution for injection or concentrate for solution for infusion, 5ml ampoules Pinewood Laboratories Ltd 14/11/1985 HM Marketed AU Solution for injection/infusion B01AB B01AB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Heparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/229/004 PA0281/229/004 Heparin sodium 1,000 IU/ml Solution for injection or concentrate for solution for infusion, 5ml vials Pinewood Laboratories Ltd 14/11/1985 HM Marketed AU Solution for injection/infusion B01AB B01AB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Heparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/230/001 PA0281/230/001 Heparin Sodium 10 IU/ml flushing solution for maintenance of patency of intravenous devices Pinewood Laboratories Ltd 14/11/1985 HM Marketed AU Irrigation solution B01AB B01AB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Heparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/229/003 PA0281/229/003 Heparin sodium 25,000 IU/ml Solution for injection or concentrate for solution for infusion, 0.2ml ampoules Pinewood Laboratories Ltd 14/11/1985 HM Marketed AU Solution for injection/infusion B01AB B01AB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Heparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0281/229/005 PA0281/229/005 Heparin sodium 5,000 IU/ml Solution for injection or concentrate for solution for infusion, 5 ml vials Pinewood Laboratories Ltd 14/11/1985 HM Marketed AU Solution for injection/infusion B01AB B01AB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Heparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/014/001 PA2299/014/001 Heparin Sodium BP 1000 IU/l in 0.9% w/v Sodium Chloride IV Infusion Baxter Holding B.V. 06/06/1984 HM Marketed AU Solution for infusion B01AB B01AB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Heparin sodium Sodium chloride Disodium phosphate dodecahydrate Citric acid monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA2299/014/002 PA2299/014/002 Heparin Sodium BP 2000 IU/l in 0.9 % w/v Sodium Chloride IV infusion Baxter Holding B.V. 06/06/1984 HM Marketed AU Solution for infusion B01AB B01AB01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Citric acid monohydrate Disodium phosphate dodecahydrate Sodium chloride Heparin sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0592/005/004 PA0592/005/004 Hepatect CP 50 IU/ml solution for infusion Biotest Pharma GmbH 22/08/2008 HM Marketed AU Solution for infusion J06BB J06BB04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Human plasma protein Hbs antibodies Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches marketed in Ireland shall be subject to Control Authority Batch Release in accordance with Article 114.2 of Directive 2001/83/EC. EU/1/20/1446/001 EU/1/20/1446/001 HEPCLUDEX 2 mg powder for solution for injection Gilead Sciences Ireland UC 31/07/2020 HM Unknown AU Powder for solution for injection J05A J05AX J05AX28 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Bulevirtide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1503/001 EU/1/20/1503/001 HEPLISAV B 20 micrograms solution for injection in pre-filled syringe Dynavax GmbH 18/02/2021 HM Unknown AU Solution for injection in pre-filled syringe J07BC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Hepatitis b surface antigen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/00/145/001 EU/1/00/145/001 Herceptin 150 mg powder for concentrate for solution for infusion Roche Registration GmbH 28/08/2000 HM Unknown AU Powder for concentrate for solution for infusion L01XC L01XC03 New active substance (Article 8(3) of Directive No 2001/83/EC) Intravenous use Trastuzumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/00/145/002 EU/1/00/145/002 Herceptin 600 mg solution for injection in vial Roche Registration GmbH HM Unknown AU Solution for injection L01XC L01XC03 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Trastuzumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/23/1762/001 EU/1/23/1762/001 Herwenda 150 mg powder for concentrate for solution for infusion Sandoz GmbH 15/11/2023 HM Unknown AU Powder for concentrate for solution for infusion L01FD01 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Trastuzumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1257/001 EU/1/17/1257/001 Herzuma 150 mg powder for concentrate for solution for infusion Celltrion Healthcare Hungary Kft. 09/02/2018 HM Unknown AU Powder for concentrate for solution for infusion L01XC L01XC03 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Intravenous use Trastuzumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/17/1257/002-003 EU/1/17/1257/002-003 Herzuma 420 mg powder for concentrate for solution for infusion Celltrion Healthcare Hungary Kft. 09/02/2018 HM Unknown AU Powder for concentrate for solution for infusion L01XC03 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Trastuzumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/15/1008/001 EU/1/15/1008/001 HETLIOZ 20 mg hard capsules Vanda Pharmaceuticals Netherlands B.V. 22/07/2015 HM Unknown AU Capsule, hard N05CH N05CH03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Tasimelteon Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1870/001 EU/1/24/1870/001 HETRONIFLY 10 mg/ml concentrate for solution for infusion Accord Healthcare S.L.U. 03/02/2025 HM Unknown AU Concentrate for solution for infusion Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Serplulimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/13/828/001-007 EU/1/13/828/001-007 Hexacima suspension for injection Sanofi Winthrop Industrie 17/04/2013 HM Unknown AU Suspension for injection J07CA J07CA09 Known active substance (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Haemophilus influenzae type b capsular polysaccharide Pertussis toxoid (polyribosylribitol phosphate) conjugated to tetanous protein Filamentous haemagglutinin Type 1 (mahoney) Diphtheria toxoid Type 2 (mef-1) Tetanus toxoid Type 3 (saukett) Hepatitis b surface antigen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23120/001/001 PA23120/001/001 Hexiprep 2.0% w/v/70.0% v/v Impregnated Pad GAMA Healthcare Ireland Ltd 16/04/2021 HM Not marketed AU Impregnated pad D08AC52 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Cutaneous use Chlorhexidine digluconate solution Isopropyl alcohol Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA1024/003/001 PA1024/003/001 Hexvix 85 mg, powder and solvent for intravesical solution Photocure ASA 23/02/2007 HM Not marketed AU Powder and solvent for intravesical solution V04CX Full application (Article 8(3) of Directive No 2001/83/EC) Intravesical use Hexaminolevulinate hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/829/001-007 EU/1/13/829/001-007 Hexyon suspension for injection Sanofi Winthrop Industrie 17/04/2013 HM Unknown AU Suspension for injection J07CA J07CA09 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use (polyribosylribitol phosphate) conjugated to tetanous protein Type 1 (mahoney) Haemophilus influenzae type b polysaccharide Diphtheria toxoid Type 2 (mef-1) Filamentous haemagglutinin Tetanus toxoid Pertussis toxoid Type 3 (saukett) Hepatitis b surface antigen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23487/002/001 PA23487/002/001 Hezkue 12.5 mg/actuation, oral suspension Aspargo Labs Italia S.r.l. 12/08/2022 HM Marketed AU Oral suspension G04BE03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Sildenafil citrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1077/027/001 PA1077/027/001 Hiberix. Haemophilus Type b (Hib) vaccine.Powder and Solvent for Solution for Injection GlaxoSmithKline (Ireland) Limited 11/06/1999 HM Not marketed AU Powder and solvent for solution for injection J07AG51 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Haemophilus influenzae type b polysaccharide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1714/001/001 PA1714/001/001 Hidrasec 100 mg hard capsules Bioproject Europe Ltd 11/05/2012 HM Not marketed AU Capsule, hard A07XA A07XA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Racecadotril Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1714/001/003 PA1714/001/003 Hidrasec Children 30mg Granules for Oral Suspension Bioproject Europe Ltd 11/05/2012 HM Not marketed AU Granules for oral suspension A07XA A07XA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Racecadotril Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1714/001/002 PA1714/001/002 Hidrasec Infants 10mg Granules for Oral Suspension Bioproject Europe Ltd 11/05/2012 HM Not marketed AU Granules for oral suspension A07XA A07XA04 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Racecadotril Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22580/002/001 PA22580/002/001 Hidrasec Infants and Children 4 mg/mL Oral Suspension Bioprojet Pharma 25/11/2022 HM Not marketed AU Oral suspension A07XA04 Known active substance (Article 8(3) of Directive No 2001/83/EC) Oral use Racecadotril Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/594/1-5 EU/1/09/594/1-5 Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules Novartis Europharm Limited 30/11/2009 HM Unknown AU Inhalation powder, hard capsule R03AC R03AC18 New active substance (Article 8(3) of Directive No 2001/83/EC) Inhalation use Indacaterol maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/09/594/6-10 EU/1/09/594/6-10 Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules Novartis Europharm Limited 30/11/2009 HM Unknown AU Inhalation powder, hard capsule R03AC R03AC18 New active substance (Article 8(3) of Directive No 2001/83/EC) Inhalation use Indacaterol maleate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/687/001-12 EU/1/11/687/001-12 Hizentra 200 mg/ml solution for subcutaneous injection CSL Behring GmbH 14/04/2011 HM Unknown AU Solution for injection J06BA01 Known active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Human normal immunoglobulin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/14/987/001 EU/1/14/987/001 Holoclar 79,000 - 316,000 cells/cm2 living tissue equivalent Holostem S.r.l. HM Unknown AU Living tissue equivalent S01XA19 Full application (Article 8(3) of Directive No 2001/83/EC) Implantation Ex vivo expanded autologous corneal epithelial cells containing stem cells Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1589/010 EU/1/21/1589/010 Hukyndra 20 mg solution for injection in pre-filled syringe Stada Arzneimittel AG 12/12/2024 HM Unknown AU Solution for injection in pre-filled syringe L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) EU/1/21/1589/004-006 EU/1/21/1589/004-006 Hukyndra 40 mg solution for injection in pre-filled pen Stada Arzneimittel AG 15/11/2021 HM Unknown AU Solution for injection in pre-filled pen L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1589/001-003 EU/1/21/1589/001-003 Hukyndra 40 mg solution for injection in pre-filled syringe Stada Arzneimittel AG 15/11/2021 HM Unknown AU Solution for injection in pre-filled syringe L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1589/008-009 EU/1/21/1589/008-009 Hukyndra 80 mg solution for injection in pre-filled pen Stada Arzneimittel AG 15/11/2021 HM Unknown AU Solution for injection in pre-filled pen L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/21/1589/007 EU/1/21/1589/007 Hukyndra 80 mg solution for injection in pre-filled syringe Stada Arzneimittel AG 15/11/2021 HM Unknown AU Solution for injection in pre-filled syringe L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1319/001-007 EU/1/18/1319/001-007 Hulio Biosimilar Collaborations Ireland Limited 17/09/2018 HM Unknown AU Solution for injection L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1319/009-010 EU/1/18/1319/009-010 Hulio 20 mg solution for injection in pre-filled syringe Biosimilar Collaborations Ireland Limited 17/09/2018 HM Unknown AU Solution for injection in pre-filled syringe L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/96/007/019 EU/1/96/007/019 Humalog Eli Lilly Nederland B.V. 05/12/2001 HM Unknown AU Solution for injection A10AB A10AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Insulin lispro Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/96/007/004 EU/1/96/007/004 Humalog 100 units/ml solution for injection in cartridge insulin lispro Eli Lilly Nederland B.V. 26/06/1997 HM Unknown AU Solution for injection in cartridge A10AB A10AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Insulin lispro Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/96/007/002 EU/1/96/007/002 Humalog 100 units/ml solution for injection in vial Eli Lilly Nederland B.V. 30/04/1996 HM Unknown AU Solution for injection A10AB A10AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Insulin lispro Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/96/007/039-042 EU/1/96/007/039-042 Humalog 200 units/ml KwikPen solution for injection in a pre-filled pen Eli Lilly and Company Limited 30/09/2014 HM Unknown AU Solution for injection A10AB A10AB04 Full application (Article 8(3) of Directive No 2001/83/EC) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/96/007/008 EU/1/96/007/008 Humalog Mix25 100 units/ml suspension for injection in cartridge Eli Lilly Nederland B.V. 19/11/1998 HM Unknown AU Suspension for injection A10AD Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Insulin lispro Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/96/007/005 EU/1/96/007/005 Humalog Mix25 100 units/ml suspension for injection in vial Eli Lilly Nederland B.V. 19/11/1998 HM Unknown AU Suspension for injection A10AD A10AD04 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Insulin lispro Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/96/007/006 EU/1/96/007/006 Humalog Mix50 100 units/ml suspension for injection in cartridge Eli Lilly Nederland B.V. HM Unknown AU Suspension for injection A10AD Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Insulin lispro Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/96/007/010 EU/1/96/007/010 Humalog NPL Eli Lilly Nederland B.V. 19/11/1998 HM Unknown AU Suspension for injection A10AD Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Insulin lispro Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2004/004/002 PA2004/004/002 Human Albumin Baxalta 200 g/l Solution for Infusion Baxalta Innovations GmbH 21/12/2006 HM Not marketed AU Solution for infusion B05AA B05AA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Plasma protein containing at least 95% human albumin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EEC. PA2004/004/001 PA2004/004/001 Human Albumin Baxalta 50 g/l Solution for Infusion Baxalta Innovations GmbH 21/12/2006 HM Marketed AU Solution for infusion B05AA B05AA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Plasma protein containing at least 95% human albumin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Batches marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EEC. PA0800/012/001 PA0800/012/001 Human Albumin CSL Behring, 200 g/l, solution for infusion CSL Behring GmbH 31/07/2020 HM Not marketed AU Solution for infusion B05AA01 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Human albumin solution Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/03/256/022 EU/1/03/256/022 Humira 20 mg solution for injection in pre-filled syringe AbbVie Deutschland GmbH & Co. KG HM Unknown AU Solution for injection in pre-filled syringe L04AB L04AB04 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/03/256/1-10 EU/1/03/256/1-10 Humira 40 mg/0.8 ml solution for injection AbbVie Deutschland GmbH & Co. KG HM Unknown AU Solution for injection L04AB L04AB04 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/03/256/020 EU/1/03/256/020 Humira 80 mg solution for injection in pre-filled syringe AbbVie Deutschland GmbH & Co. KG HM Unknown AU Solution for injection in pre-filled syringe L04AB L04AB04 New active substance (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA2276/002/004 PA2276/002/004 Humulin I (Isophane) 100 IU/ml Suspension for Injection in cartridge Eli Lilly Nederland B.V. 13/03/2015 HM Marketed AU Suspension for injection in cartridge A10AC A10AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Human insulin (recombinant dna origin) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2276/002/003 PA2276/002/003 Humulin I (Isophane) 100 IU/ml Suspension for Injection in vial Eli Lilly Nederland B.V. 13/03/2015 HM Not marketed AU Suspension for injection A10AC A10AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Subcutaneous use Human insulin (recombinant dna origin) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2276/005/002 PA2276/005/002 Humulin I KwikPen (Isophane) 100 IU/ml Suspension for Injection Eli Lilly Nederland B.V. 13/03/2015 HM Marketed AU Suspension for injection A10AC A10AC01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Human insulin (recombinant dna origin) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2276/003/004 PA2276/003/004 Humulin M3 (Mixture 3) 100 IU/ml Suspension for Injection in cartridge Eli Lilly Nederland B.V. 13/03/2015 HM Marketed AU Suspension for injection in cartridge A10AD A10AD01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Human insulin (recombinant dna origin) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2276/003/003 PA2276/003/003 Humulin M3 (Mixture 3) 100 IU/ml Suspension for Injection in vial Eli Lilly Nederland B.V. 13/03/2015 HM Not marketed AU Suspension for injection A10AD A10AD01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Subcutaneous use Human insulin (recombinant dna origin) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2276/006/002 PA2276/006/002 Humulin M3 KwikPen (mixture 3) 100 IU/ml Suspension for Injection Eli Lilly Nederland B.V. 13/03/2015 HM Marketed AU Suspension for injection A10AD A10AD01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Human insulin (recombinant dna origin) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PPA0465/501/001 PPA0465/501/001 Humulin M3 KwikPen (mixture 3) 100 IU/ml Suspension for Injection PCO Manufacturing Ltd. 19/05/2023 HM Unknown AU Suspension for injection A10AD A10AD01 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC Subcutaneous use Human insulin (recombinant dna origin) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2276/001/003 PA2276/001/003 Humulin S (Soluble) 100 IU/ml Solution for Injection in vial Eli Lilly Nederland B.V. 13/03/2015 HM Not marketed AU Solution for injection in vial A10AB A10AB01 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Subcutaneous use Human insulin (recombinant dna origin) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2276/001/004 PA2276/001/004 Humulin S (Soluble), 100 IU/ml Solution for Injection in cartridge Eli Lilly Nederland B.V. 13/03/2015 HM Marketed AU Solution for injection in cartridge A10AB01 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Human insulin (recombinant dna origin) Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0281/231/001 PA0281/231/001 Hyaluronidase 1500 I.U. Powder for Solution for Injection or Infusion Pinewood Laboratories Ltd 22/03/1984 HM Marketed AU Powder for solution for injection/infusion B06AA B06AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Not Currently Available Subcutaneous use Hyaluronidase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/96/027/006 EU/1/96/027/006 HYCAMTIN 0.25 mg hard capsules Sandoz Pharmaceuticals d.d. 18/03/2008 HM Unknown AU Capsule, hard L01CE01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Topotecan hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/96/027/007 EU/1/96/027/007 HYCAMTIN 1 mg hard capsules Sandoz Pharmaceuticals d.d. 18/03/2008 HM Unknown AU Capsule, hard L01CE01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Topotecan hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/96/027/004 EU/1/96/027/004 Hycamtin 1 mg powder for concentrate for solution for infusion Sandoz Pharmaceuticals d.d. 16/03/2000 HM Unknown AU Powder for concentrate for solution for infusion L01XX L01XX17 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Topotecan (as hydrochloride) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/96/027/005 EU/1/96/027/005 HYCAMTIN 1 mg powder for concentrate for solution for infusion Sandoz Pharmaceuticals d.d. 16/03/2000 HM Marketed AU Powder for concentrate for solution for infusion L01XX L01XX17 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Topotecan (as hydrochloride) Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/96/027/003 EU/1/96/027/003 Hycamtin 4 mg powder for concentrate for solution for infusion Sandoz Pharmaceuticals d.d. 15/04/1997 HM Unknown AU Powder for concentrate for solution for infusion L01XX L01XX17 Full application (Article 8(3) of Directive No 2001/83/EC) Topotecan hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/96/027/001 EU/1/96/027/001 HYCAMTIN 4 mg powder for concentrate for solution for infusion Sandoz Pharmaceuticals d.d. 12/11/1996 HM Unknown AU Powder for concentrate for solution for infusion L01XX L01XX17 Full application (Article 8(3) of Directive No 2001/83/EC) Topotecan hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) PA2239/021/001 PA2239/021/001 Hydrea 500 mg Hard Capsules CHEPLAPHARM Arzneimittel GmbH 01/04/1979 HM Marketed AU Capsule, hard L01XX L01XX05 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Hydroxycarbamide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1843/001/001 PA1843/001/001 Hydrex Surgical Scrub 4.0% w/v Cutaneous Solution Ecolab Deutschland GmbH 16/10/1995 HM Marketed AU Cutaneous solution D08AC D08AC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Topical Chlorhexidine gluconate Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA0206/030/001 PA0206/030/001 Hydrocortisone 1% w/w Cream Ovelle Limited 20/03/1998 HM Marketed AU Cream D07AA D07AA02 Well-established use application (Article 10a of Directive No 2001/83/EC) Topical Hydrocortisone Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA22865/003/001 PA22865/003/001 Hydrocortisone 10 mg Tablets Renata Pharmaceuticals (Ireland) Limited 20/10/2017 HM Marketed AU Tablet H02AB H02AB09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22865/003/002 PA22865/003/002 Hydrocortisone 20 mg Tablets Renata Pharmaceuticals (Ireland) Limited 20/10/2017 HM Not marketed AU Tablet H02AB H02AB09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22865/003/003 PA22865/003/003 Hydrocortisone 5 mg Tablets Renata Pharmaceuticals (Ireland) Limited 02/02/2024 HM Marketed AU Tablet H02AB09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23341/001/003 PA23341/001/003 Hydrocortisone Hualan 10 mg tablets Hualan Pharmaceuticals Limited 14/06/2024 HM Not marketed AU Tablet H02AB09 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23341/001/004 PA23341/001/004 Hydrocortisone Hualan 15 mg tablets Hualan Pharmaceuticals Limited 14/06/2024 HM Not marketed AU Tablet H02AB09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23341/001/001 PA23341/001/001 Hydrocortisone Hualan 2.5 mg tablets Hualan Pharmaceuticals Limited 14/06/2024 HM Not marketed AU Tablet H02AB09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23341/001/005 PA23341/001/005 Hydrocortisone Hualan 20 mg tablets Hualan Pharmaceuticals Limited 14/06/2024 HM Not marketed AU Tablet H02AB09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA23341/001/002 PA23341/001/002 Hydrocortisone Hualan 5 mg tablets Hualan Pharmaceuticals Limited 14/06/2024 HM Not marketed AU Tablet H02AB09 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1986/054/001 PA1986/054/001 Hydrocortone 10 mg Tablets Teva B.V. 01/04/1978 HM Marketed AU Tablet H02AB H02AB09 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Hydrocortisone Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0549/030/001 PA0549/030/001 Hydromorphone Hydrochloride 20 mg/ml Solution for Injection/Concentrate for Solution for Infusion Ethypharm 28/10/2005 HM Not marketed AU Solution for injection/infusion N02AA N02AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Hydromorphone hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA2165/023/001 PA2165/023/001 Hydromorphone hydrochloride 20 mg/ml solution for injection/infusion AS Kalceks 14/04/2022 HM Marketed AU Solution for injection/infusion N02AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Hydromorphone hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA0549/030/002 PA0549/030/002 Hydromorphone Hydrochloride 50 mg/ml Solution for Injection/Concentrate for Solution for Infusion Ethypharm 28/10/2005 HM Not marketed AU Solution for injection/infusion N02AA N02AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Hydromorphone hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA2165/023/002 PA2165/023/002 Hydromorphone hydrochloride 50 mg/ml solution for injection/infusion AS Kalceks 14/04/2022 HM Unknown AU Solution for injection/infusion N02AA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Subcutaneous use Hydromorphone hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017. PA1770/002/001 PA1770/002/001 IC0121-172-063 Hydroxocobalamin 1 mg/ml solution for injection G.L. Pharma GmbH 03/08/2018 HM Marketed AU Solution for injection B03BA B03BA03 Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Hydroxocobalamin acetate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1113/031/001 PA1113/031/001 IC0121-172-063 Hydroxy-Vit 1000 microgram/ml solution for injection Phoenix Labs Unlimited Company 24/03/2023 HM Not marketed AU Solution for injection B03BA03 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intramuscular use Hydroxocobalamin chloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22749/025/001 PA22749/025/001 Hydroxyzine hydrochloride 25 mg film-coated tablets Brillpharma (Ireland) Limited 02/12/2022 HM Not marketed AU Film-coated tablet N05BB N05BB01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Hydroxyzine hydrochloride Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/23/1723/001 EU/1/23/1723/001 HYFTOR 2 mg/g Gel Plusultra Pharma GmbH 15/05/2023 HM Unknown AU Gel L04AA10 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Topical Sirolimus Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/24/1874/002-003 EU/1/24/1874/002-003 Hympavzi 150 mg solution for injection in pre-filled pen Pfizer Europe MA EEIG 18/11/2024 HM Unknown AU Solution for injection in pre-filled pen B02BX11 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Marstacimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/24/1874/001 EU/1/24/1874/001 Hympavzi 150 mg solution for injection in pre-filled syringe Pfizer Europe MA EEIG 18/11/2024 HM Unknown AU Solution for injection in pre-filled syringe B02BX11 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Marstacimab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0549/031/002 PA0549/031/002 Hyoscine Hydrobromide Martindale Pharma 600 micrograms/ml Solution for Injection Ethypharm 26/08/2005 HM Marketed AU Solution for injection A04AD Generic application (Article 10(1) of Directive No 2001/83/EC) Intramuscular use Subcutaneous use Hyoscine hydrobromide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only HOR1149/015/001 HOR1149/015/001 Hypericum A. Nelson & Company Limited 29/10/2010 HM Not marketed AU Pillules Not Currently Available Oral use Hypericum perforatum Product not subject to medical prescription Supply through non-pharmacy outlets and pharmacies Advertising to the general public PA2239/007/001 PA2239/007/001 Hypnovel 10 mg/2 ml Solution for Injection CHEPLAPHARM Arzneimittel GmbH 18/04/1983 HM Marketed AU Solution for injection N05CD N05CD08 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Rectal use Midazolam hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA2239/007/002 PA2239/007/002 Hypnovel 10 mg/5 ml Solution for Injection CHEPLAPHARM Arzneimittel GmbH 27/03/1985 HM Marketed AU Solution for injection N05CD N05CD08 Full application (Article 8(3) of Directive No 2001/83/EC) Intramuscular use Intravenous use Rectal use Midazolam hydrochloride Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only This product contains a substance listed in schedule 4, part 1 to the Misuse of Drugs Regulations 2017. PA0822/195/001 PA0822/195/001 Hypovase 0.5mg Tablets Pfizer Healthcare Ireland Unlimited Company 01/04/1979 HM Marketed AU Tablet C02CA C02CA01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Prazosin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/840/001-006 EU/1/13/840/001-006 HyQvia 100 mg/mL solution for infusion for subcutaneous use Baxalta Innovations GmbH HM Unknown AU Solution for infusion J06BA J06BA02 Full application (Article 8(3) of Directive No 2001/83/EC) Subcutaneous use Human normal immunoglobulin Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1286/007 EU/1/18/1286/007 Hyrimoz 20 mg solution for injection in pre-filled syringe Sandoz GmbH 27/03/2020 HM Unknown AU Solution for injection in pre-filled syringe L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) EU/1/18/1286/004-006 EU/1/18/1286/004-006 Hyrimoz 40 mg solution for injection in pre-filled pen Sandoz GmbH 26/07/2018 HM Unknown AU Solution for injection in pre-filled pen L04AB L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1286/001-003 EU/1/18/1286/001-003 Hyrimoz 40 mg solution for injection in pre-filled syringe Sandoz GmbH 26/07/2018 HM Unknown AU Solution for injection in pre-filled syringe L04AB L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1286/010-011 EU/1/18/1286/010-011 Hyrimoz 80 mg solution for injection in pre-filled pen Sandoz GmbH 26/07/2018 HM Unknown AU Solution for injection in pre-filled pen L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/18/1286/008-009 EU/1/18/1286/008-009 Hyrimoz 80 mg solution for injection in pre-filled syringe Sandoz GmbH 26/07/2018 HM Unknown AU Solution for injection in pre-filled syringe L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1142/005/004 PA1142/005/004 Hytrin 10mg Tablets Amdipharm Limited 25/05/1989 HM Not marketed AU Tablet G04CA G04CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Terazosin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1142/005/001 PA1142/005/001 Hytrin 1mg and 2mg Tablets (Starter Pack) Amdipharm Limited 25/05/1989 HM Not marketed AU Tablet G04CA G04CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Terazosin Terazosin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1142/005/002 PA1142/005/002 Hytrin 2mg Tablets Amdipharm Limited 25/05/1989 HM Not marketed AU Tablet G04CA G04CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Terazosin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1142/005/003 PA1142/005/003 Hytrin 5mg Tablets Amdipharm Limited 25/05/1989 HM Marketed AU Tablet G04CA G04CA03 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Terazosin Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/10/659/003 EU/1/10/659/003 Iasibon 1 mg concentrate for solution for infusion Pharmathen S.A. 21/01/2011 HM Unknown AU Concentrate for solution for infusion M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibandronic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/10/659/004 EU/1/10/659/004 Iasibon 2 mg concentrate for solution for infusion Pharmathen S.A. 21/01/2011 HM Unknown AU Concentrate for solution for infusion M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibandronic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/10/659/001-002&8-10 EU/1/10/659/001-002&8-10 IC0141-023-003 Iasibon 50 mg film-coated tablets Pharmathen S.A. 21/01/2011 HM Unknown AU Film-coated tablet M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibandronic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). EU/1/10/659/005-007 EU/1/10/659/005-007 Iasibon 6 mg concentrate for solution for infusion Pharmathen S.A. 21/01/2011 HM Unknown AU Concentrate for solution for infusion M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibandronic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA2315/184/001 PA2315/184/001 IC0141-062-003 Ibandronic Acid 150 mg film-coated tablets Accord Healthcare Ireland Ltd. 21/01/2011 HM Marketed AU Film-coated tablet M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibandronate sodium monohydrate Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA1122/018/001 PA1122/018/001 Ibandronic Acid 6 mg Concentrate for Solution for Infusion Noridem Enterprises Limited 03/05/2013 HM Not marketed AU Concentrate for solution for infusion M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Ibandronate sodium monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Summary of Product Characteristics, section 4.2). EU/1/12/798/001 EU/1/12/798/001 Ibandronic acid Accord 2 mg concentrate for solution for infusion Accord Healthcare S.L.U. HM Unknown AU Concentrate for solution for infusion M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Ibandronate sodium monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/12/798/005-006 EU/1/12/798/005-006 Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe Accord Healthcare S.L.U. HM Unknown AU Solution for injection in pre-filled syringe M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Ibandronic acid Ibandronate sodium monohydrate Ibandronate sodium Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/12/798/002-004 EU/1/12/798/002-004 Ibandronic acid Accord 6 mg concentrate for solution for infusion Accord Healthcare S.L.U. HM Unknown AU Concentrate for solution for infusion M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Ibandronate sodium monohydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA0126/240/001 PA0126/240/001 IC0141-062-003 Ibandronic Acid Clonmel 150 mg film-coated tablets Clonmel Healthcare Ltd 28/01/2011 HM Marketed AU Film-coated tablet M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibandronic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/685/001-005 EU/1/11/685/001-005 IC0141-023-003 Ibandronic Acid Sandoz 50 mg film-coated tablets Sandoz GmbH HM Unknown AU Film-coated tablet M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibandronic acid Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics,section 4.2). EU/1/10/642/003-004 EU/1/10/642/003-004 IC0141-062-003 Ibandronic Acid Teva 150 mg film-coated tablets Teva Pharma B.V. 17/09/2010 HM Unknown AU Film-coated tablet M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibandronic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/10/642/001-002 EU/1/10/642/001-002 IC0141-023-003 Ibandronic Acid Teva 50 mg film-coated tablets Teva Pharma B.V. 17/09/2010 HM Unknown AU Film-coated tablet M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibandronic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23266/027/001 PA23266/027/001 IC0141-062-003 Ibandronic Acid Viatris 150 mg Film-coated Tablets Viatris Limited 02/07/2010 HM Marketed AU Film-coated tablet M05BA M05BA06 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibandronic acid Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/16/1147/0012-013 EU/1/16/1147/0012-013 IBRANCE 100 mg film-coated tablets Pfizer Europe MA EEIG 13/02/2020 HM Unknown AU Film-coated tablet L01XE33 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Palbociclib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1147/003-004 EU/1/16/1147/003-004 IBRANCE 100 mg hard capsules Pfizer Europe MA EEIG 09/11/2016 HM Unknown AU Capsule, hard L01EF01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Palbociclib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1147/014-015 EU/1/16/1147/014-015 IBRANCE 125 mg film-coated tablets Pfizer Europe MA EEIG 13/02/2020 HM Unknown AU Film-coated tablet L01XE33 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Palbociclib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1147/005-006 EU/1/16/1147/005-006 IBRANCE 125 mg hard capsules Pfizer Europe MA EEIG 09/11/2016 HM Unknown AU Capsule, hard L01EF01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Palbociclib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1147/010-011 EU/1/16/1147/010-011 IBRANCE 75 mg film-coated tablets Pfizer Europe MA EEIG 13/02/2020 HM Unknown AU Film-coated tablet L01XE33 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Palbociclib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1147/001-002 EU/1/16/1147/001-002 IBRANCE 75 mg hard capsules Pfizer Europe MA EEIG 09/11/2016 HM Unknown AU Capsule, hard L01EF01 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Palbociclib Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA23128/011/001 PA23128/011/001 Ibugel 5% w/w Gel Dermal Laboratories (Ireland) Limited 19/09/1995 HM Marketed AU Gel M02AA M02AA13 Informed consent application (Article 10c of Directive No 2001/83/EC) Topical Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2315/165/001 PA2315/165/001 Ibuprofen 200 mg Film-coated Tablets Accord Healthcare Ireland Ltd. 07/10/2016 HM Marketed AU Film-coated tablet M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA22749/022/004 PA22749/022/004 Ibuprofen 200 mg soft capsules Brillpharma (Ireland) Limited 31/05/2019 HM Not marketed AU Capsule, soft M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen ph. eur. Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Subject to the following restriction: maximum strength 200 mg, maximum pack size 50, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children over 12 years. PA1186/022/001 PA1186/022/001 Ibuprofen 200mg Coated Tablets Chefaro Ireland DAC, 29/11/2013 HM Marketed AU Coated tablet M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Subject to the following restriction: maximum strength 200 mg, maximum pack size 50, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children over 12 years. PA23341/002/001 PA23341/002/001 Ibuprofen 200mg Film-coated tablets Hualan Pharmaceuticals Limited 12/12/2025 HM Not marketed AU Film-coated tablet M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Maximum pack size: 50, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children over 12 years. PA2315/165/002 PA2315/165/002 Ibuprofen 400 mg Film-coated Tablets Accord Healthcare Ireland Ltd. 07/10/2016 HM Marketed AU Film-coated tablet M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23341/002/002 PA23341/002/002 Ibuprofen 400mg Film-coated Tablets Hualan Pharmaceuticals Limited 12/12/2025 HM Not marketed AU Film-coated tablet M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Not applicable Advertising to healthcare professionals only maximum strength 400 mg, maximum pack size 25, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children over 12 years. PA2315/165/003 PA2315/165/003 Ibuprofen 600 mg Film-coated Tablets Accord Healthcare Ireland Ltd. 07/10/2016 HM Not marketed AU Film-coated tablet M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA23341/002/003 PA23341/002/003 Ibuprofen 600mg Film-coated Tablets Hualan Pharmaceuticals Limited 12/12/2025 HM Not marketed AU Film-coated tablet M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Not applicable Advertising to healthcare professionals only PA0736/041/003 PA0736/041/003 Ibuprofen B. Braun 200 mg solution for infusion B. Braun Melsungen AG 15/05/2020 HM Not marketed AU Solution for infusion M01AE01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Ibuprofen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0736/041/001 PA0736/041/001 Ibuprofen B. Braun 400 mg solution for infusion B. Braun Melsungen AG 06/10/2017 HM Marketed AU Solution for infusion M01AE M01AE01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Ibuprofen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA0736/041/002 PA0736/041/002 Ibuprofen B. Braun 600 mg solution for infusion B. Braun Melsungen AG 06/10/2017 HM Not marketed AU Solution for infusion M01AE M01AE01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Intravenous use Ibuprofen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA22773/001/001 PA22773/001/001 Ibuprofen Banner 100 mg soft chewable capsules Patheon Softgels B.V. 11/10/2019 HM Not marketed AU Chewable capsule, soft M01AE01 Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Retail sale through pharmacies only in pack size not exceeding 100 tablets. Prescription-only in pack sizes exceeding 100 tablets. Direct to the public for pack size not exceeding 100 tablets. To the professions as a prescription-only medicine for pack siz PA0126/402/001 PA0126/402/001 Ibuprofen Boots 200 mg film-coated tablets Clonmel Healthcare Ltd 30/01/2026 HM Not marketed AU Film-coated tablet M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Medicinal product not subject to medical prescription, supply through pharmacies only and promotion to the public subject to the following restrictions: maximum strength 200 mg, maximum pack size 50, maximum dose: 400 mg, maximum daily dose 1200 mg, limite PA0126/402/002 PA0126/402/002 Ibuprofen Boots 400 mg film-coated tablets Clonmel Healthcare Ltd 30/01/2026 HM Not marketed AU Film-coated tablet M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Medicinal product not subject to medical prescription, supply through pharmacies only and promotion to the public subject to the following restrictions: maximum strength 400 mg, maximum pack size 25, maximum dose: 400 mg, maximum daily dose 1200 mg, limite PA0126/417/001 PA0126/417/001 Ibuprofen Clonmel 200 mg film-coated tablets Clonmel Healthcare Ltd 16/01/2026 HM Not marketed AU Film-coated tablet M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Medicinal product not subject to medical prescription, supply through pharmacies only and promotion to the public subject to the following restrictions: maximum strength 200 mg, maximum pack size 50, maximum dose: 400 mg, maximum daily dose 1200 mg, limite PA0126/417/002 PA0126/417/002 Ibuprofen Clonmel Max Strength 400 mg film-coated tablets Clonmel Healthcare Ltd 16/01/2026 HM Not marketed AU Film-coated tablet M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Medicinal product not subject to medical prescription, supply through pharmacies only and promotion to the public subject to the following restrictions: maximum strength 400 mg, maximum pack size 25, maximum dose: 400 mg, maximum daily dose 1200 mg, limite PA2090/002/001 PA2090/002/001 Ibuprofen Farmalider 200 mg film-coated tablets Farmalider S.A. 05/01/2018 HM Not marketed AU Film-coated tablet M01AE M01AE01 Well-established use application (Article 10a of Directive No 2001/83/EC) Oral use Ibuprofen ph. eur. Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Subject to the following restriction: maximum strength 200 mg, maximum pack size 50, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children over 12 years. EU/1/23/1791/001 EU/1/23/1791/001 Ibuprofen Gen.Orph 5 mg/mL solution for injection Gen.Orph 16/02/2024 HM Unknown AU Solution for injection C01EB16 Generic application (Article 10(1) of Directive No 2001/83/EC) Intravenous use Ibuprofen Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). PA1186/022/002 PA1186/022/002 Ibuprofen Max 400mg Film-coated Tablets Chefaro Ireland DAC, 29/11/2013 HM Not marketed AU Film-coated tablet M01AE M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product not subject to medical prescription Supply through pharmacies only Advertising to the general public Subject to the following restrictions: maximum strength 400 mg, maximum pack size 25, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children over 12 years. PA0126/415/001 PA0126/415/001 Ibuprofen Rx Clonmel 200 mg film-coated tablets Clonmel Healthcare Ltd 30/01/2026 HM Not marketed AU Film-coated tablet M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA0126/415/002 PA0126/415/002 Ibuprofen Rx Clonmel 400 mg film-coated tablets Clonmel Healthcare Ltd 30/01/2026 HM Not marketed AU Film-coated tablet M01AE01 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Ibuprofen Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA25288/010/001 PA25288/010/001 Icalziss 340 mmol/L solution for infusion Vantive Belgium SRL 14/03/2025 HM Not marketed AU Solution for infusion B05XA07 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Calcium chloride dihydrate Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/484/007-012 EU/1/08/484/007-012 Icandra 50 mg/1000 mg film-coated tablets Novartis Europharm Limited HM Unknown AU Film-coated tablet A10BD Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/484/001-006 EU/1/08/484/001-006 Icandra 50 mg/850 mg film-coated tablets Novartis Europharm Limited HM Unknown AU Film-coated tablet A10BD08 Informed consent application (Article 10c of Directive No 2001/83/EC) Oral use Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/21/1567/001-002 EU/1/21/1567/001-002 IC0148-033-063 Icatibant Accord 30 mg solution for injection in pre-filled syringe Accord Healthcare S.L.U. 16/07/2021 HM Unknown AU Solution for infusion in pre-filled syringe B06AC02 Generic application (Article 10(1) of Directive No 2001/83/EC) Subcutaneous use Icatibant Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) . EU/1/13/839/001-002 EU/1/13/839/001-002 Iclusig 15 mg film-coated tablets Incyte Biosciences Distribution B.V. 01/07/2013 HM Unknown AU Film-coated tablet L01XE L01XE24 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ponatinib hci Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/839/006 EU/1/13/839/006 Iclusig 30 mg film-coated tablets Incyte Biosciences Distribution B.V. 21/11/2015 HM Unknown AU Film-coated tablet L01XE L01XE24 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ponatinib hci Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/13/839/003-004 EU/1/13/839/003-004 Iclusig 45 mg film-coated tablets Incyte Biosciences Distribution B.V. 01/07/2013 HM Unknown AU Film-coated tablet L01XE L01XE24 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Ponatinib hci Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only PA1347/022/001 PA1347/022/001 Icorvida SR 1.5mg Prolonged-release Tablets KRKA, d.d., Novo mesto 03/02/2012 HM Marketed AU Prolonged-release tablet C03BA C03BA11 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Indapamide Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/19/1356/001 EU/1/19/1356/001 IDACIO 40 mg/0.8 ml Solution for injection Fresenius Kabi Deutschland GmbH 02/04/2019 HM Unknown AU Solution for injection L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1356/002 EU/1/19/1356/002 IDACIO 40 mg Solution for injection Fresenius Kabi Deutschland GmbH 02/04/2019 HM Unknown AU Solution for injection in pre-filled syringe L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/19/1356/003 EU/1/19/1356/003 IDACIO 40 mg Solution for injection Fresenius Kabi Deutschland GmbH 02/04/2019 HM Unknown AU Solution for injection in pre-filled pen L04AB04 Similar biological application (Article 10(4) of Directive No 2001/83/EC) Subcutaneous use Adalimumab Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/20/1471/001-002 EU/1/20/1471/001-002 Idefirix 11 mg powder for concentrate for solution for infusion Hansa Biopharma AB 25/08/2020 HM Unknown AU Powder for concentrate for solution for infusion L04AA L04AA41 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Imlifidase Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1095/003 EU/1/16/1095/003 IDELVION 1000 IU powder and solvent for solution for injection CSL Behring GmbH 11/05/2016 HM Unknown AU Powder and solvent for solution for injection B02BD Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Rix-fp Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1095/004 EU/1/16/1095/004 IDELVION 2000 IU powder and solvent for solution for injection CSL Behring GmbH 11/05/2016 HM Unknown AU Powder and solvent for solution for injection B02BD Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Rix-fp Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1095/001 EU/1/16/1095/001 IDELVION 250 IU powder and solvent for solution for injection CSL Behring GmbH 11/05/2016 HM Unknown AU Powder and solvent for solution for injection B02BD Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Rix-fp Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1095/009 EU/1/16/1095/009 IDELVION 3500 IU powder and solvent for solution for injection CSL Behring GmbH 11/05/2016 HM Unknown AU Powder and solvent for solution for injection B02BD04 Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Albutrepenonacog Alfa Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). EU/1/16/1095/002 EU/1/16/1095/002 IDELVION 500 IU powder and solvent for solution for injection CSL Behring GmbH 11/05/2016 HM Unknown AU Powder and solvent for solution for injection B02BD Full application (Article 8(3) of Directive No 2001/83/EC) Intravenous use Rix-fp Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). PA1033/001/001 PA1033/001/001 IDEOS 500mg/400 IU Chewable Tablets Laboratoire Innotech International 08/01/1996 HM Marketed AU Chewable tablet A12AX Hybrid application (Article 10(3) of Directive No 2001/83/EC) Oral use Calcium Colecalciferol Product not subject to medical prescription Supply through pharmacies only Advertising to healthcare professionals only PA22808/001/001 PA22808/001/001 Idrolax 10g, powder for oral solution in a sachet Mayoly Pharma France 22/02/2002 HM Not marketed AU Powder for oral solution in sachet A06AD A06AD15 Full application (Article 8(3) of Directive No 2001/83/EC) Oral use Macrogol 4000 Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only PA2226/001/001 PA2226/001/001 IELMAG3 0.2 mg kit for radiopharmaceutical preparation ROTOP Pharmaka GmbH 09/08/2013 HM Marketed AU Kit for radiopharmaceutical preparation V09CA V09CA03 Well-established use application (Article 10a of Directive No 2001/83/EC) Intravenous use Mertiatide Product subject to prescription which may not be renewed (A) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/673/001-008 EU/1/11/673/001-008 IC0158-192-014 Ifirmacombi 150 mg/12.5 mg film-coated tablets KRKA, d.d., Novo mesto 04/03/2011 HM Unknown AU Film-coated tablet C09DA C09DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Hydrochlorothiazide Irbesartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/673/009-016 EU/1/11/673/009-016 IC0158-199-014 Ifirmacombi 300 mg/12.5 mg film-coated tablets KRKA, d.d., Novo mesto 04/03/2011 HM Unknown AU Film-coated tablet C09DA C09DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Hydrochlorothiazide Irbesartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/11/673/017-024 EU/1/11/673/017-024 IC0158-200-003 Ifirmacombi 300 mg/25 mg film-coated tablets KRKA, d.d., Novo mesto 04/03/2011 HM Unknown AU Film-coated tablet C09DA C09DA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Hydrochlorothiazide Irbesartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/480/7-12 EU/1/08/480/7-12 IC0157-062-014 Ifirmasta 150 mg film-coated tablets KRKA, d.d., Novo mesto 03/12/2008 HM Unknown AU Film-coated tablet C09CA C09CA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Irbesartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/480/13-18 EU/1/08/480/13-18 IC0157-029-014 Ifirmasta 300 mg film-coated tablets KRKA, d.d., Novo mesto 03/12/2008 HM Unknown AU Film-coated tablet C09CA C09CA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Irbesartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/08/480/1-6 EU/1/08/480/1-6 IC0157-028-014 Ifirmasta 75 mg film-coated tablets KRKA, d.d., Novo mesto 03/12/2008 HM Unknown AU Film-coated tablet C09CA C09CA04 Generic application (Article 10(1) of Directive No 2001/83/EC) Oral use Irbesartan Product subject to prescription which may be renewed (B) Supply through pharmacies only Advertising to healthcare professionals only EU/1/15/990/001-002 EU/1/15/990/001-002 IKERVIS 1 mg/mL eye drops, emulsion Santen OY 28/05/2015 HM Unknown AU Eye drops, emulsion S01XA S01XA18