List of nationally authorised medicinal products
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1 7 July 2016 EMA/437334/2016 Procedure Management and Committees Support Division Active substance: Terazosin Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 Product Name (in authorisation country) MRP/DCP Authorisation number National Authorisation Number MAH of product in the member state Member State where product is authorised Flotrin Max Mibe Gmbh Arzneimittel Germany Flotrin Pro Mibe Gmbh Arzneimittel Germany Flotrin Start Mibe Gmbh Arzneimittel Germany Flotrin Uro Mibe Gmbh Arzneimittel Germany Hytrin 58/270/96-A/C & 58/270/96-B/C & 58/270/96-C/C Amdipharm Limited Czech Republic Hytrin OGYI-T-4842/01 & OGYI- T-4842/02 & OGYI-T- 4842/03 Amdipharm Limited Hungary Itrin & Ecupharma Terafluss & & Rottapharm S.P.A. Teraprost & & * Malesci Istituto Farmacobiologico - S.P.A. Unoprost & & * Laboratori Guidotti S.P.A. Uro-Hytrin BE & BE & BE & BE Amdipharm Limited Belgium Uro-Hytrin Starter Pack BE Amdipharm Limited Belgium Urodie Urodie Urodie * Urodie Hytrinex a & a & b Amdipharm Limited Sweden Sinalfa a & a & a & b Amdipharm Limited Sweden EMA/437334/2016 Page 2/6
3 URO-HYTRIN 2 mg /comprimés 1739/ Amdipharm Limited Luxembourg URO-HYTRIN 1 mg /comprimés 1739/ Amdipharm Limited Luxembourg URO-HYTRIN 5 mg /comprimés 1739/ Amdipharm Limited Luxembourg URO-HYTRIN 10 mg /comprimés 1739/ Amdipharm Limited Luxembourg URO-HYTRIN Starter pack mg comprimés 1739/ Amdipharm Limited Luxembourg TERAZOSAB 1mg comprimes 1739/ Amdipharm Limited Luxembourg TERAZOSAB 2mg comprimes 1739/ Amdipharm Limited Luxembourg TERAZOSAB 5mg comprimes 1739/ Amdipharm Limited Luxembourg TERAZOSAB 10mg comprimes 1739/ Amdipharm Limited Luxembourg Hytrin 1mg comprimes 1739/ Amdipharm Limited Luxembourg Hytrin 2mg comprimes 1739/ Amdipharm Limited Luxembourg Hytrin 5mg comprimes 1739/ Amdipharm Limited Luxembourg Hytrin 10mg comprimes 1739/ Amdipharm Limited Luxembourg Magnurol 2 mg tablet Amdipharm Limited Spain Magnurol 5 mg tablet Amdipharm Limited Spain HYTRIN RVG Amdipharm Limited Netherlands HYTRIN 1 mg + 2 mg starter pack RVG Amdipharm Limited Netherlands HYTRIN 5 mg 88303/ Amdipharm Limited Greece HYTRIN starter pack 12158/ Amdipharm Limited Greece HYTRINE 2 mg tabs Amdipharm Limited France HYTRIN 2 mg 58/0581/97-S Amdipharm Limited Slovakia TERAZOSIN Starter Pack 58/0581/97-S Amdipharm Limited Slovakia HYTRIN 10mg 58/0581/97-S Amdipharm Limited Slovakia DEFLOX 2mg Amdipharm Limited Spain DEFLOX 5mg Amdipharm Limited Spain EMA/437334/2016 Page 3/6
4 HYTRIN 5mg S00416 Amdipharm Limited Cyprus HYTRIN 1 mg comprimidos , 1/46/85 Amdipharm Limited Portugal SINALFA Amdipharm Limited Denmark Hytrin 1mg Tablets MA 625/00101 Amdipharm Limited Malta Hytrin 2mg Tablets MA 625/00102 Amdipharm Limited Malta Hytrin 5mg Tablets MA 625/00103 Amdipharm Limited Malta Hytrin 10mg Tablets MA 625/00104 Amdipharm Limited Malta HYTRIN 2 mg 88311/ Amdipharm Limited Greece HYTRIN 2 mg comprimidos , 1/46/85 Amdipharm Limited Portugal HYTRIN 10 mg comprimidos , 1/46/85 Amdipharm Limited Portugal HYTRINE 10 mg tabs Amdipharm Limited France HYTRIN 5 mg comprimidos , 1/46/85 Amdipharm Limited Portugal Hytrin BPH 10mg Tablets PL 20072/0035 Amdipharm Limited United Kingdom Hytrin BPH 1mg Tablets PL 20072/0032 Amdipharm Limited United Kingdom Hytrin BPH 2mg Tablets PL 20072/0033 Amdipharm Limited United Kingdom Hytrin BPH 5mg Tablets PL 20072/0034 Amdipharm Limited United Kingdom Hytrin Tablets 10mg PL 20072/0031 Amdipharm Limited United Kingdom Hytrin Tablets 1mg PL 20072/0028 Amdipharm Limited United Kingdom Hytrin Tablets 2mg PL 20072/0029 Amdipharm Limited United Kingdom Hytrin Tablets 5mg PL 20072/0030 Amdipharm Limited United Kingdom DYSALFA 5 mg comprime tabs & tabs Amdipharm Limited France DYSALFA 1 mg comprime tabs & tabs Amdipharm Limited France HYTRINE 5 mg tabs & tabs Amdipharm Limited France Vicard 1 mg-tabletten Amdipharm Limited Austria RVG & RVG HYTRIN & RVG Amdipharm Limited Netherlands EMA/437334/2016 Page 4/6
5 HYTRIN HYTRINE 1 mg BE a & BE a & BE b & BE b Amdipharm Limited Belgium tabs & tabs & tabs Amdipharm Limited France Sinalfa 2 mg tabletter 8259 Amdipharm Limited Norway Hytrin tablets 2 mg 7678 Amdipharm Limited Poland Hytrin tablets 5 mg 7679 Amdipharm Limited Poland Hytrin tablets 10 mg 7680 Amdipharm Limited Poland HYTRIN 5 mg 58/0581/97-S Amdipharm Limited Slovakia Vicard 5 mg-tabletten Amdipharm Limited Austria Vicard 2 mg-tabletten Amdipharm Limited Austria Uroflo 5 mg-tabletten Amdipharm Limited Austria TERAZOSAB BE & BE Amdipharm Limited Belgium Hytrinex 2 mg tabletter Amdipharm Limited Sweden Uroflo 2 mg-tabletten Amdipharm Limited Austria SINALFA Amdipharm Limited Denmark Heitrin 1 mg Tabletten Amdipharm Limited Germany Uroflo 1 mg-tabletten Amdipharm Limited Austria Heitrin 2 mg Tabletten Amdipharm Limited Germany TERAZOSAB BE & BE Amdipharm Limited Belgium Heitrin 5 mg Tabletten Amdipharm Limited Germany HYTRIN Tablets 1mg PA 1142/5/1 Amdipharm Limited Ireland HYTRIN Tablets 2mg PA 1142/5/2 Amdipharm Limited Ireland EMA/437334/2016 Page 5/6
6 HYTRIN Tablets 5mg PA 1142/5/3 Amdipharm Limited Ireland HYTRIN Tablets 10mg PA 1142/5/4 Amdipharm Limited Ireland SINALFA Amdipharm Limited Denmark HYTRIN 5 mg comprimidos , 1/46/85 Amdipharm Limited Portugal HYTRIN 1 mg + 2 mg comprimidos , 1/46/85 Amdipharm Limited Portugal Sinalfa startpack (1 mg + 2 mg) tabletter Amdipharm Limited Norway Sinalfa 10 mg tabletter Amdipharm Limited Norway Sinalfa 5 mg tabletter Amdipharm Limited Norway EMA/437334/2016 Page 6/6
List of nationally authorised medicinal products
5 November 2015 EMA/230130/2016 Procedure Management and Committees Support Active substance: cabergoline Procedure no.: PSUSA/00000477/201503 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
List of nationally authorised medicinal products
11 February 2016 EMA/255959/2016 Procedure Management and Committees Support Active substance: calcitonin salmon, synthetic analogue of eel calcitonin Procedure No.: PSUSA/00000494/201506 30 Churchill
List of nationally authorised medicinal products
01 December 2016 Human Medicines Evaluation Division Active substance: Procedure no.: PSUSA/00002591/201604 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile
List of nationally authorised medicinal products
21 June 2017 EMA/610895/2017 Human Medicines Evaluation Division Active substance: felbamate Procedure no.: PSUSA/00010155/201609 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
List of nationally authorised medicinal products
3 December 2015 EMA/98477/2016 Procedure Management and Committees Support Active substance: acarbose Procedure no.: PSUSA/00000017/201503 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
List of nationally authorised medicinal products
11 January 2018 EMA/24585/2018 Human Medicines Evaluation Division Active substance: esomeprazole / naproxen Procedure no.: PSUSA/00001270/201704 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
List of nationally authorised medicinal products
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List of nationally authorised medicinal products
06 July 2017 EMA/436040/2017 Human Medicines Evaluation Division Active substance: Procedure no.: PSUSA/00001815/201610 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20
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08 March 2018 EMA/170163/2018 Human Medicines Evaluation Division Active substance: enalapril / hydrochlorothiazide Procedure no.: PSUSA/00001212/201707 30 Churchill Place Canary Wharf London E14 5EU United
List of nationally authorised medicinal products
17 May 2018 EMA/303456/2018 Human Medicines Evaluation Division Active substance: bromazepam Procedure no.: PSUSA/00000435/201708 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
List of nationally authorised medicinal products
12 April 2018 EMA/231137/2018 Human Medicines Evaluation Division Active substance: fluvoxamine Procedure no.: PSUSA/00001458/201707 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
List of nationally authorised medicinal products
12 January 2017 EMA/36356/2017 Human Medicines Evaluation Division Active substance: hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine Procedure no.: PSUSA/00001696/201605
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29 November 2018 EMA/880324/2018 Human Medicines Evaluation Division Active substance: enalapril Procedure no.: PSUSA/00001211/201803 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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