List of nationally authorised medicinal products
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1 01 December 2016 Human Medicines Evaluation Division Active substance: 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 where Accupril 10 mg Filmtabletten not available BE PFIZER S.A. (BELGIUM) BE Accupril 10 mg Filmtabletten not available PFIZER S.A. (BELGIUM) LU Accupril 20 mg Filmtabletten not available BE PFIZER S.A. (BELGIUM) BE Accupril 20 mg Filmtabletten not available PFIZER S.A. (BELGIUM) LU Accupril 40 mg Filmtabletten not available BE PFIZER S.A. (BELGIUM) BE Accupril 40 mg Filmtabletten not available PFIZER S.A. (BELGIUM) LU Accupril 5 mg Filmtabletten not available BE PFIZER S.A. (BELGIUM) BE Accupril 5 mg Filmtabletten not available PFIZER S.A. (BELGIUM) LU Accupril 10 mg Filmtabletten not available PFIZER PHARMA GMBH DE Page 2/13
3 where Accupril 20 mg Filmtabletten not available PFIZER PHARMA GMBH DE Accupril 5 mg Filmtabletten not available PFIZER PHARMA GMBH DE ACCUPRIN 10 mg compresse not available PFIZER ITALIA S.R.L. IT ACCUPRIN 20 mg compresse not available PFIZER ITALIA S.R.L. IT ACCUPRIN 20 mg compresse not available PFIZER ITALIA S.R.L. IT ACCUPRIN 40 mg compresse not available PFIZER ITALIA S.R.L. IT ACCUPRIN 5 mg compresse not available PFIZER ITALIA S.R.L. IT ACCUPRO 10 potahované tablety not available 58/312/91-B/C PFIZER, SPOL. S R.O. CZ ACCUPRO 10 Filmom obalené tablety not available 58/0312/91 C/S PFIZER LIMITED SK Page 3/13
4 where ACCUPRO 10 mg apvalkotās tabletes not available PFIZER LIMITED LV Accupro 10 mg comprimate filmate not available 7888/2006/01 PFIZER EUROPE MA EEIG RO Accupro 10 mg Film - Coated tablets not available PA 0822/007/002 PFIZER HEALTHCARE IRELAND IE Accupro 10 mg filmdragerade tabletter not available PFIZER OY FI Accupro 10 mg filmtabletta not available OGYI-T-4163/02 PFIZER KFT. HU Accupro 10 mg Filmtabletten not available PFIZER CORPORATION AT AUSTRIA GESELLSCHAFT M.B.H. ACCUPRO 10 mg plėvele not available LT/1/2000/0234/003 PFIZER LIMITED LT ACCUPRO 10 mg plėvele not available LT/1/2000/0234/004 PFIZER LIMITED LT ACCUPRO 10, 10 mg, tabletki powlekane not available R/7070 PFIZER EUROPE MA EEIG PL Page 4/13
5 where ACCUPRO 20 Filmom obalené tablety not available 58/0312/91 C/S PFIZER LIMITED SK ACCUPRO 20 mg apvalkotās tabletes not available PFIZER LIMITED LV Accupro 20 mg comprimate filmate not available 4506/2004/01 PFIZER EUROPE MA EEIG RO Accupro 20 mg Film - Coated tablets not available PA 0822/007/003 PFIZER HEALTHCARE IRELAND IE Accupro 20 mg filmdragerade tabletter not available PFIZER OY FI Accupro 20 mg filmtabletta not available OGYI-T-4163/03 PFIZER KFT. HU Accupro 20 mg Filmtabletten not available PFIZER CORPORATION AT AUSTRIA GESELLSCHAFT M.B.H. ACCUPRO 20 mg plėvele not available LT/1/2000/0234/006 PFIZER LIMITED LT ACCUPRO 20 mg plėvele not available LT/1/2000/0234/005 PFIZER LIMITED LT Page 5/13
6 where ACCUPRO 20 mg plėvele not available LT/1/2000/0234/007 PFIZER LIMITED LT ACCUPRO 20 potahované tablety not available 58/312/91-C/C PFIZER, SPOL. S R.O. CZ ACCUPRO 20, 20 mg, tabletki powlekane not available R/7071 PFIZER EUROPE MA EEIG PL ACCUPRO 40 mg apvalkotās tabletes not available PFIZER LIMITED LV Accupro 40 mg Film - Coated tablets not available PA 0822/007/004 PFIZER HEALTHCARE IRELAND IE ACCUPRO 40 mg plėvele not available LT/1/2000/0234/001 PFIZER LIMITED LT ACCUPRO 40, 40 mg, tabletki powlekane not available PFIZER EUROPE MA EEIG PL ACCUPRO 5 Filmom obalené tablet not available 58/0312/91 C/S PFIZER LIMITED SK Accupro 5 mg comprimate filmate not available 4505/2004/01 PFIZER EUROPE MA EEIG RO Page 6/13
7 where Accupro 5 mg Film - Coated tablets not available PA 0822/007/001 PFIZER HEALTHCARE IRELAND IE Accupro 5 mg filmdragerade tabletter not available PFIZER OY FI Accupro 5 mg filmtabletta not available OGYI-T-4163/01 PFIZER KFT. HU Accupro 5 mg Filmtabletten not available PFIZER CORPORATION AT AUSTRIA GESELLSCHAFT M.B.H. ACCUPRO 5 mg plėvele not available LT/1/2000/0234/002 PFIZER LIMITED LT ACCUPRO 5 potahované tablety not available 58/312/91-A/C PFIZER, SPOL. S R.O. CZ ACCUPRO 5, 5 mg, tabletki powlekane not available R/7069 PFIZER EUROPE MA EEIG PL Accupro Tablets 10 mg not available PL 00057/0515 PFIZER LIMITED UK Accupro Tablets 20 mg not available PL 00057/0516 PFIZER LIMITED UK Page 7/13
8 where Accupro Tablets 40 mg not available PL 00057/0517 PFIZER LIMITED UK Accupro Tablets 5 mg not available PL 00057/0514 PFIZER LIMITED UK Accupro, tabletter, filmovertrukne not available PFIZER APS DK Accupro, tabletter, filmovertrukne not available PFIZER APS DK Accupro, tabletter, filmovertrukne not available PFIZER APS DK Accupro mg Filmtabletten not available PFIZER PHARMA GMBH DE Accupro mg Filmtabletten not available PFIZER PHARMA GMBH DE Accupro 5 5 mg Filmtabletten not available PFIZER PHARMA GMBH DE ACCUPRON not available PFIZER HELLAS, A.E. CY Page 8/13
9 where ACCUPRON not available PFIZER HELLAS, A.E. CY ACCUPRON not available 41131/10/ PFIZER HELLAS, A.E. GR ACCUPRON not available 41129/10/ PFIZER HELLAS, A.E. GR ACCUPRON not available 41126/10/ PFIZER HELLAS, A.E. GR ACEQUIN 20 mg compresse ACEQUIN 20 mg compresse ACEQUIN 5 mg compresse ACUITEL 20 mg, comprimé not available RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. not available RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. not available RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. not available PFIZER HOLDING ANCE IT IT IT ACUITEL 20 mg, comprimé not available PFIZER HOLDING ANCE Page 9/13
10 where ACUITEL 20 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 20 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 20 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 5 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 5 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 5 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 5 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 5 mg, scored filmcoated tablets not available PFIZER HOLDING ANCE Acuprel 20 mg comprimidos recubiertos con película not available PARKE-DAVIS, S.L. ES Page 10/13
11 where Acuprel 40 mg comprimidos recubiertos con película not available PARKE-DAVIS, S.L. ES Acuprel 5 mg comprimidos recubiertos con película not available PARKE-DAVIS, S.L. ES Acupril 10, tabletten 10 mg not available RVG PFIZER B.V. NL Acupril 20 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 20 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 20, tabletten 20 mg not available RVG PFIZER B.V. NL Acupril 40 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 40 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 40, tabletten 40 mg not available RVG PFIZER B.V. NL Page 11/13
12 where Acupril 5 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 5 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 5 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 5, tabletten 5 mg not available RVG PFIZER B.V. NL Ectren 20 mg comprimidos recubiertos con película not available LABORATORIOS MENARINI, S.A. ES Ectren 40 mg comprimidos recubiertos con película not available LABORATORIOS MENARINI, S.A. ES QUINAZIL 20 mg compresse QUINAZIL 20 mg compresse QUINAZIL 5 mg compresse not available MALESCI ISTITUTO FARMACOBIOLOGICO - S.P.A. not available MALESCI ISTITUTO FARMACOBIOLOGICO - S.P.A. not available MALESCI ISTITUTO FARMACOBIOLOGICO - S.P.A. IT IT IT Page 12/13
13 where Quinhexal 10 mg Film-coated Tablets UK/H/0660/002 PL 10880/0067 HEXAL AG UK Quinhexal 20 mg Film-coated Tablets UK/H/0660/003 PL 10880/0068 HEXAL AG UK Quinhexal 40 mg Film-coated Tablets UK/H/0660/004 PL 10880/0069 HEXAL AG UK Quinhexal 5 mg Film-coated Tablets UK/H/0660/001 PL 10880/0066 HEXAL AG UK Акупро 10 mg филмирани таблетки not available PFIZER EUROPE MA EEIG BG Акупро 20 mg филмирани таблетки not available PFIZER EUROPE MA EEIG BG Page 13/13
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
More informationList of nationally authorised medicinal products
27 October 2016 EMA/719205/2016 Human Medicines Evaluation Division Active substance: ethinylestradiol / gestodene (except for transdermal application) Procedure no.: PSUSA/00001308/201603 30 Churchill
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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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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
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1 December 2016 EMA/750653/2016 Human Medicines Evaluation Division Active substance: valganciclovir Procedure no.: PSUSA/00003089/201603 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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12 April 2018 EMA/243033/2018 Human Medicines Evaluation Division Active substance: fenofibrate Procedure no.: PSUSA/00001362/201707 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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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
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12 April 2018 EMA/382206/2018 Human Medicines Evaluation Division Active substance(s): naproxen Procedure No.: PSUSA/00002125/201708 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
More informationList of nationally authorised medicinal products
10 September 2015 EMA/612853/2015 Procedure Management and Committees Support Active substance: tobramycin (nebuliser solution) Procedure no.: PSUSA/00009316/201412 30 Churchill Place Canary Wharf London
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10 September 2015 EMA/677092/2015 Procedure Management and Committees Support Active substance: glatiramer Procedure no.: PSUSA/00001529/201411 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
More informationList of nationally authorised medicinal products
29 September 2017 EMA/658556/2017 Procedure Management and Committees Support Active substance: loratadine Procedure no.: PSU/00001907/201702 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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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
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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
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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
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7 July 2016 EMA/437334/2016 Procedure Management and Committees Support Division Active substance: Terazosin Procedure no.: PSUSA/00002895/201511 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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21 February 2018 EMA/208334/2018 Human Medicines Evaluation Division Active substance: ibuprofen / pseudoephedrine Procedure no.: PSUSA/00001711/201707 30 Churchill Place Canary Wharf London E14 5EU United
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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
More informationList of nationally authorised medicinal products
26 October 2017 EMA/690754/2017 Human Medicines Evaluation Division Active substance: fish oil / olive oil / soybean oil / triglycerides mediumchain Procedure no.: PSUSA/00010223/201702 30 Churchill Place
More informationList 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
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6 September 2018 EMA/608492/2018 Human Medicines Evaluation Division Active substance: betahistine Procedure no.: PSUSA/00000389/201712 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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10 September 2015 EMA/622830/2015 Procedure Management and Committees Support Active substance: azelastine Procedure no.: PSUSA/00000277/201412 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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12 April 2018 EMA/223740/2018 Human Medicines Evaluation Division Active substance: fludarabine Procedure no.: PSUSA/00001406/201708 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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8 March 2018 EMA/182668/2018 Human Medicines Evaluation Division Active substance(s): triamcinolone (topical and nasal formulations) Procedure No.: PSUSA/00003017/201707 30 Churchill Place Canary Wharf
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6 September 2018 EMA/615391/2018 Human Medicines Evaluation Division Active substance: tobramycin (nebuliser solution) (apart from centrally authorised product) Procedure no.: PSUSA/00009316/201712 30
More informationList of nationally authorised medicinal products
30 November 2017 EMA/817337/2017 Human Medicines Evaluation Division Active substance: Itraconazole Procedure no.: PSUSA/00001798/201703 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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30 November 2017 EMA/812360/2017 Human Medicines Evaluation Division Active substance(s): mupirocin Procedure No.: PSUSA/00002096/201703 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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09 June 2017 EMA/36849/2017 Human Medicines Evaluation Division Active substance(s): brimonidine / timolol Procedure No.: PSUSA/00000431/201609 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
More informationList of nationally authorised medicinal products
30 November 2017 EMA/806830/2017 Human Medicines Evaluation Division Active substance: piroxicam Procedure no.: PSUSA/00002438/201704 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
More informationList 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
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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
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30 November 2017 EMA/817351/2017 Human Medicines Evaluation Division Active substance: Lidocaine / prilocaine (not centrally authorised product) Procedure no.: PSUSA/00001867/201703 30 Churchill Place
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1 September 2017 EMA/580096/2017 Human Medicines Evaluation Division Active substance: terbutaline Procedure no.: PSUSA/00002897/201612 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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28 September 2017 EMA/639167/2017 Human Medicines Evaluation Division Active substance: zanamivir Procedure no.: PSUSA/00003141/201701 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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14 April 2016 EMA/284169/2016 Procedure Management and Committees Support Active substance: influenza vaccine (split virion, inactivated) (non centrally products) Procedure no.: PSUSA/00010298/201508 30
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11 October 2017 EMA/784453/2017 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance(s): ipratropium / salbutamol Procedure No.: PSUSA/00001781/201701 30
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28 September 2017 EMA/658449/2017 Human Medicines Evaluation Division Active substance: olodaterol Procedure no.: PSUSA/00010245/201703 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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