List of nationally authorised medicinal products
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- Oswin Bryan
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1 08 March 2018 EMA/170163/2018 Human Medicines Evaluation Division Active substance: enalapril / hydrochlorothiazide 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 RENACOR? Tabletten not available TEOFARMA S.R.L. DE Renitec comp 20 mg/12,5 mg not available MERCK SHARP & DOHME SE tabletter Co-Renitec 20 mg/12,5 mg not available MERCK SHARP & DOHME AT Tabletten GES.M.B.H. Co-Renitec 20 mg / 12,5 mg, not available MSD BELGIUM BA/SPRL LU comprimés Renitec comp tablett not available MERCK SHARP & DOHME FI Renitec plus tablett not available MERCK SHARP & DOHME FI Renitec plus tabletti not available MERCK SHARP & DOHME FI Renitec comp tabletti not available MERCK SHARP & DOHME FI Synerpril 20 mg/6 mg tabletter not available MERCK SHARP & DOHME SE Co-Mepril -Tabletten not available KWIZDA PHARMA GMBH AT ACEDIUR 20 mg/12,5 mg ACESISTEM 20 mg + 12,5 mg ACESISTEM 20 mg + 12,5 mg not available ALFASIGMA ESPAÑA, S.L. ES not available ALFASIGMA S.P.A. IT not available ALFASIGMA S.P.A. IT EMA/170163/2018 Page 2/6
3 where Innozide 20 mg/12.5 mg Tablets not available PA1286/012/001 MERCK SHARP & DOHME IRELAND (HUMAN HEALTH) LTD Renitecmax 20 mg/6 mg DK/H/0110/ LABORATORIOS BIOPAT, S.A. CO-RENITEC 20 mg/12,5 mg not available LABORATORIOS ABELLÓ, S.A. CO-RENITEC 20 mg/ 12,5 mg not available MERCK SHARP & DOHME tabletid OU RENITEC PLUS 20 mg/ 6 mg not available MERCK SHARP & DOHME tabletid OU Renitec Comp 20 mg/12,5 mg, not available MERCK SHARP & DOHME tabletter Renitec Plus 20 mg/6 mg not available OGYI-T-8234/01 MSD PHARMA HUNGARY tabletta KFT. Co-Renitec 20 mg/12,5 mg not available OGYI-T-8234/02 MSD PHARMA HUNGARY tabletta KFT. VASORETIC 20 mg + 12,5 mg not available MERCK SHARP & DOHME LTD. Ко-Ренитек 20 mg/12,5 mg not available MERCK SHARP & DOHME таблетки BULGARIA EOOD CO-RENITEC 10 mg/ 25 mg not available MERCK SHARP & DOHME tabletid OU VASORETIC 20 mg + 12,5 mg not available MERCK SHARP & DOHME LTD. Renitec Comp Mite 20 mg/6 mg, tabletter not available MERCK SHARP & DOHME IE ES ES EE EE NO HU HU IT BG EE IT NO EMA/170163/2018 Page 3/6
4 where RENITEC PLUS 20/6, tabletten DK/H/0110/001 RVG MERCK SHARP & DOHME NL 20/6 mg CO-RENITEC, tabletten 20/12,5 not available RVG MERCK SHARP & DOHME NL mg Innozide 20/12.5 mg tablets not available PL 00025/0249 MERCK SHARP & DOHME UK LTD. Crinoretic 20 mg/12,5 mg not available VIFOR PHARMA ESPA A, ES S.L. Enalapril /Hydrochlorothiazide not available PL 11311/0490 TILLOMED LABORATORIES UK 20 mg/12.5 mg tablets LTD CONDIUREN 20 mg + 12,5 mg not available DAIICHI SANKYO EUROPE IT GMBH CONDIUREN 20 mg + 12,5 mg not available DAIICHI SANKYO EUROPE IT GMBH Renidur 20 mg + 12,5 mg not available MERCK SHARP & DOHME, PT Renidur 20 mg + 12,5 mg not available MERCK SHARP & DOHME, PT Renidur 20 mg + 12,5 mg not available MERCK SHARP & DOHME, PT Renidur 20 mg + 12,5 mg not available MERCK SHARP & DOHME, PT Sinertec 20 mg/6 mg DK/H/0110/ MSD ITALIA S.R.L. IT Renitecmax 20 mg/6 mg DK/H/0110/ LABORATORIOS BIOPAT, ES S.A. Synerpril, tabletter DK/H/0110/ MERCK SHARP & DOHME DK EMA/170163/2018 Page 4/6
5 where Renitec plus 20 mg/6 mg DK/H/0110/ MERCK SHARP & DOHME AT Tabletten GES.M.B.H. RENITEC PLUS 20/6, tabletten DK/H/0110/001 RVG MERCK SHARP & DOHME NL 20/6 mg HIPOARTEL PLUS 20 mg /12,5 not available FAES FARMA, S.A. ES mg Innozide 20 mg/12.5 mg Tablets not available PA1286/012/001 MERCK SHARP & DOHME IE IRELAND (HUMAN HEALTH) LTD Co-Enac Hexal - Tabletten not available HEXAL PHARMA GMBH AT Enalapril HCT Sandoz 20/12,5 mg Tabletten Enalapril plus - 1A Pharma 20 mg/12,5 mg Tabletten Enalapril Maleate/Hydrochlorothiazide 20 mg/12.5 mg tablets Enalapril maleate/hydrochlorothiazide 20/12.5mg Tablets Gentipress 20 mg/6 mg Co-Renitec 20 mg/12,5 mg Tabletten Co-Renitec 20 mg / 12,5 mg, tabletten NL/H/1095/ HEXAL AG DE NL/H/1096/ A PHARMA GMBH DE NL/H/0377/001 PL 04416/1358 SANDOZ LTD UK NL/H/0336/001 PL 04416/0460 SANDOZ LTD UK not available NEOPHARMED GENTILI IT S.R.L. not available BE MSD BELGIUM BA/SPRL BE not available BE MSD BELGIUM BA/SPRL BE EMA/170163/2018 Page 5/6
6 where Co-Renitec 20 mg / 12,5 mg, not available BE MSD BELGIUM BA/SPRL BE comprimés Renitec comp tablett not available MERCK SHARP & DOHME FI Renitec plus tablett not available MERCK SHARP & DOHME FI Renitec plus tabletti not available MERCK SHARP & DOHME FI Renitec comp tabletti not available MERCK SHARP & DOHME FI EMA/170163/2018 Page 6/6
List of nationally authorised medicinal products
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
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
More informationList 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
More informationList 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
More informationList of nationally authorised medicinal products
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
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
More informationList 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
More informationList 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
More informationList of nationally authorised medicinal products
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
More informationList 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
More informationList 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
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
More informationList of nationally authorised medicinal products
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
More informationList 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
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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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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
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
More informationList of nationally authorised medicinal products
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
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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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
More informationList 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
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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
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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
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
More informationList of nationally authorised medicinal products
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
More informationList of nationally authorised medicinal products
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
More informationList of nationally authorised medicinal products
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
More informationList of nationally authorised medicinal products
5 May 2017 EMA/288255/2017 Human Medicines Evaluation Division Active substance: pilocarpine (ophthalmic formulation) Procedure no.: PSUSA/00002410/201608 30 Churchill Place Canary Wharf London E14 5EU
More informationList of nationally authorised medicinal products
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
More informationList of nationally authorised medicinal products
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
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
More informationList of nationally authorised medicinal products
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
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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12 July 2018 EMA/462856/2018 Human Medicines Evaluation Division Active substance: econazole, econazole nitrate / triamcinolone acetonide, econazole nitrate / zinc oxide Procedure no.: PSUSA/00001195/201711
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30 November 2017 EMA/795271/2017 Human Medicines Evaluation Division Active substance: vinorelbine Procedure no.: PSUSA/00003124/201704 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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13 September 2017 EMA/706786/2017 Human Medicines Evaluation Division Active substance: Octenidine dihydrochloride / phenoxyethanol Procedure no.: PSUSA/00002199/201701 30 Churchill Place Canary Wharf
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6 September 2018 EMA/619619/2018 Human Medicines Evaluation Division Active substance: haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus
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30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European
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20 July 2016 EMA/270645/2015 Procedure Management and Committees Support Active substance: apomorphine Procedure no.: PSUSA/00000227/201511 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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12 July 2018 EMA/497430/2018 Human Medicines Evaluation Division Active substance: tafluprost / timolol Procedure no.: PSUSA/00010324/201712 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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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
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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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8 March 2018 EMA/182904/2018 Human Medicines Evaluation Division Active substance(s): fluticasone propionate / formoterol fumarate dihydrate Procedure No.: PSUSA/00010339/201707 30 Churchill Place Canary
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