List of nationally authorised medicinal products
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1 10 September 2015 EMA/677092/2015 Procedure Management and Committees Support Active substance: glatiramer 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 MRP/DCP Copaxone Teva Santé FR Copaxone UP-I Pliva Hrvatska D.O.O.; Prilaz Baruna Filipovica HR , Zagreb, Croatia Copaxone 20 Mg/Ml UK-H Teva Pharma Gmbh DE Copaxone 20 Mg/Ml UK-H / IT Copaxone 20 Mg/Ml UK-H / Teva Pharma Gmbh AT Copaxone 20 Mg/Ml UK-H / /0463/06-S Teva Pharmaceuticals Cr, S.R.O. SK Copaxone 20 Mg/Ml UK-H / /481/06-C Teva Pharmaceuticals Cr, S.R.O. CZ Copaxone 20 Mg/Ml UK-H / -004 OGYI-T- 9993/01 Copaxone 40mg UK/H/0453/ n/a Teva Pharma Gmbh AT Copaxone UK/H/0453/ BE BE Copaxone UK/H/0453/ BE BE Copaxone UK/H/0453/ n/a Pliva Hrvatska D.O.O.; Prilaz Baruna Filipovica HR 25, Zagreb, Croatia Copaxone UK/H/0453/ CY Copaxone UK/H/0453/ n/a CY Copaxone UK/H/0453/ PL/10921/0026 UK EMA/677092/2015 Page 2/7
3 MRP/DCP Copaxone UK/H/0453/ PL 10921/0023 UK Copaxone UP-I UP-I Pliva Hrvatska D.O.O.; Prilaz Baruna Filipovica HR , Zagreb, Croatia Copaxone n/a BG Copaxone n/a Teva Santé FR Copaxone UK/H/0453/ n/a Copaxone UK/H/0453/ I-1251/13 Teva Pharmaceuticals ltd; Ridings Point, Copaxone UK/H/0453/ n/a Teva Pharmaceuticals ltd; Ridings Point, Copaxone UK/H/0453/ Teva Pharmaceuticals ltd; Ridings Point, Copaxone UK/H/0453/ Copaxone UK/H/0453/ Copaxone UK/H/0453/ Copaxone UK/H/0453/ n/a Copaxone UK/H/0453/ SK SL ES ES ES SE NO PL PL EMA/677092/2015 Page 3/7
4 MRP/DCP Copaxone UK/H/0453/ Copaxone UK/H/0453/ Copaxone UK/H/0453/ /2015/01-04 copaxone UK/H/0453/ Copaxone UK/H/0453/ n/a Copaxone UK/H/0453/ MA/504/00102 Copaxone UK/H/0453/ MA/504/00104 Copaxone UK/H/0453/ RVG Copaxone UK/H/0453/ RVG Copaxone UK/H/0453/ Copaxone UK/H/0453/ Copaxone UK/H/0453/ /1/05/0240/ PT PT RO LU LU MT MT NL NL NO LV EMA/677092/2015 Page 4/7
5 MRP/DCP COPAXONE UK/H/0453/ /1/05/0240/0 04 COPAXONE UK/H/0453/ /1/05/0240/0 03 COPAXONE UK/H/0453/ /1/05/0240/0 05 COPAXONE UK/H/0453/ /1/05/0240/0 02 Copaxone UK/H/0453/ PA 1014/001/004 Copaxone UK/H/0453/ IT Copaxone UK/H/0453/ IT Copaxone UK/H/0453/ IT Copaxone UK/H/0453/ n/a IT Copaxone UK/H/0453/ IT Copaxone UK/H/0453/ LV 993/ /02 IE EMA/677092/2015 Page 5/7
6 MRP/DCP 9903/ /01-03 Copaxone UK/H/0453/ IS/1/04/002/01 IS Copaxone UK/H/0453/ IS/1/14/096/01 IS Copaxone UK/H/0453/ PA IE 1014/001/002 COPAXONE UK/H/0453/ n/a FI Acetate de glatiramere UK/H/0453/ n/a Teva Santé FR Teva Copaxone UK/H/0453/ Teva Pharma Gmbh DE Copaxone UK/H/0453/ Copaxone UK/H/0453/ n/a GR 9993/03 Copaxone UK/H/0453/ /043/15-C Teva Pharmaceuticals Cr, S.R.O. CZ Copaxone UK/H/0453/ Copaxone UK/H/0453/ Copaxone UK/H/0453/ GR DK DK EE EMA/677092/2015 Page 6/7
7 MRP/DCP Copaxone UK/H/0453/ COPAXONE UK/H/0453/ EE FI EMA/677092/2015 Page 7/7
List 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
List 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
List 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
List of nationally authorised medicinal products
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
List of nationally authorised medicinal products
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
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
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
List of nationally authorised medicinal products
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
List 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
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
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
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
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
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
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
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
List 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
List 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
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
List 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
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
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
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
List 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
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
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
List 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
List 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
List of nationally authorised medicinal products
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
List of nationally authorised medicinal products
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
List of nationally authorised medicinal products
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
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
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
List 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
List 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
List 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
List of nationally authorised medicinal products
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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List of nationally authorised medicinal products
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EMA/156109/2018 European Medicines Agency decision P/0103/2018 of 19 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral for plazomicin (sulfate) (EMEA-001639-PIP02-17)