List of nationally authorised medicinal products
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1 14 April 2016 EMA/284169/2016 Procedure Management and Committees Support Active substance: influenza vaccine (split virion, inactivated) (non centrally products) 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 provided the source is acknowledged.
2 Afluria DE/H/1938/001 59/241/14-C biocsl GmbH CZ Afluria Injeksjonsvæske, suspensjon, i ferdigfylt sprøyte Vaksine mot influensa (inaktivert, splittvirus) DE/H/1938/ BIO CSL GMBH NO Afluria injektionsvätska, suspension i förfylld spruta Vaccin mot influensa (spjälkat virus inaktiverat) DE/H/1938/ BIO CSL GMBH SE Afluria Suspensão injetável, em seringa pré-cheia Vacina contra a gripe (virião fragmentado, inativado) DE/H/1938/ BIO CSL GMBH PT Afluria Suspensão injetável, em seringa pré-cheia Vacina contra a gripe (virião fragmentado, inativado) DE/H/1938/ BIO CSL GMBH PT Afluria Suspensão injetável, em seringa pré-cheia Vacina contra a gripe (virião fragmentado, inativado) DE/H/1938/ BIO CSL GMBH PT Afluria Suspensão injetável, em seringa pré-cheia Vacina contra a gripe (virião fragmentado, inativado) DE/H/1938/ BIO CSL GMBH PT Afluria suspensie voor injectie, in een voorgevulde spuit DE/H/1938/001 RVG BIO CSL GMBH NL EMA/284169/2016 Page 2/9
3 Influenzavaccin (split virus, geïnactiveerd) Afluria Suspension injectable dans une seringue préremplie. Vaccin contre l influenza (virion fragmenté, inactivé) DE/H/1938/001 BE BIO CSL GMBH BE Afluria Suspensión inyectable en jeringa precargada DE/H/1938/ BIO CSL GMBH ES Afluria Suspensión inyectable en jeringa precargada DE/H/1938/ BIO CSL GMBH ES Afluria, injektioneste, suspensio, esitäytetyssä ruiskussa. Influenssarokote (pilkottu, inaktivoitu) DE/H/1938/ BIO CSL GMBH FI Afluria, injektionsvæske, suspension, fyldt injektionssprøjte DE/H/1938/ BIO CSL GMBH DK Afluria, suspension injectable dans une seringue préremplie. Vaccin contre l influenza (virion fragmenté, inactivé) DE/H/1938/ / BIO CSL GMBH LU Afluria, Suspension zur Injektion in Fertigspritzen Influenza-Impfstoff (Spaltvirus, inaktiviert) DE/H/1938/001 PEI.H BIO CSL GMBH DE a-rix DE/H/0124/001 BE BE a-rix DE/H/0124/ Biologicals S.A LU EMA/284169/2016 Page 3/9
4 a-rix-tetra PEI/H/ BE BE a-rix-tetra PEI/H/ , LU Enzira Suspension for injection, pre-filled syringe Influenza vaccine (split virion, inactivated) DE/H/1938/001 PA 1373/1/1 BIO CSL GMBH IE Enzira Suspension for injection, pre-filled syringe Influenza vaccine (split virion, inactivated) DE/H/1938/001 PL 22236/0001 BIO CSL GMBH UK Fluarix DE/H/0124/ Pharma GmbH AT Fluarix DE/H/0124/ EOOD BG Fluarix DE/H/0124/001 HR-H d.o.o CR Fluarix DE/H/0124/ (Cyprus) Limited CY Fluarix DE/H/0124/001 59/1184/93-C, CZ Fluarix DE/H/0124/001 PEI.H Biologicals S.A DE Fluarix DE/H/0124/ Pharma A/S DK Fluarix DE/H/0124/ S.A. ES Fluarix DE/H/0124/ ET Fluarix DE/H/0124/ FI Fluarix DE/H/0124/001 NL10811 Laboratoire Fluarix DE/H/0124/ / GR EMA/284169/2016 Page 4/9
5 A.E.B.E. Fluarix DE/H/0124/001 OGYI-T-8421/01 OGYI-T-8421/02 Kft. HU Fluarix DE/H/0124/001 PA 1077/25/1 (Ireland) Limited IE Fluarix DE/H/0124/ ehf IS Fluarix DE/H/0124/ S.p.A IT Fluarix DE/H/0124/001 LT/1/5/0274/ Lietuva UAB, LT Fluarix DE/H/0124/ Biologicals S.A LV Fluarix DE/H/0124/001 MA 172/01001 SmithKline Beecham PLC MT Fluarix DE/H/0124/001 RVG B.V., NL Fluarix DE/H/0124/ AS NO Fluarix DE/H/0124/ PL Fluarix DE/H/0124/ SmithKline & French Portuguesa-Produtos Farmaceuticos LDA PT Fluarix DE/H/0124/ /2010/01-06 RO Fluarix DE/H/0124/ AB SE Fluarix DE/H/0124/001 H/04/00626/ GSK d.o.o SI EMA/284169/2016 Page 5/9
6 Fluarix DE/H/0124/001 59/0270/06-S Slovakia s.r.o SK Fluarix DE/H/0124/001 PL 10592/0118 SmithKline Beecham PLC, UK Fluarix Tetra PEI/H/ Pharma GmbH AT Fluarix Tetra PEI/H/ /145/14-C CZ Fluarix Tetra PEI/H/ PEI.H GmbH & Co. KG DE Fluarix Tetra PEI/H/ , ES Fluarix Tetra PEI/H/ NL42097 Laboratoire, Fluarix Tetra PEI/H/ / A.E.B.E. GR Fluarix Tetra PEI/H/ , IT Fluarix Tetra PEI/H/ /0114/14-S, SK Fluarix Tetra PEI/H/ PL 10592/0302 SmithKline Beecham Limited UK Influsplit SSW DE/H/0124/001 PEI.H GmbH & Co. KG DE Istivac /H/122/ ; ; ; ; ; ; ; Sanofi Pasteur MSD s.a. PT Istivac Infantil /H/139/ ; ; ; ; ; PT Mutagrip /H/122/ DK Mutagrip /H/122/ Sanofi Pasteur MSD s.a. ES EMA/284169/2016 Page 6/9
7 Mutagrip /H/122/ Mutagrip /H/122/01 NL Mutagrip /H/122/ / Mutagrip /H/122/ /H/121/ /H/121/01 BE /H/121/01 II-1582/ /H/121/ UP/I /12-02/145 /H/121/01 59/1035/94-C /H/121/01 PEI.H /H/121/ Sanofi Pasteur MSD S.N.C., Sanofi Pasteur MSD SNC, Sanofi Pasteur MSD S.N.C., Sanofi Pasteur MSD GMBH, Germany /H/121/ Sanofi Pasteur MSD s.a. ES /H/121/ ET /H/121/ FI /H/121/01 NL /H/121/01 NL /H/121/ / Sanofi Pasteur MSD SNC, GR /H/121/01 OGYI-T-8606/01-16 HU FI GR LU AT BE BG CR CY CZ DE DK EMA/284169/2016 Page 7/9
8 /H/121/01 PA 544/34/1 Sanofi Pasteur MSD; Ireland IE /H/121/01 IS/1/07/042/01 IS /H/121/ Sanofi Pasteur MSD SNC, IT /H/121/01 LT/1/07/0789/ LT /H/121/ LU /H/121/ LV MA573/00101 MT /H/121/01 RVG NL /H/121/ NO R/0498 PL /H/121/ ; ; ; ; ; ; Sanofi Pasteur MSD s.a. PT 1289/2008/ RO /H/121/ SE 5363-I-1718/11 SI /H/121/01 59/0228/07-S SK /H/121/01 PL 6745/0095 Sanofi Pasteur MSD Ltd, UK EMA/284169/2016 Page 8/9
9 Enfants /H/139/01 NL Junior /H/139/01 II-0008/ UK BG EMA/284169/2016 Page 9/9
List of nationally authorised medicinal products
12 April 2018 EMA/227889/2018 Human Medicines Evaluation Division Active substance(s): typhoid polysaccharide vaccine Procedure No.: PSUSA/00003065/201708 30 Churchill Place Canary Wharf London E14 5EU
List 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
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
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
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
11 October 2017 EMA/691535/2017 Human Medicines Evaluation Division Active substance: Haemophilus type b conjugate vaccines Procedure no.: PSUSA/00001584/201702 30 Churchill Place Canary Wharf London E14
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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/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
11 September 2017 EMA/604559/2017 Human Medicines Evaluation Division Active substance: iron / parenteral preparations Procedure no.: PSUSA/00010236/201701 30 Churchill Place Canary Wharf London E14 5EU
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
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
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
6 September 2018 EMA/619619/2018 Human Medicines Evaluation Division Active substance: haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus
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
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
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
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
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
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
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
European Medicines Agency decision
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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
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