List of nationally authorised medicinal products
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- Mabel Elizabeth Lewis
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1 21 June 2017 EMA/610895/2017 Human Medicines Evaluation Division Active substance: felbamate 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 Taloxa -TABS600 mg FR/H/0061/ MSD LGIUM Taloxa -SUSP 600 mg/5 ml Suspension zum Einnehmen FR/H/0061/ MSD LGIUM FR/H/0061/ MSD LGIUM Taloxa -SUSP, 600 mg/5 ml suspensie voor oraal gebruik Taloxa -SUSP 600 mg/5 ml suspension buvable Taloxa -SUSP 600 mg/5 ml Suspension zum Einnehmen Taloxa -TABS 600 mg s FR/H/0061/ MSD LGIUM FR/H/0061/ MSD LGIUM FR/H/0061/ MSD LGIUM FR/H/0061/ MSD LGIUM Taloxa -TABS600 mg FR/H/0061/ MSD LGIUM Taloxa-TABS 600 mg tabletten FR/H/0061/ MSD LGIUM EMA/610895/2017 Page 2/11
3 s FR/H/0061/ MSD LGIUM tabletten FR/H/0061/ MSD LGIUM FR/H/0061/ MSD LGIUM FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR EMA/610895/2017 Page 3/11
4 FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR EMA/610895/2017 Page 4/11
5 FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR FR/H/0061/ MSD FRANCE FR EMA/610895/2017 Page 5/11
6 TALOXA 600 mg/5 ml sospensione orale FR/H/0061/ MSD ITALIA S.R.L. IT Taloxa-TABS 600 mg tabletten FR/H/0061/002 RVG MERCK SHARP & DOHME NL TALOXA 400 mg compresse FR/H/0061/ MSD ITALIA S.R.L. IT FR/H/0061/ MERCK SHARP & DOHME, FR/H/0061/ MERCK SHARP & DOHME, FR/H/0061/ MERCK SHARP & DOHME, FR/H/0061/ MSD FRANCE FR FR/H/0061/ MERCK SHARP & DOHME, TALOXA 600 mg compresse FR/H/0061/ MSD ITALIA S.R.L. IT EMA/610895/2017 Page 6/11
7 TALOXA 600, 600 mg, FR/H/0061/ MSD SHARP & DOHME GMBH DE FR/H/0061/ MERCK SHARP & DOHME, FR/H/0061/ MERCK SHARP & DOHME, FR/H/0061/ MERCK SHARP & DOHME, FR/H/0061/ MERCK SHARP & DOHME, FR/H/0061/ MERCK SHARP & DOHME, FR/H/0061/ MERCK SHARP & DOHME, /5 ml FR/H/0061/ MERCK SHARP & DOHME, /5 ml FR/H/0061/ MERCK SHARP & DOHME, EMA/610895/2017 Page 7/11
8 /5 ml FR/H/0061/ MERCK SHARP & DOHME, /5 ml FR/H/0061/ MERCK SHARP & DOHME, FR/H/0061/ MSD FRANCE FR /5 ml FR/H/0061/ MERCK SHARP & DOHME, /5 ml FR/H/0061/ MERCK SHARP & DOHME, /5 ml FR/H/0061/ MERCK SHARP & DOHME, Taloxa-SUSP, 600 mg/5 ml suspensie voor oraal gebruik TALOXA Saft, 600 mg/5 ml, Suspension zum Einnehmen /5 ml FR/H/0061/003 RVG MERCK SHARP & DOHME FR/H/0061/ MSD SHARP & DOHME GMBH FR/H/0061/ MERCK SHARP & DOHME, NL DE EMA/610895/2017 Page 8/11
9 /5 ml FR/H/0061/ MERCK SHARP & DOHME, s FR/H/0061/ MSD LGIUM Taloxa-TABS 600 mg s FR/H/0061/ MSD LGIUM tabletten FR/H/0061/ MSD LGIUM Taloxa-TABS 600 mg s FR/H/0061/ MSD LGIUM LU s FR/H/0061/ MSD LGIUM LU Taloxa -SUSP 600 mg/5 ml suspension buvable Taloxa -SUSP 600 mg/5 ml suspension buvable Taloxa -SUSP, 600 mg/5 ml suspensie voor oraal gebruik FR/H/0061/ MSD LGIUM FR/H/0061/ MSD LGIUM FR/H/0061/ MSD LGIUM LU EMA/610895/2017 Page 9/11
10 Taloxa-TABS 600 mg tabletten FR/H/0061/ MSD LGIUM /5 ml orale Suspension not available MERCK SHARP & DOHME GES.M.B.H. AT not available MERCK SHARP & DOHME GES.M.B.H. AT /5 ml orale Suspension not available MERCK SHARP & DOHME GES.M.B.H. AT not available MERCK SHARP & DOHME GES.M.B.H. AT TALOXA 600 mg tabletter not available 8224 MERCK SHARP & DOHME NO tabletter not available MERCK SHARP & DOHME SE Taloxa 120 mg/ml oral suspension not available MERCK SHARP & DOHME SE tabletta not available OGYI-T-5129/02 MSD PHARMA HUNGARY KFT. HU EMA/610895/2017 Page 10/11
11 TALOXA 120 mg/ml mikstur, suspensjon not available 8222 MERCK SHARP & DOHME NO EMA/610895/2017 Page 11/11
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Initial (Full) Marketing Authorisation application accelerated assessment timetables
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
European Medicines Agency decision
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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
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
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/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
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
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
European Medicines Agency decision
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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
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
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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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
European Medicines Agency decision
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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
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
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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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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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