List of nationally authorised medicinal products
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- Milo Chandler
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1 11 January 2018 EMA/24585/2018 Human Medicines Evaluation Division Active substance: esomeprazole / naproxen 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 tabletter med modifierad frisättning Вимово 500 mg/20 mg таблетки с изменено освобождаване VimovoTM 500 mg/20 mg Tabletten mit veränderter Wirkstofffreisetzung VimovoTM 500 mg/20 mg Tabletten mit veränderter Wirkstofffreisetzung Vimovo 500 mg/20 mg säädellysti vapauttavat tabletit VIMOVO 500 mg/20 mg ilgstošās darbības tabletes tabletten met gereguleerde afgifte comprimés à libération modifiée tabletten met gereguleerde afgifte comprimés à libération modifiée NL/H/1848/ ASTRAZENECA AB SE NL/H/1848/ ASTRAZENECA AB BG NL/H/1848/ ASTRAZENECA OSTERREICH AT GMBH NL/H/1848/ ASTRAZENECA GMBH DE NL/H/1848/ ASTRAZENECA AB FI NL/H/1848/ ASTRAZENECA AB LV NL/H/1848/001 BE ASTRAZENECA S.A. / N.V. BE NL/H/1848/001 BE ASTRAZENECA S.A. / N.V. BE NL/H/1848/001 BE ASTRAZENECA S.A. / N.V. BE NL/H/1848/001 BE ASTRAZENECA S.A. / N.V. BE NL/H/1848/001 LT/1/10/2302/003 ASTRAZENECA AB LT NL/H/1848/001 LT/1/10/2302/009 ASTRAZENECA AB LT NL/H/1848/001 LT/1/10/2302/012 ASTRAZENECA AB LT EMA/24585/2018 Page 2/8
3 atpalaidavimo tabletes comprimidos de libertação comprimidos de libertação comprimidos de libertação NL/H/1848/001 LT/1/10/2302/001 ASTRAZENECA AB LT NL/H/1848/001 LT/1/10/2302/004 ASTRAZENECA AB LT NL/H/1848/001 LT/1/10/2302/002 ASTRAZENECA AB LT NL/H/1848/001 LT/1/10/2302/007 ASTRAZENECA AB LT NL/H/1848/001 LT/1/10/2302/010 ASTRAZENECA AB LT NL/H/1848/001 LT/1/10/2302/005 ASTRAZENECA AB LT NL/H/1848/001 LT/1/10/2302/011 ASTRAZENECA AB LT NL/H/1848/001 LT/1/10/2302/008 ASTRAZENECA AB LT NL/H/1848/001 LT/1/10/2302/006 ASTRAZENECA AB LT NL/H/1848/ ASTRAZENECA PRODUTOS PT FARMACEUTICOS LDA NL/H/1848/ ASTRAZENECA PRODUTOS PT FARMACEUTICOS LDA NL/H/1848/ ASTRAZENECA PRODUTOS PT FARMACEUTICOS LDA EMA/24585/2018 Page 3/8
4 comprimidos de libertação VIMOVO 500 mg/20 mg comprimidos de liberación VIMOVO 500 mg/20 mg modifiedrelease tablets VIMOVO 500 mg/20 mg tabletten met gereguleerde afgifte comprimés à libération modifiée VIMOVO 500 mg/20 mg modifiedrelease tablets Vimovo, 500 mg/20 mg toimeainet modifitseeritult vabastavad tabletid Vimovo 500 mg/20 mg tabletter med modifisert frisetting comprimate cu eliberare modificată NL/H/1848/ ASTRAZENECA PRODUTOS FARMACEUTICOS LDA PT NL/H/1848/ ASTRAZENECA ES FARMACÉUTICA SPAIN, S.A. NL/H/1848/001 PL 17901/0263 ASTRAZENECA UK LIMITED UK NL/H/1848/001 RVG ASTRAZENECA BV NL NL/H/1848/ ASTRAZENECA S.A. / N.V. LU NL/H/1848/001/DC PA 970/60/1 ASTRAZENECA UK LIMITED IE NL/H/1848/ /M ASTRAZENECA S.P.A. IT NL/H/1848/ ASTRAZENECA AB EE NL/H/1848/ ASTRAZENECA AB NO NL/H/1848/ /2016/01 ASTRAZENECA AB RO NL/H/1848/ /2016/02 ASTRAZENECA AB RO NL/H/1848/ /2016/05 ASTRAZENECA AB RO EMA/24585/2018 Page 4/8
5 NL/H/1848/ /2016/03 ASTRAZENECA AB RO NL/H/1848/ /2016/04 ASTRAZENECA AB RO NL/H/1848/ /2016/06 ASTRAZENECA AB RO NL/H/1848/ /2016/07 ASTRAZENECA AB RO NL/H/1848/ /2016/13 ASTRAZENECA AB RO NL/H/1848/ /2016/12 ASTRAZENECA AB RO NL/H/1848/ /2016/11 ASTRAZENECA AB RO NL/H/1848/ /2016/10 ASTRAZENECA AB RO NL/H/1848/ /2016/09 ASTRAZENECA AB RO EMA/24585/2018 Page 5/8
6 NL/H/1848/ /2016/08 ASTRAZENECA AB RO NL/H/1848/ /2016/14 ASTRAZENECA AB RO NL/H/1848/ /2016/15 ASTRAZENECA AB RO NL/H/1848/ /2016/16 ASTRAZENECA AB RO NL/H/1848/ /2016/18 ASTRAZENECA AB RO NL/H/1848/ /2016/17 ASTRAZENECA AB RO NL/H/1848/ /2016/19 ASTRAZENECA AB RO NL/H/1848/ /2016/20 ASTRAZENECA AB RO NL/H/1848/ /2016/21 ASTRAZENECA AB RO EMA/24585/2018 Page 6/8
7 NL/H/1848/ /2016/22 ASTRAZENECA AB RO NL/H/1848/ /2016/23 ASTRAZENECA AB RO NL/H/1848/ /2016/24 ASTRAZENECA AB RO NL/H/1848/ /M ASTRAZENECA S.P.A. IT NL/H/1848/ /M ASTRAZENECA S.P.A. IT NL/H/1848/ /M ASTRAZENECA S.P.A. IT NL/H/1848/ /M ASTRAZENECA S.P.A. IT NL/H/1848/ /M ASTRAZENECA S.P.A. IT NL/H/1848/ /M ASTRAZENECA S.P.A. IT NL/H/1848/ /M ASTRAZENECA S.P.A. IT NL/H/1848/ /M ASTRAZENECA S.P.A. IT NL/H/1848/ /M ASTRAZENECA S.P.A. IT EMA/24585/2018 Page 7/8
8 NL/H/1848/ /M ASTRAZENECA S.P.A. IT NL/H/1848/ /M ASTRAZENECA S.P.A. IT EMA/24585/2018 Page 8/8
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
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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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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
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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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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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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
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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
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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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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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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
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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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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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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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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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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
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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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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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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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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
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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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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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22 May 2015 EMA/COMP/369082/2008 Rev.5 Committee for Orphan Medicinal Products Beraprost sodium (modified release tablet) for the treatment of pulmonary arterial First publication 23 April 2009 Rev.1:
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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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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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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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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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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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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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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
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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
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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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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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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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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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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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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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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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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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