List of nationally authorised medicinal products
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1 09 June 2017 EMA/36849/2017 Human Medicines Evaluation Division Active substance(s): brimonidine / timolol 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 Brimonidin/Timolol AL 2 mg/ml + 5 mg/ml Augentropfen, Lösung Brimonidin/Timolol Stada 2 mg/ml + 5 mg/ml Augentropfen BRIMONIDINA E TIMOLOLO EG 2 mg/ml + 5 mg/ml collirio, soluzione BRIMONIDINA E TIMOLOLO EG 2 mg/ml + 5 mg/ml collirio, soluzione BRIMONIDINA E TIMOLOLO EG 2 mg/ml + 5 mg/ml collirio, soluzione Brimonidina/Timolol ratiopharm 2 mg/ml + 5 mg/ml colirio en solución Brimonidina/Timolol STADA 2 mg/ml + 5 mg/ml colirio en solución Brimonidina/Timolol Teva 2 mg/ml + 5 mg/ml colirio en solución Brimonidine Tartrate /Timolol 2 mg/ml + 5 mg/ml eye drops, solution Brimonidine Tartrate/Timolol 2 mg/ml + 5 mg/ml Eye Drops, Solution Brimonidine/Timolol Stada Arzneimittel AG, øjendråber, opløsning Brimonidine/Timolol Stada, øjendråber, opløsning DK/H/2372/ ALIUD PHARMA GMBH DE DK/H/2371/ STADA ARZNEIMITTEL AG AT DK/H/2372/ EG SPA IT DK/H/2372/ EG SPA IT DK/H/2372/ EG SPA IT DK-H DC RATIOPHARM ESPANA SA ES DK/H/2372/ LABORATORIO STADA, S.L. ES DK/H/2114/ TEVA PHARMA S.L.U ES DK/H/2526/001 PL04569/1631 GENERICS [UK] LIMITED UK DK/H/2114/001 PL 00289/2019 TEVA UK LIMITED UK DK/H/2371/ STADA ARZNEIMITTEL AG DK DK/H/2372/ STADA ARZNEIMITTEL AG DK EMA/36849/2017 Page 2/6
3 Brimonidine/Timolol ratiopharm 2 mg/ml + 5 mg/ml, oogdruppels, Brimonidine/Timolol Teva 2 mg/ml + 5 mg/ml, oogdruppels, Brimonidintartrat/Timolol "DOC Generici" Brimonidintartrat/Timolol Teva Brimoplus, 0,2% + 0,5%, krople do oczu, roztwór Brimotimo, øjendråber, opløsning acu pilieni, šķīdums akių lašai (tirpalas) akių lašai (tirpalas) silmatilgad, lahus mg/ml Augentropfen mg/ml Augentropfen mg/ml Augentropfen, Lösung DK/H/2129/001 RVG RATIOPHARM NEDERLAND B.V DK/H/2114/001 RVG TEVA NEDERLAND B.V. NL DK/H/2524/ DOC GENERICI S.R.L. IT DK/H/2114/ TEVA DENMARK A/S DK DK/H/2114/ TEVA PL POLSKA SP. Z O.O. DK/H/2129/ TEVA DENMARK A/S DK UK/H/0807/ ALLERGAN UK/H/0807/001 LT/1/13/3463/001 ALLERGAN UK/H/0807/001 LT/1/13/3463/002 ALLERGAN UK/H/0807/ ALLERGAN UK/H/0807/001 Z. NR ALLERGAN UK/H/0807/ ALLERGAN NL LV LT LT EE AT DE BE EMA/36849/2017 Page 3/6
4 mg/ml augndropar, lausn mg/ml colirio en solución. mg/ml colírio, solução mg/ml collirio, soluzione mg/ml collirio, soluzione mg/ml eye drops, solution mg/ml eye drops, solution mg/ml eye drops, solution mg/ml kapi za oko, otopina mg/ml kapljice za oko, raztopina mg/ml očná roztoková instilácia mg/ml Ocní kapky, roztok UK/H/0807/001 IS/1/05/053/01 ALLERGAN UK/H/0807/ ALLERGAN UK/H/0807/ ALLERGAN UK/H/0807/ ALLERGAN UK/H/0807/ ALLERGAN UK/H/0807/001 PA 148/64/1 ALLERGAN UK/H/0807/001 MA102/00701 ALLERGAN UK/H/0807/001 PL 41443/0006 ALLERGAN not available UP/I /13-02/141 ALLERGAN UK/H/0807/ I-1310/10 ALLERGAN UK/H/0807/001 64/0131/06-S ALLERGAN UK/H/0807/001 64/486/05-C ALLERGAN IS ES PT IT IT IE MT UK HR SK CZ EMA/36849/2017 Page 4/6
5 mg/ml ögondroppar, lösning mg/ml oogdruppels, mg/ml øyedråper, oppløsning. mg/ml piciituri oftalmice, solutie mg/ml piciituri oftalmice, solutie mg/ml silmätipat, liuos mg/ml οφθαλμικές σταγόνες, διάλυμα mg/ml οφθαλμικές σταγόνες, διάλυμα mg/ml, collyre en solution mg/ml, collyre en solution mg/ml, collyre en solution mg/ml, oogdruppels, UK/H/0807/ ALLERGAN UK/H/0807/ ALLERGAN UK/H/0807/ /2013/01 ALLERGAN UK/H/0807/ /2013/02 ALLERGAN UK/H/0807/ ALLERGAN UK/H/0807/001 M.L.: ALLERGAN UK/H/0807/ / ALLERGAN UK/H/0807/ ALLERGAN UK/H/0807/ ALLERGAN SE LU NO RO RO FI CY GR BE FR FR BE EMA/36849/2017 Page 5/6
6 mg/ml, oogdruppels, Combigan szemcsepp 2 mg/ml + 5 mg/ml oldatos szemcsepp Combigan szemcsepp 2 mg/ml + 5 mg/ml oldatos szemcsepp Combigan, 2 mg/ml + 5 mg/ml øjendråber, opløsning Combigan, 2 mg/ml + 5 mg/ml, krople do oczu, roztwór COMBIGAN 2 mg/ml + 5 mg/ml ögondroppar, lösning UK/H/0807/001 RVG ALLERGAN UK/H/0807/001 OGYI-T-20114/02 ALLERGAN UK/H/0807/001 OGYI-T-20114/01 ALLERGAN UK/H/0807/ ALLERGAN UK/H/0807/ ALLERGAN UK/H/0807/ ALLERGAN Zolbrinex DK/H/2525/ PHARMASWISS ČESKÁ Zolbrinex 2 mg/5 mg v 1 ml DK/H/2525/001 H/16/02238/001 PHARMASWISS ČESKÁ kapljice za oko, raztopina Zolbrinex 2 mg/5 mg v 1 ml DK/H/2525/001 H/16/02238/002 PHARMASWISS ČESKÁ kapljice za oko, raztopina Zolbrinex 2 mg/5 mg v 1 ml DK/H/2525/001 H/16/02238/003 PHARMASWISS ČESKÁ kapljice za oko, raztopina Комбиган 2 mg/ml + 5 UK/H/0807/ ALLERGAN mg/ml капки за очи, разтвор NL HU HU DK PL FI DK BG EMA/36849/2017 Page 6/6
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
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6 September 2018 EMA/612350/2018 Human Medicines Evaluation Division Active substance: azelastine Procedure no.: PSUSA/00000277/201712 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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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/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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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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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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26 October 2017 EMA/663700/2017 Human Medicines Evaluation Division Active substance: cromoglicic acid Procedure no.: PSUSA/00000883/201702 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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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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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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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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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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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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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
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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
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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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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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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
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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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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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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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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
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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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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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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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