List of nationally authorised medicinal products
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1 6 September 2018 EMA/608492/2018 Human Medicines Evaluation Division Active substance: betahistine 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 ANTIVOM Or.so.d. 8 mg/ml ANTIVOM Tablets 16 mg/tab ANTIVOM Tablets 8 mg/tab ANTIVOM Δισκία 24 mg/tab ANTIVOM Δισκίο 16 mg/tab ANTIVOM Πόσιμες σταγόνες, διάλυμα 8 mg/ml ANTIVOM, Δισκία 8mg/tab not available 74191/ UNI-PHARMA KLEON TSETIS not available 75137/ UNI-PHARMA KLEON TSETIS not available 29837/ UNI-PHARMA KLEON TSETIS not available 97424/ UNI-PHARMA KLEON TSETIS not available UNI-PHARMA KLEON TSETIS not available UNI-PHARMA KLEON TSETIS not available UNI-PHARMA KLEON TSETIS Betabare 24 mg NL/H/1639/001 RVG EGIS S NL tabletten PLC Betagen 24 mg tabletta CZ/H/0399/001 OGYI-T-9498/03 GENERICS [UK] HU Betahistin "2care4", DK/H/2474/ CARE4 GENERICS APS DK tabletter Betahistin "Orifarm Generics", tabletter DK/H/2171/ ORIFARM GENERICS A/S DK GR GR GR GR CY CY CY EMA/608492/2018 Page 2/13
3 Betahistin 2care4 24 mg tabletter Betahistin Arcana 24 mg - Betahistin Mylan 24 mg tablety Betahistin Mylan 24 mg tablety Betahistina BGP 16 mg comprimidos EFG Betahistine 24 mg tablets Betahistine 2HCI, tabletten 16 mg Betahistine 2HCI, tabletten 8 mg Betahistine Apotex 24 mg, tabletten BETAHISTINE ARROW 24 mg, BETAHISTINE BIPHAR 24 mg, BETAHISTINE BIPHAR 24 mg, BETAHISTINE BIPHAR 24 mg, BETAHISTINE BIPHAR 24 mg, Betahistine dihcl 24 mg Teva, tabletten Betahistine dihcl Actavis 24 mg, tabletten Betahistine dihcl Apotex 16 mg DK/H/2474/ CARE4 GENERICS APS SE CZ/H/0399/ ARCANA ARZNEIMITTEL AT GMBH CZ/H/0399/001 83/605/08-C GENERICS [UK] CZ CZ/H/0399/001 83/0546/08-S GENERICS [UK] SK not available BGP PRODUCTS ES OPERATIONS, S.L. PT/H/0867/003 PL 16363/0419 MILPHARM UK not available RVG 57550=13612 BGP PRODUCTS B.V. NL not available RVG 57549=05852 BGP PRODUCTS B.V. NL not available RVG APOTEX EUROPE B.V. NL not available ARROW GENERIQUES FR not available MYLAN MEDICAL SAS FR not available MYLAN MEDICAL SAS FR not available MYLAN MEDICAL SAS FR not available MYLAN MEDICAL SAS FR not available RVG TEVA NEDERLAND B.V. NL NL/H/1412/001 RVG ACTAVIS GROUP HF. NL not available RVG APOTEX EUROPE B.V. NL EMA/608492/2018 Page 3/13
4 Betahistine dihcl Apotex 8 mg Betahistine dihcl Aurobindo 24 mg, tabletten tabletten tabletten Betahistine Mylan 24 mg BETAHISTINE MYLAN PHARMA 8 mg, BETAHISTINE MYLAN PHARMA 8 mg, BETAHISTINE MYLAN PHARMA 8 mg, BETAHISTINE MYLAN PHARMA 8 mg, not available RVG APOTEX EUROPE B.V. NL PT/H/0867/003 RVG AUROBINDO PHARMA B.V. NL not available BE EUROGENERICS N.V./S.A. BE not available BE EUROGENERICS N.V./S.A. BE not available EUROGENERICS N.V./S.A. LU not available EUROGENERICS N.V./S.A. LU not available BE EUROGENERICS N.V./S.A. BE not available BE EUROGENERICS N.V./S.A. BE not available BE EUROGENERICS N.V./S.A. BE not available BE EUROGENERICS N.V./S.A. BE CZ/H/0399/001 BE MYLAN BVBA/SPRL BE not available MYLAN S.A.S FR not available MYLAN S.A.S FR not available MYLAN S.A.S FR not available MYLAN S.A.S FR EMA/608492/2018 Page 4/13
5 BETAHISTINE RPG 8 mg, Betahistine.2HCl Disphar 24 mg, tabletten Betahistinum 123ratio, tabletki, 24 mg BETASERC 16 mg - Betaserc 16 mg not available NL RANBAXY PHARMACIE GENERIQUES FR not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR not available RVG DISPHAR INTERNATIONAL NL B.V. PL/H/0240/ RATIO SP. Z O.O. PL not available BGP PRODUCTS GES. M. B. AT H. not available MYLAN EPD BVBA/SPRL LU EMA/608492/2018 Page 5/13
6 Betaserc 16 mg not available BGP PRODUCTS PT comprimidos UNIPESSOAL, LDA. Betaserc 16 mg not available BGP PRODUCTS PT comprimidos UNIPESSOAL, LDA. Betaserc 16 mg tablete not available HR-H MYLAN HRVATSKA D.O.O. HR Betaserc 16 mg tabletes not available BGP PRODUCTS B.V. LV Betaserc 16 mg tabletės not available LT/1/95/0848/002 BGP PRODUCTS B.V. LT Betaserc 16 mg tabletid not available BGP PRODUCTS SIA EE Betaserc 16 mg tabletta not available OGYI-T-10004/05 MYLAN EPD KFT. HU Betaserc 16 mg not available BE MYLAN EPD BVBA/SPRL BE Betaserc 16 mg tabletter not available BGP PRODUCTS B.V. FI Betaserc 16 mg tabletti not available BGP PRODUCTS B.V. FI Betaserc 16 mg, not available BE MYLAN EPD BVBA/SPRL BE Betaserc 16 mg, not available BE MYLAN EPD BVBA/SPRL BE tabletten Betaserc 16 tablety not available 83/309/00-C MYLAN IRE HEALTHCARE CZ Betaserc 16, tabletten 16 not available RVG BGP PRODUCTS B.V. NL mg BETASERC 24 mg - not available BGP PRODUCTS GES. M. B. AT H. burnoje FI/H/0827/001 LT/1/95/0848/006 BGP PRODUCTS SIA LT disperguojamos tabletės burnoje FI/H/0827/001 LT/1/95/0848/007 BGP PRODUCTS SIA LT disperguojamos tabletės burnoje FI/H/0827/001 LT/1/95/0848/008 BGP PRODUCTS SIA LT disperguojamos tabletės burnoje FI/H/0827/001 LT/1/95/0848/009 BGP PRODUCTS SIA LT disperguojamos tabletės burnoje FI/H/0827/001 LT/1/95/0848/010 BGP PRODUCTS SIA LT disperguojamos tabletės FI/H/0827/ /2014/01 MYLAN HEALTHCARE GMBH RO EMA/608492/2018 Page 6/13
7 orodispersabile orodispersabile orodispersabile orodispersabile orodispersabile comprimidos comprimidos munsönderfallande tabletter mutē disperģējamās tabletes orodisperzibilne tablete orodisperzibilne tablete orodisperzibilne tablete orodisperzibilne tablete FI/H/0827/ /2014/02 MYLAN HEALTHCARE GMBH RO FI/H/0827/ /2014/03 MYLAN HEALTHCARE GMBH RO FI/H/0827/ /2014/04 MYLAN HEALTHCARE GMBH RO FI/H/0827/ /2014/05 MYLAN HEALTHCARE GMBH RO AT/H/0446/001 BE MYLAN EPD BVBA/SPRL BE AT/H/0446/ MYLAN EPD BVBA/SPRL LU not available BGP PRODUCTS UNIPESSOAL, LDA. not available BGP PRODUCTS UNIPESSOAL, LDA. FI/H/0827/ MYLAN IRE HEALTHCARE FI/H/0827/ BGP PRODUCTS SIA LV FI/H/0827/001 H/04/00271/004 BGP PRODUCTS B.V. SI FI/H/0827/001 H/04/00271/008 BGP PRODUCTS B.V. SI FI/H/0827/001 H/04/00271/007 BGP PRODUCTS B.V. SI FI/H/0827/001 H/04/00271/006 BGP PRODUCTS B.V. SI PT PT FI EMA/608492/2018 Page 7/13
8 FI/H/0827/001 H/04/00271/005 BGP PRODUCTS B.V. SI orodisperzibilne tablete suussa FI/H/0827/ MYLAN IRE HEALTHCARE FI hajoavat tabletit tablete not available HR-H MYLAN HRVATSKA D.O.O. HR tablete not available H/04/00271/002 BGP PRODUCTS B.V. SI tablete not available H/04/00271/003 BGP PRODUCTS B.V. SI tablete not available H/04/00271/001 BGP PRODUCTS B.V. SI tabletes not available BGP PRODUCTS B.V. LV tabletės not available LT/1/95/0848/004 BGP PRODUCTS B.V. LT tabletės not available LT/1/95/0848/005 BGP PRODUCTS B.V. LT tabletės not available LT/1/95/0848/003 BGP PRODUCTS B.V. LT tabletid not available BGP PRODUCTS SIA EE tabletta not available OGYI-T-10004/01 MYLAN EPD KFT. HU AT/H/0446/001 BE MYLAN EPD BVBA/SPRL BE tabletten AT/H/0446/001 BE MYLAN EPD BVBA/SPRL BE tabletter not available BGP PRODUCTS B.V. FI tabletti not available BGP PRODUCTS B.V. FI, not available 2717/2010/02 BGP PRODUCTS B.V. RO, not available 2717/2010/03 BGP PRODUCTS B.V. RO, not available 2717/2010/04 BGP PRODUCTS B.V. RO, not available 2717/2010/01 BGP PRODUCTS B.V. RO BETASERC 24 mg, not available MYLAN MEDICAL SAS FR BETASERC 24 mg, not available MYLAN MEDICAL SAS FR BETASERC 24 mg, not available MYLAN MEDICAL SAS FR BETASERC 24 mg, not available MYLAN MEDICAL SAS FR EMA/608492/2018 Page 8/13
9 BETASERC 24 mg, FI/H/0827/ MYLAN MEDICAL SAS FR orodispersible BETASERC 24 mg, FI/H/0827/ MYLAN MEDICAL SAS FR orodispersible BETASERC 24 mg, FI/H/0827/ MYLAN MEDICAL SAS FR orodispersible BETASERC 24 mg, FI/H/0827/ MYLAN MEDICAL SAS FR orodispersible BETASERC 24 mg, FI/H/0827/ MYLAN MEDICAL SAS FR orodispersible Betaserc 24 tablety not available 83/368/03-C MYLAN IRE HEALTHCARE CZ Betaserc 24, tabletten 24 AT/H/0446/001 RVG BGP PRODUCTS B.V. NL mg BETASERC 8 mg - not available BGP PRODUCTS GES. M. B. AT H. Betaserc 8 mg not available 2192/2009/02 BGP PRODUCTS B.V. RO Betaserc 8 mg not available 2192/2009/01 BGP PRODUCTS B.V. RO Betaserc 8 mg tabletes not available BGP PRODUCTS B.V. LV Betaserc 8 mg tabletės not available LT/1/95/0848/001 BGP PRODUCTS B.V. LT Betaserc 8 mg tabletid not available BGP PRODUCTS SIA EE Betaserc 8 mg tabletta not available OGYI-T-10004/04 MYLAN EPD KFT. HU Betaserc 8 mg tabletter not available 9987 BGP PRODUCTS B.V. FI Betaserc 8 mg tabletti not available 9987 BGP PRODUCTS B.V. FI Betaserc 8 mg, not available BE MYLAN EPD BVBA/SPRL BE Betaserc 8 mg, not available MYLAN EPD BVBA/SPRL LU Betaserc 8 mg, not available BE MYLAN EPD BVBA/SPRL BE Betaserc 8 mg, tabletten not available BE MYLAN EPD BVBA/SPRL BE Betaserc 8 tablety not available 83/123/89-C MYLAN IRE HEALTHCARE CZ EMA/608492/2018 Page 9/13
10 Betaserc 8, tabletten 8 not available RVG BGP PRODUCTS B.V. NL mg Betaserc Odis 24 mg FI/H/0827/ BGP PRODUCTS PT comprimidos orodispersíveis UNIPESSOAL, LDA. Betaserc Odis 24 mg FI/H/0827/ BGP PRODUCTS PT comprimidos orodispersíveis UNIPESSOAL, LDA. Betaserc ODT, 24 mg, FI/H/0827/ MYLAN IRE HEALTHCARE PL tabletki ulegające rozpadowi w jamie ustnej Betaserc, 24 mg suus FI/H/0827/ BGP PRODUCTS SIA EE dispergeeruvad tabletid BETASERC, 24 mg, not available MYLAN HEALTHCARE SP. PL tabletki Z.O.O. BETASERC, 8 mg, not available R/3705 MYLAN HEALTHCARE SP. PL tabletki Z.O.O. Betaserc, tabletter 16 not available BGP PRODUCTS B.V. DK mg Betaserc, tabletter 8 mg not available BGP PRODUCTS B.V. DK Betaserc 16 mg tablets not available MA 1102/00102 BGP PRODUCTS B.V. MT BETASERC 16 mg not available 41613/07/ BGP PRODUCTS LTD GR δισκία (GREECE) Betaserc 16, δισκίων not available VARNAVAS HADJIPANAYIS CY 16 mg LTD. (LATSIA) Betaserc 24 mg tablets not available MA 1102/00103 BGP PRODUCTS B.V. MT Betaserc 24 mg δισκία FI/H/0827/ VARNAVAS HADJIPANAYIS CY διασπειρόμενα στο στόμα LTD. (LATSIA) Betaserc 24 mg δισκία FI/H/0827/ / BGP PRODUCTS LTD GR διασπειρόμενα στο στόμα (GREECE) Betaserc 8 mg tablets not available MA 1102/00101 BGP PRODUCTS B.V. MT BETASERC 8 mg δισκία not available 41610/07/ BGP PRODUCTS LTD GR EMA/608492/2018 Page 10/13
11 (GREECE) Betaserc 8, δισκίων 8 not available 7546 VARNAVAS HADJIPANAYIS CY mg LTD. (LATSIA) BETAVERT, δισκίο 24mg NL/H/1781/ / FARMASYN S.A. GR EXTOVYL, gélule not available LABORATOIRES JUVISE FR S EXTOVYL, gélule not available LABORATOIRES JUVISE FR S EXTOVYL, gélule not available LABORATOIRES JUVISE FR S FORTAMID 16 mg not available FARMACEUTICI FORMENTI IT S.P.A. FORTAMID 16 mg not available FARMACEUTICI FORMENTI IT S.P.A. Histigen, 24 mg, tabletki CZ/H/0399/ GENERICS [UK] PL LECTIL 16 mg, not available BOUCHARA RECORDATI FR sécable LECTIL 16 mg, not available BOUCHARA RECORDATI FR sécable LECTIL 16 mg, not available BOUCHARA RECORDATI FR sécable LECTIL 16 mg, not available BOUCHARA RECORDATI FR sécable LECTIL 16 mg, not available BOUCHARA RECORDATI FR sécable LECTIL 16 mg, not available BOUCHARA RECORDATI LU sécable LECTIL not available BOUCHARA RECORDATI FR LECTIL not available BOUCHARA RECORDATI FR LECTIL not available BOUCHARA RECORDATI FR LECTIL not available BOUCHARA RECORDATI FR LECTIL not available BOUCHARA RECORDATI LU LECTIL not available BOUCHARA RECORDATI LU MeniSerc 16 not available 83/0157/01-S TS PHARMA S.R.O. SK EMA/608492/2018 Page 11/13
12 MeniSerc 24 not available 83/0275/04-S TS PHARMA S.R.O. SK MICROSER not available 2727/2002/01 GRÜNENTHAL ITALIA S.R.L. RO Microser 12,5 mg/ml not available GRÜNENTHAL ITALIA S.R.L. IT gocce orali soluzione Microser 16 mg not available GRÜNENTHAL ITALIA S.R.L. IT Microser 16 mg not available GRÜNENTHAL ITALIA S.R.L. IT Microser 24 mg not available GRÜNENTHAL ITALIA S.R.L. IT Microser 24 mg not available GRÜNENTHAL ITALIA S.R.L. IT Microser 8 mg not available GRÜNENTHAL ITALIA S.R.L. IT Microser 8 mg not available GRÜNENTHAL ITALIA S.R.L. IT Microser 8 mg not available GRÜNENTHAL ITALIA S.R.L. IT RIBRAIN not available 42767/07/ GALENICA SA GR RIBRAIN not available 74468/ GALENICA SA GR Serc 16 mg comprimidos not available QUALIGEN, S.L. ES Serc 16mg Tablets not available PA 2010/16/2 MYLAN IRE HEALTHCARE IE Serc 24 mg comprimidos not available QUALIGEN, S.L. ES Serc 8 mg comprimidos not available QUALIGEN, S.L. ES SERC 8 mg, not available MYLAN MEDICAL SAS FR SERC 8 mg, not available MYLAN MEDICAL SAS FR SERC 8 mg, not available MYLAN MEDICAL SAS FR SERC 8 mg, not available MYLAN MEDICAL SAS FR Serc 8 mg/ml solución not available QUALIGEN, S.L. ES oral Serc 8mg Tablets not available PA 2010/16/1 MYLAN IRE HEALTHCARE IE Serc -16 not available PL 46302/0048 MYLAN PRODUCTS UK EMA/608492/2018 Page 12/13
13 Serc -8 not available PL 46302/0049 MYLAN PRODUCTS UK Vasomotal 24 mg not available MYLAN HEALTHCARE GMBH DE Vasomotal 16 mg not available MYLAN HEALTHCARE GMBH DE Vasomotal Tropfen 8 not available MYLAN HEALTHCARE GMBH DE mg/ml VERTISERC 16 mg not available BGP PRODUCTS S.R.L. IT VERTISERC 16 mg not available BGP PRODUCTS S.R.L. IT VERTISERC 24 mg not available BGP PRODUCTS S.R.L. IT VERTISERC 8 mg not available BGP PRODUCTS S.R.L. IT VERTISERC 8 mg/ml not available BGP PRODUCTS S.R.L. IT gocce orali, soluzione Бетасерк 16 mg not available BGP PRODUCTS B.V. BG таблетки Бетасерк 24 mg not available MYLAN HEALTHCARE GMBH BG таблетки Бетасерк 24 mg FI/H/0827/ MYLAN HEALTHCARE GMBH BG таблетки, диспергиращи се в устата Бетахистин Ауробиндо 8 mg таблетки PT/H/0867/ AUROBINDO PHARMA (MALTA) BG EMA/608492/2018 Page 13/13
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
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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 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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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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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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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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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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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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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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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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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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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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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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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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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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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/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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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21 February 2018 EMA/208334/2018 Human Medicines Evaluation Division Active substance: ibuprofen / pseudoephedrine Procedure no.: PSUSA/00001711/201707 30 Churchill Place Canary Wharf London E14 5EU United
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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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12 April 2018 EMA/223740/2018 Human Medicines Evaluation Division Active substance: fludarabine Procedure no.: PSUSA/00001406/201708 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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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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