List of nationally authorised medicinal products
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1 12 April 2018 EMA/231137/2018 Human Medicines Evaluation Division Active substance: fluvoxamine 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 DUMIROX 100 mg DUMIROX 100 mg Dumirox 100 mg comprimidos recubiertos con película DUMIROX 50 mg DUMIROX 50 mg Dumirox 50 mg comprimidos recubiertos con película Dumyrox 100 mg comprimidos revestidos por película Dumyrox 100 mg comprimidos revestidos por película Dumyrox 50 mg comprimidos revestidos por película Dumyrox 50 mg comprimidos revestidos por película National Number not available BGP PRODUCTS S.R.L. IT not available BGP PRODUCTS S.R.L. IT DE/H/5314/ BGP PRODUCTS OPERATIONS SL not available BGP PRODUCTS S.R.L. IT not available BGP PRODUCTS S.R.L. IT DE/H/5314/ BGP PRODUCTS OPERATIONS SL DE/H/5314/ BGP PRODUCTS UNIPESSOAL, LDA. DE/H/5314/ BGP PRODUCTS UNIPESSOAL, LDA. DE/H/5314/ BGP PRODUCTS UNIPESSOAL, LDA. DE/H/5314/ BGP PRODUCTS UNIPESSOAL, LDA. ES ES PT PT PT PT EMA/231137/2018 Page 2/12
3 Dumyrox 50 mg comprimidos revestidos por película Dumyrox 50 mg comprimidos revestidos por película DUMYROX Επικαλυμμένα με λεπτό υμένιο δισκία 100mg DUMYROX Επικαλυμμένα με λεπτό υμένιο δισκία 50mg Faverin 100 mg coated National Number DE/H/5314/ BGP PRODUCTS UNIPESSOAL, LDA. DE/H/5314/ BGP PRODUCTS UNIPESSOAL, LDA. DE/H/5314/ BGP PRODUCTS LTD (GREECE) DE/H/5314/ BGP PRODUCTS LTD (GREECE) DE/H/5314/002 PA 2136/3/2 MYLAN PRODUCTS LIMITED IE PT PT GR GR Faverin 100 mg coated DE/H/5314/002 PL 46302/0033 MYLAN PRODUCTS LIMITED UK Faverin 100mg coated not available VARNAVAS HADJIPANAYIS LTD. (LATSIA) CY Faverin 100mg coated not available VARNAVAS HADJIPANAYIS LTD. (LATSIA) CY Faverin 50 mg coated DE/H/5314/001 PA 2136/3/1 MYLAN PRODUCTS LIMITED IE EMA/231137/2018 Page 3/12
4 Faverin 50 mg coated National Number DE/H/5314/001 PL 46302/0034 MYLAN PRODUCTS LIMITED UK Faverin 50mg -coated not available VARNAVAS HADJIPANAYIS LTD. (LATSIA) CY Faverin 50mg -coated not available VARNAVAS HADJIPANAYIS LTD. (LATSIA) CY fevarin 100 om obalené tablety not available 30/0055/97-S BGP PRODUCTS B.V. SK fevarin 100 om obalené tablety not available 30/0055/97-S BGP PRODUCTS B.V. SK apvalkotās tabletes not available BGP PRODUCTS B.V. LV apvalkotās tabletes not available BGP PRODUCTS B.V. LV FEVARIN 100 mg FEVARIN 100 mg DE/H/5314/ BGP PRODUCTS B.V. IT DE/H/5314/ BGP PRODUCTS B.V. IT EMA/231137/2018 Page 4/12
5 comprimate ate National Number not available 8835/2016/01 BGP PRODUCTS B.V. RO comprimate ate not available 8835/2016/01 BGP PRODUCTS B.V. RO dragerad tablett DE/H/5314/ BGP PRODUCTS B.V. SE om obložene tablete not available HR-H MYLAN HRVATSKA D.O.O. HR om obložene tablete not available HR-H MYLAN HRVATSKA D.O.O. HR tabletta not available OGYI-T-1422/01 BGP PRODUCTS B.V. HU tabletta not available OGYI-T-1422/01 BGP PRODUCTS B.V. HU plėvele dengtos tabletės not available LT/1/97/1993/003 BGP PRODUCTS B.V. LT plėvele dengtos tabletės not available LT/1/97/1993/003 BGP PRODUCTS B.V. LT EMA/231137/2018 Page 5/12
6 potahované tablety National Number not available 30/070/89-B/C BGP PRODUCTS B.V. CZ potahované tablety not available 30/070/89-B/C BGP PRODUCTS B.V. CZ tabletter, drasjerte DE/H/5314/ BGP PRODUCTS B.V. NO Fevarin 100, omhulde tabletten DE/H/5314/002 RVG BGP PRODUCTS B.V. NL fevarin 50 om obalené tablety not available 30/0055/97-S BGP PRODUCTS B.V. SK fevarin 50 om obalené tablety not available 30/0055/97-S BGP PRODUCTS B.V. SK apvalkotās tabletes not available BGP PRODUCTS B.V. LV apvalkotās tabletes not available BGP PRODUCTS B.V. LV FEVARIN 50 mg DE/H/5314/ BGP PRODUCTS B.V. IT EMA/231137/2018 Page 6/12
7 comprimate ate National Number not available 8834/2016/01 BGP PRODUCTS B.V. RO comprimate ate not available 8834/2016/01 BGP PRODUCTS B.V. RO dragerad tablett DE/H/5314/ BGP PRODUCTS B.V. SE tabletta not available OGYI-T-1422/02 BGP PRODUCTS B.V. HU tabletta not available OGYI-T-1422/02 BGP PRODUCTS B.V. HU plėvele dengtos tabletės not available LT/1/97/1993/002 BGP PRODUCTS B.V. LT plėvele dengtos tabletės not available LT/1/97/1993/001 BGP PRODUCTS B.V. LT plėvele dengtos tabletės not available LT/1/97/1993/002 BGP PRODUCTS B.V. LT plėvele dengtos tabletės not available LT/1/97/1993/001 BGP PRODUCTS B.V. LT EMA/231137/2018 Page 7/12
8 potahované tablety National Number not available 30/070/89-A/C BGP PRODUCTS B.V. CZ potahované tablety not available 30/070/89-A/C BGP PRODUCTS B.V. CZ tabletter, drasjerte DE/H/5314/ BGP PRODUCTS B.V. NO Fevarin 50, omhulde tabletten DE/H/5314/001 RVG BGP PRODUCTS B.V. NL Fevarin, 100 mg õhukese polümeerikattega tabletid not available BGP PRODUCTS B.V. EE Fevarin, 100 mg õhukese polümeerikattega tabletid not available BGP PRODUCTS B.V. EE Fevarin, 100 mg, tabletki powlekane not available R/3478 BGP PRODUCTS POLAND SP. Z.O.O. PL Fevarin, 100 mg, tabletki powlekane not available R/3478 BGP PRODUCTS POLAND SP. Z.O.O. PL Fevarin, 50 mg õhukese polümeerikattega tabletid not available BGP PRODUCTS B.V. EE EMA/231137/2018 Page 8/12
9 Fevarin, 50 mg õhukese polümeerikattega tabletid National Number not available BGP PRODUCTS B.V. EE Fevarin, 50 mg, tabletki powlekane not available R/3477 BGP PRODUCTS POLAND SP. Z.O.O. PL Fevarin, 50 mg, tabletki powlekane not available R/3477 BGP PRODUCTS POLAND SP. Z.O.O. PL Fevarin 100 mg Filmtabletten DE/H/5314/ MYLAN HEALTHCARE GMBH DE Fevarin 50 mg Filmtabletten DE/H/5314/ MYLAN HEALTHCARE GMBH DE Floxyfral 100 mg Filmtabletten DE/H/5314/ BGP PRODUCTS GES. M. B. H. AT FLOXYFRAL 100 mg comprimés pelliculés DE/H/5314/002 BE MYLAN EPD SPRL BE FLOXYFRAL 100 mg comprimés pelliculés DE/H/5314/ MYLAN EPD SPRL LU FLOXYFRAL 100 mg omhulde tabletten DE/H/5314/002 BE MYLAN EPD SPRL BE EMA/231137/2018 Page 9/12
10 Floxyfral 100 mg Filmtabletten National Number DE/H/5314/002 BE MYLAN EPD SPRL BE FLOXYFRAL 100 mg, FLOXYFRAL 100 mg, FLOXYFRAL 100 mg, FLOXYFRAL 100 mg, FLOXYFRAL 100 mg, Floxyfral 50 mg Filmtabletten DE/H/5314/ MYLAN MEDICAL SAS FR DE/H/5314/ MYLAN MEDICAL SAS FR DE/H/5314/ MYLAN MEDICAL SAS FR DE/H/5314/ MYLAN MEDICAL SAS FR DE/H/5314/ MYLAN MEDICAL SAS FR DE/H/5314/ BGP PRODUCTS GES. M. B. AT H. FLOXYFRAL 50 mg, FLOXYFRAL 50 mg, DE/H/5314/ MYLAN MEDICAL SAS FR DE/H/5314/ MYLAN MEDICAL SAS FR EMA/231137/2018 Page 10/12
11 FLOXYFRAL 50 mg, FLOXYFRAL 50 mg, Fluvoxamine 100 mg -coated National Number DE/H/5314/ MYLAN MEDICAL SAS FR DE/H/5314/ MYLAN MEDICAL SAS FR not available PL 11311/0489 TILLOMED LABORATORIES LTD UK Fluvoxamine 50 mg coated not available PL 11311/0488 TILLOMED LABORATORIES LTD UK Luvox 100 mg om obložene tablete not available HR-H MYLAN HRVATSKA D.O.O. HR Luvox 100 mg om obložene tablete not available HR-H MYLAN HRVATSKA D.O.O. HR MAVERAL 100 mg MAVERAL 100 mg MAVERAL 50 mg not available BGP PRODUCTS S.R.L. IT not available BGP PRODUCTS S.R.L. IT not available BGP PRODUCTS S.R.L. IT EMA/231137/2018 Page 11/12
12 MAVERAL 50 mg Феварин 100 mg филмирани таблетки National Number not available BGP PRODUCTS S.R.L. IT not available BGP PRODUCTS B.V. BG Феварин 100 mg филмирани таблетки not available BGP PRODUCTS B.V. BG Феварин 50 mg филмирани таблетки not available BGP PRODUCTS B.V. BG Феварин 50 mg филмирани таблетки not available BGP PRODUCTS B.V. BG EMA/231137/2018 Page 12/12
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
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
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
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
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
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
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
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
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
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
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
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
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
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/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
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
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 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
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
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
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
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
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
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
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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List of nationally authorised medicinal products
24 January 2018 EMA/270645/2015 Human Medicines Evaluation Division Active substance: azithromycin (systemic use formulations) Procedure no.: PSUSA/00010491/201704 30 Churchill Place Canary Wharf London
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
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
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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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
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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
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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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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
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
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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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
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/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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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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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
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