11 January 2018 EMA/32390/2018 Human Medicines Evaluation Division Active substance(s): eprosartan Procedure No.: PSUSA/00001243/201704 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact An agency of the European Union European Medicines Agency, 2018. Reproduction provided the source is acknowledged.
Teveten 400 mg - Filmtabletten DE/H/0114/003 1-22117 BGP PRODUCTS GES. M. B. H. AT Теветен 600 mg филмирани таблетки not available 20011115 BGP PRODUCTS B.V. BG tablets not available 19260 VARNAVAS HADJIPANAYIS LTD. (LATSIA) CY TEVETEN 600 mg potahované tablety not available 58/022/01-C BGP PRODUCTS B.V. CZ Teveten 400 mg Filmtabletten DE/H/0114/003 39573.02.00 MYLAN HEALTHCARE GMBH DE Teveten, 600 mg õhukese polümeerikattega tabletid not available 370301 BGP PRODUCTS B.V. EE Futuran 600 mg comprimidos recubiertos con película not available 64.578 BGP PRODUCTS OPERATIONS SL ES Eprosartán Mylan Pharmaceuticals 600 mg comprimidos recubiertos con película EFG not available 78964 MYLAN PHARMACEUTICALS S.L. ES TEVETENS 600 mg comprimidos recubiertos con película not available 63.506 BGP PRODUCTS OPERATIONS SL ES pelliculé not available 345 989-7 MYLAN MEDICAL SAS FR pelliculé not available 356 353.1 MYLAN MEDICAL SAS FR pelliculé not available 356 354.8 MYLAN MEDICAL SAS FR pelliculé not available 371 490.6 MYLAN MEDICAL SAS FR pelliculé not available 372 060.5 MYLAN MEDICAL SAS FR pelliculé not available 371 491.2 MYLAN MEDICAL SAS FR pelliculé not available 345 988-0 MYLAN MEDICAL SAS FR TEVETEN 600 mg plėvele dengtos tabletės not available LT/1/2000/1097/005 BGP PRODUCTS B.V. LT TEVETEN 600 mg plėvele dengtos tabletės not available LT/1/2000/1097/006 BGP PRODUCTS B.V. LT TEVETEN 600 mg plėvele not available LT/1/2000/1097/004 BGP PRODUCTS B.V. LT EMA/32390/2018 Page 2/5
dengtos tabletės TEVETEN 600 mg filmom obložene tablete not available UP/I-530-09/12-02/131 MYLAN HRVATSKA D.O.O. HR Teveten 600 mg filmtabletta not available OGYI-T-7742/04 BGP PRODUCTS B.V. HU Teveten 600 mg filmtabletta not available OGYI-T-7742/02 BGP PRODUCTS B.V. HU rivestite con film DE/H/0114/003 033331099 BGP PRODUCTS S.R.L. IT rivestite con film DE/H/0114/003 033331101 BGP PRODUCTS S.R.L. IT rivestite con film DE/H/0114/003 033331113 BGP PRODUCTS S.R.L. IT rivestite con film DE/H/0114/003 033331125 BGP PRODUCTS S.R.L. IT rivestite con film DE/H/0114/003 033331087 BGP PRODUCTS S.R.L. IT Teveten 600 mg apvalkotās tabletes not available 01-0436 BGP PRODUCTS B.V. LV Teveten 600 mg, filmdrasjerte tabletter not available 99-7902 BGP PRODUCTS B.V. NO Teveten, 600 mg, tabletki powlekane not available 8684 BGP PRODUCTS POLAND SP. Z.O.O. PL Teveten 400, filmomhulde tabletten 400 mg not available RVG 22260 BGP PRODUCTS B.V. NL Teveten 600, filmomhulde tabletten 600 mg not available RVG 23983 BGP PRODUCTS B.V. NL NAVITEN 600 mg not available 58/0262/01-S BGP PRODUCTS B.V. SK tablets not available MA 1064/00601 BGP PRODUCTS LTD. MT Teveten 300mg film-coated tablets not available PL 46302/0050 MYLAN PRODUCTS LIMITED UK Teveten 600mg film-coated tablets not available PL 46302/0051 MYLAN PRODUCTS LIMITED UK REGULATEN 600 mg comprimidos recubiertos con película not available 63509 BGP PRODUCTS OPERATIONS SL ES NAVIXEN 600 mg comprimidos not available 63508 BGP PRODUCTS OPERATIONS SL ES EMA/32390/2018 Page 3/5
recubiertos con película TEVETEN 400 mg, film-coated tablets DE/H/0114/003 PA 2010/17/1 MYLAN IRE HEALTHCARE LIMITED IE Eprosartan-ratiopharm 600 mg Filmtabletten not available 67772.00.00 RATIOPHARM GMBH DE Eprosartan-CT 600 mg Filmtabletten not available 67771.00.00 ABZ-PHARMA GMBH DE Teveten 600 mg - Filmtabletten DE/H/0114/004 1-23401 BGP PRODUCTS GES. M. B. H. AT pelliculés DE/H/0114/004 BE209806 MYLAN EPD SPRL BE pelliculés DE/H/0114/004 BE209815 MYLAN EPD SPRL BE pelliculés DE/H/0114/004 2007119550 MYLAN EPD SPRL LU TEVETEN 600 mg, filmomhulde tabletten DE/H/0114/004 BE209815 MYLAN EPD SPRL BE TEVETEN 600 mg, filmomhulde tabletten DE/H/0114/004 BE209806 MYLAN EPD SPRL BE Teveten Mono 600 mg Filmtabletten DE/H/0114/004 39573.03.00 MYLAN HEALTHCARE GMBH DE TEVETEN 600 mg, επικαλυμμένα με λεπτό υμένιο δισκία DE/H/0114/004 74510/18-11-2008 BGP PRODUCTS LTD (GREECE) GR Teveten 600 mg tabletti, kalvopäällysteinen DE/H/0114/004 14674 MYLAN FINLAND OY FI rivestite con film DE/H/0114/004 033331152 BGP PRODUCTS S.R.L. IT rivestite con film DE/H/0114/004 033331164 BGP PRODUCTS S.R.L. IT rivestite con film DE/H/0114/004 033331188 BGP PRODUCTS S.R.L. IT rivestite con film DE/H/0114/004 033331176 BGP PRODUCTS S.R.L. IT rivestite con film DE/H/0114/004 033331149 BGP PRODUCTS S.R.L. IT DE/H/0114/004 033331137 BGP PRODUCTS S.R.L. IT EMA/32390/2018 Page 4/5
rivestite con film revestidos por película DE/H/0114/004 3061181 BGP PRODUCTS UNIPESSOAL, LDA. PT revestidos por película DE/H/0114/004 3061280 BGP PRODUCTS UNIPESSOAL, LDA. PT revestidos por película DE/H/0114/004 3061389 BGP PRODUCTS UNIPESSOAL, LDA. PT revestidos por película DE/H/0114/004 3061488 BGP PRODUCTS UNIPESSOAL, LDA. PT revestidos por película DE/H/0114/004 3061587 BGP PRODUCTS UNIPESSOAL, LDA. PT revestidos por película DE/H/0114/004 3061082 BGP PRODUCTS UNIPESSOAL, LDA. PT Teveten 600 mg, filmdragerade tabletter DE/H/0114/004 15721 BGP PRODUCTS B.V. SE Teveten 600 mg Filmtabletten DE/H/0114/004 BE209815 MYLAN EPD SPRL BE Teveten 600 mg Filmtabletten DE/H/0114/004 BE209806 MYLAN EPD SPRL BE Teveten 600 mg filmdragerade tabletter DE/H/0114/004 14674 MYLAN FINLAND OY FI Teveten 600 mg Filmtabletten DE/H/0114/004 2007119550 MYLAN EPD SPRL LU tablets DE/H/0114/004 PA 2010/17/2 MYLAN IRE HEALTHCARE LIMITED IE EMA/32390/2018 Page 5/5