List of nationally authorised medicinal products

Transcription

1 12 April 2018 EMA/243033/2018 Human Medicines Evaluation Division Active substance: fenofibrate 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 where FÉNOFIBRATE BIOGARAN 300 mg, gélule FENOFIBRATE TEVA SANTE 160 mg, comprimé pelliculé not available BIOGARAN FR not available NL31090 TEVA SANTÉ FR Lipofen 100 mg cápsula not available LABORATÓRIOS VITÓRIA, SA Lipofen 100 mg cápsula not available LABORATÓRIOS VITÓRIA, SA Elipsia 145 mg Filmtablette not available ABBOTT LABORATORIES Fenofibrat Abbott 160mg Filmtabletten not available ABBOTT LABORATORIES Lipanthyl 200 mg, kapsel, hård IE/H/0120/ MYLAN MEDICAL SAS SE Lipantil Micro 200 mg capsule, hard IE/H/0120/002 PA 2010/15/2 MYLAN IRE HEALTHCARE IE Apteor 160 mg Filmtablette /H/0236/ MYLAN HEALTHCARE /H/0236/ BGP PRODUCTS S.R.L. IT /H/0236/ BGP PRODUCTS S.R.L. IT /H/0236/ BGP PRODUCTS S.R.L. IT /H/0236/ BGP PRODUCTS S.R.L. IT /H/0236/ BGP PRODUCTS S.R.L. IT EMA/243033/2018 Page 2/13

3 where /H/0236/ BGP PRODUCTS S.R.L. IT /H/0236/ BGP PRODUCTS S.R.L. IT /H/0236/ BGP PRODUCTS S.R.L. IT /H/0236/ BGP PRODUCTS S.R.L. IT /H/0236/ BGP PRODUCTS S.R.L. IT /H/0236/ BGP PRODUCTS S.R.L. IT Lipanthyl S 215 mg, potahovaná tableta Lipanthyl Supra 215 mg, 215 mg, tabletki powlekane LIPANTHYL SUPRA 215 mg filmom obalené tablety Lipantil Supra 215 mg, filmcoated tablet IE/H/0157/001 31/288/05-C MYLAN IRE HEALTHCARE IE/H/0157/ BGP PRODUCTS POLAND SP. Z.O.O. IE/H/0157/001 31/0390/05-S MYLAN IRE HEALTHCARE IE/H/0157/001 PA 2010/15/4 MYLAN IRE HEALTHCARE CZ PL SK IE Secalip 250 mg cápsulas duras de liberación prolongada not available LACER S.A. ES Secalip 200 mg cápsulas duras not available LACER S.A. ES Secalip supra 160 mg comprimidos recubiertos con película /H/0235/ LACER S.A. ES EMA/243033/2018 Page 3/13

4 where Secalip 145 mg comprimidos recubiertos con película /H/0497/ LACER S.A. ES Lipcor 200 mg-kapseln not available BGP PRODUCTS GES. M. B. H. AT Secalip 250 mg cápsulas duras de liberación prolongada not available LACER S.A. ES Secalip 200 mg cápsulas duras not available LACER S.A. ES CATALIP 200 mg cápsulas not available LABORATÓRIO MEDINFAR CATALIP 200 mg cápsulas not available LABORATÓRIO MEDINFAR CATALIP 267 MICRONIZADO 267 mg cápsulas Catalip 267 Micronizado 267 mg cápsulas Lipanthyl 200 Micronised, 200 mg Hartkapseln not available LABORATÓRIO MEDINFAR not available LABORATÓRIO MEDINFAR not available BE MYLAN EPD SPRL BE Lipanthyl 267 Micronised, 267 mg Hartkapseln LIPANTHYL 267 Micronised, 267 mg, capsules, hard Lipanthyl 67 Micronised, 67 mg Hartkapseln LIPANTHYL 267 Micronised gélules not available BE MYLAN EPD SPRL BE not available BE MYLAN EPD SPRL BE not available BE MYLAN EPD SPRL BE not available BE MYLAN EPD SPRL BE EMA/243033/2018 Page 4/13

5 where LIPANTHYL 267 Micronised gélules LIPANTHYL 200 Micronised gélules LIPANTHYL 67 Micronised, 67 mg gélules not available MYLAN EPD SPRL LU not available BE MYLAN EPD SPRL BE not available BE MYLAN EPD SPRL BE LIPANTHYL-200 MICRONISED not available MYLAN EPD SPRL LU LIPANTHYL 67 Micronised, 67 mg gélules LIPANTHYL 200 Micronised, capsules, hard LIPANTHYL 67 Micronised, capsules, hard Липантил Супра 160 mg филмирани таблетки Липантил 200M 200 mg капсули, твърди not available MYLAN EPD SPRL LU not available BE MYLAN EPD SPRL BE not available BE MYLAN EPD SPRL BE not available MYLAN MEDICAL SAS BG not available MYLAN MEDICAL SAS BG Lipidil NT 145 mg, filmcoated tablet LIPANTHYL SUPRA 160 mg Potahovaná tableta LIPANTHYL 267 M tvrdá tobolka not available VARNAVAS HADJIPANAYIS LTD. (LATSIA) not available 31/463/00-C MYLAN IRE HEALTHCARE not available 31/105/00-C MYLAN IRE HEALTHCARE CY CZ CZ Lipidil 200 mg Hartkapseln not available MYLAN HEALTHCARE EMA/243033/2018 Page 5/13

6 where Lipanthyl, 200 mg kõvakapslid not available BGP PRODUCTS SIA EE LIPANTHYL 200 micronisé, gélule LIPANTHYL 200 micronisé, gélule LIPANTHYL 200 micronisé, gélule not available MYLAN MEDICAL SAS FR not available MYLAN MEDICAL SAS FR not available MYLAN MEDICAL SAS FR LIPANTHYL 67 Micronisé, gélule not available MYLAN MEDICAL SAS FR LIPIDIL 145 mg filmom obložene tablete TRICOR 145 mg filmom obložene tablete LIPIDIL 160 mg filmom obložene tablete TRICOR 160 mg filmom obložene tablete TRICOR 215 mg filmom obložene tablete not available UP/I /12-02/101 MYLAN HRVATSKA D.O.O. HR not available UP/I /12-02/102 MYLAN HRVATSKA D.O.O. HR not available UP/I /12-02/99 MYLAN HRVATSKA D.O.O. HR not available UP/I /12-02/100 MYLAN HRVATSKA D.O.O. HR not available UP/I /12-02/104 MYLAN HRVATSKA D.O.O. HR Lipidil Supra 160 mg filmtabletta not available OGYI-T-7695/01 MYLAN PRODUCTS HU Lipidil 267 mg kemény kapszula not available OGYI-T-8697/01 MYLAN EPD KFT. HU FULCRO 200 mg capsule rigide not available BGP PRODUCTS S.R.L. IT LIPANTHYL 200 mg kietosios kapsulės not available LT/1/96/2568/001 MYLAN MEDICAL SAS LT EMA/243033/2018 Page 6/13

7 where LIPANTHYL 67 Micronisé, gélule not available MYLAN MEDICAL SAS FR LIPANTHYL 67 Micronisé, gélule not available MYLAN MEDICAL SAS FR LIPANTHYL 67 Micronisé, gélule not available MYLAN MEDICAL SAS FR LIPANTHYL 67 Micronisé, gélule not available MYLAN MEDICAL SAS FR LIPANTHYL 67 Micronisé, gélule not available MYLAN MEDICAL SAS FR Lipanthyl 200 mg cietās kapsulas not available BGP PRODUCTS SIA LV Lipanthyl Supra 160, 160 mg, tabletki powlekane Lipanthyl 200M, 200 mg, kapsułki Lipanthyl 267M, 267 mg, kapsułki not available 9039 BGP PRODUCTS POLAND SP. Z.O.O. not available R/2587 BGP PRODUCTS POLAND SP. Z.O.O. not available 4928 BGP PRODUCTS POLAND SP. Z.O.O. PL PL PL LIPANTIL NANO 145 mg comprimate filmate Lipanthyl Supra 160 mg comprimate cu eliberare modificată Lipanthyl Supra 160 mg comprimate cu eliberare modificată LIPANTHYL SUPRA 160 mg filmom obalené tablety not available 9126/2016/01 MYLAN MEDICAL SAS RO not available 1075/2008/02 MYLAN MEDICAL SAS RO not available 1075/2008/01 MYLAN MEDICAL SAS RO not available 31/0394/00-S MYLAN IRE HEALTHCARE SK EMA/243033/2018 Page 7/13

8 where Lipantil Micro 200 mg, capsules Lipantil Micro 267 mg, capsules Lipantil Micro 67 mg, capsules FENOFIBRATE EG 160 mg, comprimé pelliculé not available PL 46302/0042 MYLAN PRODUCTS not available PL 46302/0043 MYLAN PRODUCTS not available PL 46302/0044 MYLAN PRODUCTS not available NL31362 EG LABO LABORATOIRES EUROGENERICS UK UK UK FR LIPSIN 200 mg capsule rigide not available I.B.N. SAVIO S.R.L. IT Lipofene 100 mg capsule not available TEOFARMA S.R.L. IT FENOFIBRATE TEVA 300 mg, gélule FENOFIBRATE TEVA 100 mg, gélule not available NL21839 TEVA SANTÉ FR not available NL21838 TEVA SANTÉ FR Lipantil Micro 67 mg capsule, hard IE/H/0120/001 PA 2010/15/1 MYLAN IRE HEALTHCARE IE Secalip 145 mg comprimidos recubiertos con película /H/0497/ LACER S.A. ES Lipanthyl Nanopartikel 145 mg - Filmtabletten /H/0497/ BGP PRODUCTS GES. M. B. H. AT Lipanthylnano 145 mg Filmtabletten Lipanthylnano 145 mg comprimés pelliculés Lipanthylnano 145 mg comprimés pelliculés /H/0497/001 BE MYLAN EPD SPRL BE /H/0497/001 BE MYLAN EPD SPRL BE /H/0497/ MYLAN EPD SPRL LU EMA/243033/2018 Page 8/13

9 where Lipanthylnano 145 mg filmomhulde tabletten /H/0497/001 BE MYLAN EPD SPRL BE Lipanthyl NT 145 mg, potahované tablety /H/0497/001 31/214/05-C MYLAN IRE HEALTHCARE CZ Lipanthyl Penta 145 mg, kalvopäällysteinen tabletti LIPANTHYL 145 mg, comprimé pelliculé LIPANTHYL 145 mg, comprimé pelliculé LIPANTHYL 145 mg, comprimé pelliculé /H/0497/ MYLAN MEDICAL SAS FI /H/0497/ MYLAN MEDICAL SAS FR /H/0497/ MYLAN MEDICAL SAS FR /H/0497/ MYLAN MEDICAL SAS FR LIPIDIL NT 145mg επικαλυμμένο με λεπτό υμένιο δισκίο /H/0497/ / BGP PRODUCTS LTD (GREECE) Lipidil 145 mg filmtabletta /H/0497/001 OGYI-T-8967/02 MYLAN EPD KFT. HU GR /H/0497/ /M BGP PRODUCTS S.R.L. IT /H/0497/ /M BGP PRODUCTS S.R.L. IT /H/0497/ /M BGP PRODUCTS S.R.L. IT /H/0497/ /M BGP PRODUCTS S.R.L. IT /H/0497/ /M BGP PRODUCTS S.R.L. IT EMA/243033/2018 Page 9/13

10 where /H/0497/ /M BGP PRODUCTS S.R.L. IT /H/0497/ /M BGP PRODUCTS S.R.L. IT /H/0497/ /M BGP PRODUCTS S.R.L. IT /H/0497/ /M BGP PRODUCTS S.R.L. IT /H/0497/ /M BGP PRODUCTS S.R.L. IT /H/0497/ /M BGP PRODUCTS S.R.L. IT Lipanthyl NT 145, 145 mg, tabletki powlekane LIPANTHYL NT 145 mg filmom obalené tablety LIPIDIL 145 ONE 145 mg Filmtabletten Lipantil Supra 145 mg filmcoated tablet /H/0497/ BGP PRODUCTS POLAND SP. Z.O.O. /H/0497/001 31/0396/05-S MYLAN IRE HEALTHCARE /H/0497/ MYLAN HEALTHCARE /H/0497/001 PA 2010/15/3 MYLAN IRE HEALTHCARE PL SK IE Lipanthyl Penta 145 mg, filmdragerad tablett /H/0497/ MYLAN MEDICAL SAS FI /H/0500/ /M BGP PRODUCTS S.R.L. IT /H/0500/ /M BGP PRODUCTS S.R.L. IT /H/0500/ /M BGP PRODUCTS S.R.L. IT EMA/243033/2018 Page 10/13

11 where /H/0500/ /M BGP PRODUCTS S.R.L. IT /H/0500/ /M BGP PRODUCTS S.R.L. IT /H/0500/ /M BGP PRODUCTS S.R.L. IT /H/0500/ /M BGP PRODUCTS S.R.L. IT /H/0500/ /M BGP PRODUCTS S.R.L. IT /H/0500/ /M BGP PRODUCTS S.R.L. IT /H/0500/ /M BGP PRODUCTS S.R.L. IT /H/0500/ /M BGP PRODUCTS S.R.L. IT Liperial 145 mg Filmtablette /H/0500/ MYLAN HEALTHCARE Secalip supra 160 mg comprimidos recubiertos con película LIPANTHYL 160 mg, comprimé pelliculé LIPANTHYL 160 mg, comprimé pelliculé LIPANTHYL 160 mg, comprimé pelliculé /H/0235/ LACER S.A. ES /H/0235/ MYLAN MEDICAL SAS FR /H/0235/ MYLAN MEDICAL SAS FR /H/0235/ MYLAN MEDICAL SAS FR EMA/243033/2018 Page 11/13

12 where Supralip 160 mg, film-coated tablet Lipidil-Ter 160 mg Filmtablette /H/0235/001 PL 46302/0024 MYLAN PRODUCTS /H/0235/ MYLAN HEALTHCARE UK CATALIP 200 mg cápsulas not available LABORATÓRIO MEDINFAR CATALIP 200 mg cápsulas not available LABORATÓRIO MEDINFAR CATALIP 267 MICRONIZADO 267 mg cápsulas Catalip 267 Micronizado 267 mg cápsulas not available LABORATÓRIO MEDINFAR not available LABORATÓRIO MEDINFAR Xafenor 145 mg Filmtablette /H/0498/ MYLAN HEALTHCARE Supralip 145 mg comprimidos revestidos por película Supralip 145 mg comprimidos revestidos por película Supralip 145 mg comprimidos revestidos por película /H/0498/ BGP PRODUCTS UNIPESSOAL, LDA. /H/0498/ BGP PRODUCTS UNIPESSOAL, LDA. /H/0498/ BGP PRODUCTS UNIPESSOAL, LDA. Fenogal Lidose 200 mg gélules not available BE LABORATOIRES SMB S.A. BE Fenogal Lidose 200 mg capsules, hard Fenogal Lidose 200 mg Hartkapseln not available BE LABORATOIRES SMB S.A. BE not available BE LABORATOIRES SMB S.A. BE EMA/243033/2018 Page 12/13

13 where Fenogal Lidose 200 mg gélules not available LABORATOIRES SMB S.A. LU Fenogal Lidose 200 mg Hartkapseln FENOFIBRATE BIOGARAN 100 mg, gélule FENOFIBRATE BIOGARAN 100 mg, gélule FENOFIBRATE BIOGARAN 100 mg, gélule not available LABORATOIRES SMB S.A. LU not available BIOGARAN FR not available BIOGARAN FR not available BIOGARAN FR EMA/243033/2018 Page 13/13