List of nationally authorised medicinal products

Transcription

1 27 October 2016 EMA/719205/2016 Human Medicines Evaluation Division Active substance: ethinylestradiol / gestodene (except for transdermal application) 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 National Number Alessia HEXAL 0,06 mg/ 0,015 mg Filmtabletten /H/0424/ HEXAL AG DE Arianna 60 microgrammi / 15 microgrammi compresse rivestite con film /H/0159/ BAYER SPA IT Arianna 60 microgrammi / 15 microgrammi compresse rivestite con film /H/0159/ BAYER SPA IT Arianna 60 microgrammi / 15 microgrammi compresse rivestite con film /H/0159/ BAYER SPA IT Etinilestradiol + Gestodeno Stallpharma 0,02 mg + 0,075 mg Comprimidos revestidos not available Etinilestradiol + Gestodeno Stallpharma 0,02 mg + 0,075 mg Comprimidos revestidos not available Etinilestradiol + Gestodeno Stallpharma 0,02 mg + 0,075 mg Comprimidos revestidos not available STALLPHARMA, PRODUTOS FARMACÊUTICOS LDA. STALLPHARMA, PRODUTOS FARMACÊUTICOS LDA. STALLPHARMA, PRODUTOS FARMACÊUTICOS LDA. PT Fedra 0,075 mg + 0,02 mg compresse rivestite not available BAYER SPA IT FEMODEN not available 56/220/93-C BAYER PHARMA AG CZ Femoden 0,03 mg/0,075 mg obložene tablete not available 5363-I-2183/12 BAYER PHARMA AG SI Femoden 0,03mg/0,075 mg obalené tablety not available 17/140/94-S BAYER PHARMA AG SK Femoden 75/30 mikrogrammi kaetud tabletid not available BAYER PHARMA AG EE Femoden 75/30 mikrogramu apvalkotās tabletes not available BAYER PHARMA AG LV PT PT EMA/719205/2016 Page 2/14

3 National Number Femoden 75/30 mikrogramų dengtos tabletės not available LT/1/96/2476/001 BAYER PHARMA AG LT Femoden bevont tabletta not available OGYI-T-2360/02 BAYER PHARMA AG HU Femoden bevont tabletta not available OGYI-T-2360/01 BAYER PHARMA AG HU Femoden dragerade tabletter not available 9970 BAYER OY FI Femoden päällystetyt tabletit not available 9970 BAYER OY FI Femoden, 0,075 mg + 0,03 mg, tabletki powlekane not available R/0601 BAYER PHARMA AG PL Femodene not available PL 00010/0529 BAYER PLC UK Femodene 0,075 / 0,030 mg, comprimés enrobés not available BE BAYER SA NV BE Femodene 0,075 / 0,030 mg, comprimés enrobés not available BAYER SA NV LU Femodene 0,075 / 0,030 mg, omhulde tabletten not available BE BAYER SA NV BE Femodene 0,075 / 0,030 mg, überzogene Tabletten not available BE BAYER SA NV BE Femodene 0,075 / 0,030 mg, überzogene Tabletten not available BAYER SA NV LU FEMODENE ED not available PL 00010/0530 BAYER PLC UK Femodette not available PL 00010/0531 BAYER PLC UK Femovan 0,03mg / 0,075mg überzogene Tabletten not available JENAPHARM GMBH & CO KG DE Gestoden/Etinilestradiol Sandoz 75 micrograme/30 micrograme comprimate NL/H/3352/ /2016/01 S.C. SANDOZ S.R.L. RO Gestoden/Etinilestradiol Sandoz 75 micrograme/30 micrograme comprimate NL/H/3352/ /2016/02 S.C. SANDOZ S.R.L. RO Gestoden/Etinilestradiol NL/H/3352/ /2016/03 S.C. SANDOZ S.R.L. RO EMA/719205/2016 Page 3/14

4 National Number Sandoz 75 micrograme/30 micrograme comprimate GINODEN 0,075 mg + 0,03 mg compresse rivestite not available BAYER SPA IT Gynera, 0,03 mg + 0,075 mg, comprimido revestido not available BAYER PORTUGAL LDA PT Gynera, 0,03 mg + 0,075 mg, comprimido revestido not available BAYER PORTUGAL LDA PT Gynovin - Dragees not available BAYER AUSTRIA GMBH AT Gynovin 0,075 mg / 0,03 mg comprimidos recubiertos not available BAYER HISPANIA SL ES Harmonet not available (IS) PFIZER APS IS Harmonet 0,02 mg + 0,075 mg comprimido revestido not available LABORATÓRIOS PFIZER, LDA. PT Harmonet 0,02 mg + 0,075 mg comprimido revestido not available LABORATÓRIOS PFIZER, LDA. PT Harmonet 0,02 mg + 0,075 mg comprimido revestido not available LABORATÓRIOS PFIZER, LDA. PT Harmonet 0,02 mg + 0,075 mg comprimido revestido not available LABORATÓRIOS PFIZER, LDA. PT HARMONET 0,075 mg + 0,02 mg compresse rivestite not available PFIZER ITALIA S.R.L. IT Harmonet 0,075 mg/0,020 mg comprimés enrobés not available BE PFIZER S.A. (BELGIUM) BE Harmonet 0,075 mg/0,020 mg drajeuri (gestoden/etinilestradiol) not available 3697/2011/04 PFIZER EUROPE MA EEIG RO Harmonet 0,075 mg/0,020 mg drajeuri (gestoden/etinilestradiol) not available 3697/2011/03 PFIZER EUROPE MA EEIG RO Harmonet 0,075 mg/0,020 mg drajeuri (gestoden/etinilestradiol) not available 3697/2011/01 PFIZER EUROPE MA EEIG RO EMA/719205/2016 Page 4/14

5 National Number Harmonet 0,075 mg/0,020 mg drajeuri (gestoden/etinilestradiol) not available 3697/2011/02 PFIZER EUROPE MA EEIG RO Harmonet 0,075 mg/0,020 mg omhulde tabletten not available BE PFIZER S.A. (BELGIUM) BE Harmonet 0,075 mg/0,020 mg Überzogene Tabletten not available BE PFIZER S.A. (BELGIUM) BE Harmonet 75 mikrogramai / 20 mikrogramų dengtos tabletės not available LT/1/98/0362/002 PFIZER EUROPE MA EEIG LT Harmonet 75 mikrogramai / 20 mikrogramų dengtos tabletės not available LT/1/98/0362/001 PFIZER EUROPE MA EEIG LT Harmonet 75 mikrogrami/20 mikrogrami apvalkotās tabletes not available PFIZER EUROPE MA EEIG LV Harmonet 75 mikrogramm/20 mikrogramm bevont tabletta not available OGYI-T-6969/01 PFIZER KFT. HU Harmonet 75 mikrogramm/20 mikrogramm bevont tabletta not available OGYI-T-6969/02 PFIZER KFT. HU Harmonet 75 mikrogramov/20 mikrogramov obložene tablete not available 5363-I-718/13 PFIZER EUROPE MA EEIG SI HARMONET 75/20 microgramos comprimidos recubiertos not available WYETH FARMA, S.A ES Harmonet 75/20 mikrogrammi kaetud tabletid not available PFIZER EUROPE MA EEIG EE Harmonet tablett, dragerad not available PFIZER OY FI EMA/719205/2016 Page 5/14

6 National Number Harmonet tabletti, päällystetty not available PFIZER OY FI HARMONET obalené tablety not available 17/058/99 C PFIZER, SPOL. S R.O. CZ Harmonet, 75 mikrogramów (μg) + 20 mikrogramów (μg), tabletki drażowane not available 4871 PFIZER EUROPE MA EEIG PL HARMONET, comprimé enrobé not available HARMONET, comprimé enrobé not available Harmonet, overtrukne tabletter not available PFIZER APS DK Harmonette Dragees 75 Mikrogramm/ 20 Mikrogramm überzogene Tabletten not available PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT Kosidina 0,075 mg/0,030 mg 21+7, tabletten NL/H/3352/002 RVG SANDOZ B.V. NL Lenisagyn - 1 A Pharma /H/0425/ A PHARMA GMBH DE Logest not available 17/530/96-C BAYER PHARMA AG CZ LOGEST 0,02 mg / 0,075 mg obložene tablete not available UP/I /12-02/369 BAYER DOO HR Logest 0,02 mg/0,075 mg obalené tablety not available 17/0179/98-S BAYER PHARMA AG SK Logest 0,02 mg/0,075 mg obložene tablete not available H/00/00937/001 BAYER PHARMA AG SI Logest 0,075 mg/0,02 mg, drajeuri not available 6335/2014/01 BAYER PHARMA AG RO Logest 75 mikrogramai / 20 mikrogramų dengtos tabletės not available LT/1/97/2779/001 BAYER PHARMA AG LT Logest 75 mikrogramu/20 mikrogramu apvalkotās not available BAYER PHARMA AG LV EMA/719205/2016 Page 6/14

7 National Number tabletes Logest, 0,075 mg + 0,02 mg, tabletki powlekane not available 4189 BAYER PHARMA AG PL Logest, 75/20 mikrogrammi kaetud tabletid not available BAYER PHARMA AG EE Lunafem not available 17/215/07-C BAYER PHARMA AG CZ Meliane - Dragees not available BAYER AUSTRIA GMBH AT Meliane 0,020 mg/0,075 mg bevont tabletta not available OGYI-T-6814/01 BAYER PHARMA AG HU Meliane 0,020 mg/0,075 mg bevont tabletta not available OGYI-T-6814/02 BAYER PHARMA AG HU Meliane 0,075 / 0,020 mg, comprimés enrobés not available BE BAYER SA NV BE Meliane 0,075 / 0,020 mg, comprimés enrobés not available BAYER SA NV LU Meliane 0,075 / 0,020 mg, omhulde tabletten not available BE BAYER SA NV BE Meliane 0,075 / 0,020 mg, überzogene Tabletten not available BE BAYER SA NV BE Meliane 0,075 / 0,020 mg, überzogene Tabletten not available BAYER SA NV LU Meliane 0,075 mg / 0,02 mg comprimidos recubiertos not available BAYER HISPANIA SL ES Meliane Diario 0,075 mg/0,02 mg comprimidos recubiertos not available BAYER HISPANIA SL ES Meliane dragerade tabletter not available BAYER OY FI Meliane päällystetty tabletit not available BAYER OY FI MELIANE, comprimé enrobénot available BAYER HEALTHCARE MELIANE, comprimé enrobénot available BAYER HEALTHCARE MELODENE-15 0,06 mg/ 0,015 mg comprimidos /H/159/ BAYER HISPANIA SL ES EMA/719205/2016 Page 7/14

8 National Number recubiertos con película MELODIA 60 microgrammes / 15 microgrammes, comprimé pelliculé /H/159/ BAYER HEALTHCARE MELODIA 60 microgrammes / 15 microgrammes, comprimé pelliculé /H/159/ BAYER HEALTHCARE MICROGESTE 60 microgramas/15 microgramas comprimido revestido por película /H/0159/ BAYER PORTUGAL LDA PT MICROGESTE 60 microgramas/15 microgramas comprimido revestido por película /H/0159/ BAYER PORTUGAL LDA PT Milvane compresse rivestite not available BAYER SPA IT Milvane, 0,05 mg + 0,03 mg; 0,07 mg + 0,04 mg; 0,10 mg + 0,03 mg, tabletki powlekane not available 4340 BAYER PHARMA AG PL MINESSE 0,06 mg/0,015 mg comprimidos recubiertos con película /H/0158/ WYETH FARMA, S.A ES MINESSE 15 Mikrogramm/60 Mikrogramm Filmtabletten /H/0158/ PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT microgramas/15 microgramas comprimido revestido por película /H/0158/ LABORATÓRIOS PFIZER, LDA. PT microgramas/15 microgramas comprimido /H/0158/ LABORATÓRIOS PFIZER, LDA. PT EMA/719205/2016 Page 8/14

9 National Number revestido por película microgramas/15 microgramas comprimido revestido por película /H/0158/ LABORATÓRIOS PFIZER, LDA. PT microgrammes/15 microgrammes, comprimé pelliculé /H/0158/ microgrammes/15 microgrammes, comprimé pelliculé /H/0158/ microgrammi/15 microgrammi compresse rivestite con film /H/0158/ PFIZER ITALIA S.R.L. IT microgrammi/15 microgrammi compresse rivestite con film /H/0158/ PFIZER ITALIA S.R.L. IT microgrammi/15 microgrammi compresse rivestite con film /H/0158/ PFIZER ITALIA S.R.L. IT micrograms / 15 micrograms film-coated tablet /H/0158/001 PA 0822/144/001 PFIZER HEALTHCARE IRELAND IE micrograms / 15 micrograms film-coated tablet not available MA505/06301 PFIZER HELLAS, A.E. MT MINESSE potahované tablety not available 17/123/00-C PFIZER, SPOL. S R.O. CZ Minigeste, 0,02 mg + 0,075 mg, comprimido not available BAYER PORTUGAL LDA PT EMA/719205/2016 Page 9/14

10 National Number revestido Minigeste, 0,02 mg + 0,075 mg, comprimido revestido not available BAYER PORTUGAL LDA PT Minulet - Dragees 75 Mikrogramm/ 30 Mikrogramm überzogene Tabletten not available PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT Minulet 0,03 mg + 0,075 mg comprimido revestido not available LABORATÓRIOS PFIZER, LDA. PT Minulet 0,03 mg + 0,075 mg comprimido revestido not available LABORATÓRIOS PFIZER, LDA. PT Minulet 0,03 mg + 0,075 mg comprimido revestido not available LABORATÓRIOS PFIZER, LDA. PT MINULET 0,075 mg + 0,03mg compresse rivestite not available PFIZER ITALIA S.R.L. IT Minulet 0,075 mg/0,030 mg comprimés enrobés not available BE PFIZER S.A. (BELGIUM) BE Minulet 0,075 mg/0,030 mg omhulde tabletten not available BE PFIZER S.A. (BELGIUM) BE Minulet 0,075 mg/0,030 mg Überzogene Tabletten not available BE PFIZER S.A. (BELGIUM) BE Minulet 75 micrograms/30 micrograms Coated Tablets not available PA 0822/093/001 PFIZER HEALTHCARE IRELAND IE Minulet 75 mikrogramm/30 mikrogramm bevont tabletta not available OGYI-T-2382/02 PFIZER KFT. HU Minulet 75 mikrogramov/30 mikrogramov obložene tablete not available 5363-I-471/12 PFIZER EUROPE MA EEIG SI MINULET 75/30 microgramos comprimidos recubiertos not available WYETH FARMA, S.A ES MINULET obalené tablety not available 17/200/89 C PFIZER, SPOL. S R.O. CZ Minulet tablett, dragerad not available 9971 PFIZER OY FI EMA/719205/2016 Page 10/14

11 National Number Minulet tabletti, päällystetty not available 9971 PFIZER OY FI MINULET, comprimé enrobé not available MINULET, comprimé enrobé not available Minulet, dragees not available RVG PFIZER B.V. NL Minulet, overtrukne tabletter not available PFIZER APS DK Mirelle 0,06 mg/0,015 mg filmom obalené tablety not available 17/0322/00-S BAYER PHARMA AG SK Mirelle 15 Mikrogramm/60 Mikrogramm Filmtabletten /H/159/ BAYER AUSTRIA GMBH AT Mirelle 60 / 15 mikrogramų plėvele dengtos tabletės not available LT/1/01/2826/001 BAYER PHARMA AG LT Mirelle 60 microgram / 15 microgram, filmomhulde tablet /H/159/01 BE BAYER SA NV BE Mirelle 60 microgrammes / 15 microgrammes, comprimé pelliculé /H/159/01 BE BAYER SA NV BE Mirelle 60 microgrammes / 15 microgrammes, comprimé pelliculé /H/159/ BAYER SA NV LU MIRELLE 60 mikrogram/15 mikrogram, filmdragerade tabletter /H/159/ BAYER OY FI Mirelle 60 Mikrogramm/15 Mikrogramm, Filmtabletten /H/159/01 BE BAYER SA NV BE Mirelle 60 Mikrogramm/15 Mikrogramm, Filmtabletten /H/159/ BAYER SA NV LU Mirelle 60/15 mikrogrammi õhukese polümeerikattega tabletid not available BAYER PHARMA AG EE EMA/719205/2016 Page 11/14

12 National Number Mirelle 60/15 mikrogramu apvalkotās tabletes not available BAYER PHARMA AG LV Mirelle 60 mikrog / 15 mikrog, kalvopäällysteiset tabletit /H/159/ BAYER OY FI MONEVA, comprimé enrobé not available BAYER HEALTHCARE MONEVA, comprimé enrobé not available BAYER HEALTHCARE OPTINESSE 75 microgrammes/20 microgrammes, comprimé enrobé not available NL LABORATOIRES MAJORELLE OPTINESSE 75 microgrammes/30 microgrammes, comprimé enrobé not available NL LABORATOIRES MAJORELLE PHAEVA, comprimé enrobé not available BAYER HEALTHCARE PHAEVA, comprimé enrobé not available BAYER HEALTHCARE SYLVIANE, comprimé pelliculé not available BAYER HEALTHCARE SYLVIANE, comprimé pelliculé not available BAYER HEALTHCARE TRI MINULET, comprimé enrobé not available TRI MINULET, comprimé enrobé not available TRI MINULET, comprimé enrobé not available TRI MINULET, comprimé enrobé not available TRIADENE not available PL 00010/0563 BAYER PLC UK Tri-Femoden dragerade tabletter not available BAYER OY FI Tri-FemodenÒ päällystetyt tabletit not available BAYER OY FI EMA/719205/2016 Page 12/14

13 National Number Tri-Gynera, (0,03 mg + 0,05 mg) + (0,04 mg + 0,07 mg) + (0,03 mg + 0,10 mg), comprimidos revestidos not available BAYER PORTUGAL LDA PT Tri-Gynera, (0,03 mg + 0,05 mg) + (0,04 mg + 0,07 mg) + (0,03 mg + 0,10 mg), comprimidos revestidos not available BAYER PORTUGAL LDA PT Trigynovin comprimidos recubiertos not available BAYER HISPANIA SL ES Tri-Minulet (0,03 mg + 0,05 mg) + (0,04 mg + 0,07 mg) + (0,03 mg + 0,1 mg) comprimidos revestidos not available LABORATÓRIOS PFIZER, LDA. PT Tri-Minulet (0,03 mg + 0,05 mg) + (0,04 mg + 0,07 mg) + (0,03 mg + 0,1 mg) comprimidos revestidos not available LABORATÓRIOS PFIZER, LDA. PT Tri-Minulet Coated* Tablets not available PA 822/099/001 PFIZER HEALTHCARE IRELAND IE TRIMINULET compresse rivestite not available PFIZER ITALIA S.R.L. IT Tri-Minulet comprimés enrobés not available BE PFIZER S.A. (BELGIUM) BE TRI-MINULET comprimidos recubiertos not available WYETH FARMA, S.A ES Tri-Minulet omhulde tabletten not available BE PFIZER S.A. (BELGIUM) BE Tri-Minulet Überzogene Tabletten not available BE PFIZER S.A. (BELGIUM) BE Triodena - Dragees not available BAYER AUSTRIA GMBH AT Triodena bevont tabletta not available OGYI-T-5465/02 BAYER PHARMA AG HU EMA/719205/2016 Page 13/14

14 National Number Triodena bevont tabletta not available OGYI-T-5465/01 BAYER PHARMA AG HU Triodene, comprimés enrobés not available BE BAYER SA NV BE Triodene, comprimés enrobés not available 0442/ BAYER SA NV LU Triodene, omhulde tabletten not available BE BAYER SA NV BE Triodene, überzogene Tabletten not available BE BAYER SA NV BE Triodene, überzogene Tabletten not available 0442/ BAYER SA NV LU Yaluvea 0,06 mg / 0,015 mg Filmtabletten NL/H/1901/ HORMOSAN PHARMA GMBH DE Логест 0,02 mg/0,075 mg обвити таблетки not available BAYER PHARMA AG BG Фемоден 0,03 mg/0,075 mg обвити таблетки not available BAYER PHARMA AG BG EMA/719205/2016 Page 14/14