List of nationally authorised medicinal products
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1 17 March 2016 EMA/346191/2016 Procedure Management and Committees Support Active substance: ethinylestradiol / gestodene (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 provided the source is acknowledged.
2 apleek 60 mikrog/24 tuntia + 13 mikrog/24 tuntia depotlaastari FR/H/0547/ BAYER OY FI apleek 60 mikrog/24 timmar + 13 mikrog/24 timmar depotplåster FR/H/0547/ BAYER OY FI EILEEN 60 mikrogrammi/13 FR/H/0547/ BAYER PHARMA AG EE mikrogrammi/24 tunnis transdermaalne plaaster apleek 60 micrograms/24 hours + FR/H/0547/001/DC PL 04854/0145 GEDEON RICHTER PLC UK 13 micrograms/24 hours Apleek FR/H/0547/001/DC BAYER AB DK apleek 60 microgram/24 uur + 13 microgram/24 uur pleister voor transdermaal gebruik apleek 60 míkrógrömm/24 klst míkrógrömm /24 klst. forðaplástur Eileen 60 mikrogramų/ 13 mikrogramų/ 24 val. transderminis pleistras apleek 60 micrograms/24 hours + 13 micrograms/24 hours Eileen 60 mikrogramų/ 13 mikrogramų/ 24 val. transderminis pleistras FR/H/0547/001 RVG BAYER BV NL FR/H/0547/001/DC IS/1/14/023/01 BAYER AB IS FR/H/0547/001/DC LT/1/14/3535/001 BAYER PHARMA AG LT FR/H/0547/001/DC PA1410/69/1 BAYER LTD IE FR/H/0547/001/DC LT/1/14/3535/002 BAYER PHARMA AG LT EMA/346191/2016 Page 2/6
3 Eileen 60 mikrogramų/ 13 mikrogramų/ 24 val. transderminis pleistras apleek 60 Mikrogramm/24 Stunden + 13 Mikrogramm/24 Stunden Transdermales Pflaster Eileen 60 mikrogrami/13 mikrogrami/24 stundās transdermāls plāksteris apleek 60 mikrogramov/24 hodín + 13 mikrogramov/24 hodín transdermálna náplasť apleek 60 Mikrogramm/24 Stunden + 13 Mikrogramm/24 Stunden transdermales Pflaster apleek 0,06 mg/0,013 mg cada 24 horas parche transdérmico FR/H/0547/001/DC LT/1/14/3535/003 BAYER PHARMA AG LT FR/H/0547/001/DC BAYER AUSTRIA GMBH AT FR/H/0547/ Gedeon Richter Plc. LV FR/H/0547/001 17/0143/14-S BAYER SPOL SRO SK FR/H/0547/001/DC JENAPHARM GMBH & CO KG DE FR/H/0547/ BAYER HISPANIA SL ES аплийк 60 микрограма/24 часа + 13 микрограма/24 часа трансдермален пластир apleek 60 micrograme/24 ore + 13 micrograme/24 ore plasture transdermic apleek 60 microgramms/24 hours + 13 microgramms/24 hours FR/H/0547/ BAYER PHARMA AG BG FR/H/0547/001/DC 6542/2014/ BAYER PHARMA AG RO FR/H/0547/001/DC 5363-I-640/14 BAYER D.O.O SI EMA/346191/2016 Page 3/6
4 apleek 60 micrograms/24 hours + 13 micrograms/24 hours apleek 60 μικρογραμμάρια/24 ώρες + 13 μικρογραμμάρια/24 ώρες διαδερμικό έμπλαστρο heures, dispositif transdermique Lisvy 60 mikrogramů/24 hodin + 13 mikrogramů/24 hodin transdermální náplast apleek 60 μικρογραμμάρια/24 ώρες + 13 μικρογραμμάρια/24 ώρες διαδερμικό έμπλαστρο heures, dispositif transdermique heures, dispositif transdermique apleek 60 Mikrogramm/24 Stunden + 13 Mikrogram/24 transdermales Pflaster heures dispositif transdermique FR/H/0547/001 MA513/04901 BAYER PLC MT FR/H/0547/ BAYER HELLAS SA CY FR/H/0547/001/DC BAYER HEALTHCARE FR FR/H/0547/001/DC 17/129/14-C Gedeon Richter Plc CZ FR/H/0547/001/DC 73711/ BAYER HELLAS SA GR FR/H/0547/001/DC BAYER HEALTHCARE FR FR/H/0547/001/DC BAYER HEALTHCARE FR FR/H/0547/ BAYER SA NV LU FR/H/0547/ BAYER SA NV LU EMA/346191/2016 Page 4/6
5 apleek 60 mikrogramm/24 óra és 13 mikrogramm/24 óra transzdermális tapasz apleek 60 mikrogramm/24 óra és 13 mikrogramm/24 óra transzdermális tapasz apleek 60 mikrogramm/24 óra és 13 mikrogramm/24 óra transzdermális tapasz apleek 60 mikrogramów/24 godziny + 13 mikrogramów/24 godziny system transdermalny plaster Apleek 60 microgramas/24 horas + 13 microgramas/24 horas adesivo transdérmico Apleek 60 microgramas/24 horas + 13 microgramas/24 horas adesivo transdérmico Apleek 60 microgramas/24 horas + 13 microgramas/24 horas adesivo transdérmico Enciela 60 microgrammi/24 ore + 13 microgrammi/24 ore cerotto transdermico Enciela 60 microgrammi/24 ore + 13 microgrammi/24 ore cerotto transdermico FR/H/0547/001/DC OGYI-T-22643/01 BAYER PHARMA AG HU FR/H/0547/001/DC OGYI-T-22643/03 BAYER PHARMA AG HU FR/H/0547/001/DC OGYI-T-22643/02 BAYER PHARMA AG HU FR/H/0547/001/DC BAYER PHARMA AG PL FR/H/0547/001/DC BERLEX ESPECIALIDADES FARMACEUTICAS LDA FR/H/0547/001/DC BERLEX ESPECIALIDADES FARMACEUTICAS LDA FR/H/0547/001/DC BERLEX ESPECIALIDADES FARMACEUTICAS LDA FR/H/0547/001/DC BAYER SPA IT FR/H/0547/001/DC BAYER SPA IT PT PT PT EMA/346191/2016 Page 5/6
6 Enciela 60 microgrammi/24 ore + FR/H/0547/001/DC BAYER SPA IT 13 microgrammi/24 ore cerotto transdermico Apleek FR/H/0547/001/DC BE BAYER SA NV BE EMA/346191/2016 Page 6/6
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