List of nationally authorised medicinal products

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1 11 October 2017 EMA/757865/2017 Human Medicines Evaluation Division 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 authorised provided the source is acknowledged.

2 apleek 60 μικρογραμμάρια/24 ώρες + 13 μικρογραμμάρια/24 ώρες διαδερμικό έμπλαστρο Lisvy 60 mikrogramm/24 óra és 13 mikrogramm/24 óra transzdermális tapasz Lisvy 60 mikrogramm/24 óra és 13 mikrogramm/24 óra transzdermális tapasz Lisvy 60 mikrogramm/24 óra és 13 mikrogramm/24 óra transzdermális tapasz Lisvy 60 Mikrogramm/24 Stunden + 13 Mikrogramm/24 Stunden transdermales Pflaster Lisvy 60 mikrogramů/24 hodin + 13 mikrogramů/24 hodin transdermální náplast Lisvy 60 Mikrogramm/24 Stunden + 13 Mikrogramm/24 Stunden transdermales Pflaster Lisvy 60 micrograme/24 ore + 13 micrograme/24 ore, plasture transdermic Lisvy 60 micrograme/24 ore + 13 micrograme/24 ore, plasture transdermic Lisvy 60 micrograme/24 ore + 13 micrograme/24 ore, plasture transdermic FR/H/0547/ BAYER HELLAS SA CY FR/H/0547/001 OGYI-T-22643/01 GEDEON RICHTER HU FR/H/0547/001 OGYI-T-22643/02 GEDEON RICHTER HU FR/H/0547/001 OGYI-T-22643/03 GEDEON RICHTER HU FR/H/0547/ GEDEON RICHTER DE FR/H/0547/001 17/129/14-C GEDEON RICHTER CZ FR/H/0547/ GEDEON RICHTER AT FR/H/0547/ /2014/01 GEDEON RICHTER RO FR/H/0547/ /2014/02 GEDEON RICHTER RO FR/H/0547/ /2014/03 GEDEON RICHTER RO EMA/695016/2017 Page 2/6

3 Lisvy 60 microgramas/24 horas + 13 microgramas/24 horas adesivo transdérmico Lisvy 60 microgramas/24 horas + 13 microgramas/24 horas adesivo transdérmico Lisvy 60 microgramas/24 horas + 13 microgramas/24 horas adesivo transdérmico Lisvy 60 míkrógrömm/24 klst míkrógrömm /24 klst. forðaplástur Lisvy 60 mikrogramov/24 hodín + 13 mikrogramov/24 hodín transdermálna náplasť Eileen 60 mikrogrammi/13 mikrogrammi/24 tunnis transdermaalne plaaster Enciela 60 microgrammi/24 ore + 13 microgrammi/24 ore cerotto transdermico Enciela 60 microgrammi/24 ore + 13 microgrammi/24 ore cerotto transdermico Enciela 60 microgrammi/24 ore + 13 microgrammi/24 ore cerotto transdermico Eileen 60 mikrogramų/ 13 mikrogramų/ 24 val. transderminis pleistras FR/H/0547/ GEDEON RICHTER FR/H/0547/ GEDEON RICHTER FR/H/0547/ GEDEON RICHTER FR/H/0547/001 IS/1/14/023/01 GEDEON RICHTER FR/H/0547/001 17/0143/14-S GEDEON RICHTER FR/H/0547/ GEDEON RICHTER FR/H/0547/ GEDEON RICHTER FR/H/0547/ GEDEON RICHTER FR/H/0547/ GEDEON RICHTER FR/H/0547/001 LT/1/14/3535/001 GEDEON RICHTER PT PT PT IS SK EE IT IT IT LT EMA/695016/2017 Page 3/6

4 Eileen 60 mikrogramų/ 13 mikrogramų/ 24 val. transderminis pleistras Eileen 60 mikrogramų/ 13 mikrogramų/ 24 val. transderminis pleistras Lisvy 60 micrograms/24 hours + 13 Lisvy 60 mikrogramów/24 godziny + 13 mikrogramów/24 godziny system transdermalny plaster Lisvy 60 microgram/24 uur + 13 microgram/24 uur pleister voor transdermaal gebruik Lisvy 60 microgrammes/24 heures + 13 microgrammes/24 heures dispositif Lisvy 60 Mikrogramm/24 Stunden + 13 Mikrogram/24 Stunden transdermales Pflaster Lisvy 60 mikrog/24 tuntia + 13 mikrog/24 tuntia depotlaastari Lisvy 60 mikrog/24 timmar + 13 mikrog/24 timmar depotplåster Lisvy 60 microgrammes/24 heures + 13 microgrammes/24 heures, dispositif FR/H/0547/001 LT/1/14/3535/002 GEDEON RICHTER FR/H/0547/001 LT/1/14/3535/003 GEDEON RICHTER FR/H/0547/001 PA1330/019/001 GEDEON RICHTER FR/H/0547/ GEDEON RICHTER FR/H/0547/001 BE GEDEON RICHTER FR/H/0547/001 BE GEDEON RICHTER FR/H/0547/001 BE GEDEON RICHTER FR/H/0547/ GEDEON RICHTER FR/H/0547/ GEDEON RICHTER FR/H/0547/ GEDEON RICHTER LT LT IE PL BE BE BE FI FI FR EMA/695016/2017 Page 4/6

5 Lisvy 60 microgrammes/24 heures + 13 microgrammes/24 heures, dispositif FR/H/0547/ GEDEON RICHTER Lisvy 60 microgrammes/24 heures + FR/H/0547/ GEDEON RICHTER 13 microgrammes/24 heures, dispositif Eileen 60 mikrogrami/13 FR/H/0547/ GEDEON RICHTER mikrogrami/24 stundās transdermāls plāksteris Lisvy 0,06 mg/0,013 mg cada 24 horas FR/H/0547/ GEDEON RICHTER parche transdérmico Lisvy 60 mikrogramov/24 ur + 13 FR/H/0547/001 H/14/00204/001 GEDEON RICHTER mikrogramov/24 ur transdermalni obliž Lisvy 60 mikrogramov/24 ur + 13 FR/H/0547/001 H/14/00204/002 GEDEON RICHTER mikrogramov/24 ur transdermalni obliž Lisvy 60 mikrogramov/24 ur + 13 FR/H/0547/001 H/14/00204/003 GEDEON RICHTER mikrogramov/24 ur transdermalni obliž Lisvy 60 microgrammes/24 heures + FR/H/0547/ GEDEON RICHTER 13 microgrammes/24 heures dispositif Lisvy FR/H/0547/ GEDEON RICHTER Lisvy 60 micrograms/24 hours + 13 FR/H/0547/ GEDEON RICHTER Lisvy 60 microgram/24 uur + 13 FR/H/0547/001 RVG GEDEON RICHTER microgram/24 uur pleister voor transdermaal gebruik FR FR LV ES SI SI SI LU DK BG NL EMA/695016/2017 Page 5/6

6 Lisvy 60 micrograms/24 hours + 13 Lisvy 60 micrograms/24 hours + 13 Lisvy 60 μικρογραμμάρια/24 ώρες + 13 μικρογραμμάρια/24 ώρες διαδερμικό έμπλαστρο FR/H/0547/001 MA1031/00201 GEDEON RICHTER FR/H/0547/001 PL 04854/0145 GEDEON RICHTER FR/H/0547/ GEDEON RICHTER MT UK GR EMA/695016/2017 Page 6/6

List of nationally authorised medicinal products

List of nationally authorised medicinal products 12 April 2018 EMA/235952/2018 Human Medicines Evaluation Division Active substance: ethinylestradiol / gestodene (transdermal application) Procedure no.: PSUSA/00010145/201708 30 Churchill Place Canary

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