11 October 2017 EMA/757865/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: ethinylestradiol / gestodene (transdermal application)

Procedure no.: PSUSA/00010145/201702

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, 2017. Reproduction is authorised provided the source is acknowledged.

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in

Member State where

country)

number

Number

the member state

product is authorised

apleek 60 μικρογραμμάρια/24 ώρες +

FR/H/0547/001

22062

BAYER HELLAS SA

CY

FR/H/0547/001

OGYI-T-22643/01

GEDEON RICHTER

HU

13 μικρογραμμάρια/24 ώρες διαδερμικό έμπλαστρο Lisvy 60 mikrogramm/24 óra és 13 mikrogramm/24 óra transzdermális

PLC.

tapasz Lisvy 60 mikrogramm/24 óra és 13

FR/H/0547/001

OGYI-T-22643/02

mikrogramm/24 óra transzdermális

GEDEON RICHTER

HU

PLC.

tapasz Lisvy 60 mikrogramm/24 óra és 13

FR/H/0547/001

OGYI-T-22643/03

mikrogramm/24 óra transzdermális

GEDEON RICHTER

HU

PLC.

tapasz Lisvy 60 Mikrogramm/24 Stunden +

FR/H/0547/001

88394.00.00

13 Mikrogramm/24 Stunden

GEDEON RICHTER

DE

PLC.

transdermales Pflaster Lisvy 60 mikrogramů/24 hodin + 13

FR/H/0547/001

17/129/14-C

mikrogramů/24 hodin transdermální

GEDEON RICHTER

CZ

PLC.

náplast Lisvy 60 Mikrogramm/24 Stunden +

FR/H/0547/001

1-35535

13 Mikrogramm/24 Stunden

GEDEON RICHTER

AT

PLC.

transdermales Pflaster Lisvy 60 micrograme/24 ore + 13

FR/H/0547/001

6542/2014/01

micrograme/24 ore, plasture

GEDEON RICHTER

RO

PLC.

transdermic Lisvy 60 micrograme/24 ore + 13

FR/H/0547/001

6542/2014/02

micrograme/24 ore, plasture

GEDEON RICHTER

RO

PLC.

transdermic Lisvy 60 micrograme/24 ore + 13 micrograme/24 ore, plasture

FR/H/0547/001

6542/2014/03

GEDEON RICHTER

RO

PLC.

transdermic List of nationally authorised medicinal products EMA/695016/2017

Page 2/6

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in

Member State where

country)

number

Number

the member state

product is authorised

Lisvy 60 microgramas/24 horas + 13

FR/H/0547/001

5635446

GEDEON RICHTER

PT

microgramas/24 horas adesivo

PLC.

transdérmico Lisvy 60 microgramas/24 horas + 13

FR/H/0547/001

5635453

microgramas/24 horas adesivo

GEDEON RICHTER

PT

PLC.

transdérmico Lisvy 60 microgramas/24 horas + 13

FR/H/0547/001

5638440

microgramas/24 horas adesivo

GEDEON RICHTER

PT

PLC.

transdérmico Lisvy 60 míkrógrömm/24 klst. + 13

FR/H/0547/001

IS/1/14/023/01

míkrógrömm /24 klst. forðaplástur Lisvy 60 mikrogramov/24 hodín + 13

GEDEON RICHTER

IS

PLC. FR/H/0547/001

17/0143/14-S

mikrogramov/24 hodín transdermálna

GEDEON RICHTER

SK

PLC.

náplasť Eileen 60 mikrogrammi/13

FR/H/0547/001

839514

mikrogrammi/24 tunnis

GEDEON RICHTER

EE

PLC.

transdermaalne plaaster Enciela 60 microgrammi/24 ore + 13

FR/H/0547/001

042423018

microgrammi/24 ore cerotto

GEDEON RICHTER

IT

PLC.

transdermico Enciela 60 microgrammi/24 ore + 13

FR/H/0547/001

042423020

microgrammi/24 ore cerotto

GEDEON RICHTER

IT

PLC.

transdermico Enciela 60 microgrammi/24 ore + 13

FR/H/0547/001

042423032

microgrammi/24 ore cerotto

GEDEON RICHTER

IT

PLC.

transdermico Eileen 60 mikrogramų/ 13 mikrogramų/ 24 val. transderminis

FR/H/0547/001

LT/1/14/3535/001

GEDEON RICHTER

LT

PLC.

pleistras

List of nationally authorised medicinal products EMA/695016/2017

Page 3/6

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in

Member State where

country)

number

Number

the member state

product is authorised

Eileen 60 mikrogramų/ 13

FR/H/0547/001

LT/1/14/3535/002

GEDEON RICHTER

LT

mikrogramų/ 24 val. transderminis

PLC.

pleistras Eileen 60 mikrogramų/ 13

FR/H/0547/001

LT/1/14/3535/003

mikrogramų/ 24 val. transderminis

GEDEON RICHTER

LT

PLC.

pleistras Lisvy 60 micrograms/24 hours + 13

FR/H/0547/001

PA1330/019/001

micrograms/24 hours transdermal

GEDEON RICHTER

IE

PLC.

patch Lisvy 60 mikrogramów/24 godziny +

FR/H/0547/001

22229

13 mikrogramów/24 godziny system

GEDEON RICHTER

PL

PLC.

transdermalny plaster Lisvy 60 microgram/24 uur + 13

FR/H/0547/001

BE452302

microgram/24 uur pleister voor

GEDEON RICHTER

BE

PLC.

transdermaal gebruik Lisvy 60 microgrammes/24 heures +

FR/H/0547/001

BE452302

13 microgrammes/24 heures dispositif

GEDEON RICHTER

BE

PLC.

transdermique Lisvy® 60 Mikrogramm/24 Stunden +

FR/H/0547/001

BE452302

13 Mikrogram/24 Stunden

GEDEON RICHTER

BE

PLC.

transdermales Pflaster Lisvy 60 mikrog/24 tuntia + 13

FR/H/0547/001

31074

mikrog/24 tuntia depotlaastari Lisvy 60 mikrog/24 timmar + 13

13 microgrammes/24 heures, dispositif

FI

PLC. FR/H/0547/001

31074

mikrog/24 timmar depotplåster Lisvy 60 microgrammes/24 heures +

GEDEON RICHTER GEDEON RICHTER

FI

PLC. FR/H/0547/001

278 845-2

GEDEON RICHTER

FR

PLC.

transdermique

List of nationally authorised medicinal products EMA/695016/2017

Page 4/6

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in

Member State where

country)

number

Number

the member state

product is authorised

Lisvy 60 microgrammes/24 heures +

FR/H/0547/001

278 846-9

GEDEON RICHTER

FR

13 microgrammes/24 heures, dispositif

PLC.

transdermique Lisvy 60 microgrammes/24 heures +

FR/H/0547/001

586 743-6

13 microgrammes/24 heures, dispositif

GEDEON RICHTER

FR

PLC.

transdermique Eileen 60 mikrogrami/13

FR/H/0547/001

14-0115

mikrogrami/24 stundās transdermāls

GEDEON RICHTER

LV

PLC.

plāksteris Lisvy 0,06 mg/0,013 mg cada 24 horas

FR/H/0547/001

79138

parche transdérmico Lisvy 60 mikrogramov/24 ur + 13

FR/H/0547/001

H/14/00204/001

FR/H/0547/001

H/14/00204/002

SI

GEDEON RICHTER

SI

PLC. FR/H/0547/001

H/14/00204/003

mikrogramov/24 ur transdermalni obliž Lisvy 60 microgrammes/24 heures +

GEDEON RICHTER PLC.

mikrogramov/24 ur transdermalni obliž Lisvy 60 mikrogramov/24 ur + 13

ES

PLC.

mikrogramov/24 ur transdermalni obliž Lisvy 60 mikrogramov/24 ur + 13

GEDEON RICHTER

GEDEON RICHTER

SI

PLC. FR/H/0547/001

2014060099

13 microgrammes/24 heures dispositif

GEDEON RICHTER

LU

PLC.

transdermique Lisvy

FR/H/0547/001

51611

GEDEON RICHTER

DK

PLC. Lisvy 60 micrograms/24 hours + 13

FR/H/0547/001

20140147

micrograms/24 hours transdermal

GEDEON RICHTER

BG

PLC.

patch Lisvy 60 microgram/24 uur + 13 microgram/24 uur pleister voor

FR/H/0547/001

RVG 112679

GEDEON RICHTER

NL

PLC.

transdermaal gebruik

List of nationally authorised medicinal products EMA/695016/2017

Page 5/6

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in

Member State where

country)

number

Number

the member state

product is authorised

Lisvy 60 micrograms/24 hours + 13

FR/H/0547/001

MA1031/00201

GEDEON RICHTER

MT

micrograms/24 hours transdermal

PLC.

patch Lisvy 60 micrograms/24 hours + 13

FR/H/0547/001

PL 04854/0145

micrograms/24 hours transdermal

GEDEON RICHTER

UK

PLC.

patch Lisvy 60 μικρογραμμάρια/24 ώρες + 13 μικρογραμμάρια/24 ώρες διαδερμικό

FR/H/0547/001

73711

GEDEON RICHTER

GR

PLC.

έμπλαστρο

List of nationally authorised medicinal products EMA/695016/2017

Page 6/6

(transdermal application) PSUSA 00010145 201702 - European ...

Oct 11, 2017 - Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525. Send a question via our website www.ema.europa.eu/contact. © European ...
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