05 May 2017 EMA/382258/2015 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance(s): drospirenone / ethinylestradiol

Procedure No.: PSUSA/00010217/201609

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Product full name (in authorisation country)

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

aida® 0,020 mg/3,0 mg Filmtabletten Aliane 0,02 mg/3 mg Filmtabletten Aliane 3 mg + 0,02 mg comprimidos revestidos por película Aliane 3 mg + 0,02 mg comprimidos revestidos por película Belanette 0,02 mg/3 mg potahované tablety BELANETTE 0,02 mg/3 mg, comprimé pelliculé BELANETTE 0,02 mg/3 mg, comprimé pelliculé Belanette 28, filmomhulde tabletten, 0,02 mg/3 mg Belanette, filmomhulde tabletten, 0,02 mg/3 mg CLEODETTE 0,02 MG/3 MG, POTAHOVANÉ TABLETY CLEODETTE 0,02 MG/3 MGFILMOM OBALENÉ TABLETY Cleodette 0,03mg/3mg plevele dengtos tabletes Cleonita 3 mg/0,02 mg comprimate filmate CONVULINE 0,03 mg / 3 mg, comprimé pelliculé CONVULINE 0,03 mg/3 mg, comprimé pelliculé Diza 0,02 mg / 3 mg kalvopäällysteiset tabletit Diza 0,02 mg/3 mg filmdrasjerte tabletter Diza 0,02 mg/3 mg, filmdragerade tabletter Drosbelalleflex 3 mg /0,02 mg comprimidos recubiertos con película Drosiane 0,03 mg/3 mg 21+7 Filmtabletten

NL/H/0703/001 NL/H/0702/001 NL/H/0702/001

64270.00.00 1-26450 5866389

JENAPHARM GMBH & CO KG BAYER AUSTRIA GMBH LUSAL LDA

Member State where product is authorised DE AT PT

NL/H/0702/001

5866488

LUSAL LDA

PT

NL/H/0702/001

17/197/06-C

BAYER PHARMA AG

CZ

NL/H/0702/001

376 418-1

BAYER HEALTHCARE

FR

NL/H/0702/001

376 419-8

BAYER HEALTHCARE

FR

NL/H/705/01

RVG 33189

BAYER BV

NL

NL/H/0702/001

RVG 33186

BAYER BV

NL

PT/H/0707/001

17/012/14-C

ACTAVIS GROUP PTC EHF.

CZ

PT/H/0707/001

17/0066/14-S

ACTAVIS GROUP PTC EHF.

SK

PT/H/0707/002

LT/1/14/3490/006-010

ACTAVIS GROUP PTC EHF.

LT

PT/H/0707/001

6468/2014/01-05

ACTAVIS GROUP PTC EHF.

RO

NL/H/0218/001

356 169-6

BAYER HEALTHCARE

FR

NL/H/0218/01

356 170-4

BAYER HEALTHCARE

FR

NL/H/2917/001

33348

EXELTIS HEALTHCARE S.L

FI

NL/H/2917/001

15/04368

EXELTIS HEALTHCARE S.L

NO

NL/H/2917/001

52853

EXELTIS HEALTHCARE S.L

SE

NL/H/2917/001

80604

EXELTIS HEALTHCARE S.L

ES

NO/H/0146/002

1-28931

SANDOZ GMBH

AT

List of nationally authorised medicinal products EMA/382258/2015

Page 2/13

Product full name (in authorisation country)

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

Drosiane mite 0,02 mg/3 mg 21+7 Filmtabletten Eloine 0,02 mg/ 3 mg, filmuhúðaðar töflur Eloine 0,02 mg/3 mg Filmtabletten Eloine 0,02 mg/3 mg potahované tablety Eloine 0,02 mg/3 mg, filmdragerade tabletter Eloine 0.02 mg / 3 mg film coated tablets ELOINE 0.02 mg / 3 mg film coated tablets Eloine 3 mg / 0,02 mg comprimidos recubiertos con película Eloine, filmovertrukne tabletter Ethinylestradiol / Drospirenon 0,03 mg / 3 mg Berlipharm, filmomhulde tabletten Ethinylestradiol/Drospirenon 24+4 0,02 mg/3 mg Berlipharm filmomhulde tabletten ÉTHINYLESTRADIOL/DROSPIRÉNONE BIOGARAN® 0,02 mg/3 mg, comprimé pelliculé ÉTHINYLESTRADIOL/DROSPIRÉNONE BIOGARAN® 0,02 mg/3 mg, comprimé pelliculé ÉTHINYLESTRADIOL/DROSPIRÉNONE BIOGARANcontinu® 0,02 mg/3 mg, comprimé pelliculé ÉTHINYLESTRADIOL/DROSPIRÉNONE BIOGARANcontinu® 0,02 mg/3 mg, comprimé pelliculé Flexyess 3 mg + 0,02 mg comprimidos revestidos por película

NO/H/0146/001

1-28929

SANDOZ GMBH

Member State where product is authorised AT

NL/H/1270/01

IS/1/08/021/01

BAYER AB

IS

NL/H/1270/001 NL/H/1270/01

1-27587 17/315/ 08-C

BAYER AUSTRIA GMBH BAYER PHARMA AG

AT CZ

NL/H/1270/01

26273

BAYER AB

SE

NL/H/1270/01

MA513/01301

BAYER PLC

MT

NL/H/1270/01

PL 00010/0575

BAYER PLC

UK

NL/H/1270/01

70233

BAYER HISPANIA SL

ES

NL/H/1270/01 NL/H/0218/001

42444 RVG 25414

BAYER AB BERLIPHARM BV

DK NL

NL/H/1270/001

RVG 100827

BERLIPHARM BV

NL

not available

3400949972142

BIOGARAN

FR

not available

3400949972081

BIOGARAN

FR

not available

3400949972951

BIOGARAN

FR

not available

3400949973033

BIOGARAN

FR

NL/H/2041/001

5559109

BERLEX ESPECIALIDADES FARMACEUTICAS LDA

PT

List of nationally authorised medicinal products EMA/382258/2015

Page 3/13

Product full name (in authorisation country)

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

Flexyess 3 mg + 0,02 mg comprimidos revestidos por película Flexyess 3 mg + 0,02 mg comprimidos revestidos por película Jangee Flexibilis 3 mg/0,02 mg filmtabletta JASMINE 0,03 mg/3 mg, comprimé pelliculé JASMINE 0,03 mg/3 mg, comprimé pelliculé JASMINELLE 0,02 mg/3 mg, comprimé pelliculé JASMINELLE 0,02 mg/3 mg, comprimé pelliculé JASMINELLECONTINU 0,02 mg/3 mg, comprimé pelliculé JASMINELLECONTINU 0,02 mg/3 mg, comprimé pelliculé Linatera 0,02 mg/3 mg filmdragerade tabletter Linatera 0,02 mg/3 mg kalvopäällysteiset tabletit Linatera 3 mg + 0,02 mg comprimidos revestidos por película

NL/H/2041/001

5559067

NL/H/2041/001

5559075

NL/H/2917/001

OGYI-T-22993/01

NL/H/215/01

356 055-0

BERLEX ESPECIALIDADES FARMACEUTICAS LDA BERLEX ESPECIALIDADES FARMACEUTICAS LDA EXELTIS MAGYARORSZÁG KFT. BAYER HEALTHCARE

NL/H/215/01

356 056-7

BAYER HEALTHCARE

FR

NL/H/701/01

376 400-5

BAYER HEALTHCARE

FR

NL/H/701/01

376 398-0

BAYER HEALTHCARE

FR

NL/H/704/001

376 444-2

BAYER HEALTHCARE

FR

NL/H/704/001

376 445-9

BAYER HEALTHCARE

FR

NL/H/1270/001

24322

BAYER OY

FI

NL/H/1270/01

24322

BAYER OY

FI

NL/H/1270/001

5114145

PT

Linatera 3 mg + 0,02 mg comprimidos revestidos por película

NL/H/1270/001

5114152

Liofora 0,02 mg / 3 mg kalvopäällysteiset tabletit LIOFORA 0,02 mg/3 mg filmdragerade tabletter Liofora 3 mg / 0,02 mg comprimidos recubiertos con película Liofora Diario 3 mg / 0,02 mg comprimidos recubiertos con película

NL/H/702/01

21724

BERLIFARMA ESPECIALIDADES FARMACEUTICAS LDA BERLIFARMA ESPECIALIDADES FARMACEUTICAS LDA BAYER OY

NL/H/0702/001

21724

BAYER OY

FI

NL/H/0702/001

68.026

BAYER HISPANIA SL

ES

NL/H/0705/001

68.025

BAYER HISPANIA SL

ES

List of nationally authorised medicinal products EMA/382258/2015

Member State where product is authorised PT PT HU FR

PT FI

Page 4/13

Product full name (in authorisation country)

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

Liofora, filmomhulde tabletten, 0,02 mg/3 mg Naraya Flex, 0,02 mg + 3 mg, tabletki powlekane Perliq 0,02 mg/3 mg compresse rivestite con film Perliq 0.02 mg/3 mg film coated tablets Perynella 0,02 mg/3 mg comprimés pelliculés Perynella 0,02 mg/3 mg comprimés pelliculés Perynella 0,02 mg/3 mg filmomhulde tabletten Petibelle 3 mg + 0,03 mg comprimidos revestidos por película Petibelle 3 mg + 0,03 mg comprimidos revestidos por película Petibelle 3 mg + 0,03 mg comprimidos revestidos por película Petibelle 3 mg + 0,03 mg comprimidos revestidos por película Petibelle® 0,03 mg/3 mg Filmtabletten Talia 0,02 mg/3 mg apvalkotās tabletes Talia 0,02 mg/3 mg filmomhulde tabletten Talia 3 mg/0,02 mg õhukese polümeerikattega tabletid Velmari 0,02 mg/3 mg comprimidos revestidos por película VELMARI Langzyklus 0,02 mg/ 3 mg Filmtabletten VELMARI Langzyklus 0,02 mg/3 mg Filmtabletten YADINE Yadine 0,03 mg/3 mg filmom obalené tablety

NL/H/0703/001

RVG 33188

BAYER BV

Member State where product is authorised NL

NL/H/2917/001

23261

EXELTIS POLAND SP. Z O.O.

PL

NL/H/2917/001

044159010

EXELTIS HEALTHCARE S.L

IT

NL/H/2917/001 NL/H/2917/001

PL 44081/0002 BE485955

EXELTIS HEALTHCARE S.L EXELTIS GERMANY GMBH

UK BE

NL/H/2917/001

2016060211

EXELTIS GERMANY GMBH

LU

NL/H/2917/001

BE485955

EXELTIS GERMANY GMBH

BE

NL/H/0218/001

3350188

LUSAL LDA

PT

NL/H/0218/001

3350287

LUSAL LDA

PT

NL/H/0218/001

3767787

LUSAL LDA

PT

NL/H/0218/001

3767886

LUSAL LDA

PT

NL/H/0218/001 NL/H/2917/001 NL/H/2917/001

49652.00.00 15-0347 RVG 113422

JENAPHARM GMBH & CO KG UAB EXELTIS BALTICS QUALITEC EUROPA, S.L.

DE LV NL

NL/H/2917/001

900515

UAB EXELTIS BALTICS

EE

NL/H/2917/001

5672860

EXELTIS HEALTHCARE S.L

PT

NL/H/2917/001

89823.00.00

EXELTIS GERMANY GMBH

DE

NL/H/2917/001

137109

EXELTIS GERMANY GMBH

AT

not available not available

17 / 606 / 00-C 17/0098/02-S

BAYER PHARMA AG BAYER PHARMA AG

CZ SK

List of nationally authorised medicinal products EMA/382258/2015

Page 5/13

Product full name (in authorisation country)

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

Yadine filmtabletta Yadine filmtabletta Yarina 0,03 mg/3 mg filmsko obložene tablete Yarina 3000/ 30 mikrogramu apvalkotās tabletes Yarina 3000/30 mikrogramų plėvele dengtos tabletės Yarina, 3000 μg/30 μg õhukese polümeerikattega tabletid Yasmin 0,03 / 3 mg filmuhúðaðar töflur Yasmin 0,03 mg / 3 mg filmom obložene tablete Yasmin 0,03 mg / 3 mg filmom obložene tablete Yasmin 0,03 mg / 3 mg filmom obložene tablete Yasmin 0,03 mg / 3 mg filmom obložene tablete Yasmin 0,03 mg/3 mg - Filmtabletten Yasmin 0,03 mg/3 mg compresse rivestite con film Yasmin 0,03 mg/3 mg compresse rivestite con film Yasmin 0,03 mg/3 mg compresse rivestite con film Yasmin 0,03 mg/3 mg compresse rivestite con film Yasmin 0,03 mg/3 mg comprimés pelliculés Yasmin 0,03 mg/3 mg comprimés pelliculés Yasmin 0,03 mg/3 mg filmdrasjerte tabletter Yasmin 0,03 mg/3 mg filmomhulde tabletten

not available not available not available

OGYI-T-7473/02 OGYI-T-7473/01 H/01/01685/001

BAYER PHARMA AG BAYER PHARMA AG BAYER PHARMA AG

Member State where product is authorised HU HU SI

not available

00-0463

BAYER PHARMA AG

LV

not available

LT/1/01/2564/001

BAYER PHARMA AG

LT

not available

342401

BAYER PHARMA AG

EE

NL/H/215/01 NL/H/0215/001

IS/1/00/013/01 HR-H-993460030

BAYER PHARMA AG BAYER DOO

IS HR

NL/H/0215/001

HR-H-993460030

BAYER DOO

HR

NL/H/0215/001

HR-H-993460030

BAYER DOO

HR

NL/H/0215/001

HR-H-993460030

BAYER DOO

HR

NL/H/0215/001 NL/H/0215/001

1-23811 035023035

BAYER AUSTRIA GMBH BAYER SPA

AT IT

NL/H/0215/001

035023011

BAYER SPA

IT

NL/H/0215/001

035023047

BAYER SPA

IT

NL/H/0215/001

035023023

BAYER SPA

IT

NL/H/0215/001

BE218066

BAYER SA NV

BE

NL/H/215/01

2009050310

BAYER SA NV

LU

NL/H/215/01

00-2880

BAYER PHARMA AG

NO

NL/H/0215/001

BE218066

BAYER SA NV

BE

List of nationally authorised medicinal products EMA/382258/2015

Page 6/13

Product full name (in authorisation country)

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

Yasmin 0,03 mg/3 mg Filmtabletten Yasmin 0,03 mg/3 mg Filmtabletten Yasmin 0,03 mg/3 mg kalvopäällysteiset tabletit Yasmin 0,03 mg/3 mg, comprimate filmate Yasmin 0.03 mg / 3 mg film-coated tablets Yasmin 28 0,03 / 3 mg filmuhúðaðar töflur Yasmin 28 0,03 mg/3mg, filmdrasjerte tabletter Yasmin 28, 0,03 mg/3 mg, filmdragerade tabletter Yasmin 28, filmomhulde tabletten, 0,03 mg/3 mg Yasmin 28, filmovertrukne tabletter Yasmin 3 mg / 0,03 mg comprimidos recubiertos con película Yasmin 3 mg + 0,03 mg comprimidos revestidos por película Yasmin 3 mg + 0,03 mg comprimidos revestidos por película Yasmin 3 mg + 0,03 mg comprimidos revestidos por película Yasmin 3 mg + 0,03 mg comprimidos revestidos por película Yasmin Diario 3 mg / 0,03 mg comprimidos recubiertos con película Yasmin, 0,03 mg + 3,00 mg, tabletki powlekane Yasmin, 0,03 mg/3 mg, filmdragerade tabletter Yasmin, film-coated tablets, 0.03 mg/3 mg

NL/H/0215/001 NL/H/215/01 NL/H/0215/001

BE218066 2009050310 15767

BAYER SA NV BAYER SA NV BAYER OY

Member State where product is authorised BE LU FI

not available

2796/2010/01

BAYER PHARMA AG

RO

NL/H/0215/001

PA1410/23/1

BAYER LTD

IE

NL/H/217/01

IS/1/00/014/01

BAYER PHARMA AG

IS

NL/H/217/01

00-2881

BAYER PHARMA AG

NO

NL/H/0217/001

16328

BAYER PHARMA AG

SE

NL/H/0217/001

RVG 25413

BAYER BV

NL

NL/H/217/01 NL/H/215/01

31586 63.576

BAYER PHARMA AG BAYER HISPANIA SL

DK ES

NL/H/215/01

3339181

BAYER PORTUGAL LDA

PT

NL/H/215/01

3339280

BAYER PORTUGAL LDA

PT

NL/H/215/01

3767985

BAYER PORTUGAL LDA

PT

NL/H/215/01

3768082

BAYER PORTUGAL LDA

PT

NL/H/217/01

63.575

BAYER HISPANIA SL

ES

not available

11011

BAYER PHARMA AG

PL

NL/H/0215/001

16327

BAYER PHARMA AG

SE

not available

MA 513/03201

BAYER PLC

MT

List of nationally authorised medicinal products EMA/382258/2015

Page 7/13

Product full name (in authorisation country)

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

Yasmin, film-coated tablets, 0.03 mg/3 mg Yasmin, filmomhulde tabletten, 0,03 mg/3 mg Yasmin, filmovertrukne tabletter Yasmin® 0,03 mg/3 mg filmdragerade tabletter Yasmin® 0,03 mg/3 mg Filmtabletten Yasmin® επικαλυμμένο με λεπτό υμένιο δισκίο 0,03 mg / 3 mg Yasminelle 0,02 g/3 mg filmom obalené tablety Yasminelle 0,02 mg / 3 mg comprimés pelliculés Yasminelle 0,02 mg / 3 mg comprimés pelliculés Yasminelle 0,02 mg / 3 mg comprimés pelliculés Yasminelle 0,02 mg / 3 mg filmomhulde tabletten Yasminelle 0,02 mg / 3 mg Filmtabletten Yasminelle 0,02 mg / 3 mg Filmtabletten Yasminelle 0,02 mg / 3 mg Filmtabletten Yasminelle 0,02 mg / 3 mg plėvele dengtos tabletės Yasminelle 0,02 mg / 3 mg plėvele dengtos tabletės Yasminelle 0,02 mg / 3 mg plėvele dengtos tabletės Yasminelle 0,02 mg / 3 mg plėvele dengtos tabletės Yasminelle 0,02 mg /3 mg, filmuhúðaðar töflur Yasminelle 0,02 mg/3 mg apvalkotās tabletes

NL/H/215/01

PL 00010/0571

BAYER PLC

Member State where product is authorised UK

NL/H/0215/001

RVG 23827

BAYER BV

NL

NL/H/0215/001 NL/H/0215/001

31587 15767

BAYER PHARMA AG BAYER OY

DK FI

NL/H/0215/001 NL/H/0215/001

49651.00.00 4016/21-01-2016

JENAPHARM GMBH & CO KG BAYER HELLAS SA

DE GR

NL/H/0701/001

17/0259/06-S

BAYER PHARMA AG

SK

NL/H/0701/001

BE288206

BAYER SA NV

BE

NL/H/701/01

0442/06110022

BAYER SA NV

LU

NL/H/701/01

2006110022

BAYER SA NV

LU

NL/H/0701/001

BE288206

BAYER SA NV

BE

NL/H/0701/001 NL/H/701/01 NL/H/701/01 NL/H/0701/001

BE288206 0442/06110022 2006110022 LT/1/06/0520/001

BAYER BAYER BAYER BAYER

SA NV SA NV SA NV PHARMA AG

BE LU LU LT

NL/H/0701/001

LT/1/06/0520/003

BAYER PHARMA AG

LT

NL/H/0701/001

LT/1/06/0520/004

BAYER PHARMA AG

LT

NL/H/0701/001

LT/1/06/0520/002

BAYER PHARMA AG

LT

NL/H/701/01

IS/1/06/008/01

BAYER PHARMA AG

IS

NL/H/0701/001

06-0161

BAYER PHARMA AG

LV

List of nationally authorised medicinal products EMA/382258/2015

Page 8/13

Product full name (in authorisation country)

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

Yasminelle 0,02 mg/3 mg compresse rivestite con film Yasminelle 0,02 mg/3 mg compresse rivestite con film Yasminelle 0,02 mg/3 mg compresse rivestite con film Yasminelle 0,02 mg/3 mg compresse rivestite con film Yasminelle 0,02 mg/3 mg filmdragerade tabletter Yasminelle 0,02 mg/3 mg filmsko obložene tablete Yasminelle 0,02 mg/3 mg filmsko obložene tablete Yasminelle 0,02 mg/3 mg filmsko obložene tablete Yasminelle 0,02 mg/3 mg filmsko obložene tablete Yasminelle 0,02 mg/3 mg Filmtabletten Yasminelle 0,02 mg/3 mg kalvopäällysteiset tabletit Yasminelle 0,02 mg/3 mg potahované tablety Yasminelle 0.02 mg / 3 mg film-coated tablets Yasminelle 0.02 mg / 3 mg film-coated tablets Yasminelle 28, 0,02 mg/3 mg, filmdragerade tabletter Yasminelle 28, 0,02 mg/3 mg, filmdrasjerte tabletter Yasminelle 28, filmomhulde tabletten, 0,02 mg/3 mg Yasminelle 28, filmovertrukne tabletter Yasminelle 3 mg / 0,02 mg comprimidos recubiertos con película

NL/H/0701/001

037199039

BAYER SPA

Member State where product is authorised IT

NL/H/0701/001

037199015

BAYER SPA

IT

NL/H/0701/001

037199027

BAYER SPA

IT

NL/H/0701/001

037199041

BAYER SPA

IT

NL/H/701/01

21723

BAYER OY

FI

NL/H/701/01

H/06/01686/003

BAYER PHARMA AG

SI

NL/H/701/01

H/06/01686/002

BAYER PHARMA AG

SI

NL/H/701/01

H/06/01686/001

BAYER PHARMA AG

SI

NL/H/701/01

H/06/01686/004

BAYER PHARMA AG

SI

NL/H/701/01 NL/H/701/01

1-26451 21723

BAYER AUSTRIA GMBH BAYER OY

AT FI

NL/H/701/01

17/192/06-C

BAYER PHARMA AG

CZ

NL/H/701/01

PA 1410/024/001

BAYER LTD

IE

NL/H/701/01

MA639/00101

BAYER LTD

MT

NL/H/704/01

23086

BAYER PHARMA AG

SE

NL/H/704/01

05-3805

BAYER PHARMA AG

NO

NL/H/704/01

RVG 33187

BAYER BV

NL

NL/H/704/01 NL/H/701/01

38688 67.982

BAYER PHARMA AG BAYER HISPANIA SL

DK ES

List of nationally authorised medicinal products EMA/382258/2015

Page 9/13

Product full name (in authorisation country)

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

Yasminelle 3 mg + 0,02 mg comprimidos revestidos por película Yasminelle 3 mg + 0,02 mg comprimidos revestidos por película Yasminelle Diario 3 mg / 0,02 mg comprimidos recubiertos con película Yasminelle filmtabletta Yasminelle filmtabletta Yasminelle, 0,02 mg + 3 mg, tabletki powlekane Yasminelle, 0,02 mg/3 mg õhukese polümeerikattega tabletid Yasminelle, 0,02 mg/3 mg, filmdragerade tabletter Yasminelle, 0,02 mg/3 mg, filmdrasjerte tabletter Yasminelle, filmomhulde tabletten, 0,02 mg/3 mg Yasminelle, filmovertrukne tabletter Yasminelle® 0,02 mg/3 mg Filmtabletten Yasminelle® επικαλυμμένα με λεπτό υμένιο δισκία 0,02 mg / 3 mg Yasminelle® επικαλυμμένα με λεπτό υμένιο δισκία 0,02 mg / 3 mg YAZ 0,02 mg / 3 mg apvalkotās tabletes YAZ 0,02 mg / 3 mg filmom obložene tablete YAZ 0,02 mg / 3 mg filmom obložene tablete YAZ 0,02 mg / 3 mg filmom obložene tablete YAZ 0,02 mg / 3 mg filmom obložene tablete YAZ 0,02 mg / 3 mg, compresse rivestite con film

NL/H/0701/001

5866280

NL/H/0701/001

5866181

NL/H/704/01

67.983

BERLEX ESPECIALIDADES FARMACEUTICAS LDA BERLEX ESPECIALIDADES FARMACEUTICAS LDA BAYER HISPANIA SL

NL/H/702/01 NL/H/702/01 NL/H/701/01

OGYI-T 20121/01 OGYI-T 20121/02 12364

BAYER PHARMA AG BAYER PHARMA AG BAYER PHARMA AG

HU HU PL

NL/H/701/01

514706

BAYER PHARMA AG

EE

NL/H/701/01

23085

BAYER PHARMA AG

SE

NL/H/701/01

05-3792

BAYER PHARMA AG

NO

NL/H/701/01

RVG 31781

BAYER BV

NL

NL/H/701/01 NL/H/701/01

38687 64268.00.00

BAYER PHARMA AG JENAPHARM GMBH & CO KG

DK DE

NL/H/701/01

20125

BAYER HELLAS SA

CY

NL/H/701/01

4022/21-1-2016

BAYER HELLAS SA

GR

NL/H/1269/01 NL/H/1269/01

08-0167 HR-H-604240169-01

BAYER PHARMA AG BAYER DOO

LV HR

NL/H/1269/01

HR-H-604240169-02

BAYER DOO

HR

NL/H/1269/01

HR-H-604240169-03

BAYER DOO

HR

NL/H/1269/01

HR-H-604240169-04

BAYER DOO

HR

NL/H/1269/01

038542015

BAYER SPA

IT

List of nationally authorised medicinal products EMA/382258/2015

Member State where product is authorised PT PT ES

Page 10/13

Product full name (in authorisation country)

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

YAZ 0,02 mg / 3 mg, compresse rivestite con film YAZ 0,02 mg / 3 mg, compresse rivestite con film YAZ 0,02 mg / 3 mg, comprimé pelliculé. YAZ 0,02 mg / 3 mg, comprimé pelliculé. YAZ 0,02 mg / 3 mg, comprimé pelliculé. YAZ 0,02 mg /3 mg filmom obalené tablety YAZ 0,02 mg/ 3 mg, filmuhúðaðar töflur YAZ 0,02 mg/3 mg comprimate filmate Yaz 0,02 mg/3 mg comprimés pelliculés Yaz 0,02 mg/3 mg comprimés pelliculés Yaz 0,02 mg/3 mg filmomhulde tabletten YAZ 0,02 mg/3 mg filmsko obložene tablete YAZ 0,02 mg/3 mg filmsko obložene tablete YAZ 0,02 mg/3 mg filmsko obložene tablete YAZ 0,02 mg/3 mg filmsko obložene tablete YAZ 0,02 mg/3 mg Filmtabletten Yaz 0,02 mg/3 mg Filmtabletten Yaz 0,02 mg/3 mg Filmtabletten Yaz 0,02 mg/3 mg kalvopäällysteiset tabletit YAZ 0,02 mg/3 mg plėvele dengtos tabletės YAZ 0,02 mg/3 mg plėvele dengtos tabletės

NL/H/1269/01

038542039

BAYER SPA

Member State where product is authorised IT

NL/H/1269/01

038542027

BAYER SPA

IT

NL/H/1269/01

388 404-0

BAYER HEALTHCARE

FR

NL/H/1269/01

388 405-7

BAYER HEALTHCARE

FR

NL/H/1269/01

574 189-9

BAYER HEALTHCARE

FR

NL/H/1269/01

17/0217/08-S

BAYER SPOL SRO

SK

NL/H/1269/01 NL/H/1269/01 NL/H/1269/01 NL/H/1269/01 NL/H/1269/01

IS/1/08/020/01 5060/2012/01-03 BE321386 2008090015 BE321386

BAYER BAYER BAYER BAYER BAYER

IS RO BE LU BE

NL/H/1269/01

H/08/01688/001

BAYER D.O.O

SI

NL/H/1269/01

H/08/01688/002

BAYER D.O.O

SI

NL/H/1269/01

H/08/01688/004

BAYER D.O.O

SI

NL/H/1269/01

H/08/01688/003

BAYER D.O.O

SI

NL/H/1269/01 NL/H/1269/01 NL/H/1269/01 NL/H/1269/01

1-27586 BE321386 2008090015 24321

BAYER BAYER BAYER BAYER

AT BE LU FI

NL/H/1269/01

LT/1/08/1204/003

BAYER PHARMA AG

LT

NL/H/1269/01

LT/1/08/1204/001

BAYER PHARMA AG

LT

List of nationally authorised medicinal products EMA/382258/2015

AB PHARMA AG SA NV SA NV SA NV

AUSTRIA GMBH SA NV SA NV OY

Page 11/13

Product full name (in authorisation country)

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

YAZ 0,02 mg/3 mg plėvele dengtos tabletės YAZ 0,02 mg/3 mg plėvele dengtos tabletės Yaz 0,02 mg/3 mg tabletter, filmdrasjerte Yaz 0,02 mg/3 mg, filmdragerade tabletter Yaz 0,02 mg / 3 mg filmdragerade tabletter YAZ 0,02 mg /3 mg potahované tablety Yaz 0.02 mg / 3 mg film coated tablets Yaz 0.02 mg / 3 mg film-coated tablets YAZ 24+4 0,02 mg/3 mg filmomhulde tabletten YAZ 3 mg / 0,02 mg comprimidos recubiertos con película Yaz 3 mg + 0,02 mg comprimidos revestidos por película Yaz 3 mg + 0,02 mg comprimidos revestidos por película Yaz, 0,02 mg + 3,0 mg, tabletki powlekane YAZ, 0,02 mg/3 mg õhukese polümeerikattega tabletid Yaz, filmovertrukne tabletter YAZ® 0,02 mg / 3 mg Filmtabletten Yira 3 mg / 0,03 mg comprimidos recubiertos con película Yirala 0,03 mg/3 mg - Filmtabletten Yvidually 0,02 mg/3 mg, filmomhulde tabletten Yvidually® 0,02 mg/3 mg Filmtabletten Джаз 0,02 mg/3 mg филмирани таблетки

NL/H/1269/01

LT/1/08/1204/004

BAYER PHARMA AG

Member State where product is authorised LT

NL/H/1269/01

LT/1/08/1204/002

BAYER PHARMA AG

LT

NL/H/1269/01

07-5386

BAYER AB

NO

NL/H/1269/01

26267

BAYER AB

SE

NL/H/1269/01

24321

BAYER OY

FI

NL/H/1269/001 NL/H/1269/001 NL/H/1269/01 NL/H/1269/001

17/ 316/ 08 - C MA639/00601 PA1410/056/001 RVG 33842

BAYER BAYER BAYER BAYER

CZ MT IE NL

NL/H/1269/01

70093

BAYER HISPANIA SL

ES

NL/H/1269/01

5114137

PT

NL/H/1269/01

5114129

NL/H/1269/01

14780

BERLEX ESPECIALIDADES FARMACEUTICAS LDA BERLEX ESPECIALIDADES FARMACEUTICAS LDA BAYER PHARMA AG

NL/H/1269/01

586208

BAYER PHARMA AG

EE

NL/H/1269/01 NL/H/1269/01 NL/H/218/01

42417 71898.00.00 63.577

BAYER AB JENAPHARM GMBH & CO KG BAYER HISPANIA SL

DK DE ES

NL/H/218/01 NL/H/2041/001

1-23812 RVG 108807

BAYER AUSTRIA GMBH BAYER BV

AT NL

NL/H/2041/001 NL/H/1269/01

83235.00.00 20090142

JENAPHARM GMBH & CO KG BAYER PHARMA AG

DE BG

List of nationally authorised medicinal products EMA/382258/2015

PHARMA AG LTD LTD BV

PT PL

Page 12/13

Product full name (in authorisation country)

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

Елоин 0,02 mg/3 mg филмирани таблетки Флексиес 0,02 mg/3 mg филмирани таблетки Ясмин 0,03 mg/3 mg филмирани таблетки

NL/H/1270/01

20090309

BAYER PHARMA AG

Member State where product is authorised BG

NL/H/2041/001

20120567

BAYER PHARMA AG

BG

not available

20010803

BAYER PHARMA AG

BG

List of nationally authorised medicinal products EMA/382258/2015

Page 13/13

drospirenone / ethinylestradiol - European Medicines Agency - Europa ...

May 5, 2017 - Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525. Send a question via our ... List of nationally authorised medicinal products.
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