01 September 2017 EMA/562418/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance(s): dienogest

Procedure No.: PSUSA/00003167/201612

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

Product name (in authorisation country) Visanne

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

NL/H/1569/01/DC

44408

BAYER AB

DK

Visanne 2 mg compresse

NL/H/1569/001

041407026

BAYER SPA

IT

Visanne 2 mg compresse

NL/H/1569/001

041407014

BAYER SPA

IT

Visanne 2 mg compresse

NL/H/1569/001

041407038

BAYER SPA

IT

Visanne 2 mg comprimate

NL/H/1569/001

7329/2015/01

BAYER PHARMA AG

RO

Visanne 2 mg comprimate

NL/H/1569/001

7329/2015/03

BAYER PHARMA AG

RO

Visanne 2 mg comprimate

NL/H/1569/001

7329/2015/02

BAYER PHARMA AG

RO

Visanne 2 mg comprimidos

NL/H/1569/001

5262720

BERLEX ESPECIALIDADES FARMACEUTICAS LDA

PT

Visanne 2 mg comprimidos

NL/H/1569/001

5262712

BERLEX ESPECIALIDADES FARMACEUTICAS LDA

PT

Visanne 2 mg tablete

NL/H/1569/001

HR-H-736913531-01

BAYER DOO

HR

Visanne 2 mg tablete

NL/H/1569/001

HR-H-736913531-02

BAYER DOO

HR

Visanne 2 mg tablete

NL/H/1569/001

HR-H-736913531-03

BAYER DOO

HR

Visanne 2 mg tablete

NL/H/1569/01/DC

H/10/01647/001

BAYER D.O.O

SI

Visanne 2 mg tablets

NL/H/1569/001

PA 1410/59/1

BAYER LTD

IE

Visanne 2 mg tablets

NL/H/1569/01/DC

MA 513/01501

BAYER PLC

MT

Visanne 2 mg tabletta

NL/H/1569/001

OGYI-T-21199/03

BAYER PHARMA AG

HU

List of nationally authorised medicinal products EMA/562418/2017

Page 2/4

Product name (in authorisation country) Visanne 2 mg tabletta

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

NL/H/1569/001

OGYI-T-21199/02

BAYER PHARMA AG

HU

Visanne 2 mg tabletta

NL/H/1569/001

OGYI-T-21199/01

BAYER PHARMA AG

HU

Visanne 2 mg Tabletten

NL/H/1569/01/DC

1-29018

BAYER AUSTRIA GMBH

AT

Visanne 2 mg Tabletten

NL/H/1569/001

75382.00.00

JENAPHARM GMBH & CO KG

DE

Visanne 2 mg tabletter

NL/H/1569/01/DC

27060

BAYER OY

FI

Visanne 2 mg tabletter

NL/H/1569/001

09-6487

BAYER AB

NO

Visanne 2 mg tabletter

NL/H/1569/01/DC

41818

BAYER AB

SE

Visanne 2 mg tablety

NL/H/1569/001

56/196/10-C

BAYER PHARMA AG

CZ

Visanne 2 mg tablety

NL/H/1569/001

56/0879/09-S

BAYER SPOL SRO

SK

Visanne 2 mg töflur

NL/H/1569/001

IS/1/09/044/01

BAYER AB

IS

VISANNE 2 mg, comprimé

NL/H/1569/001

34009 347 113 1 2

BAYER HEALTHCARE

FR

VISANNE 2 mg, comprimé

NL/H/1569/001

34009 576 766 3 6

BAYER HEALTHCARE

FR

VISANNE 2 mg, comprimé

NL/H/1569/001

34009 576 768 6 5

BAYER HEALTHCARE

FR

Visanne 2 mg, tabletten

NL/H/1569/001

RVG 104058

BAYER BV

NL

Visanne, 2 mg, tabletki

NL/H/1569/001

16693

BAYER PHARMA AG

PL

List of nationally authorised medicinal products EMA/562418/2017

Page 3/4

Product name (in authorisation country) Visannette 2 mg comprimidos

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

NL/H/1569/01/DC

71929

BAYER HISPANIA SL

ES

Visannette 2 mg tabletes

NL/H/1569/001

10-0059

BAYER PHARMA AG

LV

Visannette 2 mg tabletės

NL/H/1569/001

LT/1/10/1981/003

BAYER PHARMA AG

LT

Visannette 2 mg tabletės

NL/H/1569/001

LT/1/10/1981/002

BAYER PHARMA AG

LT

Visannette 2 mg tabletės

NL/H/1569/001

LT/1/10/1981/001

BAYER PHARMA AG

LT

Visannette 2 mg tabletid

NL/H/1569/01/DC

667710

BAYER PHARMA AG

EE

Visannette 2 mg δισκία

NL/H/1569/001

20744

BAYER HELLAS SA

CY

Visannette 2 mg δισκία

NL/H/1569/001

75707/8-11-2010

BAYER HELLAS SA

GR

Visannette 2 mg, comprimés

NL/H/1569/01/DC

BE358547

BAYER SA NV

BE

Visannette 2 mg, comprimés

NL/H/1569/001

2010030117

BAYER SA NV

LU

Visannette 2 mg, Tabletten

NL/H/1569/001

BE358547

BAYER SA NV

BE

Visannette 2 mg, Tabletten

NL/H/1569/001

2010030117

BAYER SA NV

LU

Visannette 2mg, tabletten

NL/H/1569/001

BE358547

BAYER SA NV

BE

List of nationally authorised medicinal products EMA/562418/2017

Page 4/4

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