Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2008 to 30 June 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Date: 2008-07-25
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

C 188/16

EN

Official Journal of the European Union

25.7.2008

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 June 2008 to 30 June 2008

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council (1)
or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council (2))

(2008/C 188/05)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision

Name(s) of the
medicinal product

Holder(s) of the
marketing authorization

Member State concerned

Date of notification

17.6.2008

Yasminelle

See Annex I

See Annex I

17.6.2008

Belanette

See Annex II

See Annex II

19.6.2008

19.6.2008

(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

ANNEX I

Member State

Marketing autorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Belgium

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Bayer Austria GmbH
(Schering Austria GmbH)
Herbststr. 6-10
A-1160 Wien

Bayer S.A./N.V.
Avenue Louise 143
B-1050 Brussel

Bayer Hellas AG
18-20 Sorou Str
GR-15125 Amaroussion Athens

Bayer Schering Pharma AG
D-13342 Berlin

Bayer Schering Pharma AG
D-13342 Berlin

Bayer Schering Pharma AG
D-13342 Berlin

Bayer Schering Pharma Oy
Pansiontie 47
FI-20210 Turku

Bayer Santé
13, rue Jean Jaurès
F-92807 Puteaux Cedex

Bayer Vital GmbH
D-51368 Leverkusen

Bayer Hellas AG
18-20 Sorou Str
GR-15125 Amaroussion Athens

Bayer Schering Pharma AG
D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Jasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

.

.

2
5
7
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

1
8
8
/
1
7

Member State

Marketing autorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Iceland

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Norway

Poland

Portugal

Slovakia

Bayer Schering Pharma AG
D-13342 Berlin

Bayer Ltd
The Atrium
Blackthorn Road
Dublin 18
Ireland

Bayer S.p.A.
Viale Certosa, 130
I-20156 Milano

Bayer Schering Pharma AG
D-13342 Berlin

Bayer Schering Pharma AG
D-13342 Berlin

Bayer S.A./N.V.
Avenue Louise 143
B-1050 Brussel

Bayer Schering Pharma AG
D-13342 Berlin

Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Nederland

Bayer Schering Pharma AG
D-13342 Berlin

Schering Polska Sp. z o.o.
ul. Migdałowa 4
PL-02-796 Warszawa

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Berlex, Especialidades Farmacêuticas, Lda.
Rua da Quinta do Pinheiro, No. 5
P-2794-003 Carnaxide

Bayer Schering Pharma AG
D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

C

1
8
8
/
1
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
5
7
2
0
0
8

Member State

Marketing autorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Slovenia

Spain

Sweden

United Kingdom

Bayer Schering Pharma AG
D-13342 Berlin

Química Farmacéutica Bayer, S.L.
Av. Baix Llobregat, 3-5
E-08970 Sant Joan Despí, Barcelona

Bayer Schering Pharma AG
D-13342 Berlin

Schering Health Care Ltd
The Brow
Burgess Hill
West Sussex
RH15 9NE
United Kindgom

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Oral use

Oral use

Oral use

.

.

2
5
7
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

1
8
8
/
1
9

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

ANNEX II

Member State

Marketing autorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Belgium

Cyprus

Bayer Austria GmbH
(Schering Austria GmbH)
Herbststr. 6-10
A-1160 Wien

Bayer S.A./N.V.
Avenue Louise 143
B-1050 Brussel

Bayer Hellas AG
18-20 Sorou Str
GR-15125 Amaroussion Athens

Aliane

0,02 mg/3 mg

Film-coated tablets

Oral use

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

Czech Republic

Bayer Schering Pharma AG
D-13342 Berlin

Belanette

0,02 mg/3 mg

Film-coated tablets

Oral use

Denmark

Estonia

Finland

France

Germany

Greece

Bayer Schering Pharma AG
D-13342 Berlin

Bayer Schering Pharma AG
D-13342 Berlin

Bayer Schering Pharma Oy
Pansiontie 47
FI-20210 Turku

Bayer Santé
13, rue Jean Jaurès
F-92807 Puteaux Cedex

Jenapharm GmbH & Co. KG
Otto-Schott-Str. 15
D-07745 Jena

Bayer Hellas AG
18-20 Sorou Str
GR-15125 Amaroussion Athens

Liofora

Aliane

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

0,02 mg/3 mg

Film-coated tablets

Oral use

0,02 mg/3 mg

Film-coated tablets

Oral use

Belanette

0,02 mg/3 mg

Film-coated tablets

Oral use

aida

0,02 mg/3 mg

Film-coated tablets

Oral use

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

C

1
8
8
/
2
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
5
7
2
0
0
8

Member State

Marketing autorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Norway

Poland

Portugal

Slovakia

Slovenia

Bayer Schering Pharma AG
D-13342 Berlin

Bayer Ltd
The Atrium
Blackthorn Road
Dublin 18
Ireland

Bayer S.p.A.
Viale Certosa, 130
I-20156 Milano

Bayer Schering Pharma AG
D-13342 Berlin

Bayer Schering Pharma AG
D-13342 Berlin

Bayer S.A./N.V.
Avenue Louise 143
B-1050 Brussel

Bayer Schering Pharma AG
D-13342 Berlin

Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Nederland

Bayer Schering Pharma AG
D-13342 Berlin

Bayer Schering Pharma AG
D-13353 Berlin

Lusal, Produção Químico-Farmacêutica
Luso-Alemã, Lda.
Estrada Nacional 249, Km 15
P-2725-397 Mem Martins

Bayer Schering Pharma AG
D-13342 Berlin

Bayer Schering Pharma AG
D-13342 Berlin

Aliane

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

0,02 mg/3 mg

Film-coated tablets

Oral use

Aliane

0,02 mg/3 mg

Film-coated tablets

Oral use

Aliane

Aliane

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

0,02 mg/3 mg

Film-coated tablets

Oral use

0,02 mg/3 mg

Film-coated tablets

Oral use

Aliane

0,02 mg/3 mg

Film-coated tablets

Oral use

Belanette

0,02 mg/3 mg

Film-coated tablets

Oral use

Liofora

Aliane

Aliane

Aliane

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

0,02 mg/3 mg

Film-coated tablets

Oral use

0,02 mg/3 mg

Film-coated tablets

Oral use

0,02 mg/3 mg

Film-coated tablets

Oral use

0,02 mg/3 mg

Film-coated tablets

Oral use

.

.

2
5
7
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

1
8
8
/
2
1

Member State

Marketing autorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Spain

Sweden

Química Farmacéutica Bayer, S.L.
Av. Baix Llobregat, no 3-5
E-08970 Sant Joan Despí, Barcelona

Bayer Schering Pharma AG
D-13342 Berlin

Liofora

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

0,02 mg/3 mg

Film-coated tablets

Oral use

C

1
8
8
/
2
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
5
7
2
0
0
8