Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 November 2005  to  19 November 2005 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2005-12-30
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

30.12.2005

EN

Official Journal of the European Union

C 334/35

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 November 2005 to 19 November 2005

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2005/C 334/07)

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

7.11.2005

Coversyl

See Annex

See Annex

24.11.2005

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

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

ANNEX

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Austria

Belgium

Belgium

Denmark

Denmark

Finland

Finland

France

France

Germany

Germany

Greece

Greece

Iceland

Iceland

Ireland

Ireland

Italy

Servier Austria GmbH

Servier Austria GmbH

Servier Benelux S.A.

Servier Benelux S.A.

Les Laboratoires Servier

Les Laboratoires Servier

Les Laboratoires Servier

Les Laboratoires Servier

Les Laboratoires Servier

Les Laboratoires Servier

COVERSUM

COVERSUM

COVERSYL

COVERSYL

COVERSYL

COVERSYL

COVERSYL

COVERSYL

COVERSYL

COVERSYL

Les Laboratoires Servier

COVERSUM COR

Les Laboratoires Servier

COVERSUM

Servier Hellas Pharmaceuticals S.A.

COVERSYL

Servier Hellas Pharmaceuticals S.A.

COVERSYL

Les Laboratoires Servier

Les Laboratoires Servier

Les Laboratoires Servier

Les Laboratoires Servier

Les Laboratoires Servier

Luxembourg

Servier Benelux S.A.

Luxembourg

Servier Benelux S.A.

COVERSYL

COVERSYL

COVERSYL

COVERSYL

COVERSYL

COVERSYL

COVERSYL

2 mg

4 mg

2 mg

4 mg

2 mg

4 mg

2 mg

4 mg

2 mg

4 mg

2 mg

4 mg

2 mg

4 mg

2 mg

4 mg

2 mg

4 mg

4 mg

2 mg

4 mg

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C

3
3
4
/
3
6

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

.

3
0
1
2
2
0
0
5

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Netherlands

Netherlands

Norway

Norway

Portugal

Portugal

Spain

Sweden

Sweden

Les Laboratoires Servier

Les Laboratoires Servier

Les Laboratoires Servier

Les Laboratoires Servier

Servier Portugal — Especialidades Farmacêu-
ticas

COVERSYL

COVERSYL

COVERSYL

COVERSYL

COVERSYL

Servier Portugal — Especialidades Farmacêu-
ticas

COVERSYL

Les Laboratoires Servier

Les Laboratoires Servier

Les Laboratoires Servier

United Kingdom

Les Laboratoires Servier

United Kingdom

Les Laboratoires Servier

COVERSYL

COVERSYL

COVERSYL

COVERSYL

COVERSYL

2 mg

4 mg

2 mg

4 mg

2 mg

4 mg

4 mg

2 mg

4 mg

2 mg

4 mg

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

.

3
0
1
2
2
0
0
5

.

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
3
3
4
/
3
7