Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 January 2004 to 15 February 2004 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2004-02-27
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

27.2.2004

EN

Official Journal of the European Union

C 52/9

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 January 2004 to 15 February 2004

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

— Issuing, maintenance or modification of a national marketing authorisation

(2004/C 52/03)

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

Member State concerned

Date of
notification

See Annex I

See Annex II

See Annex I

19.1.2004

See Annex II

9.2.2004

16.1.2004

Zestril

5.2.2004

Desogestrel/
ethinylestradiol
(Laurina)

(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 product, route of administration, marketing
authorisation holders, packaging and package sizes in the Member States

ANNEX I

Member State

Marketing authorisation
holder

Invented name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package size

Austria

AstraZeneca
Österreich GmbH
Schwarzenbergplatz 7
A-1037 Wien

Belgium

NV Astra-Zeneca SA
Rue Egide/Van Ophem-
straat 110
B-1180 Bruxelles/Brussel

Denmark

AstraZeneca A/S
Roskildevej 22
DK-2620 Albertslund

Acemin

Acemin

Acemin

Acemin

Acemin

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

2,5 mg

Tablet

Oral use

Aluminium/PVC blister

28

5 mg

Tablet

Oral use

Aluminium/PVC blister

28

10 mg

Tablet

Oral use

Aluminium/PVC blister

28

20 mg

Tablet

Oral use

Aluminium/PVC blister

28

30 mg

Tablet

Oral use

Aluminium/PVC blister

28

5 mg

Tablet

Oral use

Aluminium/PVC blister

28, 56

10 mg

Tablet

Oral use

Aluminium/PVC blister

28

20 mg

Tablet

Oral use

Aluminium/PVC blister

28, 56

30 mg

Tablet

Oral use

Aluminium/PVC blister

28

2,5 mg

Tablet

Oral use

Aluminium/PVC blister

14

5 mg

Tablet

Oral use

Aluminium/PVC blister

28, 98

10 mg

Tablet

Oral use

Aluminium/PVC blister

28, 98

20 mg

Tablet

Oral use

Aluminium/PVC blister

28, 98

30 mg

Tablet

Oral use

Aluminium/PVC blister

C

5
2
/
1
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
7
2
2
0
0
4

Member State

Marketing authorisation
holder

Invented name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package size

Finland

AstraZeneca Oy
Luomanportti 3
FIN-02200 Espoo

France

Germany

AstraZeneca
1, place Renault
F-92844 Rueil-Malmaison

AstraZeneca GmbH
Tinsdaler Weg 183
D-22880 Wedel

Greece

Pharmaceutical
Laboratories
446 Irakliou Avenue
GR-141 22 Iraklio
CANA SA
Athens

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Acerbon
Aceday
Listen

Acerbon
Aceday
Listen

Acerbon
Aceday
Listen

Acerbon
Aceday
Listen

Zestril

Zestril

Zestril

2,5 mg

Tablet

Oral use

Aluminium/PVC blister

14

10 mg

Tablet

Oral use

Aluminium/PVC blister

28, 98

20 mg

Tablet

Oral use

Aluminium/PVC blister

28, 98

30 mg

Tablet

Oral use

Aluminium/PVC blister

28, 98

5 mg

Tablet

20 mg

Tablet

Oral

Oral

Aluminium/PVC blister

28, 100

Aluminium/PVC blister

28, 100

2,5 mg

Tablet

Oral use

Aluminium/PVC blister

5 mg

Tablet

Oral use

Aluminium/PVC blister

10 mg

Tablet

Oral use

Aluminium/PVC blister

20 mg

Tablet

Oral use

Aluminium/PVC blister

30, 40, 50, 100
samples: 20
hospital: 400

30, 40, 50, 100
samples: 20
hospital: 400

30, 40, 50, 100
samples: 20
hospital: 400

30, 40, 50, 100
samples: 20
hospital: 400

5 mg

Tablet

Oral use

Aluminium/PVC blister

14, 28

10 mg

Tablet

Oral use

Aluminium/PVC blister

14

20 mg

Tablet

Oral use

Aluminium/PVC blister

14

.

.

2
7
2
2
0
0
4

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

5
2
/
1
1

Member State

Marketing authorisation
holder

Invented name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package size

Greece
(cont’d)

Ireland

AstraZeneca UK Ltd
600 Capability Green
Luton LU1 3LU
Ireland

Italy

AstraZeneca SpA
Via F Sforza — Palazzo
Volta
I-20080 Basiglio (MI)

Luxembourg

Netherlands

NV AstraZeneca SA
Rue Egide/Van Ophem-
straat 110
B-1180 Bruxelles/Brussel

AstraZenca BV
Postbus 599
2700 An Zoetermeer
Nederland

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

30 mg

Tablet

Oral use

Aluminium/PVC blister

14

40 mg

Tablet

Oral use

Aluminium/PVC blister

2,5 mg

Tablet

Oral use

Aluminium/PVC blister

28

5 mg

Tablet

Oral use

Aluminium/PVC blister

28

10 mg

Tablet

Oral use

Aluminium/PVC blister

28

20 mg

Tablet

Oral use

Aluminium/PVC blister

28

30 mg

Tablet

Oral use

Aluminium/PVC blister

5 mg

Tablet

Oral use

Aluminium/PVC blister

14

10 mg

Tablet

Oral use

Aluminium/PVC blister

14

20 mg

Tablet

Oral use

Aluminium/PVC blister

14

30 mg

Tablet

Oral use

Aluminium/PVC blister

5 mg

Tablet

Oral use

Aluminium/PVC blister

28, 56

20 mg

Tablet

Oral use

Aluminium/PVC blister

28, 56

5 mg

Tablet

Oral use

Aluminium/PVC blister
and Aluminium
PVC/PVDC blister

30

EAV hospital pack: 50

HDPE

30

C

5
2
/
1
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
7
2
2
0
0
4

Member State

Marketing authorisation
holder

Invented name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package size

Netherlands
(cont’d)

Zestril

10 mg

Tablet

Oral use

Aluminium/PVC blister
and Aluminium
PVC/PVDC blister

30

Zestril

20 mg

Tablet

Oral use

EAV hospital pack: 50

HDPE

Aluminium/PVC blister
and Aluminium
PVC/PVDC blister

30

30

EAV hospital pack: 50

HDPE

30

Zestril

30 mg

Tablet

Oral use

Aluminium/PVC blister

30

Norway

AstraZeneca AS
Postboks 200
Vinderen
N-0319 Oslo

Portugal

AstraZeneca
Produtos Farmacêuticos
Lda
Rua Humberto Madeira, 7
Valejas
P-2745-663 Barcarena

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

40 mg

2,5 mg

5 mg

10 mg

20 mg

30 mg

5 mg

10 mg

20 mg

30 mg

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

EAV hospital pack: 50

HDPE

30

Aluminium/PVC blister

14, 100

Aluminium/PVC blister

28, 98, 100

Aluminium/PVC blister

28, 98, 100

Aluminium/PVC blister

28, 98, 100

Aluminium/PVC blister

Aluminium/PVC blister

14, 28, 56

Aluminium/PVC blister

28, 56

Aluminium/PVC blister

28, 56

Aluminium/PVC blister

.

.

2
7
2
2
0
0
4

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

5
2
/
1
3

Member State

Marketing authorisation
holder

Invented name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package size

Spain

AstraZeneca
Farmaceutica Spain SA
C/Serrano Galvache 56
Edificio Roble ES
E-28033 Madrid

Sweden

Sweden Hässle
Läkemedel AB
S-431 86 Mölndal

United Kingdom

AstraZeneca UK Limited
600 Capability Green
Luton
Bedfordshire LU1 3LU
United Kingdom

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

Zestril

5 mg

Tablet

Oral use

Aluminium/PVC blister

60, 500

20 mg

Tablet

Oral use

Aluminium/PVC blister

28, 500

30 mg

Tablet

Oral use

Aluminium/PVC blister

2,5 mg

Tablet

Oral use

Aluminium/PVC blister

14

5 mg

Tablet

Oral use

Aluminium/PVC blister

28, 98, 100

5 mg

Tablet

Oral use

Polypropylene tube

100

10 mg

Tablet

Oral use

Aluminium/PVC blister

28, 98, 100

10 mg

Tablet

Oral use

Polypropylene tube

100

20 mg

Tablet

Oral use

Aluminium/PVC blister

28, 98, 100

20 mg

Tablet

Oral use

Polypropylene tube

100

30 mg

Tablet

Oral use

Aluminium/PVC blister

28, 98, 100

2,5 mg

Tablet

Oral use

Aluminium/PVC blister

28

5 mg

Tablet

Oral use

Aluminium/PVC blister

28

10 mg

Tablet

Oral use

Aluminium/PVC blister

28

20 mg

Tablet

Oral use

Aluminium/PVC blister

28

30

Tablet

Oral use

C

5
2
/
1
4

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
7
2
2
0
0
4

List of the names, pharmaceutical form, strengths of the medicinal product, route of administration, marketing
authorisation holders, packaging and package sizes in the Member States

ANNEX II

.

.

2
7
2
2
0
0
4

Member State

Marketing authorisation holder

Invented name

Strengths

Pharmaceutical form

Route of
administration

Packaging

Package sizes

Austria

Organon GesmbH
Siebenbrunnengasse 21/D/IV
A-1050 Wien

Laurina

Laurina 28

Belgium

Organon Europe BV
Kloosterstraat 6
5349 AB Oss
Nederland

Laurina

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Placebo tablets:
(no active substance)

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 21 tablets
3 sachets × 1 blister × 21 tablets
6 sachets × 1 blister × 21 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 28 tablets
3 sachets × 1 blister × 28 tablets
6 sachets × 1 blister × 28 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 21 tablets
3 sachets × 1 blister × 21 tablets
6 sachets × 1 blister × 21 tablets

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

5
2
/
1
5

Member State

Marketing authorisation holder

Invented name

Strengths

Pharmaceutical form

Route of
administration

Packaging

Package sizes

Belgium
(cont’d)

Laurina 28

Denmark

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH Oss
Nederland

Laurina

Laurina 28

Finland

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH Oss
Nederland

Laurina

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Placebo tablets:
(no active substance)

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Placebo tablets:
(no active substance)

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 28 tablets
3 sachets × 1 blister × 28 tablets
6 sachets × 1 blister × 28 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 21 tablets
3 sachets × 1 blister × 21 tablets
6 sachets × 1 blister × 21 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 28 tablets
3 sachets × 1 blister × 28 tablets
6 sachets × 1 blister × 28 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 21 tablets
3 sachets × 1 blister × 21 tablets
6 sachets × 1 blister × 21 tablets

C

5
2
/
1
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

.

.

2
7
2
2
0
0
4

Member State

Marketing authorisation holder

Invented name

Strengths

Pharmaceutical form

Route of
administration

Packaging

Package sizes

Finland
(cont’d)

Laurina 28

Germany

Organon GmbH
Mittenheimer Straße 62
D-85764 Oberschleißheim,
München

Novial

Novial 28

Greece

Organon Hellas SA
122 Vouliagmenis
Av. Helliniko
GR-16 777 Athens

Laurina

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Placebo tablets:
(no active substance)

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Placebo tablets:
(no active substance)

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 28 tablets
3 sachets × 1 blister × 28 tablets
6 sachets × 1 blister × 28 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 21 tablets
3 sachets × 1 blister × 21 tablets
6 sachets × 1 blister × 21 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 28 tablets
3 sachets × 1 blister × 28 tablets
6 sachets × 1 blister × 28 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 21 tablets
3 sachets × 1 blister × 21 tablets
6 sachets × 1 blister × 21 tablets

.

.

2
7
2
2
0
0
4

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

5
2
/
1
7

Member State

Marketing authorisation holder

Invented name

Strengths

Pharmaceutical form

Route of
administration

Packaging

Package sizes

Greece
(cont’d)

Laurina 28

Ireland

Organon (Ireland) Limited
PO Box 2857
Drynam Road
Swords Co. Dublin
Ireland

Novial

Novial 28

Luxembourg

Organon Europe BV
Kloosterstraat 6
5349 AB Oss
Nederland

Laurina

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Placebo tablets:
(no active substance)

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Placebo tablets:
(no active substance)

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 28 tablets
3 sachets × 1 blister × 28 tablets
6 sachets × 1 blister × 28 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 21 tablets
3 sachets × 1 blister × 21 tablets
6 sachets × 1 blister × 21 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 28 tablets
3 sachets × 1 blister × 28 tablets
6 sachets × 1 blister × 28 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 21 tablets
3 sachets × 1 blister × 21 tablets
6 sachets × 1 blister × 21 tablets

C

5
2
/
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
7
2
2
0
0
4

Member State

Marketing authorisation holder

Invented name

Strengths

Pharmaceutical form

Route of
administration

Packaging

Package sizes

Portugal

Laurina

Organon Portuguesa
Produtos Químicos e
Farmacêuticos
Lda. Avenida Conde de
Valbom, n.o 30 — 2.o
P-1069-037 Lisboa

Laurina 28

Spain

Novial

Organon Española SA
Ctra. De Hospitalet, 147-149
Cityparc Ronda de Dalt Edf.
Amsterdam
E-08940 Cornella de
Llobregat,
Barcelona

Novial 28

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Placebo tablets:
(no active substance)

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Yellow tablets:
50 micrograms desogestrel,
35 micrograms ethinylestradiol

Red tablets:
100 micrograms desogestrel,
30 micrograms ethinylestradiol

White tablets:
150 micrograms desogestrel,
30 micrograms ethinylestradiol

Placebo tablets:
(no active substance)

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 21 tablets
3 sachets × 1 blister × 21 tablets
6 sachets × 1 blister × 21 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 28 tablets
3 sachets × 1 blister × 28 tablets
6 sachets × 1 blister × 28 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 21 tablets
3 sachets × 1 blister × 21 tablets

Film coated tablets Oral use

Blister (PVC/Alu)

1 sachets × 1 blister × 28 tablets
3 sachets × 1 blister × 28 tablets

.

.

2
7
2
2
0
0
4

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

5
2
/
1
9