Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 June to 15 July 2002 (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: 2002-07-26
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, medicinal product, pharmaceutical product, preparation for market

C 178/8

EN

Official Journal of the European Communities

26.7.2002

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 June to 15 July 2002

(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))

(2002/C 178/05)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision

Name(s) of the
medicinal product

Holder(s) of the
marketing authorisation

Member State concerned

Date of notification

26.6.2002

Midazolam

See Annex I

See Annex I

27.6.2002

— Lift of suspension of a marketing authorisation

Date of the decision

Name(s) of the
medicinal product

Holder(s) of the
marketing authorisation

Member State concerned

Date of notification

26.6.2002

Sertindole

See Annex II

See Annex II

27.6.2002

(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

.

.

2
6
7
2
0
0
2

Member State

Marketing authorisation
holder address

Marketing
authorisation
holder telephone
(contact person)

Marketing
authorisation
holder fax

Product name

Strength

Pharma-
ceutical form

Route of administration

Packaging

Concentration

Package size

AUSTRIA

Roche Austria GmbH
Engelhorngasse 3
A-1211 Wien

(43-1)
27 73 92 89
C. Wachter

(43-1)
27 73 92 54

Dormicum 5 mg/5 ml
5 mg/1 ml
15 mg/3 ml
50 mg/10 ml

Solution
for
injection

BELGIUM

NV Roche SA
Rue Dante 75
B-1070 Bruxelles

(32-2)
525 82 41
A. De Wilde

(32-2)
525 82 95

Dormicum 5 mg/5 ml

15 mg/3 ml
50 mg/10 ml

Solution
for
injection

Glass
ampoules
white

5 mg/5 ml — i.v., i.m.,
rectal
5 mg/1 ml — i.v., i.m.,
rectal
15 mg/3 ml — i.v., i.m.,
rectal
50 mg/10 ml — i.v.,
rectal

i.m.,

5 mg/5 ml —
1 mg/ml
5 mg/1 ml —
5 mg/ml
15 mg/3 ml —
5 mg/ml
50 mg/10 ml —
5 mg/ml

5 mg/5 ml —
10 amps.
5 mg/1 ml —
10 amps.
15 mg/3 ml —
5 amps.
50 mg/10 ml —
5 amps.

5 mg/5 ml — i.v., i.m.,
rectal
15 mg/3 ml — i.v., i.m.
50 mg/10 ml — i.v.,
perfusion

Colourless
Glass
ampoules

5 mg/5 ml —
1 mg/ml
15 mg/3 ml —
5 mg/ml
50 mg/10 ml —
5 mg/ml

5 mg/5 ml —
1 amps.
15 mg/3 ml —
2 amps.
50 mg/10 ml —
5 amps.

DENMARK

Roche a/s
Industriholmen 59
DK-2650 Hvidovre

(45) 36 39 98 20
Johanna Nielsen

(45)
36 39 98 00

Dormicum 5 mg/5 ml
5 mg/1 ml
15 mg/3 ml
50 mg/10 ml

Solution
for
injection

5 mg/5 ml — i.v.
5 mg/1 ml — i.v., i.m.
15 mg/3 ml — i.v., i.m.
50 mg/10 ml — i.v., i.m.

Glass
ampoules

FINLAND

Roche Oy
Sinimäentie 10 A
PO Box 12
FIN-02630 Espoo

(358-9)
52 53 33 32
S. Fagerstrom

(358-9)
52 53 33 50

Dormicum 5 mg/5 ml

15 mg/3 ml
50 mg/10 ml

Solution
for
injection

5 mg/5 ml — i.v., i.m.
15 mg/3 ml — i.v., i.m.
50 mg/10 ml — i.v.

Glass
ampoules

5 mg/5 ml —
1 mg/ml
5 mg/1 ml —
5 mg/ml
15 mg/3 ml —
5 mg/ ml
50 mg/10 ml —
5 mg/ml

5 mg/5 ml —
10 amps.
5 mg/1 ml —
10 amps.
15 mg/3 ml —
5 amps.
50 mg/10 ml —
5 amps.

5 mg/5 ml —
1 mg/ml
15 mg/3 ml —
5 mg/ml
50 mg/10 ml —
5 mg/ml

5 mg/5 ml —
10 amps.
15 mg/3 ml —
5 amps.
50 mg/10 ml —
5 amps.

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
C
o
m
m
u
n
i
t
i
e
s

C

1
7
8
/
9

Member State

Marketing authorisation
holder address

Marketing
authorisation
holder telephone
(contact person)

Marketing
authorisation
holder fax

Product name

Strength

Pharma-
ceutical form

Route of administration

Packaging

Concentration

Package size

FRANCE

Produits Roche
52, bd du Parc
F-92521 Neuilly-sur-Seine
Cedex

(33-1)
46 40 27 92
B. Marchenay

(33-1)
46 40 52 66

(Versed for
2 mg/2 ml)
Hypnovel

Solution
for
injection

2 mg/2 ml
5 mg/5 ml
5 mg/1 ml
15 mg/3 ml
50 mg/10 ml

Glass
ampoules

2 mg/2 ml — i.v.
5 mg/5 ml — i.v., i.m.,
rectal
5 mg/1 ml — i.m., rectal
15 mg/3 ml — i.m., rectal
50 mg/10 ml — i.v.

GERMANY

Hoffmann-La Roche AG
Emil-Barell-Straße 1
Postfach 1270
D-79639 Grenzach-
Wyhlen

(49-762)
414 33 10
A. Zeissler

(49-762)
414 54 36

Dormicum 5 mg/5 ml
5 mg/1 ml
15 mg/3 ml
50 mg/10 ml

Solution
for
injection

Colourless
type I glass
ampoules

5 mg/5 ml — i.m. or i.v.
injection
5 mg/1 ml — i.m. or i.v.
injection
15 mg/3 ml — i.m. or i.v.
injection
50 mg/10 ml — i.v.
injection

GREECE

Roche (Hellas) SA
4, Alamanas & Delfon
Street
GR-15125 Maroussi

(30-1) 616 61 56
K. Tzogani

(30-1)
619 64 92

Dormicum 5 mg/5 ml

15 mg/3 ml
50 mg/10 ml

Solution
for
injection

5 mg/5 ml — i.v., i.m.,
rectal
15 mg/3 ml — i.v., i.m.
50 mg/10 ml — i.v.

Glass
ampoules

ICELAND

F. Hoffmann-La Roche Ltd
CH-4070 Basel

(45) 36 39 98 20
Johanna Nielsen
(Roche Denmark)

(45)
36 39 98 00

Dormicum 5 mg/5 ml
5 mg/1 ml
15 mg/3 ml
50 mg/10 ml

Solution
for
injection

5 mg/5 ml — i.v.
5 mg/1 ml — i.v., i.m.
15 mg/3 ml — i.v., i.m.
50 mg/10 ml — i.v., i.m.

Glass
ampoules

2 mg/2 ml —
1 mg/ml
5 mg/5 ml —
1 mg/ml
5 mg/1 ml —
5 mg/ml
15 mg/3 ml —
5 mg/ml
50 mg/10 ml —
5 mg/ml

5 mg/5 ml —
1 mg/ml
5 mg/1 ml —
5 mg/ml
15 mg/3 ml —
5 mg/ml
50 mg/10 ml —
5 mg/ml

2 mg/2 ml —
2 amps.
5 mg/5 ml —
1, 6 amps.
5 mg/1 ml —
6 amps.
15 mg/3 ml —
6 amps.
50 mg/10 ml —
1, 6 amps.

5 mg/5 ml —
5 amps.
5 mg/1 ml —
5, 25 amps.
15 mg/3 ml —
5 amps.
50 mg/10 ml —
5 amps.

5 mg/5 ml —
1 mg/ml
15 mg/3 ml —
5 mg/ml
50 mg/10 ml —
5 mg/ml

5 mg/5 ml —
10 amps.
15 mg/3 ml —
5 amps.
50 mg/10 ml —
5 amps.

5 mg/5 ml —
1 mg/ml
5 mg/1 ml —
5 mg/ml
15 mg/3 ml —
5 mg/ml
50 mg/10 ml —
5 mg/ml

5 mg/5 ml —
10 amps.
5 mg/1 ml —
10 amps.
15 mg/3 ml —
5 amps.
50 mg/10 ml —
5 amps.

C

1
7
8
/
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
C
o
m
m
u
n
i
t
i
e
s

.

.

2
6
7
2
0
0
2

Member State

Marketing authorisation
holder address

Marketing
authorisation
holder telephone
(contact person)

Marketing
authorisation
holder fax

Product name

Strength

Pharma-
ceutical form

Route of administration

Packaging

Concentration

Package size

IRELAND

Roche Products Limited
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

(44-1707)
36 56 10
C. Robson

(44-1707)
37 78 38

Hypnovel

10 mg/2 ml
10 mg/5 ml

ITALY

Roche SpA
Piazza Durante, 11
I-20131 Milano

(39-03)
92 47 44 36
A. Chiarotti

(39-03)
92 47 47 40

Ipnovel

5 mg/1 ml
15 mg/3 ml

LUXEMBOURG NV Roche SA
Rue Dante, 75
B-1070 Bruxelles

(32-2) 525 82 41
A. De Wilde

(32-2)
525 82 95

Dormicum 5 mg/5 ml

15 mg/3 ml
50 mg/10 ml

Solution
for
injection

Solution
for
injection

Solution
for
injection

10 mg/2 ml — i.v., i.m.
10 mg/5 ml — i.v.

Glass
ampoules

10 mg/2 ml —
5 mg/ml
10 mg/5 ml —
2 mg/ml

10 mg/2 ml —
10 amps.
10 mg/5 ml —
10 amps.

5 mg/1 ml — i.v., i.m.
15 mg/3 ml — i.v., i.m.

Ampoules

5 mg/1 ml —
5 mg/ml
15 mg/3 ml —
5 mg/ml

5 mg/1 ml —
1 amps.
15 mg/3 ml —
1 amps.

5 mg/5 ml — i.v., i.m.,
rectal
15 mg/3 ml — i.v., i.m.
50 mg/10 ml — i.v.,
perfusion

Glass
ampoules

5 mg/5 ml —
1 mg/ml
15 mg/3 ml —
5 mg/ml
50 mg/10 ml —
5 mg/ml

5 mg/5 ml —
1 amp.
15 mg/3 ml —
2 amps.
50 mg/10 ml —
5 amps.

NETHERLANDS Roche Nederland BV

Nijverheidsweg 38
PO Box 42
3640 AA Mijdrecht
Nederland

(31)
297 23 20 94
T. Van Oesch

(31)
297 23 20 93

Dormicum 5 mg/5 ml
5 mg/1 ml
15 mg/3 ml
50 mg/10 ml

Solution
for
injection

5 mg/5 ml — i.v., i.m.
5 mg/1 ml — i.v., i.m.
15 mg/3 ml — i.v., i.m.
50 mg/10 ml — i.v., i.m.

Ampoules

NORWAY

F. Hoffmann-La Roche Ltd
CH-4070 Basel

(47) 22 78 90 34
M. Stroem

(47)
22 78 90 99

Dormicum 5 mg/5 ml
5 mg/1 ml
15 mg/3 ml

Solution
for
injection

5 mg/5 ml — i.m.
5 mg/1 ml — i.v.
15 mg/3 ml — i.v.

Ampoules

5 mg/5 ml —
1 mg/ml
5 mg/1 ml —
5 mg/ml
15 mg/3 ml —
5 mg/ml
50 mg/10 ml —
5 mg/ml

5 mg/5 ml —
10 amps.
5 mg/1 ml —
10 amps.
15 mg/3 ml —
5 amps.
50 mg/10 ml —
5 amps.

5 mg/5 ml —
1 mg/ml
5 mg/1 ml —
5 mg/ml
15 mg/3 ml —
5 mg/ml

5 mg/5 ml —
10 amps.
5 mg/1 ml —
10 amps.
15 mg/3 ml —
10 amps.

.

.

2
6
7
2
0
0
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
C
o
m
m
u
n
i
t
i
e
s

C

1
7
8
/
1
1

Member State

Marketing authorisation
holder address

Marketing
authorisation
holder telephone
(contact person)

Marketing
authorisation
holder fax

Product name

Strength

Pharma-
ceutical form

Route of administration

Packaging

Concentration

Package size

PORTUGAL

Roche Farmacêutica
Quimica, Lda
Estrada Nacional, 249-1
P-2720-413 Amadora

(351)
214 25 70 97
Clara Saragoca

(351)
214 18 66 77

Dormicum 15 mg/3 ml

50 mg/10 ml

Solution
for
injection

15 mg/3 ml — i.v.,
infusion, rectal
50 mg/10 ml — i.v.,
infusion, rectal

i.m.,

i.m.,

Glass
ampoules
type I

15 mg/3 ml —
5 mg/ml
50 mg/10 ml —
5 mg/ml

15 mg/3 ml —
5 amps.
50 mg/10 ml —
5 amps.

SPAIN

Productos Roche, SA
Josefa Valcárcel, 42
E-28027 Madrid

(34-91)
324 82 53
A. Rivas

(34-91)
324 81 54

Dormicum 5 mg/5 ml

15 mg/3 ml

Solution
for
injection

5 mg/5 ml — i.v., i.m.,
rectal
15 mg/3 ml — i.v., i.m.

Glass
ampoules
type I

SWEDEN

Roche AB
Box 47327
S-100 74 Stockholm

(46-8) 726 12 95
L. Knoph

(46-8)
744 06 81

Dormicum 5 mg/1 ml
5 mg/5 ml
15 mg/3 ml
50 mg/10 ml

Solution
for
injection

5 mg/1 ml — i.v.
5 mg/5 ml — i.v.
15 mg/3 ml — i.v.
50 mg/10 ml — i.v.

Glass
ampoules
type I

UNITED
KINGDOM

Roche Products Limited
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

(44-707)
36 56 10
C. Robson

(44-1707)
37 78 38

Hypnovel

10 mg/2 ml
10 mg/5 ml

Solution
for
injection

10 mg/2 ml — i.v., i.m.
10 mg/5 ml — i.v.

Glass
ampoules

5 mg/5 ml —
1 mg/ml
15 mg/3 ml —
5 mg/ml

5 mg/5 ml —
10 amps.
15 mg/3 ml —
5 amps.

5 mg/5 ml —
1 mg/ml
5 mg/1 ml —
5 mg/ml
15 mg/3 ml —
5 mg/ml
50 mg/10 ml —
5 mg/ml

5 mg/5 ml —
10 amps.
5 mg/1 ml —
10 amps.
15 mg/3 ml —
5 amps.
50 mg/10 ml —
5 amps.

10 mg/2 ml —
5 mg/ml
10 mg/5 ml —
2 mg/ml

10 mg/2 ml —
10 amps.
10 mg/5 ml —
10 amps.

C

1
7
8
/
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
C
o
m
m
u
n
i
t
i
e
s

.

.

2
6
7
2
0
0
2

26.7.2002

EN

Official Journal of the European Communities

C 178/13

ANNEX II

LIST OF THE NAMES OF THE MEDICINAL PRODUCTS, MARKETING AUTHORISATION HOLDERS,
STRENGTHS, PHARMACEUTICAL FORMS, ROUTE OF ADMINISTRATION, PACKAGING AND PACKAGE
SIZES IN THE MEMBER STATES

SERTINDOLE-CONTAINING MEDICINAL PRODUCTS WITH MARKETING AUTHORISATION IN THE EUROPEAN
UNION

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

AUSTRIA

BELGIUM

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

Serdolect 4 mg
Filmtabletten

4 mg

Film-coated
tablet

Oral use

Serdolect 8 mg
Filmtabletten

8 mg

Film-coated
tablet

Oral use

Serdolect 12 mg
Filmtabletten

12 mg

Film-coated
tablet

Oral use

Serdolect 16 mg
Filmtabletten

16 mg

Film-coated
tablet

Oral use

Serdolect 20 mg
Filmtabletten

20 mg

Film-coated
tablet

Oral use

Serdolect 24 mg
Filmtabletten

24 mg

Film-coated
tablet

Oral use

Blister
Polypropylene
container

Blister
Polypropylene
container

Blister
Polypropylene
container

Blister
Polypropylene
container

Blister
Polypropylene
container

Blister
Polypropylene
container

30
100

28
100

28
100

28
100

28
100

28
100

Serdolect

4 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

8 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

12 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

16 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

20 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

C 178/14

EN

Official Journal of the European Communities

26.7.2002

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

BELGIUM
(cont’d)

DENMARK

FINLAND

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

Serdolect

24 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

4 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

8 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

12 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

16 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

20 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

24 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

Serdolect

4 mg

Film-coated
tablet

Oral use

Blister
Polypropylene
container

30
100

Serdolect

8 mg

Film-coated
tablet

Oral use

Not applicable

Not applicable

Serdolect

12 mg

Film-coated
tablet

Oral use

Serdolect

16 mg

Film-coated
tablet

Oral use

Serdolect

20 mg

Film-coated
tablet

Orale use

Blister
Polypropylene
container

Blister
Polypropylene
container

Blister
Polypropylene
container

28
100

28
100

28
100

26.7.2002

EN

Official Journal of the European Communities

C 178/15

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

FINLAND
(cont’d)

GERMANY

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

Serdolect

24 mg

Film-coated
tablet

Oral use

Not applicable

Not applicable

Zerdol 4 mg

4 mg

Film-coated
tablet

Oral use

Blister

20
100 (5 × 20)

Zerdol 8 mg

8 mg

Film-coated
tablet

Oral use

Blister

Zerdol 12 mg

12 mg

Film-coated
tablet

Oral use

Blister

Zerdol 16 mg

16 mg

Film-coated
tablet

Oral use

Blister

Zerdol 20 mg

20 mg

Film-coated
tablet

Oral use

Blister

Zerdol 24 mg

24 mg

Film-coated
tablet

Oral use

Blister

20
50
100 (5 × 20)

20
50
100 (5 × 20)

20
50
100 (5 × 20)

20
50
100 (5 × 20)

20
50
100 (5 × 20)

Serdolect 4 mg

4 mg

Film-coated
tablet

Oral use

Blister

20
100 (5 × 20)

Serdolect 8 mg

8 mg

Film-coated
tablet

Oral use

Blister

Serdolect 12 mg

12 mg

Film-coated
tablet

Oral use

Blister

Serdolect 16 mg

16 mg

Film-coated
tablet

Oral use

Blister

Serdolect 20 mg

20 mg

Film-coated
tablet

Oral use

Blister

20
50
100 (5 × 20)

20
50
100 (5 × 20)

20
50
100 (5 × 20)

20
50
100 (5 × 20)

C 178/16

EN

Official Journal of the European Communities

26.7.2002

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

GERMANY
(cont’d)

GREECE

IRELAND

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

Serdolect 24 mg

24 mg

Film-coated
tablet

Oral use

Blister

20
50
100 (5 × 20)

Lundbeck Hellas
Kifisias 64
GR-15125 Marousi

Lundbeck Hellas
Kifisias 64
GR-15125 Marousi

Lundbeck Hellas
Kifisias 64
GR-15125 Marousi

Lundbeck Hellas
Kifisias 64
GR-15125 Marousi

Lundbeck Hellas
Kifisias 64
GR-15125 Marousi

Lundbeck Hellas
Kifisias 64
GR-15125 Marousi

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

Serdolect

4 mg

Film-coated
tablet

Oral use

Blister

Serdolect

8 mg

Film-coated
tablet

Oral use

Blister

Serdolect

12 mg

Film-coated
tablet

Oral use

Blister

Serdolect

16 mg

Film-coated
tablet

Oral use

Blister

Serdolect

20 mg

Film-coated
tablet

Oral use

Blister

Serdolect

24 mg

Film-coated
tablet

Oral use

Blister

30

20
28

20
28

20
28

20
28

20
28

Serdolect

4 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect

8 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect

12 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect

16 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect

20 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect

24 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

26.7.2002

EN

Official Journal of the European Communities

C 178/17

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

ITALY

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

Serdolect

4 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect

8 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect

12 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect

16 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect

20 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect

24 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

LUXEMBOURG

Lundbeck SA
225 Avenue Molière
B-1050 Brussels

Serdolect

4 mg

Film-coated
tablet

Oral use

Blister

NETHERLANDS

Lundbeck SA
225 Avenue Molière
B-1050 Brussels

Lundbeck SA
225 Avenue Molière
B-1050 Brussels

Lundbeck SA
225 Avenue Molière
B-1050 Brussels

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

Serdolect

12 mg

Film-coated
tablet

Oral use

Blister

Serdolect

16 mg

Film-coated
tablet

Oral use

Blister

Serdolect

20 mg

Film-coated
tablet

Oral use

Blister

30

28

28

28

Serdolect 4 mg

4 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect 8 mg

8 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect 12 mg

12 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

C 178/18

EN

Official Journal of the European Communities

26.7.2002

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

NETHERLANDS
(cont’d)

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

Serdolect 16 mg

16 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

PORTUGAL

SPAIN

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

Serdolect 20 mg

20 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect 24 mg

24 mg

Film-coated
tablet

Oral use

Blister

Polyproylene
container

Serdolect

4 mg

Coated tablet

Oral use

Blister

30

Serdolect

12 mg

Coated tablet

Oral use

Blister

28

Serdolect

16 mg

Coated tablet

Oral use

Blister

28

Serdolect

20 mg

Coated tablet

Oral use

Blister

28

Serdolect

4 mg

Film-coated
tablet

Oral use

Blister

Serdolect

8 mg

Film-coated
tablet

Oral use

Blister

30
98

28

Serdolect

12 mg

Film-coated
tablet

Oral use

Blister

28

Serdolect

16 mg

Film-coated
tablet

Oral use

Blister

28

Serdolect

20 mg

Film-coated
tablet

Oral use

Blister

28

26.7.2002

EN

Official Journal of the European Communities

C 178/19

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

SPAIN
(cont’d)

UNITED
KINGDOM

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Ottiliavej 9
Valby
DK-2500 Copenhagen

Serdolect

24 mg

Film-coated
tablet

Oral use

Blister

28

Serdolect

4 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

8 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

12 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

16 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

20 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

Serdolect

24 mg

Film-coated
tablet

Oral use

Blister

Polypropylene
container

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100

20, 28, 30, 50,
98, 100
100