Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 February 2001 to 15 March 2001 (Decisions taken pursuant to Article 14 of Directive 75/319/EEC or Article 22 of Directive 81/851/EEC)
Date: 2001-03-30
Institutions: European Commission
Subjects: market approval, marketing, medicinal product, pharmaceutical legislation

30.3.2001

EN

Official Journal of the European Communities

C 100/5

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 February 2001 to 15 March 2001

(Decisions taken pursuant to Article 14 of Directive 75/319/EEC (1) or Article 22 of Directive 81/851/EEC (2))

(cid:151) Suspension of a national marketing authorisation

(2001/C 100/03)

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the marketing authorisation

Member State concerned

Date of
notification

22.2.2001

Sertindole

See Annex

See Annex

23.2.2001

(1) OJ L 147, 9.6.1975, p. 13; as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).
(2) OJ L 317, 6.11.1981, p. 1; as last amended by Directive 93/40/EEC (OJ L 214, 24.8.1993, p. 31).

ANNEX

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

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

AUSTRIA

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

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

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

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

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

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

Serdolect
4 mg
Filmtabletten

Serdolect
8 mg
Filmtabletten

Serdolect
12 mg
Filmtabletten

Serdolect
16 mg
Filmtabletten

Serdolect
20 mg
Filmtabletten

Serdolect
24 mg
Filmtabletten

4 mg

Film-coated tablet Oral use

Blister

8 mg

Film-coated tablet Oral use

Blister

12 mg

Film-coated tablet Oral use

Blister

16 mg

Film-coated tablet Oral use

Blister

20 mg

Film-coated tablet Oral use

Blister

24 mg

Film-coated tablet Oral use

Blister

30

28

28

28

28

28

C 100/6

EN

Official Journal of the European Communities

30.3.2001

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

BELGIUM

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

Serdolect

4 mg

Film-coated tablet Oral use

Blister

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

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

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

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

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

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

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

30.3.2001

EN

Official Journal of the European Communities

C 100/7

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

DENMARK

FINLAND

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

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

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

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

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

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

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

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

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

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

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

Serdolect

4 mg

Film-coated tablet Oral use

Blister

Serdolect

8 mg

Film-coated tablet Oral use

Not applicable

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

Not applicable

Serdolect

4 mg

Film-coated tablet Oral use

Blister

Serdolect

8 mg

Film-coated tablet Oral use

Not applicable

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

30
100

Not
applicable

28
100

28
100

28
100

Not
applicable

30

100

Not
applicable

28

100

28

100

28

100

C 100/8

EN

Official Journal of the European Communities

30.3.2001

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

FINLAND
(cont(cid:146)d)

GERMANY

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

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

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

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

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

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

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

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

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

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

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

Serdolect

24 mg

Film-coated tablet Oral use

Not applicable

Not
applicable

Zerdol 4 mg

4 mg

Film-coated tablet Oral use

Blister

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

Serdolect
4 mg

Serdolect
8 mg

Serdolect
12 mg

Serdolect
16 mg

4 mg

Film-coated tablet Oral use

Blister

8 mg

Film-coated tablet Oral use

Blister

12 mg

Film-coated tablet Oral use

Blister

16 mg

Film-coated tablet Oral use

Blister

20
100

20
50
100

20
50
100

20
50
100

20
50
100

20
50
100

20
100

20
50
100

20
50
100

20
50
100

30.3.2001

EN

Official Journal of the European Communities

C 100/9

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

GERMANY
(cont(cid:146)d)

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

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

Serdolect
20 mg

Serdolect
24 mg

20 mg

Film-coated tablet Oral use

Blister

24 mg

Film-coated tablet Oral use

Blister

GREECE

Lundbeck Hellas
Kifisias 64
GR-15125 Marousi

Serdolect

4 mg

Film-coated tablet Oral use

Blister

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

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

IRELAND

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

Serdolect

4 mg

Film-coated tablet Oral use

Blister

Polypropylene
container

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

Serdolect

8 mg

Film-coated tablet Oral use

Blister

Polypropylene
container

20
50
100

20
50
100

30

20
28

20
28

20
28

20
28

20

20
28
30
50
98
100

100

20
28
30
50
98
100

100

C 100/10

EN

Official Journal of the European Communities

30.3.2001

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

IRELAND
(cont(cid:146)d)

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

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

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

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

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

ITALY

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

Serdolect

4 mg

Film-coated tablet Oral use

Blister

Polypropylene
container

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

Serdolect

8 mg

Film-coated tablet Oral use

Blister

Polypropylene
container

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

30.3.2001

EN

Official Journal of the European Communities

C 100/11

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

ITALY
(cont(cid:146)d)

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

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

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

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

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

LUXEMBOURG

Lundbeck SA
225, Avenue MoliŁre
B-1050 Bruxelles

Serdolect

4 mg

Film-coated tablet Oral use

Blister

Polypropylene
container

Lundbeck SA
225, Avenue MoliŁre
B-1050 Bruxelles

Lundbeck SA
225, Avenue MoliŁre
B-1050 Bruxelles

Lundbeck SA
225, Avenue MoliŁre
B-1050 Bruxelles

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

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

30

28

28

28

C 100/12

EN

Official Journal of the European Communities

30.3.2001

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

NETHERLANDS

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

Serdolect
4 mg

4 mg

Film-coated tablet Oral use

Blister

Polypropylene
container

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

Serdolect
8 mg

8 mg

Film-coated tablet Oral use

Blister

Polypropylene
container

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

Serdolect
12 mg

12 mg

Film-coated tablet Oral use

Blister

Polypropylene
container

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

Serdolect
16 mg

16 mg

Film-coated tablet Oral use

Blister

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

Serdolect
20 mg

20 mg

Film-coated tablet Oral use

Blister

Polypropylene
container

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

Serdolect
24 mg

24 mg

Film-coated tablet Oral use

Blister

Polypropylene
container

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

30.3.2001

EN

Official Journal of the European Communities

C 100/13

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

PORTUGAL

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

Serdolect

4 mg

Coated tablet

Oral use

Blister

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

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

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

Serdolect

12 mg

Coated tablet

Oral use

Blister

Serdolect

16 mg

Coated tablet

Oral use

Blister

Serdolect

20 mg

Coated tablet

Oral use

Blister

SPAIN

Lundbeck Espaæa
Avda. Diagonal, 605, 9o, 1a
E-08028 Barcelona

Serdolect

4 mg

Film-coated tablet Oral use

Blister

Lundbeck Espaæa
Avda. Diagonal, 605, 9o, 1a
E-08028 Barcelona

Lundbeck Espaæa
Avda. Diagonal, 605, 9o, 1a
E-08028 Barcelona

Lundbeck Espaæa
Avda. Diagonal, 605, 9o, 1a
E-08028 Barcelona

Lundbeck Espaæa
Avda. Diagonal, 605, 9o, 1a
E-08028 Barcelona

Lundbeck Espaæa
Avda. Diagonal, 605, 9o, 1a
E-08028 Barcelona

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

28

28

28

30
98

28

28

28

28

28

C 100/14

EN

Official Journal of the European Communities

30.3.2001

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

UNITED
KINGDOM

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

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

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

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

Serdolect

4 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

28
30

28
30

28
30

28
30

Notification of a cooperation agreement

(Case COMP/38.091/F1 (cid:151) Electrabel/EDF/Endesa/Enel/Iberdrola/National Grid/Nuon/RWE/Scottish
Power/United Utilities/Vattenfall (cid:151) Eutilia)

(2001/C 100/04)

(Text with EEA relevance)

1.
On 26 February 2001 the Commission received a notification of agreements pursuant to Article 4 of
Council Regulation No 17 (1), by which Electrabel SA (Belgium), (cid:201)lectricitØ de France (France), Endesa Net
Factory SL (Spain), Enel SpA (Italy), Iberdrola SA (Spain), National Grid Holdings Limited (UK), NV Nuon
(Netherlands), RWE Systems AG (Germany), Scottish Power UK plc (UK), United Utilities BV (Netherlands)
and Vattenfall AB (Sweden), establish a joint venture named Eutilia (http://www.eutilia.com), an electronic
market place which will be active in the electricity utility related goods and services industry.

The joint venture will operate a comprehensive on-line market place for the procurement of elec-
2.
tricity utility related goods and services and in a later stage also for other utility related goods and services.
It may subsequently expand its activities to supply chain integration services, transaction support services
and hosting services. Eutilia will be open to the entire utility related goods and services industry, including
electricity utilities and suppliers.

Upon preliminary examination, the Commission finds that the notified cooperation agreement could

3.
fall within the scope of Regulation No 17.

The Commission invites interested third parties to submit any observations they may have on the

4.
proposed operation.

Observations must reach the Commission not later than 15 working days following the date of this
reference

5.
publication. Observations can be sent by fax (No (32-2) 295 01 28) or by post under
COMP/38.091/F1 to:

European Commission,
Directorate-General for Competition,
Antitrust Registry,
Rue Joseph II/Jozef II-straat 70,
B-1000 Brussels.

(1) OJ 13, 21.2.1962, p. 204/62.