Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 December 2005  to  31 December 2005 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2006-01-27
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

C 20/4

EN

Official Journal of the European Union

27.1.2006

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 December 2005 to 31 December 2005

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

(2006/C 20/03)

— 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

19.12.2005

Sertindole

See Annex

See Annex

21.12.2005

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

27.1.2006

EN

Official Journal of the European Union

C 20/5

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

ANNEX

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Austria

Austria

Austria

Austria

Austria

Austria

Belgium

Belgium

Belgium

Belgium

Belgium

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

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

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

8 mg

film coated tablet

Oral use

12 mg

film coated tablet

Oral use

16 mg

film coated tablet

Oral use

20 mg

film coated tablet

Oral use

24 mg

film coated tablet

Oral use

Serdolect

4 mg

film coated tablet

Oral use

Serdolect

8 mg

film coated tablet

Oral use

Serdolect

12 mg

film coated tablet

Oral use

Serdolect

16 mg

film coated tablet

Oral use

Serdolect

20 mg

film coated tablet

Oral use

Serdolect

24 mg

film coated tablet

Oral use

C 20/6

EN

Official Journal of the European Union

27.1.2006

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Estonia

Estonia

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 4 mg

4 mg

film coated tablet

Oral use

Serdolect 12 mg

12 mg

film coated tablet

Oral use

Serdolect 16 mg

16 mg

film coated tablet

Oral use

Serdolect 20 mg

20 mg

film coated tablet

Oral use

Serdolect

4 mg

film coated tablet

Oral use

Serdolect

8 mg

film coated tablet

Oral use

Serdolect

12 mg

film coated tablet

Oral use

Serdolect

16 mg

film coated tablet

Oral use

Serdolect

20 mg

film coated tablet

Oral use

Serdolect

24 mg

film coated tablet

Oral use

Serdolect

4 mg

tablet

Oral use

Serdolect

12 mg

tablet

Oral use

27.1.2006

EN

Official Journal of the European Union

C 20/7

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Estonia

Estonia

Finland

Finland

Finland

Finland

Finland

Finland

France

France

France

France

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

16 mg

tablet

Oral use

Serdolect

20 mg

tablet

Oral use

Serdolect

4 mg

film coated tablet

Oral use

Serdolect

8 mg

film coated tablet

Oral use

Serdolect

12 mg

film coated tablet

Oral use

Serdolect

16 mg

film coated tablet

Oral use

Serdolect

20 mg

film coated tablet

Oral use

Serdolect

24 mg

film coated tablet

Oral use

Serdolect

4 mg

film coated tablet

Oral use

Serdolect

8 mg

film coated tablet

Oral use

Serdolect

12 mg

film coated tablet

Oral use

Serdolect

16 mg

film coated tablet

Oral use

C 20/8

EN

Official Journal of the European Union

27.1.2006

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

France

France

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Greece

Greece

Greece

Greece

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

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

20 mg

film coated tablet

Oral use

Serdolect

24 mg

film coated tablet

Oral use

Zerdol 4 mg

4 mg

film coated tablet

Oral use

Zerdol 8 mg

8 mg

film coated tablet

Oral use

Serdolect 4 mg

4 mg

film coated tablet

Oral use

Serdolect 8 mg

8 mg

film coated tablet

Oral use

Serdolect 12 mg

12 mg

film coated tablet

Oral use

Serdolect 16 mg

16 mg

film coated tablet

Oral use

Serdolect 20 mg

20 mg

film coated tablet

Oral use

Serdolect 24 mg

24 mg

film coated tablet

Oral use

Serdolect

4 mg

film coated tablet

Oral use

Serdolect

8 mg

film coated tablet

Oral use

Serdolect

12 mg

film coated tablet

Oral use

Serdolect

16 mg

film coated tablet

Oral use

27.1.2006

EN

Official Journal of the European Union

C 20/9

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Greece

Greece

Hungary

Hungary

Hungary

Hungary

Iceland

Iceland

Iceland

Iceland

Iceland

Iceland

Ireland

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

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

film coated tablet

Oral use

Serdolect

24 mg

film coated tablet

Oral use

Serdolect

4 mg

Film coated tablet

Oral use

Serdolect

12 mg

Film coated tablet

Oral use

Serdolect

16 mg

Film coated tablet

Oral use

Serdolect

20 mg

Film coated tablet

Oral use

Serdolect

4 mg

Film coated tablet

Oral use

Serdolect

8 mg

Film coated tablet

Oral use

Serdolect

12 mg

Film coated tablet

Oral use

Serdolect

16 mg

Film coated tablet

Oral use

Serdolect

20 mg

Film coated tablet

Oral use

Serdolect

24 mg

Film coated tablet

Oral use

Serdolect

4 mg

film coated tablet

Oral use

C 20/10

EN

Official Journal of the European Union

27.1.2006

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Ireland

Ireland

Ireland

Ireland

Ireland

Italy

Italy

Italy

Italy

Italy

Italy

Latvia

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

8 mg

film coated tablet

Oral use

Serdolect

12 mg

film coated tablet

Oral use

Serdolect

16 mg

film coated tablet

Oral use

Serdolect

20 mg

film coated tablet

Oral use

Serdolect

24 mg

film coated tablet

Oral use

Serdolect

4 mg

film coated tablet

Oral use

Serdolect

8 mg

film coated tablet

Oral use

Serdolect

12 mg

film coated tablet

Oral use

Serdolect

16 mg

film coated tablet

Oral use

Serdolect

20 mg

film coated tablet

Oral use

Serdolect

24 mg

film coated tablet

Oral use

Serdolect 4 mg

4 mg

Film coated tablets

Oral use

27.1.2006

EN

Official Journal of the European Union

C 20/11

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Latvia

Latvia

Latvia

Lithuania

Lithuania

Lithuania

Lithuania

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Netherlands

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

Lundbeck SA
225 Avenue Molière
B-1050 Brussels

Lundbeck SA
225 Avenue Molière
B-1050 Brussels

Lundbeck SA
225 Avenue Molière
B-1050 Brussels

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

Serdolect 12 mg

12 mg

Film coated tablets

Oral use

Serdolect 16 mg

16 mg

Film coated tablets

Oral use

Serdolect 20 mg

20 mg

Film coated tablets

Oral use

Serdolect

4 mg

Film coated tablets

Oral use

Serdolect

12 mg

Film coated tablets

Oral use

Serdolect

16 mg

Film coated tablets

Oral use

Serdolect

20 mg

Film coated tablets

Oral use

Serdolect

4 mg

film coated tablet

Oral use

Serdolect

8 mg

film coated tablet

Oral use

Serdolect

12 mg

film coated tablet

Oral use

Serdolect

16 mg

film coated tablet

Oral use

Serdolect

20 mg

film coated tablet

Oral use

Serdolect

24 mg

film coated tablet

Oral use

Serdolect 4 mg

4 mg

film coated tablet

Oral use

C 20/12

EN

Official Journal of the European Union

27.1.2006

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Netherlands

Netherlands

Netherlands

Netherlands

Netherlands

Norway

Norway

Norway

Norway

Poland

Poland

Poland

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 8 mg

8 mg

film coated tablet

Oral use

Serdolect 12 mg

12 mg

film coated tablet

Oral use

Serdolect 16 mg

16 mg

film coated tablet

Oral use

Serdolect 20 mg

20 mg

film coated tablet

Oral use

Serdolect 24 mg

24 mg

film coated tablet

Oral use

Serdolect

4 mg

Film coated tablet

Oral use

Serdolect

12 mg

Film coated tablet

Oral use

Serdolect

16 mg

Film coated tablet

Oral use

Serdolect

20 mg

Film coated tablet

Oral use

Serdolect

4 mg

Film coated tablet

Oral use

Serdolect

12 mg

Film coated tablet

Oral use

Serdolect

16 mg

Film coated tablet

Oral use

27.1.2006

EN

Official Journal of the European Union

C 20/13

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Poland

Portugal

Portugal

Portugal

Portugal

Slovakia

Slovakia

Slovakia

Slovakia

Spain

Spain

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
Otillavej 7-9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Otillavej 7-9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Otillavej 7-9
Valby
DK-2500 Copenhagen

Serdolect

20 mg

Film coated tablet

Oral use

Serdolect

4 mg

Film coated tablet

Oral use

Serdolect

12 mg

Film coated tablet

Oral use

Serdolect

16 mg

Film coated tablet

Oral use

Serdolect

20 mg

Film coated tablet

Oral use

Serdolect 4 mg

4 mg

Film coated tablet

Oral use

Serdolect 12 mg

12 mg

Film coated tablet

Oral use

Serdolect 16 mg

16 mg

Film coated tablet

Oral use

Serdolect 20 mg

20 mg

Film coated tablet

Oral use

Serdolect

4 mg

film coated tablet

Oral use

Serdolect

8 mg

film coated tablet

Oral use

Serdolect

12 mg

film coated tablet

Oral use

C 20/14

EN

Official Journal of the European Union

27.1.2006

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Spain

Spain

Spain

Sweden

Sweden

Sweden

Sweden

UK

UK

UK

UK

UK

UK

H. Lundbeck A/S
Otillavej 7-9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Otillavej 7-9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Otillavej 7-9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Otillavej 7-9
Valby
DK-2500 Coepnhagen

H. Lundbeck A/S
Otillavej 7-9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Otillavej 7-9
Valby
DK-2500 Copenhagen

H. Lundbeck A/S
Otillavej 7-9
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

16 mg

film coated tablet

Oral use

Serdolect

20 mg

film coated tablet

Oral use

Serdolect

24 mg

film coated tablet

Oral use

Serdolect

4 mg

Film coated tablet

Oral use

Serdolect

12 mg

Film coated tablet

Oral use

Serdolect

16 mg

Film coated tablet

Oral use

Serdolect

20 mg

Film coated tablet

Oral use

Serdolect

4 mg

film coated tablet

Oral use

Serdolect

8 mg

Film coated tablet

Oral use

Serdolect

12 mg

film coated tablet

Oral use

Serdolect

16 mg

film coated tablet

Oral use

Serdolect

20 mg

film coated tablet

Oral use

Serdolect

24 mg

Film coated tablet

Oral use