Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 January 2006  to  31 January 2006  (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2006-02-24
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

24.2.2006

EN

Official Journal of the European Union

C 46/25

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 January 2006 to 31 January 2006

(Decisions

taken pursuant

to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive

2001/82/EC (2))

(2006/C 46/04)

— 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

9.1.2006

Actilyse

See Annex I

See Annex I

24.1.2006

Ionsys

Janssen-Cilag
International NV,
Turnhoutseweg 30, B-2340 Beerse

This Decision is addressed
to the Member States

Date of
notification

10.1.2006

25.1.2006

24.1.2006

Exubera

Aventis/Pfizer
Ramsgate
Road, Sandwich, Kent CT13 9NJ,
United Kingdom

EEIG,

This Decision is addressed
to the Member States

25.1.2006

31.1.2006

Macugen

Pfizer Limited, Sandwich, Kent
CT13 9NJ, United Kingdom

This Decision is addressed
to the Member States

1.2.2006

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

ANNEX I

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

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Austria

Boehringer Ingelheim Austria GmbH

Actilyse

20, 50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Belgium

n.v. Boehringer Ingelheim s.a.

Actilyse

10, 20, 50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Cyprus

Cyprus Pharm. Organization Ltd.

Actilyse

50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml

Czech Republic

Boehringer Ingelheim International GmbH

Actilyse

10, 20, 50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml

Denmark

Boehringer Ingelheim International GmbH

Actilyse

10, 20, 50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Estonia

Boehringer Ingelheim International GmbH

Actilyse

50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml

Finland

Boehringer Ingelheim International GmbH

Actilyse

10, 20, 50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

France

Boehringer Ingelheim, France

Actilyse

10, 20, 50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Germany

Boehringer Ingelheim Pharma KG

Actilyse

10, 20, 50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Greece

Boehringer Ingelheim Hellas AE

Actilyse

10, 20, 50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Hungary

Boehringer Ingelheim International GmbH

Actilyse

50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml

Ireland

Boehringer Ingelheim Ltd, Royaume-Uni

Actilyse

10, 20, 50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

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Italy

Latvia

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Boehringer Ingelheim Italia spa

Actilyse

20, 50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Boehringer Ingelheim International GmbH

Actilyse

Lituania

Boehringer Ingelheim International GmbH

Actilyse

50 mg

50 mg

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml

Povder and solvent
injection and infusion

for solution for

Intravenous use

1 mg/ml

Luxembourg

n.v. Boehringer Ingelheim s.a., Belgique

Actilyse

10, 20, 50 mg

Malta

Boehringer Ingelheim Ltd., Royaume-Uni

Actilyse

50 mg

Netherlands

Boehringer Ingelheim b.v.

Actilyse

10, 20, 50 mg

Poland

Boehringer Ingelheim International GmbH

Actilyse

10, 20, 50 mg

Portugal

Boehringer Ingelheim, Lda

Actilyse

10, 20, 50 mg

Slovakia

Boehringer Ingelheim International GmbH

Actilyse

20, 50 mg

Slovenia

Boehringer Ingelheim International GmbH

Actilyse

50 mg

Spain

Boehringer Ingelheim International GmbH

Actilyse

10, 20, 50 mg

Sweden

Boehringer Ingelheim International GmbH

Actilyse

10, 20, 50 mg

United Kingdom

Boehringer Ingelheim Ltd.

Actilyse

10, 20, 50 mg

Iceland

Boehringer Ingelheim International GmbH

Actilyse

50 mg

Norway

Boehringer Ingelheim International GmbH

Actilyse

10, 20 50 mg

Powder and solvent for solution for
injection and infusion

Powder and solvent for solution for
injection and infusion

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Intravenous use

1 mg/ml or 2 mg/ml

Intravenous use

1 mg/ml or 2 mg/ml

Powder and solvent for solution for
infusion

Intravenous use

1 mg/ml

Powder and solvent for solution for
injection and infusion

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Intravenous use

1 mg/ml or 2 mg/ml

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml

Powder and solvent for solution for
injection and infusion

Powder and solvent for solution for
injection and infusion

Powder and solvent for solution for
injection and infusion

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Intravenous use

1 mg/ml or 2 mg/ml

Intravenous use

1 mg/ml or 2 mg/ml

Intravenous use

1 mg/ml or 2 mg/ml

Powder and solvent for solution for
injection and infusion

Intravenous use

1 mg/ml

.

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