# C_2006046EN.01002501.xml

| 24.2.2006 | EN | Official Journal of the European Union | C 46/25 |
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24.2.2006

EN

Official Journal of the European Union

C 46/25

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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))

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1

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 | Date of notification |
| --- | --- | --- | --- | --- |
| 9.1.2006 | Actilyse | See Annex I | See Annex I | 10.1.2006 |
| 24.1.2006 | Ionsys | Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse | This Decision is addressed to the Member States | 25.1.2006 |
| 24.1.2006 | Exubera | Aventis/Pfizer EEIG, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | 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 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

9.1.2006

Actilyse

See Annex I

See Annex I

10.1.2006

24.1.2006

Ionsys

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

This Decision is addressed to the Member States

25.1.2006

24.1.2006

Exubera

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

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

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

1

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

2

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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 |
| Italy | 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 |
| Latvia | Boehringer Ingelheim International GmbH | Actilyse | 50 mg | Powder and solvent for solution for injection and infusion | Intravenous use | 1 mg/ml |
| Lituania | Boehringer Ingelheim International GmbH | Actilyse | 50 mg | Povder and solvent for solution for injection and infusion | Intravenous use | 1 mg/ml |
| Luxembourg | n.v. Boehringer Ingelheim s.a., Belgique | Actilyse | 10, 20, 50 mg | Powder and solvent for solution for injection and infusion | Intravenous use | 1 mg/ml or 2 mg/ml |
| Malta | Boehringer Ingelheim Ltd., Royaume-Uni | Actilyse | 50 mg | Powder and solvent for solution for injection and infusion | Intravenous use | 1 mg/ml or 2 mg/ml |
| Netherlands | Boehringer Ingelheim b.v. | Actilyse | 10, 20, 50 mg | Powder and solvent for solution for injection and infusion | Intravenous use | 1 mg/ml or 2 mg/ml |
| Poland | Boehringer Ingelheim International GmbH | Actilyse | 10, 20, 50 mg | Powder and solvent for solution for infusion | Intravenous use | 1 mg/ml |
| Portugal | Boehringer Ingelheim, Lda | Actilyse | 10, 20, 50 mg | Powder and solvent for solution for injection and infusion | Intravenous use | 1 mg/ml or 2 mg/ml |
| Slovakia | Boehringer Ingelheim International GmbH | Actilyse | 20, 50 mg | Powder and solvent for solution for injection and infusion | Intravenous use | 1 mg/ml or 2 mg/ml |
| Slovenia | Boehringer Ingelheim International GmbH | Actilyse | 50 mg | Powder and solvent for solution for injection and infusion | Intravenous use | 1 mg/ml |
| Spain | 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 |
| Sweden | 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 |
| United Kingdom | Boehringer Ingelheim Ltd. | Actilyse | 10, 20, 50 mg | Powder and solvent for solution for injection and infusion | Intravenous use | 1 mg/ml or 2 mg/ml |
| Iceland | Boehringer Ingelheim International GmbH | Actilyse | 50 mg | Powder and solvent for solution for injection and infusion | Intravenous use | 1 mg/ml or 2 mg/ml |
| Norway | Boehringer Ingelheim International GmbH | Actilyse | 10, 20 50 mg | Powder and solvent for solution for injection and infusion | Intravenous use | 1 mg/ml |

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

Italy

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

Latvia

Boehringer Ingelheim International GmbH

Actilyse

50 mg

Powder and solvent for solution for injection and infusion

Intravenous use

1 mg/ml

Lituania

Boehringer Ingelheim International GmbH

Actilyse

50 mg

Povder and solvent for solution for injection and infusion

Intravenous use

1 mg/ml

Luxembourg

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

Actilyse

10, 20, 50 mg

Powder and solvent for solution for injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Malta

Boehringer Ingelheim Ltd., Royaume-Uni

Actilyse

50 mg

Powder and solvent for solution for injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Netherlands

Boehringer Ingelheim b.v.

Actilyse

10, 20, 50 mg

Powder and solvent for solution for injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Poland

Boehringer Ingelheim International GmbH

Actilyse

10, 20, 50 mg

Powder and solvent for solution for infusion

Intravenous use

1 mg/ml

Portugal

Boehringer Ingelheim, Lda

Actilyse

10, 20, 50 mg

Powder and solvent for solution for injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Slovakia

Boehringer Ingelheim International GmbH

Actilyse

20, 50 mg

Powder and solvent for solution for injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Slovenia

Boehringer Ingelheim International GmbH

Actilyse

50 mg

Powder and solvent for solution for injection and infusion

Intravenous use

1 mg/ml

Spain

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

Sweden

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

United Kingdom

Boehringer Ingelheim Ltd.

Actilyse

10, 20, 50 mg

Powder and solvent for solution for injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Iceland

Boehringer Ingelheim International GmbH

Actilyse

50 mg

Powder and solvent for solution for injection and infusion

Intravenous use

1 mg/ml or 2 mg/ml

Norway

Boehringer Ingelheim International GmbH

Actilyse

10, 20 50 mg

Powder and solvent for solution for injection and infusion

Intravenous use

1 mg/ml

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