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Document 52006XC0224(02)
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)
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)
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)
OJ C 46, 24.2.2006, p. 25–27
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
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 |
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 |
(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 |
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 |