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Document 52010XC0129(02)
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 November 2009 to 30 November 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 November 2009 to 30 November 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 November 2009 to 30 November 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
OJ C 22, 29.1.2010, p. 13–17
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
29.1.2010 |
EN |
Official Journal of the European Union |
C 22/13 |
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 November 2009 to 30 November 2009
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council (1) or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council (2) )
2010/C 22/03
— Issuing, maintenance or modification of a national marketing authorisation
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorisation |
Member State concerned |
Date of notification |
||||
|
6.11.2009 |
Arimidex |
See Annex |
See Annex |
9.11.2009 |
||||
|
26.11.2009 |
Multaq |
|
This Decision is addressed to the Member States |
30.11.2009 |
(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.
ANNEX
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State (EU/EEA) |
Marketing Authorisation Holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Austria |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Belgium |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Bulgaria |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Cyprus |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Czech Republic |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Denmark |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Estonia |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Finland |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
France |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Germany |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Greece |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Hungary |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Iceland |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Ireland |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Italy |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Latvia |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Lithuania |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Luxembourg |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Malta |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Netherlands |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Norway |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Poland |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Portugal |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Romania |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Slovakia |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Slovenia |
|
Arimidex 1 mg film-coated tablets |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Spain |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
Sweden |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |
||||||
|
United Kingdom |
|
Arimidex |
1 mg |
Film-coated tablets |
Oral |