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 )
Date: 2010-01-29
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, pharmaceutical product








C_2010022EN.01001301.xml










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







Sanofi-Aventis




174 avenue de France




75013 Paris




FRANCE






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







AstraZeneca Ősterreich GmbH




Schwarzenbergplatz 7




1037 Wien




ÖSTERREICH






Arimidex


1 mg


Film-coated tablets


Oral




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat




1180 Brussel




BELGIË






Arimidex


1 mg


Film-coated tablets


Oral




Bulgaria







AstraZeneca Pharmaceuticals AB




SE-151 85 Södertälje




SVERIGE






Arimidex


1 mg


Film-coated tablets


Oral




Cyprus







AstraZeneca UK LTD




Silk Road Business Park




Macclesfield




Cheshire




SK10 2NA




UNITED KINGDOM






Arimidex


1 mg


Film-coated tablets


Oral




Czech Republic







AstraZeneca UK Ltd




Silk Road Business Park




Macclesfield




Cheshire




SK10 2NA




UNITED KINGDOM






Arimidex


1 mg


Film-coated tablets


Oral




Denmark







AstraZeneca A/S




Roskildevej 22




2620 Albertslund




DANMARK






Arimidex


1 mg


Film-coated tablets


Oral




Estonia







AstraZeneca UK Ltd




15 Stanhope Gate




London




W1K 1LN




UNITED KINGDOM






Arimidex


1 mg


Film-coated tablets


Oral




Finland







AstraZeneca Oy Luomanportti 3




FI-02200 Espoo




SUOMI/FINLAND






Arimidex


1 mg


Film-coated tablets


Oral




France







AstraZeneca




1 place Renault




92844 Rueil-Malmaison Cedex




FRANCE






Arimidex


1 mg


Film-coated tablets


Oral




Germany







AstraZeneca GmbH




22876 Wedel




DEUTSCHLAND






Arimidex


1 mg


Film-coated tablets


Oral




Greece







AstraZeneca S.A.




Theotokopoulou & Astronafton str 4




151 25 Maroussi Athens




GREECE






Arimidex


1 mg


Film-coated tablets


Oral




Hungary







AstraZeneca Kft.




Törökbálint




Park u. 3.




2045




MAGYARORSZÁG/HUNGARY






Arimidex


1 mg


Film-coated tablets


Oral




Iceland







AstraZeneca UK Ltd




Silk Road Business Park




Macclesfield




Cheshire




SK10 2NA




UNITED KINGDOM






Arimidex


1 mg


Film-coated tablets


Oral




Ireland







AstraZeneca UK Limited




600 Capability Green




Luton




LU1 3LU




UNITED KINGDOM






Arimidex


1 mg


Film-coated tablets


Oral




Italy







AstraZeneca S.p.A.




Palazzo Volta




Via F. Sforza




20080 Basiglio Milano MI




ITALIA






Arimidex


1 mg


Film-coated tablets


Oral




Latvia







AstraZeneca UK Limited




Silk Road Business Park




Macclesfield




Cheshire




SK10 2NA




UNITED KINGDOM






Arimidex


1 mg


Film-coated tablets


Oral




Lithuania







AstraZeneca UK Limited




Silk Road Business Park




Macclesfield




Cheshire




SK10 2NA




UNITED KINGDOM






Arimidex


1 mg


Film-coated tablets


Oral




Luxembourg







NV AstraZeneca SA




Rue Egide Van Ophem




1180 Bruxelles




BELGIQUE






Arimidex


1 mg


Film-coated tablets


Oral




Malta







AstraZeneca UK Limited




Silk Road Business Park




Macclesfield




Cheshire




SK10 2NA




UNITED KINGDOM






Arimidex


1 mg


Film-coated tablets


Oral




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




NEDERLAND






Arimidex


1 mg


Film-coated tablets


Oral




Norway







AstraZeneca AS




Hoffsveien 70B




Box 200 Vinderen




0319 Oslo




NORWAY






Arimidex


1 mg


Film-coated tablets


Oral




Poland







AstraZeneca UK Limited




Silk Road Business Park




Macclesfield




Cheshire




SK10 2NA




UNITED KINGDOM






Arimidex


1 mg


Film-coated tablets


Oral




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira 7




Valejas




2745-663 Barcarena




PORTUGAL






Arimidex


1 mg


Film-coated tablets


Oral




Romania







AstraZeneca UK Limited




600 Capability Green




Luton




LU1 3LU




UNITED KINGDOM






Arimidex


1 mg


Film-coated tablets


Oral




Slovakia







AstraZeneca UK Limited




Silk Road Business Park




Macclesfield




Cheshire




SK10 2NA




UNITED KINGDOM






Arimidex


1 mg


Film-coated tablets


Oral




Slovenia







AstraZeneca UK Limited




15 Stanhope Gate




London




W1K 1LN




UNITED KINGDOM






Arimidex 1 mg film-coated tablets


1 mg


Film-coated tablets


Oral




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte




Edificio Roble




C/ Serrano Galvache, 56




28033 Madrid




ESPAÑA






Arimidex


1 mg


Film-coated tablets


Oral




Sweden







AstraZeneca AB




SE-151 85 Södertälje




SVERIGE






Arimidex


1 mg


Film-coated tablets


Oral




United Kingdom







AstraZeneca UK Limited




600 Capability Green




Luton




LU1 3LU




UNITED KINGDOM






Arimidex


1 mg


Film-coated tablets


Oral