# C_2010022EN.01001301.xml

| 29.1.2010 | EN | Official Journal of the European Union | C 22/13 |
| --- | --- | --- | --- |

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)
  )

(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

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 |

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

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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

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

AstraZeneca

1 place Renault

92844 Rueil-Malmaison Cedex

FRANCE

Arimidex

1 mg

Film-coated tablets

Oral

Germany

| AstraZeneca GmbH |
| --- |
| 22876 Wedel |
| DEUTSCHLAND |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

AstraZeneca UK Limited

600 Capability Green

Luton

LU1 3LU

UNITED KINGDOM

Arimidex

1 mg

Film-coated tablets

Oral

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