# C_2008056EN.01000401.xml

| 29.2.2008 | EN | Official Journal of the European Union | C 56/4 |
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29.2.2008

EN

Official Journal of the European Union

C 56/4

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2007 to 31 December 2007

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (1)
  )

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council

1

)

(2008/C 56/06)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | INN
  (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
  (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.12.2007 | Vectibix | Panitumumab | Amgen Europe B.V. |
| Minervum 7061 |
| 4817 ZK Breda |
| Nederland |

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

3.12.2007

Vectibix

Panitumumab

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/07/423/001-003

Concentrate for solution for infusion

L01XC08

5.12.2007

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.12.2007 | Busilvex | Pierre Fabre Médicament |
| 45, Place Abel Gance |
| F-92654 Boulogne Billancourt Cedex |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

4.12.2007

Busilvex

Pierre Fabre Médicament

45, Place Abel Gance

F-92654 Boulogne Billancourt Cedex

EU/1/03/254/002

6.12.2007

6.12.2007

Tritanrix HepB

| GlaxoSmithKline Biologicals s.a. |
| --- |
| rue de l'Institut 89 |
| B-1330 Rixensart |

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/96/014/001-003

10.12.2007

6.12.2007

Rotarix

| GlaxoSmithKline Biologicals s.a. |
| --- |
| rue de l'Institut 89 |
| B-1330 Rixensart |

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/05/330/001-004

10.12.2007

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.12.2007 | METACAM | Boehringer Ingelheim Vetmedica GmbH |
| D-55216 Ingelheim am Rhein |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

6.12.2007

METACAM

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein

EU/2/97/004/001

EU/2/97/004/003-030

10.12.2007

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(1)  OJ L 136, 30.4.2004, p. 1.

1

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