Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2006 to 31 December 2006 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2007-01-26
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

C 18/2

EN

Official Journal of the European Union

26.1.2007

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 December 2006 to 31 December 2006

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

(2007/C 18/02)

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

European Parliament and of the Council): 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

4.12.2006

Naglazyme

4.12.2006

Kaletra

11.12.2006

Rotarix

18.12.2006

NeoSpect

18.12.2006

Viracept

18.12.2006

ATryn

19.12.2006

SonoVue

BioMarin Europe Limited
Axtell House
23-24 Warwick Street
London W1B 5NQ
United Kingdom

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL

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

CIS bio international
Route Nationale 306
Saclay
Boîte Postale 32
F-91192 Gif-sur-Yvette

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Genzyme Europe B.V.
Gooimeer 10
1411 DD Naarden
Nederland

Bracco International B.V.
Strawinskylaan 3051
1077ZX Amsterdam
Nederland

EU/1/05/324/001

6.12.2006

EU/1/01/172/001-005

8.12.2006

EU/1/05/330/001-004

13.12.2006

EU/1/00/154/001-002

21.12.2006

EU/1/97/054/003-004
EU/1/97/054/006

20.12.2006

EU/1/06/355/001-003

20.12.2006

EU/1/01/177/001

21.12.2006

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

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the Euro-

pean Parliament and of the Council): Accepted

Date of the
decision

Name of the medicinal
product

INN
(International Non-Proprie-
tary Name)

Holder of the marketing authorization

Number of the entry in the
Community Register

Pharmaceutical form

ATC code
(Anatomical Ther-
apeutic Chemical
Code)

Date of
notification

18.12.2006

PRAC-TIC

pyriprole

20.12.2006

Medicinal Oxygen Air
Liquide Santé

Oxygen

19.12.2006

ProMeris

Metaflumizone

19.12.2006

ProMeris Duo

Metaflumizone,
Amitraz

Novartis Sanidad Animal S.L.
Calle de la Marina, 206
E-08013 Barcelona

Air Liquide Santé International
10 rue Cognacq-Jay
F-75341 Paris Cedex 07

Fort Dodge Animal Health Holland
C.J. van Houtenlaan 36
1381 CP Weesp
Nederland

Fort Dodge Animal Health Holland
C.J. van Houtenlaan 36
1381 CP Weesp
Nederland

EU/2/06/066/001-012

Spot-on solution

QP53AX26

20.12.2006

EU/2/06/067/001-002

Inhalation gas

QV03AN01

22.12.2006

EU/2/06/064/001-004

Spot-on solution

QP 53AX25

22.12.2006

EU/2/06/065/001-010

Spot-on solution

QP 53AD51

21.12.2006

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the Euro-

pean Parliament and of the Council): Rejected

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

11.12.2006

Veraflox

Bayer HealthCare AG
D-51368 Leverkusen

-

14.12.2006

Anyone wishing to consult the public assessment report on the medicinal products in question and the deci-
sions relating thereto is invited to contact:
The European Medicines Agency
7, Westferry Circus, Canary Wharf
London E14 4HB
United Kingdom

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