EN Official Journal of the European Union C 18/2

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 BioMarin Europe Limited Axtell House 23-24 Warwick Street London W1B 5NQ United Kingdom EU/1/05/324/001 6.12.2006 4.12.2006 Kaletra Abbott Laboratories Ltd Queenborough Kent ME11 5EL EU/1/01/172/001-005 8.12.2006 11.12.2006 Rotarix GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/05/330/001-004 13.12.2006 18.12.2006 NeoSpect CIS bio international Route Nationale 306 Saclay Boîte Postale 32 F-91192 Gif-sur-Yvette EU/1/00/154/001-002 21.12.2006 18.12.2006 Viracept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/97/054/003-004 EU/1/97/054/006 20.12.2006 18.12.2006 ATryn LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/06/355/001-003 20.12.2006 19.12.2006 SonoVue Bracco International B.V. Strawinskylaan 3051 1077ZX Amsterdam Nederland EU/1/01/177/001 21.12.2006

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 18.12.2006 PRAC-TIC pyriprole Novartis Sanidad Animal S.L. Calle de la Marina, 206 E-08013 Barcelona EU/2/06/066/001-012 Spot-on solution QP53AX26 20.12.2006 20.12.2006 Medicinal Oxygen Air Liquide Santé Oxygen Air Liquide Santé International 10 rue Cognacq-Jay F-75341 Paris Cedex 07 EU/2/06/067/001-002 Inhalation gas QV03AN01 22.12.2006 19.12.2006 ProMeris Metaflumizone Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp Nederland EU/2/06/064/001-004 Spot-on solution QP 53AX25 22.12.2006 19.12.2006 ProMeris Duo Metaflumizone, Amitraz Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp Nederland 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 European 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 decisions relating thereto is invited to contact:

The European Medicines Agency 7, Westferry Circus, Canary Wharf London E14 4HB United Kingdom

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