# C_2007018EN.01000201.xml

| 26.1.2007 | EN | Official Journal of the European Union | C 18/2 |
| --------- | -- | -------------------------------------- | ------ |

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

—   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 | Novartis Sanidad Animal S.L. | Calle de la Marina, 206 | E-08013 Barcelona | EU/2/06/066/001-012 |
| Novartis Sanidad Animal S.L. | | | | | | | |
| Calle de la Marina, 206 | | | | | | | |
| E-08013 Barcelona | | | | | | | |
| 20.12.2006 | Medicinal Oxygen Air Liquide Santé | Oxygen | Air Liquide Santé International 10 rue Cognacq-Jay F-75341 Paris Cedex 07 | Air Liquide Santé International | 10 rue Cognacq-Jay | F-75341 Paris Cedex 07 | EU/2/06/067/001-002 |
| Air Liquide Santé International | | | | | | | |
| 10 rue Cognacq-Jay | | | | | | | |
| F-75341 Paris Cedex 07 | | | | | | | |
| 19.12.2006 | ProMeris | Metaflumizone | 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 |
| Fort Dodge Animal Health Holland | | | | | | | |
| C.J. van Houtenlaan 36 | | | | | | | |
| 1381 CP Weesp | | | | | | | |
| Nederland | | | | | | | |
| 19.12.2006 | ProMeris Duo | Metaflumizone, Amitraz | 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 |
| Fort Dodge Animal Health Holland | | | | | | | |
| C.J. van Houtenlaan 36 | | | | | | | |
| 1381 CP Weesp | | | | | | | |
| Nederland | | | | | | | |

—   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 | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |

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 |

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

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