# C_2006236EN.01000201.xml

| 30.9.2006 | EN | Official Journal of the European Union | C 236/2 |
| --------- | -- | -------------------------------------- | ------- |

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

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

(2006/C 236/02)

—   Issuing 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 | 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 |
| -------------------------- | ----------------------------- | ----------------------------------------- | --------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------- |
| 10.8.2006 | Thelin | sitaxentan sodium | Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ United Kingdom | Encysive (UK) Limited | Alder Castle House | 10 Noble Street | London EC2V 7QJ |
| Encysive (UK) Limited | | | | | | | |
| Alder Castle House | | | | | | | |
| 10 Noble Street | | | | | | | |
| London EC2V 7QJ | | | | | | | |
| United Kingdom | | | | | | | |
| 28.8.2006 | Exjade | deferasirox | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road | Horsham | West Sussex RH12 5AB |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road | | | | | | | |
| Horsham | | | | | | | |
| West Sussex RH12 5AB | | | | | | | |
| United Kingdom | | | | | | | |

—   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 |
| --------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------- |
| 4.8.2006 | Taxotere | Aventis Pharma S.A. 20 avenue Raymond Aron F-92165 Antony Cedex | Aventis Pharma S.A. | 20 avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron | | | | |
| F-92165 Antony Cedex | | | | |
| 4.8.2006 | NovoSeven | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 4.8.2006 | Hepsera | Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB1 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB1 6GT | | | | |
| United Kingdom | | | | |
| 4.8.2006 | HBVAXPRO | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk | | | | |
| F-69007 Lyon | | | | |
| 4.8.2006 | HBVAXPRO | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk | | | | |
| F-69007 Lyon | | | | |
| 4.8.2006 | Tasmar | Valeant Pharmaceuticals Limited Cedarwood Chineham Business Park Crockford lane Basingstoke RG24 8WD United Kingdom | Valeant Pharmaceuticals Limited | Cedarwood |
| Valeant Pharmaceuticals Limited | | | | |
| Cedarwood | | | | |
| Chineham Business Park | | | | |
| Crockford lane | | | | |
| Basingstoke RG24 8WD | | | | |
| United Kingdom | | | | |
| 4.8.2006 | Enbrel | Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Limited | Huntercombe Lane South |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 4.8.2006 | Mirapexin | Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein | Boehringer Ingelheim International GmbH | Binger Strasse 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 | | | | |
| D-55216 Ingelheim am Rhein | | | | |
| 4.8.2006 | InductOs | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Ltd | Huntercombe Lane South |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 7.8.2006 | Levviax | Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 Antony | Aventis Pharma S.A. | 20, Avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20, Avenue Raymond Aron | | | | |
| F-92160 Antony | | | | |
| 7.8.2006 | Ketek | Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 Antony | Aventis Pharma S.A. | 20, Avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20, Avenue Raymond Aron | | | | |
| F-92160 Antony | | | | |
| 7.8.2006 | Lantus | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main | | | | |
| 7.8.2006 | Optisulin | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main | | | | |
| 7.8.2006 | Keppra | UCB S.A. Allée de la recherche, 60 B-1070 Bruxelles Researchdreef 60 B-1070 Brussel | UCB S.A. | Allée de la recherche, 60 |
| UCB S.A. | | | | |
| Allée de la recherche, 60 | | | | |
| B-1070 Bruxelles | | | | |
| Researchdreef 60 | | | | |
| B-1070 Brussel | | | | |
| 7.8.2006 | Fasturtec | Sanofi-Aventis 174, avenue de France F-75013 Paris | Sanofi-Aventis | 174, avenue de France |
| Sanofi-Aventis | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |
| 7.8.2006 | Zenapax | 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 | | | | |
| 7.8.2006 | KOGENATE Bayer | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 7.8.2006 | Xagrid | Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom | Shire Pharmaceutical Contracts Ltd | Hampshire International Business Park |
| Shire Pharmaceutical Contracts Ltd | | | | |
| Hampshire International Business Park | | | | |
| Chineham | | | | |
| Basingstoke | | | | |
| Hampshire RG24 8EP | | | | |
| United Kingdom | | | | |
| 7.8.2006 | Sifrol | Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein | Boehringer Ingelheim International GmbH | Binger Strasse 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 | | | | |
| D-55216 Ingelheim am Rhein | | | | |
| 7.8.2006 | Optison | Amersham Health AS Nycoveien 1-2 P.O.Box 4220 Nydalen N-0401 Oslo | Amersham Health AS | Nycoveien 1-2 |
| Amersham Health AS | | | | |
| Nycoveien 1-2 | | | | |
| P.O.Box 4220 Nydalen | | | | |
| N-0401 Oslo | | | | |
| 10.8.2006 | Tracleer | Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom | Actelion Registration Ltd | BSI Building 13th Floor |
| Actelion Registration Ltd | | | | |
| BSI Building 13th Floor | | | | |
| 389 Chiswick High Road | | | | |
| London W4 4AL | | | | |
| United Kingdom | | | | |
| 10.8.2006 | Rapilysin | 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 | | | | |
| 21.8.2006 | HBVAXPRO | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk | | | | |
| F-69007 Lyon | | | | |
| 21.8.2006 | Ziagen | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 21.8.2006 | NovoSeven | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 28.8.2006 | Bonviva | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way Shire Park |
| Roche Registration Limited | | | | |
| 6 Falcon Way Shire Park | | | | |
| Welwyn Garden City | | | | |
| Hertfordshire AL7 1TW | | | | |
| United Kingdom | | | | |
| 28.8.2006 | Aptivus | Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein | Boehringer Ingelheim International GmbH | Binger Strasse 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 | | | | |
| D-55216 Ingelheim am Rhein | | | | |
| 28.8.2006 | Twinrix Paediatric | 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 | | | | |
| 28.8.2006 | Twinrix Adult | 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 | | | | |
| 28.8.2006 | Bondenza | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way Shire Park |
| Roche Registration Limited | | | | |
| 6 Falcon Way Shire Park | | | | |
| Welwyn Garden City | | | | |
| Hertfordshire AL7 1TW | | | | |
| United Kingdom | | | | |
| 28.8.2006 | Truvada | Gilead Sciences International Limited Granta Park Abington Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited | Granta Park Abington |
| Gilead Sciences International Limited | | | | |
| Granta Park Abington | | | | |
| Cambridge CB1 6GT | | | | |
| United Kingdom | | | | |
| 28.8.2006 | Vfend | Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Sandwich |
| Pfizer Limited | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 28.8.2006 | Inductos | Wyeth Europa Ltd. Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Ltd. | Huntercombe Lane South |
| Wyeth Europa Ltd. | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 28.8.2006 | Hepsera | Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB1 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB1 6GT | | | | |
| United Kingdom | | | | |
| 28.8.2006 | Orfadin | Swedish Orphan International AB Drottninggatan 98 S-111 60 Stockholm | Swedish Orphan International AB | Drottninggatan 98 |
| Swedish Orphan International AB | | | | |
| Drottninggatan 98 | | | | |
| S-111 60 Stockholm | | | | |
| 28.8.2006 | Karvezide | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge UD8 1DH | | | | |
| United Kingdom | | | | |
| 28.8.2006 | Revatio | Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT 13 9NJ | | | | |
| United Kingdom | | | | |
| 28.8.2006 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris | Sanofi Pharma Bristol-Myers Squibb SNC | 174, avenue de France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |

—   Modification 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 | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --------------------------- | ----------------------------- | ---------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- |
| 10.8.2006 | Equilis Prequenza | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International B.V. | Wim de Körverstraat 35 |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 10.8.2006 | Equilis Prequenza te | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International B.V. | Wim de Körverstraat 35 |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 21.8.2006 | Vaxxitek HVT+ IBD | Merial 29, avenue Tony Garnier F-69007 Lyon | Merial | 29, avenue Tony Garnier |
| Merial | | | | |
| 29, avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 21.8.2006 | Naxcel | Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Sandwich |
| Pfizer Limited | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |

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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