# C_2007073EN.01000901.xml

| 30.3.2007 | EN | Official Journal of the European Union | C 73/9 |
| --------- | -- | -------------------------------------- | ------ |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2007 to 28 February 2007

(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 73/08)

—   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 |
| ------------------------------ | ----------------------------- | ----------------------------------------- | -------------------------------------------------------------------- | --------------------------------------------- | ------------------------ | ------------------------------------------------ | -------------------- |
| 12.2.2007 | Prezista | darunavir | Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg 30 | B-2340 Beerse | EU/1/06/380/001 |
| Janssen-Cilag International NV | | | | | | | |
| Turnhoutseweg 30 | | | | | | | |
| B-2340 Beerse | | | | | | | |
| 15.2.2007 | Cystadane | Betaine anhydrous | Orphan Europe SARL Immeuble ‘Le Guillaumet’ F-92046 Paris-La-Défense | Orphan Europe SARL | Immeuble ‘Le Guillaumet’ | F-92046 Paris-La-Défense | EU/1/06/379/001 |
| Orphan Europe SARL | | | | | | | |
| Immeuble ‘Le Guillaumet’ | | | | | | | |
| F-92046 Paris-La-Défense | | | | | | | |

—   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 |
| --------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- |
| 1.2.2007 | Xyrem | UCB Pharma Ltd 208 Bath Road Slough Berks SL1 3WE United Kingdom | UCB Pharma Ltd | 208 Bath Road |
| UCB Pharma Ltd | | | | |
| 208 Bath Road | | | | |
| Slough | | | | |
| Berks SL1 3WE | | | | |
| United Kingdom | | | | |
| 5.2.2007 | Aldurazyme | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| Nederland | | | | |
| 9.2.2007 | ReFacto | 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 | | | | |
| 12.2.2007 | Replagal | Shire Human Genetic Therapies AB Rinkebyvägen 11B S-182 36 Danderyd | Shire Human Genetic Therapies AB | Rinkebyvägen 11B |
| Shire Human Genetic Therapies AB | | | | |
| Rinkebyvägen 11B | | | | |
| S-182 36 Danderyd | | | | |
| 15.2.2007 | BeneFIX | 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 | | | | |
| 15.2.2007 | Trisenox | Cephalon UK Ltd 20 Alan Turing Road Surrey Research Park Guildford Surrey GU2 7YF United Kingdom | Cephalon UK Ltd | 20 Alan Turing Road |
| Cephalon UK Ltd | | | | |
| 20 Alan Turing Road | | | | |
| Surrey Research Park | | | | |
| Guildford | | | | |
| Surrey GU2 7YF | | | | |
| United Kingdom | | | | |
| 15.2.2007 | Fabrazyme | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| Nederland | | | | |
| 20.2.2007 | Ammonaps | 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 | | | | |
| 20.2.2007 | Zavesca | 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 | | | | |
| 20.2.2007 | Azopt | Alcon Laboratories (UK) Ltd Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom | Alcon Laboratories (UK) Ltd | Boundary Way |
| Alcon Laboratories (UK) Ltd | | | | |
| Boundary Way | | | | |
| Hemel Hempstead | | | | |
| Herts HP2 7UD | | | | |
| United Kingdom | | | | |
| 20.2.2007 | Erbitux | Merck KGaA Frankfurter Straße 250 D-64293 Darmstadt | Merck KGaA | Frankfurter Straße 250 |
| Merck KGaA | | | | |
| Frankfurter Straße 250 | | | | |
| D-64293 Darmstadt | | | | |
| 20.2.2007 | Lumigan | Allergan Pharmaceuticals Ireland Castlebar Road Westport Co. Mayo Ireland | Allergan Pharmaceuticals Ireland | Castlebar Road |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road | | | | |
| Westport | | | | |
| Co. Mayo | | | | |
| Ireland | | | | |
| 21.2.2007 | Avonex | Biogen Idec Ltd 5 Roxborough Way Foundation Park Maidenhead Berkshire SL6 3UD United Kindgom | Biogen Idec Ltd | 5 Roxborough Way |
| Biogen Idec Ltd | | | | |
| 5 Roxborough Way | | | | |
| Foundation Park | | | | |
| Maidenhead | | | | |
| Berkshire SL6 3UD | | | | |
| United Kindgom | | | | |
| 23.2.2007 | Raptiva | Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom | Serono Europe Limited | 56 |
| Serono Europe Limited | | | | |
| 56 | | | | |
| Marsh Wall | | | | |
| London E14 9TP | | | | |
| United Kingdom | | | | |
| 27.2.2007 | Comtess | Orion Corporation Orionintie 1 FIN-02200 Espoo | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| 27.2.2007 | Comtan | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road | | | | |
| Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| United Kingdom | | | | |
| 27.2.2007 | Norvir | Abbott laboratories Ltd Queenborough Kent ME11 5EL United-Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United-Kingdom | | | | |
| 27.2.2007 | Erbitux | Merck KGaA Frankfurter Straße 250 D-64293 Darmstadt | Merck KGaA | Frankfurter Straße 250 |
| Merck KGaA | | | | |
| Frankfurter Straße 250 | | | | |
| D-64293 Darmstadt | | | | |
| 27.2.2007 | Tarceva | 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 | | | | |
| 27.2.2007 | Pritor | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 27.2.2007 | 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 | | | | |
| 27.2.2007 | Levemir | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 27.2.2007 | Zeffix | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 28.2.2007 | EMEND | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire EN11 9BU | | | | |
| United Kingdom | | | | |
| 28.2.2007 | Telzir | Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford Road |
| Glaxo Group Ltd | | | | |
| Greenford Road | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 28.2.2007 | Kepivance | Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland | Amgen Europe B.V. | Minervum 7061 |
| Amgen Europe B.V. | | | | |
| Minervum 7061 | | | | |
| 4817 ZK Breda | | | | |
| Nederland | | | | |
| 28.2.2007 | PritorPlus | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 28.2.2007 | Osseor | Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine | Les Laboratoires Servier | 22, rue Garnier |
| Les Laboratoires Servier | | | | |
| 22, rue Garnier | | | | |
| F-92200 Neuilly-sur-Seine | | | | |
| 28.2.2007 | Hycamtin | SmithKline Beecham plc 980 Great West Road Brentford Middlesex, TW8 9GS United Kingdom | SmithKline Beecham plc | 980 Great West Road |
| SmithKline Beecham plc | | | | |
| 980 Great West Road | | | | |
| Brentford | | | | |
| Middlesex, TW8 9GS | | | | |
| United Kingdom | | | | |
| 28.2.2007 | Protelos | Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine | Les Laboratoires Servier | 22, rue Garnier |
| Les Laboratoires Servier | | | | |
| 22, rue Garnier | | | | |
| F-92200 Neuilly-sur-Seine | | | | |
| 28.2.2007 | Agenerase | Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford Road |
| Glaxo Group Ltd | | | | |
| Greenford Road | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 28.2.2007 | Zavesca | 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 | | | | |
| 28.2.2007 | Viread | 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 | | | | |

—   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 |
| ---------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------- |
| 9.2.2007 | Stronghold | 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 | | | | |
| 20.2.2007 | Nobivac Piro | 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 | | | | |
| 20.2.2007 | DRAXXIN | 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 | | | | |
| 20.2.2007 | Metacam | Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein | Boehringer Ingelheim Vetmedica GmbH | D-55216 Ingelheim am Rhein |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| D-55216 Ingelheim am Rhein | | | | |
| 23.2.2007 | Aivlosin | ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom | ECO Animal Health Ltd | 78 Coombe Road New Malden Surrey KT3 4QS |
| ECO Animal Health Ltd | | | | |
| 78 Coombe Road New Malden Surrey KT3 4QS | | | | |
| United Kingdom | | | | |
| 27.2.2007 | Fevaxyn Pentofel | Fort Dodge Laboratories Ireland Finisklin Industrial Estate — Sligo Ireland | Fort Dodge Laboratories Ireland | Finisklin Industrial Estate — Sligo |
| Fort Dodge Laboratories Ireland | | | | |
| Finisklin Industrial Estate — Sligo | | | | |
| Ireland | | | | |

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

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