# C_2008077EN.01000201.xml

| 28.3.2008 | EN | Official Journal of the European Union | C 77/2 |
| --------- | -- | -------------------------------------- | ------ |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2008 to 29 February 2008

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

(2008/C 77/02)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
| -------------------- | ----------------------------- | ----------------------------------------- | --------------------------------------------------------- | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------- |
| 21.2.2008 | Myfenax | Mycophénolate mofétil | Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 Nederland | Teva Pharma B.V. | Computerweg 10 | DR Utrecht 3542 | Nederland |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10 | | | | | | | |
| DR Utrecht 3542 | | | | | | | |
| Nederland | | | | | | | |
| EU/1/07/438/003-004 | Film-coated tablet | | | | | | |
| 21.2.2008 | Mycophenolate mofetil Teva | Mycophénolate mofétil | Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 Nederland | Teva Pharma B.V. | Computerweg 10 | DR Utrecht 3542 | Nederland |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10 | | | | | | | |
| DR Utrecht 3542 | | | | | | | |
| Nederland | | | | | | | |
| EU/1/07/439/003-004 | Film-coated tablet | | | | | | |

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
| --------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------- |
| 6.2.2008 | Sebivo | 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 | | | | |
| 6.2.2008 | Prevenar | Wyeth-Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-La-Neuve | Wyeth-Lederle Vaccines S.A. | Rue du Bosquet, 15 |
| Wyeth-Lederle Vaccines S.A. | | | | |
| Rue du Bosquet, 15 | | | | |
| B-1348 Louvain-La-Neuve | | | | |
| 6.2.2008 | 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 | | | | |
| 7.2.2008 | Ytracis | CIS bio international Boite Postale 32 F-91192 Gif-sur-Yvette Cedex | CIS bio international | Boite Postale 32 |
| CIS bio international | | | | |
| Boite Postale 32 | | | | |
| F-91192 Gif-sur-Yvette Cedex | | | | |
| 7.2.2008 | Levitra | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 7.2.2008 | Vivanza | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 13.2.2008 | Eucreas | 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 | | | | |
| 13.2.2008 | Combivir | 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 | | | | |
| 14.2.2008 | 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 | | | | |
| 18.2.2008 | ATryn | LEO Pharma A/S Industriparken 55 DK-2750 Ballerup | LEO Pharma A/S | Industriparken 55 |
| LEO Pharma A/S | | | | |
| Industriparken 55 | | | | |
| DK-2750 Ballerup | | | | |
| 26.2.2008 | Januvia | 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 | | | | |
| 26.2.2008 | Aranesp | 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 | | | | |
| 26.2.2008 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D-58638 Iserlohn | Medice Arzneimittel Pütter GmbH & Co KG | Kuhloweg 37 |
| Medice Arzneimittel Pütter GmbH & Co KG | | | | |
| Kuhloweg 37 | | | | |
| D-58638 Iserlohn | | | | |
| 26.2.2008 | NeoRecormon | 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 | | | | |
| 26.2.2008 | Nespo | Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano | Dompé Biotec S.p.A. | Via San Martino, 12 |
| Dompé Biotec S.p.A. | | | | |
| Via San Martino, 12 | | | | |
| I-20122 Milano | | | | |
| 26.2.2008 | Xelevia | 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 | | | | |
| 26.2.2008 | Arava | 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 | | | | |
| 26.2.2008 | NeuroBloc | Eisai Limited 3, Shortlands London W6 8EE United Kingdom | Eisai Limited | 3, Shortlands |
| Eisai Limited | | | | |
| 3, Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 26.2.2008 | Avastin | 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 | | | | |
| 26.2.2008 | 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 | | | | |
| 28.2.2008 | Erbitux | Merck KgaA Frankfurter Straße 250 D-64293 Darmstadt | Merck KgaA | Frankfurter Straße 250 |
| Merck KgaA | | | | |
| Frankfurter Straße 250 | | | | |
| D-64293 Darmstadt | | | | |
| 28.2.2008 | Hepsera | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT | | | | |
| United Kingdom | | | | |
| 28.2.2008 | 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 | | | | |
| 28.2.2008 | TRIZIVIR | 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 | | | | |
| 28.2.2008 | Truvada | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT | | | | |
| United Kingdom | | | | |
| 28.2.2008 | Champix | 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 | | | | |
| 28.2.2008 | Sebivo | 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 | | | | |
| 28.2.2008 | 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 | | | | |
| 28.2.2008 | CellCept | 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 | | | | |
| 28.2.2008 | 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 | | | | |
| 29.2.2008 | Osigraft | Howmedica International S. de R.L. Division of Stryker Corporation Raheen Industrial Estate Raheen Limerick Ireland | Howmedica International S. de R.L. | Division of Stryker Corporation |
| Howmedica International S. de R.L. | | | | |
| Division of Stryker Corporation | | | | |
| Raheen Industrial Estate | | | | |
| Raheen | | | | |
| Limerick | | | | |
| Ireland | | | | |
| 29.2.2008 | Ziagen | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 29.2.2008 | Epoetin alfa Hexal | HEXAL Biotech Forschungs GmbH Industriestraße 25 D-83607 Holzkirchen | HEXAL Biotech Forschungs GmbH | Industriestraße 25 |
| HEXAL Biotech Forschungs GmbH | | | | |
| Industriestraße 25 | | | | |
| D-83607 Holzkirchen | | | | |
| 29.2.2008 | Lyrica | 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 | | | | |
| 29.2.2008 | Dynepo | 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 | | | | |
| 29.2.2008 | Cialis | Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5 |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| 29.2.2008 | 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 | | | | |
| 29.2.2008 | Binocrit | Sandoz GmbH Biochemiestraße 10 A-6250 Kundl | Sandoz GmbH | Biochemiestraße 10 |
| Sandoz GmbH | | | | |
| Biochemiestraße 10 | | | | |
| A-6250 Kundl | | | | |
| 29.2.2008 | Abilify | Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom | Otsuka Pharmaceutical Europe Ltd | Hunton House |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House | | | | |
| Highbridge Business Park | | | | |
| Oxford Road | | | | |
| Uxbridge | | | | |
| Middlesex UB8 1HU | | | | |
| United Kingdom | | | | |
| 29.2.2008 | Kivexa | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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 |
| ----------------------------------- | ----------------------------- | ---------------------------------------------------------------------- | -------------------------------------------------------------- | --------------------------------------------- | -------------------------- | ------------------------------------------------ | ------------------------ |
| 13.2.2008 | Ingelvac CircoFLEX | Porcine circovirus type 2 ORF2 protein minimum RP 1,0, maximum RP 3,75 | Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein | Boehringer Ingelheim Vetmedica GmbH | D-55216 Ingelheim am Rhein | EU/2/07/079/001-004 | Suspension for injection |
| Boehringer Ingelheim Vetmedica GmbH | | | | | | | |
| D-55216 Ingelheim am Rhein | | | | | | | |

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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 |
| --------------------------- | ----------------------------- | ----------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 5.2.2008 | Aivlosin | ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom | ECO Animal Health Ltd | 78 Coombe Road |
| ECO Animal Health Ltd | | | | |
| 78 Coombe Road | | | | |
| New Malden | | | | |
| Surrey KT3 4QS | | | | |
| United Kingdom | | | | |
| 7.2.2008 | Nobilis Influenza H5N2 | 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 | | | | |
| 7.2.2008 | Advocate | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |

—   Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004)

| 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 |
| -------------------- | ----------------------------- | --------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 6.2.2008 | Advasure | 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 | | | | |

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, 30.4.2004, p. 1.

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