# C_2007251EN.01001001.xml

| 26.10.2007 | EN | Official Journal of the European Union | C 251/10 |
| ---------- | -- | -------------------------------------- | -------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2007 to 30 September 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 251/09)

—   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 |
| ----------------------------------------------------- | ----------------------------- | ----------------------------------------------------------------- | ------------------------------------------------------------------------------------------------- | ----------------------------------------------------- | -------------------- | ------------------------------------------------ | ------------------------------- |
| 7.9.2007 | Gliolan | 5-aminolevulinic acid hydrochloride | Medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3 D-20354 Hamburg | Medac Gesellschaft für klinische Spezialpräparate mbH | Fehlandtstraße 3 | D-20354 Hamburg | EU/1/07/413/001-003 |
| Medac Gesellschaft für klinische Spezialpräparate mbH | | | | | | | |
| Fehlandtstraße 3 | | | | | | | |
| D-20354 Hamburg | | | | | | | |
| 17.9.2007 | Yondelis | Trabectedin | Pharma Mar, S.A. Avda. de los Reyes 1 Polígono Industrial La Mina E-28770 Colmenar Viejo (Madrid) | Pharma Mar, S.A. | Avda. de los Reyes 1 | Polígono Industrial La Mina | E-28770 Colmenar Viejo (Madrid) |
| Pharma Mar, S.A. | | | | | | | |
| Avda. de los Reyes 1 | | | | | | | |
| Polígono Industrial La Mina | | | | | | | |
| E-28770 Colmenar Viejo (Madrid) | | | | | | | |
| 18.9.2007 | CELSENTRI | Maraviroc | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road | Sandwich | Kent CT13 9NJ |
| Pfizer Limited | | | | | | | |
| Ramsgate Road | | | | | | | |
| Sandwich | | | | | | | |
| Kent CT13 9NJ | | | | | | | |
| United Kingdom | | | | | | | |
| 20.9.2007 | ECALTA | Anidulafungin | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road | Sandwich | Kent CT13 9NJ |
| Pfizer Limited | | | | | | | |
| Ramsgate Road | | | | | | | |
| Sandwich | | | | | | | |
| Kent CT13 9NJ | | | | | | | |
| United Kingdom | | | | | | | |
| 20.9.2007 | Cervarix | Human Papilloma Virus-16 and Human Papilloma Virus 18 L1 proteins | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89 B-1330 Rixensart | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89 | B-1330 Rixensart | EU/1/07/419/001-009 |
| GlaxoSmithKline Biologicals S.A. | | | | | | | |
| rue de l'Institut 89 | | | | | | | |
| B-1330 Rixensart | | | | | | | |
| 26.9.2007 | Galvus | Vildagliptin | Novartis Europharm Limited Wimblehurst Road Orsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road | Orsham | West Sussex RH12 5AB |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road | | | | | | | |
| Orsham | | | | | | | |
| West Sussex RH12 5AB | | | | | | | |
| United Kingdom | | | | | | | |
| 27.9.2007 | Zalasta | Olanzapine | KRKA, d.d. Novo mesto Šmarješka cesta 6 SLO-8501 Novo mesto | KRKA, d.d. | Novo mesto | Šmarješka cesta 6 | SLO-8501 Novo mesto |
| KRKA, d.d. | | | | | | | |
| Novo mesto | | | | | | | |
| Šmarješka cesta 6 | | | | | | | |
| SLO-8501 Novo mesto | | | | | | | |
| EU/1/07/415/032-056 | Orodispersible 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 |
| ------------------------------------------------------------------ | ----------------------------- | ----------------------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- |
| 3.9.2007 | Arixtra | 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 | | | | |
| 3.9.2007 | Quixidar | 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 | | | | |
| 3.9.2007 | 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 | | | | |
| 3.9.2007 | 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 | | | | |
| 3.9.2007 | Mabthera | 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 | | | | |
| 3.9.2007 | 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 | | | | |
| 7.9.2007 | RotaTeq | 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 | | | | |
| 7.9.2007 | Evra | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 7.9.2007 | 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 | | | | |
| 7.9.2007 | Ambirix | 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 | | | | |
| 13.9.2007 | Tamiflu | 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 | | | | |
| 13.9.2007 | Telzir | Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Limited | Berkeley Avenue |
| Glaxo Group Limited | | | | |
| Berkeley Avenue | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 17.9.2007 | Cerezyme | 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 | | | | |
| 17.9.2007 | Exelon | 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 | | | | |
| 17.9.2007 | 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 | | | | |
| 17.9.2007 | Cialis | Lilly ICOS Limited St Bride's House 10 Salisbury Square London EC4Y 8EH United Kingdom | Lilly ICOS Limited | St Bride's House |
| Lilly ICOS Limited | | | | |
| St Bride's House | | | | |
| 10 Salisbury Square | | | | |
| London EC4Y 8EH | | | | |
| United Kingdom | | | | |
| 18.9.2007 | Actraphane | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 18.9.2007 | Protaphane | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 18.9.2007 | Insulatard | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 18.9.2007 | Xyrem | UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE United Kingdom | UCB Pharma Ltd | 208 Bath Road |
| UCB Pharma Ltd | | | | |
| 208 Bath Road | | | | |
| Slough | | | | |
| Berkshire SL1 3WE | | | | |
| United Kingdom | | | | |
| 18.9.2007 | TOVIAZ | Schwarz Pharma AG Alfred-Nobel Straße 10 D-40789 Monheim | Schwarz Pharma AG | Alfred-Nobel Straße 10 |
| Schwarz Pharma AG | | | | |
| Alfred-Nobel Straße 10 | | | | |
| D-40789 Monheim | | | | |
| Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road | Sandwich | Kent CT13 9NJ |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 18.9.2007 | Velosulin | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 18.9.2007 | Actrapid | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 18.9.2007 | Mixtard | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 19.9.2007 | Omnitrope | Sandoz GmbH Biochemiestraße 10 A-6250 Kundl | Sandoz GmbH | Biochemiestraße 10 |
| Sandoz GmbH | | | | |
| Biochemiestraße 10 | | | | |
| A-6250 Kundl | | | | |
| 19.9.2007 | Tamiflu | 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 | | | | |
| 20.9.2007 | Somavert | 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 | | | | |
| 25.9.2007 | NeuroBloc | Solstice Neurosciences Ltd Fitzwilton House Wilton Place Dublin 2 Ireland | Solstice Neurosciences Ltd | Fitzwilton House |
| Solstice Neurosciences Ltd | | | | |
| Fitzwilton House | | | | |
| Wilton Place | | | | |
| Dublin 2 | | | | |
| Ireland | | | | |
| Eisai Limited 3, Shortlands London W6 8EE United Kingdom | Eisai Limited | 3, Shortlands | London W6 8EE | United Kingdom |
| Eisai Limited | | | | |
| 3, Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 25.9.2007 | Prometax | 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 | | | | |
| 25.9.2007 | 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 | | | | |

—   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 |
| ----------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------- |
| 3.9.2007 | Oxyblobin | Biopure Netherlands B.V. Parnassustoren Locatellikade 1 1076 AZ Amsterdam Nederland | Biopure Netherlands B.V. | Parnassustoren |
| Biopure Netherlands B.V. | | | | |
| Parnassustoren | | | | |
| Locatellikade 1 | | | | |
| 1076 AZ Amsterdam | | | | |
| Nederland | | | | |
| 4.9.2007 | Econor | Novartis Animal Health Austria GmbH Biochemiestraße 10 A-6250 Kundl | Novartis Animal Health Austria GmbH | Biochemiestraße 10 |
| Novartis Animal Health Austria GmbH | | | | |
| Biochemiestraße 10 | | | | |
| A-6250 Kundl | | | | |
| 7.9.2007 | Cortavance | VIRBAC S.A. 1ère Avenue 2065 m L.I.D. F-06516 Carros | VIRBAC S.A. | 1ère Avenue 2065 m L.I.D. |
| VIRBAC S.A. | | | | |
| 1ère Avenue 2065 m L.I.D. | | | | |
| F-06516 Carros | | | | |
| 7.9.2007 | Meloxidyl | CEVA SANTE ANIMALE Z.I. la Ballastière F-33500 Libourne | CEVA SANTE ANIMALE | Z.I. la Ballastière |
| CEVA SANTE ANIMALE | | | | |
| Z.I. la Ballastière | | | | |
| F-33500 Libourne | | | | |
| 25.9.2007 | Nobivac Bb | 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 | | | | |

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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