# C_2007203EN.01000301.xml

| 31.8.2007 | EN | Official Journal of the European Union | C 203/3 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2007 to 31 July 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 203/03)

—   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 |
| -------------------------------- | ----------------------------- | ----------------------------------------- | -------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------------- |
| 20.7.2007 | MIRCERA | methoxy polyethylene glycol-epoetin beta | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way | Shire Park | Welwyn Garden City AL7 1TW |
| Roche Registration Limited | | | | | | | |
| 6 Falcon Way | | | | | | | |
| Shire Park | | | | | | | |
| Welwyn Garden City AL7 1TW | | | | | | | |
| United Kingdom | | | | | | | |
| 23.7.2007 | Orlistat GSK | Orlistat | Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Limited | Berkeley Avenue | Greenford | Middlesex UB6 0NN |
| Glaxo Group Limited | | | | | | | |
| Berkeley Avenue | | | | | | | |
| Greenford | | | | | | | |
| Middlesex UB6 0NN | | | | | | | |
| United Kingdom | | | | | | | |
| 23.7.2007 | OptiMARK | Gadoversetamide | Tyco Healthcare Deutschland GmbH Gewerbepark 1 D-93333 Neustadt/Donau | Tyco Healthcare Deutschland GmbH | Gewerbepark 1 | D-93333 Neustadt/Donau | EU/1/07/398/001-014 |
| Tyco Healthcare Deutschland GmbH | | | | | | | |
| Gewerbepark 1 | | | | | | | |
| D-93333 Neustadt/Donau | | | | | | | |
| 30.7.2007 | Aerinaze | desloratadine/pseudoephedrine sulphate | SP Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel | SP Europe | Rue de Stalle, 73 | B-1180 Bruxelles | Stallestraat, 73 |
| SP Europe | | | | | | | |
| Rue de Stalle, 73 | | | | | | | |
| B-1180 Bruxelles | | | | | | | |
| Stallestraat, 73 | | | | | | | |
| B-1180 Brussel | | | | | | | |

—   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 |
| --------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------- | ---------------------------- |
| 2.7.2007 | 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 | | | | |
| 2.7.2007 | Apidra | Sanofi-Aventis Deutschland GmbH Brueningstraße 50 D-65926 Frankfurt am Main | Sanofi-Aventis Deutschland GmbH | Brueningstraße 50 |
| Sanofi-Aventis Deutschland GmbH | | | | |
| Brueningstraße 50 | | | | |
| D-65926 Frankfurt am Main | | | | |
| 2.7.2007 | Exjade | 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 | | | | |
| 2.7.2007 | 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 | | | | |
| 2.7.2007 | 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 | | | | |
| 2.7.2007 | Stocrin | 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 | | | | |
| 2.7.2007 | Sustiva | 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 | | | | |
| 2.7.2007 | 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 | | | | |
| 3.7.2007 | 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 | | | | |
| 9.7.2007 | Zyprexa | 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 | | | | |
| 9.7.2007 | 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 | | | | |
| 9.7.2007 | Rebetol | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| Stallestraat, 73 | | | | |
| B-1180 Brussel | | | | |
| 9.7.2007 | IntronA | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| Stallestraat, 73 | | | | |
| B-1180 Brussel | | | | |
| 9.7.2007 | Simulect | 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 | | | | |
| 9.7.2007 | Vfend | 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 | | | | |
| 16.7.2007 | Neupopeg | 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 | | | | |
| 16.7.2007 | Neulasta | 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 | | | | |
| 20.7.2007 | Xigris | 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 | | | | |
| 20.7.2007 | Optison | GE Healthcare AS Nycoveien 1-2 P.O.Box 4220 Nydalen N-0401 Oslo | GE Healthcare AS | Nycoveien 1-2 |
| GE Healthcare AS | | | | |
| Nycoveien 1-2 | | | | |
| P.O.Box 4220 Nydalen | | | | |
| N-0401 Oslo | | | | |
| 20.7.2007 | Prialt | Eisai Limited, 3 Shortlands London W6 8EE United Kingdom | Eisai Limited, 3 | Shortlands |
| Eisai Limited, 3 | | | | |
| Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 20.7.2007 | REYATAZ | 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 | | | | |
| 23.7.2007 | Trisenox | Cephalon Europe 5, Rue Charles Martigny F-94700 Maisons Alfort, Cedex | Cephalon Europe | 5, Rue Charles Martigny |
| Cephalon Europe | | | | |
| 5, Rue Charles Martigny | | | | |
| F-94700 Maisons Alfort, Cedex | | | | |
| 24.7.2007 | 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 | | | | |
| 24.7.2007 | Zostavax | 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 | | | | |
| 24.7.2007 | Crixivan | 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 | | | | |
| 24.7.2007 | 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 | | | | |
| 24.7.2007 | Prezista | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 24.7.2007 | 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 | | | | |
| 24.7.2007 | 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 | | | | |
| 24.7.2007 | Onsenal | Pharmacia-Pfizer EEIG Ramsgate Road Sandwich CT13 9NJ United Kingdom | Pharmacia-Pfizer EEIG | Ramsgate Road |
| Pharmacia-Pfizer EEIG | | | | |
| Ramsgate Road | | | | |
| Sandwich CT13 9NJ | | | | |
| United Kingdom | | | | |
| 24.7.2007 | Helixate NexGen | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 24.7.2007 | KOGENATE Bayer | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 24.7.2007 | Preotact | Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde | Nycomed Danmark ApS | Langebjerg 1 |
| Nycomed Danmark ApS | | | | |
| Langebjerg 1 | | | | |
| DK-4000 Roskilde | | | | |
| 24.7.2007 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| Nederland | | | | |
| 24.7.2007 | Gardasil | 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 | | | | |
| 24.7.2007 | Silgard | 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 | | | | |
| 24.7.2007 | ReFacto | Wyeth Europa Ltd untercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Ltd | untercombe Lane South |
| Wyeth Europa Ltd | | | | |
| untercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 24.7.2007 | Advate | Baxter AG Industriesstrasse 67 A-1220 Vienna | Baxter AG | Industriesstrasse 67 |
| Baxter AG | | | | |
| Industriesstrasse 67 | | | | |
| A-1220 Vienna | | | | |
| 25.7.2007 | Rapamune | 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 | | | | |
| 25.7.2007 | Kaletra | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 25.7.2007 | Temodal | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| Stallestraat, 73 | | | | |
| B-1180 Brussel | | | | |
| 25.7.2007 | Aclasta | 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 | | | | |
| 25.7.2007 | 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 | | | | |
| 30.7.2007 | 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 | | | | |
| 30.7.2007 | Velcade | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 30.7.2007 | Suboxone | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| Stallestraat, 73 | | | | |
| B-1180 Brussel | | | | |
| 30.7.2007 | 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 | | | | |
| 30.7.2007 | Axura | Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 D-60318 Frankfurt/Main | Merz Pharmaceuticals GmbH | Eckenheimer Landstr. 100-104 |
| Merz Pharmaceuticals GmbH | | | | |
| Eckenheimer Landstr. 100-104 | | | | |
| D-60318 Frankfurt/Main | | | | |

—   Withdrawal of a marketing authorization (Article 13 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 |
| ----------------------- | ----------------------------- | ----------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 9.7.2007 | Trudexa | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| 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 |
| --------------------- | ----------------------------- | ----------------------------------------- | --------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------- |
| 10.7.2007 | Suprelorin | Deslorelin acetate | Cyton Biosciences Ltd Hyland Mews 21 High Street Clifton Bristol BS8 2YF United Kingdom | Cyton Biosciences Ltd | Hyland Mews | 21 High Street | Clifton |
| Cyton Biosciences Ltd | | | | | | | |
| Hyland Mews | | | | | | | |
| 21 High Street | | | | | | | |
| Clifton | | | | | | | |
| Bristol BS8 2YF | | | | | | | |
| United Kingdom | | | | | | | |

—   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 |
| -------------------------------- | ----------------------------- | ------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- |
| 16.7.2007 | ProteqFlu | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 16.7.2007 | Advocate | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 24.7.2007 | ProMeris Duo | Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp Nederland | Fort Dodge Animal Health Holland | C.J. van Houtenlaan 36 |
| Fort Dodge Animal Health Holland | | | | |
| C.J. van Houtenlaan 36 | | | | |
| 1381 CP Weesp | | | | |
| 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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