# C_2009231EN.01002001.xml

| 25.9.2009 | EN | Official Journal of the European Union | C 231/20 |
| --------- | -- | -------------------------------------- | -------- |

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 2009

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

2009/C 231/05

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| -------------------------------- | ----------------------------- | ---------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- | ----------------------------------------------- | -------------------- |
| 3.8.2009 | Afinitor | Everolimus | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM | Novartis Europharm Limited | Wimblehurst Road | Horsham | West Sussex |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road | | | | | | | |
| Horsham | | | | | | | |
| West Sussex | | | | | | | |
| RH12 5AB | | | | | | | |
| UNITED KINGDOM | | | | | | | |
| 3.8.2009 | Samsca | Tolvaptan | Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU UNITED KINGDOM | Otsuka Pharmaceutical Europe Ltd | Hunton House Highbridge | Business Park | Oxford Road |
| Otsuka Pharmaceutical Europe Ltd | | | | | | | |
| Hunton House Highbridge | | | | | | | |
| Business Park | | | | | | | |
| Oxford Road | | | | | | | |
| Uxbridge | | | | | | | |
| Middlesex | | | | | | | |
| UB8 1HU | | | | | | | |
| UNITED KINGDOM | | | | | | | |

—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| ----------------------------------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------- | ----------------------------------- |
| 3.8.2009 | SUTENT | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 3.8.2009 | Baraclude | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge | | | | |
| UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 3.8.2009 | INTELENCE | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 3.8.2009 | Revatio | Pfizer Limited Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Limited | Sandwich |
| Pfizer Limited | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 3.8.2009 | PegIntron | Schering Plough Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË | Schering Plough Europe | Rue de Stalle 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle 73 | | | | |
| 1180 Bruxelles | | | | |
| BELGIQUE | | | | |
| Stallestraat 73 | | | | |
| 1180 Brussel | | | | |
| BELGIË | | | | |
| 3.8.2009 | Champix | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 3.8.2009 | FOSAVANCE | 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 | | | | |
| 6.8.2009 | Lucentis | 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 | | | | |
| 6.8.2009 | TESAVEL | 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 | | | | |
| 6.8.2009 | Trevaclyn | 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 | | | | |
| 6.8.2009 | Tasigna | 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 | | | | |
| 6.8.2009 | Pelzont | 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 | | | | |
| 6.8.2009 | Tredaptive | 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 | | | | |
| 7.8.2009 | CELSENTRI | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Limited | Ramsgate Road |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 7.8.2009 | Prepandrix | GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89 1330 Rixensart BELGIQUE | GlaxoSmithKline Biologicals s.a. | Rue de l'Institut 89 |
| GlaxoSmithKline Biologicals s.a. | | | | |
| Rue de l'Institut 89 | | | | |
| 1330 Rixensart | | | | |
| BELGIQUE | | | | |
| 7.8.2009 | Lyrica | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 7.8.2009 | Revlimid | Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA UNITED KINGDOM | Celgene Europe Limited | Riverside House |
| Celgene Europe Limited | | | | |
| Riverside House | | | | |
| Riverside Walk | | | | |
| Windsor | | | | |
| Berkshire | | | | |
| SL4 1NA | | | | |
| UNITED KINGDOM | | | | |
| 13.8.2009 | Oprymea | KRKA, d. d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA | KRKA, d. d. | Novo mesto |
| KRKA, d. d. | | | | |
| Novo mesto | | | | |
| Šmarješka cesta 6 | | | | |
| SI-8501 Novo mesto | | | | |
| SLOVENIJA | | | | |
| 13.8.2008 | Clopidogrel BMS | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge | | | | |
| UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 13.8.2008 | Clopidogrel Winthrop | Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France 75013 Paris FRANCE | Sanofi Pharma Bristol-Myers Squibb SNC | 174 Avenue de France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174 Avenue de France | | | | |
| 75013 Paris | | | | |
| FRANCE | | | | |
| 18.8.2009 | Nobilis Influenza H5N6 | 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 | | | | |
| 20.8.2009 | Lyrica | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 20.8.2009 | SUTENT | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 20.8.2009 | TESAVEL | 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 | | | | |
| 20.8.2009 | Pramipexole Teva | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | Teva Pharma B.V. | Computerweg 10 |
| Teva Pharma B.V. | | | | |
| Computerweg 10 | | | | |
| 3542 DR Utrecht | | | | |
| NEDERLAND | | | | |
| 20.8.2009 | Pradaxa | Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Strasse 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 | | | | |
| 55216 Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 20.8.2009 | Apidra | Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND | Sanofi-Aventis Deutschland GmbH | 65926 Frankfurt am Main |
| Sanofi-Aventis Deutschland GmbH | | | | |
| 65926 Frankfurt am Main | | | | |
| DEUTSCHLAND | | | | |
| 21.8.2009 | PEGASYS | 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 | | | | |
| 21.8.2009 | Galvus | 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 | | | | |
| 21.8.2009 | TORISEL | 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 | | | | |
| 21.8.2009 | Jalra | 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 | | | | |
| 21.8.2009 | Mycophenolate mofetil Teva | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | Teva Pharma B.V. | Computerweg 10 |
| Teva Pharma B.V. | | | | |
| Computerweg 10 | | | | |
| 3542 DR Utrecht | | | | |
| NEDERLAND | | | | |
| 21.8.2009 | TARGRETIN | Eisai Limited, European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN UNITED KINGDOM | Eisai Limited, European Knowledge Centre | Mosquito Way |
| Eisai Limited, European Knowledge Centre | | | | |
| Mosquito Way | | | | |
| Hatfield | | | | |
| Hertfordshire | | | | |
| AL10 9SN | | | | |
| UNITED KINGDOM | | | | |
| 21.8.2009 | AVANDIA | 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 | | | | |
| 21.8.2009 | Myfenax | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | Teva Pharma B.V. | Computerweg 10 |
| Teva Pharma B.V. | | | | |
| Computerweg 10 | | | | |
| 3542 DR Utrecht | | | | |
| NEDERLAND | | | | |
| 21.8.2009 | Kaletra | Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent | | | | |
| ME11 5EL | | | | |
| UNITED KINGDOM | | | | |
| 21.8.2009 | Myozyme | 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 | | | | |
| 21.8.2009 | Luminity | Lantheus MI UK Limited One South Place London EC2M 2WG UNITED KINGDOM | Lantheus MI UK Limited | One South Place |
| Lantheus MI UK Limited | | | | |
| One South Place | | | | |
| London | | | | |
| EC2M 2WG | | | | |
| UNITED KINGDOM | | | | |
| 21.8.2009 | 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 | | | | |
| 21.8.2009 | Rotarix | GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89 1330 Rixensart BELGIQUE | GlaxoSmithKline Biologicals s.a. | Rue de l'Institut 89 |
| GlaxoSmithKline Biologicals s.a. | | | | |
| Rue de l'Institut 89 | | | | |
| 1330 Rixensart | | | | |
| BELGIQUE | | | | |
| 21.8.2009 | Privigen | CSL Behring GmbH Emil von Behring Strasse 76 35041 Marburg DEUTSCHLAND | CSL Behring GmbH | Emil von Behring Strasse 76 |
| CSL Behring GmbH | | | | |
| Emil von Behring Strasse 76 | | | | |
| 35041 Marburg | | | | |
| DEUTSCHLAND | | | | |
| 21.8.2009 | Competact | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych London WC2B 4AE UNITED KINGDOM | Takeda Global Research and Development Centre (Europe) Ltd | 61 Aldwych |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych | | | | |
| London | | | | |
| WC2B 4AE | | | | |
| UNITED KINGDOM | | | | |
| 21.8.2009 | 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 | | | | |
| 21.8.2009 | 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 | | | | |
| 25.8.2009 | Epoetin alfa Hexal | Hexal AG. Industriestrasse 25 83607 Holzkirchen DEUTSCHLAND | Hexal AG. | Industriestrasse 25 |
| Hexal AG. | | | | |
| Industriestrasse 25 | | | | |
| 83607 Holzkirchen | | | | |
| DEUTSCHLAND | | | | |
| 25.8.2009 | Avandamet | 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 | | | | |
| 25.8.2009 | Ranexa | Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare 1611 Luxembourg LUXEMBOURG | Menarini International Operations Luxembourg S.A. | 1, Avenue de la Gare |
| Menarini International Operations Luxembourg S.A. | | | | |
| 1, Avenue de la Gare | | | | |
| 1611 Luxembourg | | | | |
| LUXEMBOURG | | | | |
| 25.8.2009 | Tasigna | 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 | | | | |
| 25.8.2009 | Binocrit | Sandoz GmbH Biochemiestrasse 10 6250 Kundl ÖSTERREICH | Sandoz GmbH | Biochemiestrasse 10 |
| Sandoz GmbH | | | | |
| Biochemiestrasse 10 | | | | |
| 6250 Kundl | | | | |
| ÖSTERREICH | | | | |
| 25.8.2009 | Xiliarx | 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 | | | | |
| 27.8.2009 | Thalidomide Celgene | Celgene Europe Limited Riverside House Riverside Walk Windsor SL4 1NA UNITED KINGDOM | Celgene Europe Limited | Riverside House |
| Celgene Europe Limited | | | | |
| Riverside House | | | | |
| Riverside Walk | | | | |
| Windsor | | | | |
| SL4 1NA | | | | |
| UNITED KINGDOM | | | | |
| 27.8.2009 | CELVAPAN | Baxter AG Industriestraße 67 1221 Wien ÖSTERREICH | Baxter AG | Industriestraße 67 |
| Baxter AG | | | | |
| Industriestraße 67 | | | | |
| 1221 Wien | | | | |
| ÖSTERREICH | | | | |
| 27.8.2009 | Champix | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 27.8.2009 | Zeffix | 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 | | | | |
| 27.8.2009 | Iscover | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge | | | | |
| UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 27.8.2009 | Xeristar | Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Strasse 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 | | | | |
| 55216 Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 27.8.2009 | Vfend | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 28.8.2009 | Pelzont | 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 | | | | |
| 28.8.2009 | Tredaptive | 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 | | | | |
| 28.8.2009 | Trevaclyn | 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 | | | | |
| 28.8.2009 | Irbesartan Krka | KRKA, d.d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA | KRKA, d.d. | Novo mesto |
| KRKA, d.d. | | | | |
| Novo mesto | | | | |
| Šmarješka cesta 6 | | | | |
| SI-8501 Novo mesto | | | | |
| SLOVENIJA | | | | |
| 28.8.2009 | Volibris | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 28.8.2009 | Panretin | Eisai Limited, European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN UNITED KINGDOM | Eisai Limited, European Knowledge Centre | Mosquito Way |
| Eisai Limited, European Knowledge Centre | | | | |
| Mosquito Way | | | | |
| Hatfield | | | | |
| Hertfordshire | | | | |
| AL10 9SN | | | | |
| UNITED KINGDOM | | | | |
| 28.8.2009 | Humira | Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent | | | | |
| ME11 5EL | | | | |
| UNITED KINGDOM | | | | |
| 28.8.2009 | Forsteo | 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 | | | | |
| 28.8.2009 | Invanz | 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 | | | | |
| 28.8.2009 | Zerit | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge | | | | |
| UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 28.8.2009 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France 75013 Paris FRANCE | Sanofi Pharma Bristol-Myers Squibb SNC | 174 avenue de France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174 avenue de France | | | | |
| 75013 Paris | | | | |
| FRANCE | | | | |
| 28.8.2009 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn DEUTSCHLAND | Medice Arzneimittel Pütter GmbH & Co KG | Kuhloweg 37 |
| Medice Arzneimittel Pütter GmbH & Co KG | | | | |
| Kuhloweg 37 | | | | |
| 58638 Iserlohn | | | | |
| DEUTSCHLAND | | | | |
| 28.8.2009 | MicardisPlus | Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Strasse 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 | | | | |
| 55216 Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 28.8.2009 | 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 | | | | |
| 28.8.2009 | Aldara | Meda AB Pipers väg 2 SE-170 73 Solna SVËRIGE | Meda AB | Pipers väg 2 |
| Meda AB | | | | |
| Pipers väg 2 | | | | |
| SE-170 73 Solna | | | | |
| SVËRIGE | | | | |
| 28.8.2009 | 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 | | | | |
| 31.8.2009 | Betaferon | Bayer Schering Pharma AG Müllerstrasse 170-178 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | Müllerstrasse 170-178 |
| Bayer Schering Pharma AG | | | | |
| Müllerstrasse 170-178 | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 31.8.2009 | Neupro | Schwarz Pharma Ltd Shannon, Industrial Estate Co.Clare IRELAND | Schwarz Pharma Ltd | Shannon, Industrial Estate |
| Schwarz Pharma Ltd | | | | |
| Shannon, Industrial Estate | | | | |
| Co.Clare | | | | |
| IRELAND | | | | |
| 31.8.2009 | Icandra | 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 | | | | |
| 31.8.2009 | Mimpara | 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 | | | | |
| 31.8.2009 | Tandemact | Takeda Global Research and Development Centre (Europe) Ltd. 61 Aldwich London WC2B 4AE UNITED KINGDOM | Takeda Global Research and Development Centre (Europe) Ltd. | 61 Aldwich |
| Takeda Global Research and Development Centre (Europe) Ltd. | | | | |
| 61 Aldwich | | | | |
| London | | | | |
| WC2B 4AE | | | | |
| UNITED KINGDOM | | | | |
| 31.8.2009 | Gardasil | Sanofi Pasteur MSD, SNC 8 rue Jonas Salk 69007 Lyon FRANCE | Sanofi Pasteur MSD, SNC | 8 rue Jonas Salk |
| Sanofi Pasteur MSD, SNC | | | | |
| 8 rue Jonas Salk | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 31.8.2009 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited Unit 13, Stillorgan Industrial Park Blackrock, Co.Dublin IRELAND | Bristol-Myers Squibb and Gilead Sciences Limited | Unit 13, Stillorgan Industrial Park |
| Bristol-Myers Squibb and Gilead Sciences Limited | | | | |
| Unit 13, Stillorgan Industrial Park | | | | |
| Blackrock, Co.Dublin | | | | |
| IRELAND | | | | |

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| ---------------------- | ----------------------------- | ----------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 27.8.2009 | 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 | | | | |
| 31.8.2009 | Locatim | Biokema Anstalt Pflugstrasse 12 9490 Vaduz, Fürstentum LIECHTENSTEIN | Biokema Anstalt | Pflugstrasse 12 |
| Biokema Anstalt | | | | |
| Pflugstrasse 12 | | | | |
| 9490 Vaduz, Fürstentum | | | | |
| LIECHTENSTEIN | | | | |

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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