# C_2010022EN.01000201.xml

| 29.1.2010 | EN | Official Journal of the European Union | C 22/2 |
| --------- | -- | -------------------------------------- | ------ |

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 November 2009 to 30 November 2009

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

2010/C 22/02

—   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 |
| -------------------------- | ----------------------------------- | ------------------------------------------------- | --------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- | ----------------------------------------------- | -------------------- |
| 4.11.2009 | Repaglinide Krka | Repaglinide | KRKA, d. d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA | KRKA, d. d. | Novo mesto | Šmarješka cesta 6 | SI-8501 Novo mesto |
| KRKA, d. d. | | | | | | | |
| Novo mesto | | | | | | | |
| Šmarješka cesta 6 | | | | | | | |
| SI-8501 Novo mesto | | | | | | | |
| SLOVENIJA | | | | | | | |
| 4.11.2009 | Copalia HCT | amlodipine besylate/valsartan/hydrochlorothiazide | 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 | | | | | | | |
| 4.11.2009 | Dafiro HCT | amlodipine besylate/valsartan/hydrochlorothiazide | 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 | | | | | | | |
| 26.11.2009 | Multaq | dronedarone | Sanofi-Aventis 174 avenue de France 75013 Paris FRANCE | Sanofi-Aventis | 174 avenue de France | 75013 Paris | FRANCE |
| Sanofi-Aventis | | | | | | | |
| 174 avenue de France | | | | | | | |
| 75013 Paris | | | | | | | |
| FRANCE | | | | | | | |
| 26.11.2009 | Irbesartan/Hydrochlorothiazide Teva | hydrochlorothiazide | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | Teva Pharma B.V. | Computerweg 10 | 3542 DR Utrecht | NEDERLAND |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10 | | | | | | | |
| 3542 DR Utrecht | | | | | | | |
| NEDERLAND | | | | | | | |
| 30.11.2009 | Sildenafil Teva | Sildenafil | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | Teva Pharma B.V. | Computerweg 10 | 3542 DR Utrecht | NEDERLAND |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10 | | | | | | | |
| 3542 DR Utrecht | | | | | | | |
| NEDERLAND | | | | | | | |
| 30.11.2009 | Nevirapine Teva | nevirapine | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | Teva Pharma B.V. | Computerweg 10 | 3542 DR Utrecht | NEDERLAND |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10 | | | | | | | |
| 3542 DR Utrecht | | | | | | | |
| NEDERLAND | | | | | | | |
| 30.11.2009 | Hirobriz Breezhaler | Indacaterol | 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 | | | | | | | |
| 30.11.2009 | Onbrez Breezhaler | Indacaterol | 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 | | | | | | | |
| 30.11.2009 | Oslif Breezhaler | Indacaterol | 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 | | | | | | | |
| 30.11.2009 | Zutectra | Human Hepatitis B Immunoglobulin | Biotest Pharma GmbH Landsteinerstr. 5 63303 Dreieich DEUTSCHLAND | Biotest Pharma GmbH | Landsteinerstr. 5 | 63303 Dreieich | DEUTSCHLAND |
| Biotest Pharma GmbH | | | | | | | |
| Landsteinerstr. 5 | | | | | | | |
| 63303 Dreieich | | | | | | | |
| DEUTSCHLAND | | | | | | | |

—   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 |
| ---------------------------------------- | --------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------ |
| 4.11.2009 | 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 | | | | |
| 4.11.2009 | Optisulin | 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 | | | | |
| 4.11.2009 | Lantus | 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 | | | | |
| 4.11.2009 | Ketek | Aventis Pharma S.A. 20 avenue Raymond Aron 92160 Antony FRANCE | Aventis Pharma S.A. | 20 avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron | | | | |
| 92160 Antony | | | | |
| FRANCE | | | | |
| 4.11.2009 | Osseor | Les Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE | Les Laboratoires Servier | 22 rue Garnier |
| Les Laboratoires Servier | | | | |
| 22 rue Garnier | | | | |
| 92200 Neuilly-sur-Seine | | | | |
| FRANCE | | | | |
| 4.11.2009 | Protelos | Les Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE | Les Laboratoires Servier | 22 rue Garnier |
| Les Laboratoires Servier | | | | |
| 22 rue Garnier | | | | |
| 92200 Neuilly-sur-Seine | | | | |
| FRANCE | | | | |
| 5.11.2009 | 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 | | | | |
| 5.11.2009 | Tyverb | 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 | | | | |
| 5.11.2009 | Pre-pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals | 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 | | | | |
| 5.11.2009 | 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 | | | | |
| 5.11.2009 | Invega | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 5.11.2009 | Foscan | Biolitec Pharma Ltd United Drug House Magna Drive Dublin 24 IRELAND | Biolitec Pharma Ltd | United Drug House |
| Biolitec Pharma Ltd | | | | |
| United Drug House | | | | |
| Magna Drive | | | | |
| Dublin 24 | | | | |
| IRELAND | | | | |
| 6.11.2009 | 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 | | | | |
| 9.11.2009 | 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 | | | | |
| 11.11.2009 | Celvapan | Baxter AG Industriestraße 67 1221 Wien ÖSTERREICH | Baxter AG | Industriestraße 67 |
| Baxter AG | | | | |
| Industriestraße 67 | | | | |
| 1221 Wien | | | | |
| ÖSTERREICH | | | | |
| 11.11.2009 | Focetria | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina 1 53100 Siena SI ITALIA | Novartis Vaccines and Diagnostics S.r.l. | Via Fiorentina 1 |
| Novartis Vaccines and Diagnostics S.r.l. | | | | |
| Via Fiorentina 1 | | | | |
| 53100 Siena SI | | | | |
| ITALIA | | | | |
| 11.11.2009 | Pandemrix | 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 | | | | |
| 11.11.2009 | Insuman | 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 | | | | |
| 11.11.2009 | PegIntron | Schering Plough Europe
Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË | Rue de Stalle 73 | 1180 Bruxelles |
| Rue de Stalle 73 | | | | |
| 1180 Bruxelles | | | | |
| BELGIQUE | | | | |
| Stallestraat 73 | | | | |
| 1180 Brussel | | | | |
| BELGIË | | | | |
| 11.11.2009 | Soliris | Alexion Europe S.A.S. 25 boulevard de l'Amiral Bruix 75016 Paris FRANCE | Alexion Europe S.A.S. | 25 boulevard de l'Amiral Bruix |
| Alexion Europe S.A.S. | | | | |
| 25 boulevard de l'Amiral Bruix | | | | |
| 75016 Paris | | | | |
| FRANCE | | | | |
| 11.11.2009 | Rebetol | Schering Plough Europe
Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË | Rue de Stalle 73 | 1180 Bruxelles |
| Rue de Stalle 73 | | | | |
| 1180 Bruxelles | | | | |
| BELGIQUE | | | | |
| Stallestraat 73 | | | | |
| 1180 Brussel | | | | |
| BELGIË | | | | |
| 12.11.2009 | 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 | | | | |
| 12.11.2009 | IntronA | Schering Plough Europe
Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË | Rue de Stalle 73 | 1180 Bruxelles |
| Rue de Stalle 73 | | | | |
| 1180 Bruxelles | | | | |
| BELGIQUE | | | | |
| Stallestraat 73 | | | | |
| 1180 Brussel | | | | |
| BELGIË | | | | |
| 12.11.2009 | ViraferonPeg | Schering Plough Europe
Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË | Rue de Stalle 73 | 1180 Bruxelles |
| Rue de Stalle 73 | | | | |
| 1180 Bruxelles | | | | |
| BELGIQUE | | | | |
| Stallestraat 73 | | | | |
| 1180 Brussel | | | | |
| BELGIË | | | | |
| 19.11.2009 | IntronA | Schering Plough Europe
Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË | Rue de Stalle 73 | 1180 Bruxelles |
| Rue de Stalle 73 | | | | |
| 1180 Bruxelles | | | | |
| BELGIQUE | | | | |
| Stallestraat 73 | | | | |
| 1180 Brussel | | | | |
| BELGIË | | | | |
| 19.11.2009 | Clopidogrel Teva Pharma | Teva Pharma B.V.
Computerweg 10 3542 DR Utrecht NEDERLAND HCS bvba, H. Kennisstraat 53 2650 Edegem BELGIË | Computerweg 10 | 3542 DR Utrecht |
| Computerweg 10 | | | | |
| 3542 DR Utrecht | | | | |
| NEDERLAND | | | | |
| HCS bvba, H. | | | | |
| Kennisstraat 53 | | | | |
| 2650 Edegem | | | | |
| BELGIË | | | | |
| 20.11.2009 | Circadin | RAD Neurim Pharmaceuticals EEC Limited One Forbury Square The Forbury, Reading Berkshire RG1 3EB UNITED KINGDOM | RAD Neurim Pharmaceuticals EEC Limited | One Forbury Square |
| RAD Neurim Pharmaceuticals EEC Limited | | | | |
| One Forbury Square | | | | |
| The Forbury, Reading | | | | |
| Berkshire | | | | |
| RG1 3EB | | | | |
| UNITED KINGDOM | | | | |
| 20.11.2009 | Bondronat | 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 | | | | |
| 20.11.2009 | Ebixa | H. Lundbeck A/S Ottiliavej 9 2500 Valby DANMARK | H. Lundbeck A/S | Ottiliavej 9 |
| H. Lundbeck A/S | | | | |
| Ottiliavej 9 | | | | |
| 2500 Valby | | | | |
| DANMARK | | | | |
| 20.11.2009 | Mycamine | Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp NEDERLAND | Astellas Pharma Europe B.V. | Elisabethhof 19 |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19 | | | | |
| 2353 EW Leiderdorp | | | | |
| NEDERLAND | | | | |
| 20.11.2009 | 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 | | | | |
| 20.11.2009 | MabCampath | 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 | | | | |
| 20.11.2009 | Somavert | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 20.11.2009 | Reyataz | 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 | | | | |
| 20.11.2009 | 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 | | | | |
| 20.11.2009 | Regranex | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 20.11.2009 | Ziagen | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 20.11.2009 | Cymbalta | 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 | | | | |
| 20.11.2009 | Angiox | The Medicines Company UK Ltd 115 L Milton Park Abingdon Oxfordshire OX14 4SA UNITED KINGDOM | The Medicines Company UK Ltd | 115 L Milton Park |
| The Medicines Company UK Ltd | | | | |
| 115 L Milton Park | | | | |
| Abingdon | | | | |
| Oxfordshire | | | | |
| OX14 4SA | | | | |
| UNITED KINGDOM | | | | |
| 20.11.2009 | Agenerase | Glaxo Group Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Limited | Glaxo Wellcome House |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House | | | | |
| Berkeley Avenue | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 20.11.2009 | RoActemra | 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 | | | | |
| 23.11.2009 | Nexavar | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 23.11.2009 | Noxafil | SP Europe
Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË | Rue de Stalle 73 | 1180 Bruxelles |
| Rue de Stalle 73 | | | | |
| 1180 Bruxelles | | | | |
| BELGIQUE | | | | |
| Stallestraat 73 | | | | |
| 1180 Brussel | | | | |
| BELGIË | | | | |
| 23.11.2009 | Pritor | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 23.11.2009 | Aptivus | 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 | | | | |
| 23.11.2009 | 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 | | | | |
| 23.11.2009 | Cervarix | 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 | | | | |
| 23.11.2009 | 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 | | | | |
| 23.11.2009 | 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 | | | | |
| 23.11.2009 | Azilect | Teva Pharma GmbH Kandelstrasse 10 79199 Kirchzarten DEUTSCHLAND | Teva Pharma GmbH | Kandelstrasse 10 |
| Teva Pharma GmbH | | | | |
| Kandelstrasse 10 | | | | |
| 79199 Kirchzarten | | | | |
| DEUTSCHLAND | | | | |
| 23.11.2009 | Invega | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 23.11.2009 | Puregon | Organon N.V. Kloosterstraat 6 Postbus 20 5340 BH Oss NEDERLAND | Organon N.V. | Kloosterstraat 6 |
| Organon N.V. | | | | |
| Kloosterstraat 6 | | | | |
| Postbus 20 | | | | |
| 5340 BH Oss | | | | |
| NEDERLAND | | | | |
| 23.11.2009 | Kinzalmono | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 23.11.2009 | Micardis | 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 | | | | |
| 23.11.2009 | Kaletra | Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent | | | | |
| ME11 5EL | | | | |
| UNITED KINGDOM | | | | |
| 24.11.2009 | Synagis | Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent | | | | |
| ME11 5EL | | | | |
| UNITED KINGDOM | | | | |
| 24.11.2009 | alli | 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 | | | | |
| 25.11.2009 | Kivexa | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 26.11.2009 | Enbrel | 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 | | | | |
| 26.11.2009 | Enbrel | 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 | | | | |
| 26.11.2009 | Diacomit | Biocodex 7 avenue Gallieni 94250 Gentilly FRANCE | Biocodex | 7 avenue Gallieni |
| Biocodex | | | | |
| 7 avenue Gallieni | | | | |
| 94250 Gentilly | | | | |
| FRANCE | | | | |
| 26.11.2009 | 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 | | | | |
| 26.11.2009 | 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 | | | | |
| 27.11.2009 | Pandemrix | 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 | | | | |
| 27.11.2009 | Focetria | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina 1 53100 Siena SI ITALIA | Novartis Vaccines and Diagnostics S.r.l. | Via Fiorentina 1 |
| Novartis Vaccines and Diagnostics S.r.l. | | | | |
| Via Fiorentina 1 | | | | |
| 53100 Siena SI | | | | |
| ITALIA | | | | |
| 30.11.2009 | Velcade | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 30.11.2009 | 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 | | | | |
| 30.11.2009 | Adcirca | 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 | | | | |
| 30.11.2009 | Docetaxel Winthrop | Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex FRANCE | Aventis Pharma S.A. | 20 avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron | | | | |
| 92165 Antony Cedex | | | | |
| FRANCE | | | | |
| 30.11.2009 | Taxotere | Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex FRANCE | Aventis Pharma S.A. | 20 avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron | | | | |
| 92165 Antony Cedex | | | | |
| FRANCE | | | | |

—   Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004)

| 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 |
| -------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------- | ---------------------- |
| 11.11.2009 | Irbesartan 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 | | | | |
| 11.11.2009 | Irbesartan HCT 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 | | | | |
| 12.11.2009 | 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 | | | | |
| 26.11.2009 | Paxene | Norton Healthcare Limited Albert Basin Royal Docks London E16 2QJ UNITED KINGDOM | Norton Healthcare Limited | Albert Basin |
| Norton Healthcare Limited | | | | |
| Albert Basin | | | | |
| Royal Docks | | | | |
| London | | | | |
| E16 2QJ | | | | |
| UNITED KINGDOM | | | | |

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ----------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------- | --------------------------------------------- | ------------------- | ----------------------------------------------- | -------------------- |
| 4.11.2009 | Zolvix | Monepantel | Novartis Healthcare A/S Lyngbyvej 172 2100 Copenhagen DANMARK | Novartis Healthcare A/S | Lyngbyvej 172 | 2100 Copenhagen | DANMARK |
| Novartis Healthcare A/S | | | | | | | |
| Lyngbyvej 172 | | | | | | | |
| 2100 Copenhagen | | | | | | | |
| DANMARK | | | | | | | |

—   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 |
| ----------------------------------- | ----------------------------- | ---------------------------------------------------------------------------- | --------------------------------------------- | ------------------------ |
| 18.11.2009 | Dexdomitor | Orion Corporation Orionintie 1 FI-02200 Espoo SUOMI/FINLAND | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FI-02200 Espoo | | | | |
| SUOMI/FINLAND | | | | |
| 19.11.2009 | Improvac | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Limited | Ramsgate Road |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 20.11.2009 | Metacam | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim Vetmedica GmbH | 55216 Ingelheim am Rhein |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| 55216 Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 23.11.2009 | Halocur | 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 |

---

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

---