# C_2009260EN.01000601.xml

| 30.10.2009 | EN | Official Journal of the European Union | C 260/6 |
| ---------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 September 2009 to 30 September 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 260/04

—   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 |
| ------------------------------------- | ----------------------------- | ---------------------------------------- | -------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- | ----------------------------------------------- | -------------------- |
| 21.9.2009 | Cayston | Aztreonam | Gilead Sciences International Limited Granta Park Abington Cambridge CB21 6GT UNITED KINGDOM | Gilead Sciences International Limited | Granta Park | Abington | Cambridge |
| Gilead Sciences International Limited | | | | | | | |
| Granta Park | | | | | | | |
| Abington | | | | | | | |
| Cambridge | | | | | | | |
| CB21 6GT | | | | | | | |
| UNITED KINGDOM | | | | | | | |
| 21.9.2009 | Clopidogrel Sandoz | Clopidogrel | Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND | Acino Pharma GmbH | Am Windfeld 35 | 83714 Miesbach | DEUTSCHLAND |
| Acino Pharma GmbH | | | | | | | |
| Am Windfeld 35 | | | | | | | |
| 83714 Miesbach | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 21.9.2009 | Vizarsin | Sildenafil | 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 | | | | | | | |
| 21.9.2009 | Clopidogrel DURA | Clopidogrel | Mylan dura GmbH Wittichstraße 6 64295 Darmstadt DEUTSCHLAND | Mylan dura GmbH | Wittichstraße 6 | 64295 Darmstadt | DEUTSCHLAND |
| Mylan dura GmbH | | | | | | | |
| Wittichstraße 6 | | | | | | | |
| 64295 Darmstadt | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 21.9.2009 | Clopidogrel HCS | Clopidogrel | HCS bvba H. Kennisstraat 53 2650 Edegem BELGÏE | HCS bvba | H. Kennisstraat 53 | 2650 Edegem | BELGÏE |
| HCS bvba | | | | | | | |
| H. Kennisstraat 53 | | | | | | | |
| 2650 Edegem | | | | | | | |
| BELGÏE | | | | | | | |
| 21.9.2009 | Topotecan Teva | Topotecan | 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 | | | | | | | |
| 21.9.2009 | Zopya | Clopidogrel | Norpharm Regulatory Services Ltd. 26 Laurence Street Drogheda Co. Louth IRELAND | Norpharm Regulatory Services Ltd. | 26 Laurence Street | Drogheda | Co. Louth |
| Norpharm Regulatory Services Ltd. | | | | | | | |
| 26 Laurence Street | | | | | | | |
| Drogheda | | | | | | | |
| Co. Louth | | | | | | | |
| IRELAND | | | | | | | |
| 21.9.2009 | Zylagren | Clopidogrel | 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 | | | | | | | |
| 21.9.2009 | Clopidogrel Mylan | Clopidogrel | Mylan S.A.S 117 Allée des Parcs 69800 Saint Priest FRANCE | Mylan S.A.S | 117 Allée des Parcs | 69800 Saint Priest | FRANCE |
| Mylan S.A.S | | | | | | | |
| 117 Allée des Parcs | | | | | | | |
| 69800 Saint Priest | | | | | | | |
| FRANCE | | | | | | | |
| 21.9.2009 | Javlor | Vinflunine ditartrate | Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne FRANCE | Pierre Fabre Médicament | 45 place Abel Gance | 92100 Boulogne | FRANCE |
| Pierre Fabre Médicament | | | | | | | |
| 45 place Abel Gance | | | | | | | |
| 92100 Boulogne | | | | | | | |
| FRANCE | | | | | | | |
| 21.9.2009 | Clopidogrel Acino Pharma GmbH | Clopidogrel | Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND | Acino Pharma GmbH | Am Windfeld 35 | 83714 Miesbach | DEUTSCHLAND |
| Acino Pharma GmbH | | | | | | | |
| Am Windfeld 35 | | | | | | | |
| 83714 Miesbach | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 23.9.2009 | Clopidogrel TAD | Clopidogrel | TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven DEUTSCHLAND | TAD Pharma GmbH | Heinz-Lohmann-Straße 5 | 27472 Cuxhaven | DEUTSCHLAND |
| TAD Pharma GmbH | | | | | | | |
| Heinz-Lohmann-Straße 5 | | | | | | | |
| 27472 Cuxhaven | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 23.9.2009 | Clopidogrel Krka | Clopidogrel | 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 | | | | | | | |
| 23.9.2009 | Clopidogrel Qualimed | Clopidogrel | Qualimed 117 Allée des Parcs 69800 Saint Priest FRANCE | Qualimed | 117 Allée des Parcs | 69800 Saint Priest | FRANCE |
| Qualimed | | | | | | | |
| 117 Allée des Parcs | | | | | | | |
| 69800 Saint Priest | | | | | | | |
| FRANCE | | | | | | | |
| 23.9.2009 | Clopidogrel ratiopharm | Clopidogrel | Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND | Acino Pharma GmbH | Am Windfeld 35 | 83714 Miesbach | DEUTSCHLAND |
| Acino Pharma GmbH | | | | | | | |
| Am Windfeld 35 | | | | | | | |
| 83714 Miesbach | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 28.9.2009 | Clopidogrel Acino Pharma | Clopidogrel | Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND | Acino Pharma GmbH | Am Windfeld 35 | 83714 Miesbach | DEUTSCHLAND |
| Acino Pharma GmbH | | | | | | | |
| Am Windfeld 35 | | | | | | | |
| 83714 Miesbach | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 28.9.2009 | Zyllt | Clopidogrel | 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 | | | | | | | |

—   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 |
| ----------------------------------------------------------- | ------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------- | -------------------------------------- |
| 2.9.2009 | Zomarist | 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 | | | | |
| 2.9.2009 | Keppra | UCB Pharma SA. Allée de la Recherche/Researchdreef 60 1070 Bruxelles/Brussel BELGIQUE/BELGIË | UCB Pharma SA. | Allée de la Recherche/Researchdreef 60 |
| UCB Pharma SA. | | | | |
| Allée de la Recherche/Researchdreef 60 | | | | |
| 1070 Bruxelles/Brussel | | | | |
| BELGIQUE/BELGIË | | | | |
| 2.9.2009 | Inovelon | Eisai Limited European Knowledge Centre Mosquito Way Hatfield Herts AL10 9SN UNITED KINGDOM | Eisai Limited | European Knowledge Centre |
| Eisai Limited | | | | |
| European Knowledge Centre | | | | |
| Mosquito Way | | | | |
| Hatfield | | | | |
| Herts | | | | |
| AL10 9SN | | | | |
| UNITED KINGDOM | | | | |
| 2.9.2009 | Lumigan | Allergan Pharmaceuticals Ireland Castlebar Road Westport Co. Mayo IRELAND | Allergan Pharmaceuticals Ireland | Castlebar Road |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road | | | | |
| Westport | | | | |
| Co. Mayo | | | | |
| IRELAND | | | | |
| 2.9.2009 | Norvir | Abbott Laboratories Ltd. Queenborough Kent ME11 5EL UNITED KINGDOM | Abbott Laboratories Ltd. | Queenborough |
| Abbott Laboratories Ltd. | | | | |
| Queenborough | | | | |
| Kent | | | | |
| ME11 5EL | | | | |
| UNITED KINGDOM | | | | |
| 2.9.2009 | 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 | | | | |
| 4.9.2009 | Zevalin | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 4.9.2009 | Prialt | Eisai Limited European Knowledge Centre Mosquito Way Hatfield Herts AL10 9SN UNITED KINGDOM | Eisai Limited | European Knowledge Centre |
| Eisai Limited | | | | |
| European Knowledge Centre | | | | |
| Mosquito Way | | | | |
| Hatfield | | | | |
| Herts | | | | |
| AL10 9SN | | | | |
| UNITED KINGDOM | | | | |
| 7.9.2009 | Sebivo | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM | Novartis Europharm Limited | Wimblehurst Road |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road | | | | |
| Horsham | | | | |
| West Sussex | | | | |
| RH12 5AB | | | | |
| UNITED KINGDOM | | | | |
| 9.9.2009 | Isentress | Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | Merck Sharp & Dohme Limited | Hertford Road |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire | | | | |
| EN11 9BU | | | | |
| UNITED KINGDOM | | | | |
| 9.9.2009 | 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 | | | | |
| 14.9.2009 | Avaglim | 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 | | | | |
| 16.9.2009 | Efficib | 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 | | | | |
| 16.9.2009 | Velmetia | 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 | | | | |
| 16.9.2009 | Janumet | 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 | | | | |
| 17.9.2009 | Ribavirin 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 | | | | |
| 17.9.2009 | 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 | | | | |
| 17.9.2009 | Actos | 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 | | | | |
| 17.9.2009 | Glustin | 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 | | | | |
| 17.9.2009 | 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 | | | | |
| 17.9.2009 | Doribax | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 17.9.2009 | Duloxetine Boehringer Ingelheim | 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 | | | | |
| 17.9.2009 | Glubrava | 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 | | | | |
| 21.9.2009 | Orfadin | Swedish Orphan International AB Drottninggatan 98 SE-111 60 Stockholm SVERIGE | Swedish Orphan International AB | Drottninggatan 98 |
| Swedish Orphan International AB | | | | |
| Drottninggatan 98 | | | | |
| SE-111 60 Stockholm | | | | |
| SVERIGE | | | | |
| 21.9.2009 | Elaprase | Shire Human Genetic Therapies AB Svärdvägen 11D SE-182 33 Danderyd SVERIGE | Shire Human Genetic Therapies AB | Svärdvägen 11D |
| Shire Human Genetic Therapies AB | | | | |
| Svärdvägen 11D | | | | |
| SE-182 33 Danderyd | | | | |
| SVERIGE | | | | |
| 21.9.2009 | Alimta | 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 | | | | |
| 21.9.2009 | Ferriprox | Apotex Europe B.V. Darwingweg 20 2333 CR Leiden NEDERLAND | Apotex Europe B.V. | Darwingweg 20 |
| Apotex Europe B.V. | | | | |
| Darwingweg 20 | | | | |
| 2333 CR Leiden | | | | |
| NEDERLAND | | | | |
| 21.9.2009 | Azilect | Teva Pharma GmbH Kandelstrasse 10 79199 Kirchzarten DEUTSCHLAND | Teva Pharma GmbH | Kandelstrasse 10 |
| Teva Pharma GmbH | | | | |
| Kandelstrasse 10 | | | | |
| 79199 Kirchzarten | | | | |
| DEUTSCHLAND | | | | |
| 21.9.2009 | Trisenox | Cephalon Europe 5 Rue Charles Martigny 94700 Maisons Alfort, Cedex FRANCE | Cephalon Europe | 5 Rue Charles Martigny |
| Cephalon Europe | | | | |
| 5 Rue Charles Martigny | | | | |
| 94700 Maisons Alfort, Cedex | | | | |
| FRANCE | | | | |
| 23.9.2009 | 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 | | | | |
| 24.9.2009 | Emselex | 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 | | | | |
| 25.9.2009 | Qutenza | Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp NEDERLAND NeurogesX UK Limited 265 Strand London WC2R 1BH UNITED KINGDOM | Astellas Pharma Europe B.V. | Elisabethhof 19 |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19 | | | | |
| 2353 EW Leiderdorp | | | | |
| NEDERLAND | | | | |
| NeurogesX UK Limited | | | | |
| 265 Strand | | | | |
| London | | | | |
| WC2R 1BH | | | | |
| UNITED KINGDOM | | | | |
| 29.9.2009 | Focetria | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina 1 Siena SI ITALIA | Novartis Vaccines and Diagnostics S.r.l. | Via Fiorentina 1 |
| Novartis Vaccines and Diagnostics S.r.l. | | | | |
| Via Fiorentina 1 | | | | |
| Siena SI | | | | |
| ITALIA | | | | |
| 29.9.2009 | 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 | | | | |

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

| 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 |
| -------------------- | ----------------------------- | --------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 14.9.2009 | 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 | | | | |

—   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 |
| -------------------------- | ----------------------------- | --------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 2.9.2009 | Tekturna | 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 | | | | |

—   Issuing of a marketing authorisation 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 |
| -------------------- | ----------------------------- | ---------------------------------------- | --------------------------------------------------------------- | --------------------------------------------- | ------------------- | ----------------------------------------------- | -------------------- |
| 23.9.2009 | Palladia | Toceranib | Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd. | Ramsgate Road | Sandwich | Kent |
| Pfizer Ltd. | | | | | | | |
| Ramsgate Road | | | | | | | |
| Sandwich | | | | | | | |
| Kent | | | | | | | |
| CT13 9NJ | | | | | | | |
| UNITED KINGDOM | | | | | | | |

—   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 |
| --------------------------- | ----------------------------- | ---------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 2.9.2009 | Cerenia | Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd. | Ramsgate Road |
| Pfizer Ltd. | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 8.9.2009 | Posatex | 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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