# C_2009178EN.01001501.xml

| 31.7.2009 | EN | Official Journal of the European Union | C 178/15 |
| --------- | -- | -------------------------------------- | -------- |

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 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 178/12

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
| -------------------- | ----------------------------- | ----------------------------------------- | --------------------------------------------------------- | --------------------------------------------- | -------------------- | ------------------------------------------------ | -------------------- |
| 10.6.2009 | Renvela | Sevelamer (carbonate) | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND | Genzyme Europe B.V. | Gooimeer 10 | 1411 DD Naarden | NEDERLAND |
| Genzyme Europe B.V. | | | | | | | |
| Gooimeer 10 | | | | | | | |
| 1411 DD Naarden | | | | | | | |
| NEDERLAND | | | | | | | |
| 12.6.2009 | PANTOLOC Control | Pantoprazole | Nycomed GmbH Byk-Gulden-Str. 2 78467 Konstanz DEUTSCHLAND | Nycomed GmbH | Byk-Gulden-Str. 2 | 78467 Konstanz | DEUTSCHLAND |
| Nycomed GmbH | | | | | | | |
| Byk-Gulden-Str. 2 | | | | | | | |
| 78467 Konstanz | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 12.6.2009 | PANTOZOL Control | Pantoprazole | Nycomed GmbH Byk-Gulden-Str. 2 78467 Konstanz DEUTSCHLAND | Nycomed GmbH | Byk-Gulden-Str. 2 | 78467 Konstanz | DEUTSCHLAND |
| Nycomed GmbH | | | | | | | |
| Byk-Gulden-Str. 2 | | | | | | | |
| 78467 Konstanz | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 12.6.2009 | PANTECTA Control | Pantoprazole | Nycomed GmbH Byk-Gulden-Str. 2 78467 Konstanz DEUTSCHLAND | Nycomed GmbH | Byk-Gulden-Str. 2 | 78467 Konstanz | DEUTSCHLAND |
| Nycomed GmbH | | | | | | | |
| Byk-Gulden-Str. 2 | | | | | | | |
| 78467 Konstanz | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 12.6.2009 | CONTROLOC Control | Pantoprazole | Nycomed GmbH Byk-Gulden-Str. 2 78467 Konstanz DEUTSCHLAND | Nycomed GmbH | Byk-Gulden-Str. 2 | 78467 Konstanz | DEUTSCHLAND |
| Nycomed GmbH | | | | | | | |
| Byk-Gulden-Str. 2 | | | | | | | |
| 78467 Konstanz | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 12.6.2009 | SOMAC Control | Pantoprazole | Nycomed GmbH Byk-Gulden-Str. 2 78467 Konstanz DEUTSCHLAND | Nycomed GmbH | Byk-Gulden-Str. 2 | 78467 Konstanz | DEUTSCHLAND |
| Nycomed GmbH | | | | | | | |
| Byk-Gulden-Str. 2 | | | | | | | |
| 78467 Konstanz | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 24.6.2009 | IRESSA | Gefitinib | AstraZeneca AB SE-151 85 Sodertalje SVERIGE | AstraZeneca AB | SE-151 85 Sodertalje | SVERIGE | EU/1/09/526/001 |
| AstraZeneca AB | | | | | | | |
| SE-151 85 Sodertalje | | | | | | | |
| SVERIGE | | | | | | | |
| 29.6.2009 | Repaglinide Teva | Repaglinide | 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 | | | | | | | |
| 30.6.2009 | Victoza | Liraglutide | Novo Nordisk A/S Novo Allé 2880 Bagsvaerd DANMARK | Novo Nordisk A/S | Novo Allé | 2880 Bagsvaerd | DANMARK |
| Novo Nordisk A/S | | | | | | | |
| Novo Allé | | | | | | | |
| 2880 Bagsvaerd | | | | | | | |
| DANMARK | | | | | | | |

—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
| --------------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------- |
| 2.6.2009 | Avamys | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 2.6.2009 | Alisade | Glaxo Group Ltd Greenford Middlesex UB6 ONN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 ONN | | | | |
| UNITED KINGDOM | | | | |
| 2.6.2009 | 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 | | | | |
| 2.6.2009 | 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 | | | | |
| 2.6.2009 | 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 | | | | |
| 2.6.2009 | 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 | | | | |
| 2.6.2009 | 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 | | | | |
| 2.6.2009 | 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 | | | | |
| 2.6.2009 | 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 | | | | |
| 2.6.2009 | Sustiva | 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 | | | | |
| 2.6.2009 | 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 | | | | |
| 4.6.2009 | 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 | | | | |
| 4.6.2009 | Ovitrelle | Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM | Serono Europe Limited | 56 Marsh Wall |
| Serono Europe Limited | | | | |
| 56 Marsh Wall | | | | |
| London | | | | |
| E14 9TP | | | | |
| UNITED KINGDOM | | | | |
| 8.6.2009 | 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 | | | | |
| 8.6.2009 | Ziagen | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 8.6.2009 | Pergoveris | Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM | Serono Europe Limited | 56 Marsh Wall |
| Serono Europe Limited | | | | |
| 56 Marsh Wall | | | | |
| London | | | | |
| E14 9TP | | | | |
| UNITED KINGDOM | | | | |
| 8.6.2009 | 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 | | | | |
| 8.6.2009 | 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 | | | | |
| 8.6.2009 | 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 | | | | |
| 8.6.2009 | Kivexa | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 9.6.2009 | GONAL-f | Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM | Serono Europe Limited | 56 Marsh Wall |
| Serono Europe Limited | | | | |
| 56 Marsh Wall | | | | |
| London | | | | |
| E14 9TP | | | | |
| UNITED KINGDOM | | | | |
| 17.6.2009 | Erbitux | Merck KGaA Frankfurter Straße 250 64271 Darmstadt DEUTSCHLAND | Merck KGaA | Frankfurter Straße 250 |
| Merck KGaA | | | | |
| Frankfurter Straße 250 | | | | |
| 64271 Darmstadt | | | | |
| DEUTSCHLAND | | | | |
| 17.6.2009 | 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 | | | | |
| 18.6.2009 | Vivanza | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer AG 51368 Leverkusen DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| Bayer AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 18.6.2009 | Vasovist | TMC Pharma Services Ltd Eversley Hampshire RG27 0NT UNITED KINGDOM Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | TMC Pharma Services Ltd | Eversley |
| TMC Pharma Services Ltd | | | | |
| Eversley | | | | |
| Hampshire | | | | |
| RG27 0NT | | | | |
| UNITED KINGDOM | | | | |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 18.6.2009 | 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 | | | | |
| 18.6.2009 | Emtriva | Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM | Gilead Sciences International Limited | Cambridge |
| Gilead Sciences International Limited | | | | |
| Cambridge | | | | |
| CB21 6GT | | | | |
| UNITED KINGDOM | | | | |
| 22.6.2009 | 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 | | | | |
| 22.6.2009 | Yondelis | Pharma Mar, S.A. Avda. de los Reyes 1 Polígono Industrial La Mina 28770 Colmenar Viejo Madrid ESPAÑA | Pharma Mar, S.A. | Avda. de los Reyes 1 |
| Pharma Mar, S.A. | | | | |
| Avda. de los Reyes 1 | | | | |
| Polígono Industrial La Mina | | | | |
| 28770 Colmenar Viejo Madrid | | | | |
| ESPAÑA | | | | |
| 22.6.2009 | Levitra | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer AG 51368 Leverkusen DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| Bayer AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 23.6.2009 | 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 | | | | |
| 23.6.2009 | Prezista | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 23.6.2009 | Prezista | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 23.6.2009 | Yondelis | Pharma Mar, S.A. Avda. de los Reyes, 1 Polígono Industrial La Mina 28770 Colmenar Viejo Madrid ESPAÑA | Pharma Mar, S.A. | Avda. de los Reyes, 1 |
| Pharma Mar, S.A. | | | | |
| Avda. de los Reyes, 1 | | | | |
| Polígono Industrial La Mina | | | | |
| 28770 Colmenar Viejo Madrid | | | | |
| ESPAÑA | | | | |
| 23.6.2009 | 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 | | | | |
| 23.6.2009 | 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 | | | | |
| 24.6.2009 | Ariclaim | 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 | | | | |
| 24.6.2009 | YENTREVE | 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 | | | | |
| 24.6.2009 | 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 | | | | |
| 24.6.2009 | Neupro | Schwarz Pharma Ltd Shannon Industrial Estate Co. Clare IRELAND | Schwarz Pharma Ltd | Shannon |
| Schwarz Pharma Ltd | | | | |
| Shannon | | | | |
| Industrial Estate | | | | |
| Co. Clare | | | | |
| IRELAND | | | | |
| 24.6.2009 | 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 | | | | |
| 24.6.2009 | Axura | Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 60318 Frankfurt/Main DEUTSCHLAND | Merz Pharmaceuticals GmbH | Eckenheimer Landstr. 100-104 |
| Merz Pharmaceuticals GmbH | | | | |
| Eckenheimer Landstr. 100-104 | | | | |
| 60318 Frankfurt/Main | | | | |
| DEUTSCHLAND | | | | |
| 29.6.2009 | RotaTeq | 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 | | | | |
| 29.6.2009 | Yttriga | Nuclitec GmbH Gieselweg 1 38110 Braunschweig DEUTSCHLAND | Nuclitec GmbH | Gieselweg 1 |
| Nuclitec GmbH | | | | |
| Gieselweg 1 | | | | |
| 38110 Braunschweig | | | | |
| DEUTSCHLAND | | | | |
| 29.6.2009 | Kepivance | Biovitrum AB (publ) SE-112 76 Stockholm SVERIGE | Biovitrum AB (publ) | SE-112 76 Stockholm |
| Biovitrum AB (publ) | | | | |
| SE-112 76 Stockholm | | | | |
| SVERIGE | | | | |
| 29.6.2009 | Effentora | Cephalon Europe 5 rue Charles Martigny 94700 Maisons-Alfort FRANCE | Cephalon Europe | 5 rue Charles Martigny |
| Cephalon Europe | | | | |
| 5 rue Charles Martigny | | | | |
| 94700 Maisons-Alfort | | | | |
| FRANCE | | | | |
| 30.6.2009 | Cerezyme | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| NEDERLAND | | | | |
| 30.6.2009 | Hepsera | Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM | Gilead Sciences International Limited | Cambridge |
| Gilead Sciences International Limited | | | | |
| Cambridge | | | | |
| CB21 6GT | | | | |
| UNITED KINGDOM | | | | |
| 30.6.2009 | Kineret | Biovitrum AB (publ) SE-112 76 Stockholm SVERIGE | Biovitrum AB (publ) | SE-112 76 Stockholm |
| Biovitrum AB (publ) | | | | |
| SE-112 76 Stockholm | | | | |
| SVERIGE | | | | |
| 30.6.2009 | Ariclaim | 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 | | | | |
| 30.6.2009 | 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 | | | | |

—   Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| 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 |
| --------------------- | ----------------------------- | ----------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 9.6.2009 | Raptiva | Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM | Serono Europe Limited | 56 Marsh Wall |
| Serono Europe Limited | | | | |
| 56 Marsh Wall | | | | |
| London | | | | |
| E14 9TP | | | | |
| UNITED KINGDOM | | | | |

—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
( 2 )
): 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 |
| -------------------- | ----------------------------- | ----------------------------------------- | ---------------------------------------------------------- | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------- |
| 17.6.2009 | Leucogen | | Virbac 1ère avenue 2065 m L.I.D. 06516 Carros Cedex FRANCE | Virbac | 1ère avenue | 2065 m L.I.D. | 06516 Carros Cedex |
| Virbac | | | | | | | |
| 1ère avenue | | | | | | | |
| 2065 m L.I.D. | | | | | | | |
| 06516 Carros Cedex | | | | | | | |
| FRANCE | | | | | | | |
| 25.6.2009 | Leucofeligen FeLV/RCP | | Virbac 1ère avenue 2065 m L.I.D. 06516 Carros Cedex FRANCE | Virbac | 1ère avenue | 2065 m L.I.D. | 06516 Carros Cedex |
| Virbac | | | | | | | |
| 1ère avenue | | | | | | | |
| 2065 m L.I.D. | | | | | | | |
| 06516 Carros Cedex | | | | | | | |
| FRANCE | | | | | | | |

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
| ---------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------- | ---------------------- |
| 4.6.2009 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited Loughrea Co. Galway IRELAND | Chanelle Pharmaceuticals Manufacturing Limited | Loughrea |
| Chanelle Pharmaceuticals Manufacturing Limited | | | | |
| Loughrea | | | | |
| Co. Galway | | | | |
| IRELAND | | | | |
| 8.6.2009 | Circovac | Merial 29 avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 avenue Tony Garnier |
| Merial | | | | |
| 29 avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 22.6.2009 | ProMeris | 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 | | | | |
| 30.6.2009 | Posatex | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND S-P Veterinary Shire Park Welwyn Garden City Hertfordshire AL7 1TW UNITED KINGDOM | Intervet International B.V. | Wim de Körverstraat 35 |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| NEDERLAND | | | | |
| S-P Veterinary | | | | |
| Shire Park | | | | |
| Welwyn Garden City | | | | |
| Hertfordshire | | | | |
| AL7 1TW | | | | |
| UNITED KINGDOM | | | | |

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.

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

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