# C_2009101EN.01000301.xml

| 1.5.2009 | EN | Official Journal of the European Union | C 101/3 |
| -------- | -- | -------------------------------------- | ------- |

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2009 to 31 March 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 101/03

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

| Date of the decision | Name of the medicinal product | INN
(International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
(Anatomical Therapeutic Chemical Code) | Date of notification |
| -------------------------------- | ----------------------------- | ------------------------------------------------------------------------------ | ----------------------------------------------------------------------------- | --------------------------------------------- | ------------------------- | ------------------------------------------------ | -------------------- |
| 4.3.2009 | CELVAPAN | Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived, inactivated) | Baxter AG Industriestraße 67 A - 1221 Wien ÖSTERREICH | Baxter AG | Industriestraße 67 | A - 1221 Wien | ÖSTERREICH |
| Baxter AG | | | | | | | |
| Industriestraße 67 | | | | | | | |
| A - 1221 Wien | | | | | | | |
| ÖSTERREICH | | | | | | | |
| 6.3.2009 | MEPACT | mifamurtide | IDM Pharma S.A. 47 rue de Chaillot 75116 Paris FRANCE | IDM Pharma S.A. | 47 rue de Chaillot | 75116 Paris | FRANCE |
| IDM Pharma S.A. | | | | | | | |
| 47 rue de Chaillot | | | | | | | |
| 75116 Paris | | | | | | | |
| FRANCE | | | | | | | |
| 19.3.2009 | Fertavid | follitropin beta | SP Europe Rue de Stalle 73 B-1180 Bruxelles BELGIQUE | SP Europe | Rue de Stalle | 73 B-1180 Bruxelles | BELGIQUE |
| SP Europe | | | | | | | |
| Rue de Stalle | | | | | | | |
| 73 B-1180 Bruxelles | | | | | | | |
| BELGIQUE | | | | | | | |
| 30.3.2009 | Synflorix | Pneumococcal polysaccharide conjugate vaccine (adsorbed) | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89 1330 Rixensart BELGIQUE | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89 | 1330 Rixensart | BELGIQUE |
| GlaxoSmithKline Biologicals S.A. | | | | | | | |
| rue de l'Institut 89 | | | | | | | |
| 1330 Rixensart | | | | | | | |
| BELGIQUE | | | | | | | |
| 31.3.2009 | Ribavirin Teva | Ribavirin | 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 | | | | | | | |
| 31.3.2009 | IXIARO | Japanese Encephalitis vaccine (inactivated, adsorbed) | Intercell AG Campus Vienna Biocenter 3 A-1030 Wien ÖSTERREICH | Intercell AG | Campus Vienna Biocenter 3 | A-1030 Wien | ÖSTERREICH |
| Intercell AG | | | | | | | |
| Campus Vienna Biocenter 3 | | | | | | | |
| A-1030 Wien | | | | | | | |
| ÖSTERREICH | | | | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --------------------------------------------- | --------------------------------------- | ------------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------------- |
| 2.3.2009 | Fendrix | GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 Rixensart, B-1330 BELGIQUE | GlaxoSmithKline Biologicals s.a. | rue de l'Institut 89 |
| GlaxoSmithKline Biologicals s.a. | | | | |
| rue de l'Institut 89 | | | | |
| Rixensart, B-1330 | | | | |
| BELGIQUE | | | | |
| 2.3.2009 | 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 | | | | |
| 2.3.2009 | Fareston | Orion Corporation Orionintie 1 FIN-02200 Espoo SUOMI | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| SUOMI | | | | |
| 2.3.2009 | Nexavar | Bayer HealthCare AG D-51368 Leverkusen DEUTSCHLAND | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 2.3.2009 | 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, Sanderson Road |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road | | | | |
| Uxbridge UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 2.3.2009 | Aptivus | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Strasse 173- D - 55216 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 | | | | |
| Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 2.3.2009 | Ganfort | Allergan Pharmaceuticals Ireland Castlebar Road Westport, Co. Mayo IRELAND | Allergan Pharmaceuticals Ireland | Castlebar Road |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road | | | | |
| Westport, Co. Mayo | | | | |
| IRELAND | | | | |
| 4.3.2009 | KOGENATE Bayer | Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer HealthCare AG | 51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 4.3.2009 | Helixate NexGen | Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer HealthCare AG | 51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 4.3.2009 | 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 | | | | |
| 4.3.2009 | Cystadane | Orphan Europe S.a.r.l. Immeuble Le Wilson 70 Avenue du Général de Gaulle 92800 Puteaux FRANCE | Orphan Europe S.a.r.l. | Immeuble Le Wilson |
| Orphan Europe S.a.r.l. | | | | |
| Immeuble Le Wilson | | | | |
| 70 Avenue du Général de Gaulle | | | | |
| 92800 Puteaux | | | | |
| FRANCE | | | | |
| 4.3.2009 | Photobarr | Axcan Pharma International BV Engelenkampstraat 72 6131 JJ Sittard NEDERLAND | Axcan Pharma International BV | Engelenkampstraat 72 |
| Axcan Pharma International BV | | | | |
| Engelenkampstraat 72 | | | | |
| 6131 JJ Sittard | | | | |
| NEDERLAND | | | | |
| 6.3.2009 | Silgard | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon | | | | |
| Hertfordshire EN11 9BU | | | | |
| UNITED KINGDOM | | | | |
| 6.3.2009 | BYETTA | 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 | | | | |
| 6.3.2009 | IntronA | Schering Plough Europe Rue de Stalle, 73 1180 Bruxelles BELGIQUE | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| 1180 Bruxelles | | | | |
| BELGIQUE | | | | |
| 6.3.2009 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden NEDERLAND | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| NEDERLAND | | | | |
| 6.3.2009 | 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 | | | | |
| 6.3.2009 | ATryn | LEO Pharma A/S Industriparken 55 DK-2750 Ballerup DANMARK | LEO Pharma A/S | Industriparken 55 |
| LEO Pharma A/S | | | | |
| Industriparken 55 | | | | |
| DK-2750 Ballerup | | | | |
| DANMARK | | | | |
| 6.3.2009 | Irbesartan Hydrochlorothiazide Winthrop | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris FRANCE | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | 174 avenue de France |
| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | | | | |
| 174 avenue de France | | | | |
| F- 75013 Paris | | | | |
| FRANCE | | | | |
| 9.3.2009 | Optisulin | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main DEUTSCHLAND | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main | | | | |
| DEUTSCHLAND | | | | |
| 9.3.2009 | 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 | | | | |
| 9.3.2009 | Sustiva | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road | | | | |
| Uxbridge UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 10.3.2009 | DULOXETINE BOEHRINGER INGELHEIM | Boehringer Ingelheim International GmbH Binger Strasse 173 - D - 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Strasse 173 - D - 55216 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 - D - 55216 | | | | |
| Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 17.3.2009 | Pritor Plus | Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer HealthCare AG | 51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 17.3.2009 | Irbesartan Winthrop | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris FRANCE | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | 174 avenue de France |
| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | | | | |
| 174 avenue de France | | | | |
| F- 75013 Paris | | | | |
| FRANCE | | | | |
| 17.3.2009 | Pritor | Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer HealthCare AG | 51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 17.3.2009 | Hycamtin | SmithKline Beecham plc 980 Great West Road, Brentford Middlesex,TW8 9GS UNITED KINGDOM | SmithKline Beecham plc | 980 Great West Road, Brentford |
| SmithKline Beecham plc | | | | |
| 980 Great West Road, Brentford | | | | |
| Middlesex,TW8 9GS | | | | |
| UNITED KINGDOM | | | | |
| 17.3.2009 | Onsenal | Pfizer Limited Ramsgate Road, Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Limited | Ramsgate Road, Sandwich |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 18.3.2009 | 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, Sanderson Road |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road | | | | |
| Uxbridge UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 18.3.2009 | Atriance | Glaxo Group Limited Berkeley Avenue, Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Limited | Berkeley Avenue, Greenford |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 18.3.2009 | Kinzalkomb | Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer HealthCare AG | 51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 18.3.2009 | MicardisPlus | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Strasse 173- D - 55216 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 | | | | |
| Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 18.3.2009 | Kinzalmono | Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer HealthCare AG | 51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 19.3.2009 | Regranex | Janssen-Cilag International NV Turnhoutseweg 30 - 2340 Beerse – BELGIË | Janssen-Cilag International NV | Turnhoutseweg |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg | | | | |
| 30 - 2340 Beerse – | | | | |
| BELGIË | | | | |
| 19.3.2009 | Stalevo | Orion Corporation Orionintie 1 FIN-02200 Espoo SUOMI | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| SUOMI | | | | |
| 19.3.2009 | Micardis | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Strasse 173- D - 55216 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 | | | | |
| Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 19.3.2009 | Vectibix | Amgen Europe B.V. Minervum 7061 NL-4817 ZK Breda NEDERLAND | Amgen Europe B.V. | Minervum 7061 |
| Amgen Europe B.V. | | | | |
| Minervum 7061 | | | | |
| NL-4817 ZK Breda | | | | |
| NEDERLAND | | | | |
| 23.3.2009 | NovoSeven | Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd DANMARK | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsvaerd | | | | |
| DANMARK | | | | |
| 23.3.2009 | 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, Sanderson Road |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road | | | | |
| Uxbridge UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 25.3.2009 | Avastin | Roche Registration Limited 6 Falcon Way, Shire Park Welwyn Garden City, AL7 1TW UNITED KINGDOM | Roche Registration Limited | 6 Falcon Way, Shire Park |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park | | | | |
| Welwyn Garden City, AL7 1TW | | | | |
| UNITED KINGDOM | | | | |
| 25.3.2009 | Enbrel | Wyeth Europa Limited Huntercombe Lane South, Taplow Maidenhead, Berkshire, SL6 0PH UNITED KINGDOM | Wyeth Europa Limited | Huntercombe Lane South, Taplow |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow | | | | |
| Maidenhead, Berkshire, SL6 0PH | | | | |
| UNITED KINGDOM | | | | |
| 25.3.2009 | Telzir | Glaxo Group Ltd. Greenford Road, Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd. | Greenford Road, Greenford |
| Glaxo Group Ltd. | | | | |
| Greenford Road, Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 25.3.2009 | 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 | | | | |
| 25.3.2009 | Exjade | Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB UNITED KINGDOM | Novartis Europharm Limited | Wimblehurst Road, Horsham |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| UNITED KINGDOM | | | | |
| 25.3.2009 | Arixtra | Glaxo Group Ltd. Greenford Road, Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd. | Greenford Road, Greenford |
| Glaxo Group Ltd. | | | | |
| Greenford Road, Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 25.3.2009 | Xenical | Roche Registration Limited 6 Falcon Way, Shire Park Welwyn Garden City, AL7 1TW UNITED KINGDOM | Roche Registration Limited | 6 Falcon Way, Shire Park |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park | | | | |
| Welwyn Garden City, AL7 1TW | | | | |
| UNITED KINGDOM | | | | |
| 25.3.2009 | 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 | | | | |
| 25.3.2009 | Advagraf | Astellas Pharma Europe B.V. Elisabethhof 19 NL-2353 EW Leiderdorp NEDERLAND | Astellas Pharma Europe B.V. | Elisabethhof 19 |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19 | | | | |
| NL-2353 EW Leiderdorp | | | | |
| NEDERLAND | | | | |
| 25.3.2009 | Pradaxa | Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Strasse 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 | | | | |
| D-55216 Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 25.3.2009 | Zyprexa | Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND | Eli Lilly Nederland B.V. | Grootslag 1-5 |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| NEDERLAND | | | | |
| 25.3.2009 | ProQuad | 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 | | | | |
| 25.3.2009 | Cetrotide | 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 | | | | |
| 25.3.2009 | Tyverb | Glaxo Group Limited Berkeley Avenue, Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Limited | Berkeley Avenue, Greenford |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 25.3.2009 | Lysodren | Laboratoire HRA Pharma 15, rue Béranger 75003 Paris FRANCE | Laboratoire HRA Pharma | 15, rue Béranger |
| Laboratoire HRA Pharma | | | | |
| 15, rue Béranger | | | | |
| 75003 Paris | | | | |
| FRANCE | | | | |
| 25.3.2009 | Zyprexa Velotab | 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 | | | | |
| 25.3.2009 | 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 | | | | |
| 25.3.2009 | Extavia | Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB UNITED KINGDOM | Novartis Europharm Limited | Wimblehurst Road, Horsham |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| UNITED KINGDOM | | | | |
| 25.3.2009 | Mabthera | Roche Registration Limited 6 Falcon Way, Shire Park Welwyn Garden City, AL7 1TW UNITED KINGDOM | Roche Registration Limited | 6 Falcon Way, Shire Park |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park | | | | |
| Welwyn Garden City, AL7 1TW | | | | |
| UNITED KINGDOM | | | | |
| 25.3.2009 | Beromun | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Strasse 173- D - 55216 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 | | | | |
| Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 25.3.2009 | Dukoral | SBL Vaccin AB S-105 21 Stockholm SWEDEN | SBL Vaccin AB | S-105 21 Stockholm |
| SBL Vaccin AB | | | | |
| S-105 21 Stockholm | | | | |
| SWEDEN | | | | |
| 25.3.2009 | NeuroBloc | Eisai Limited 3, Shortlands London W6 8EE UNITED KINGDOM | Eisai Limited | 3, Shortlands |
| Eisai Limited | | | | |
| 3, Shortlands | | | | |
| London W6 8EE | | | | |
| UNITED KINGDOM | | | | |
| 25.3.2009 | Xeristar | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Strasse 173- D - 55216 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 | | | | |
| Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 27.3.2009 | Aerinaze | SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel BELGIË | SP Europe | Rue de Stalle, 73, 1180 Bruxelles, Belgique - |
| SP Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - | | | | |
| Stallestraat, 73 - 1180 Brussel | | | | |
| BELGIË | | | | |
| 27.3.2009 | Liprolog | 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 | | | | |
| 27.3.2009 | Karvezide | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road | | | | |
| Uxbridge UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 27.3.2009 | Irbesartan HCT Winthrop | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris FRANCE | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | 174 avenue de France |
| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | | | | |
| 174 avenue de France | | | | |
| F- 75013 Paris | | | | |
| FRANCE | | | | |
| 27.3.2009 | Litak | Lipomed GmbH Schönaugasse 11 D-79713 Bad Säckingen DEUTSCHLAND | Lipomed GmbH | Schönaugasse 11 |
| Lipomed GmbH | | | | |
| Schönaugasse 11 | | | | |
| D-79713 Bad Säckingen | | | | |
| DEUTSCHLAND | | | | |
| 27.3.2009 | Procoralan | 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 | | | | |
| 27.3.2009 | Mimpara | Amgen Europe B.V. Minervum 7061 NL-4817 ZK Breda NEDERLAND | Amgen Europe B.V. | Minervum 7061 |
| Amgen Europe B.V. | | | | |
| Minervum 7061 | | | | |
| NL-4817 ZK Breda | | | | |
| NEDERLAND | | | | |
| 27.3.2009 | TRIZIVIR | Glaxo Group Ltd. Greenford Road, Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd. | Greenford Road, Greenford |
| Glaxo Group Ltd. | | | | |
| Greenford Road, Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 27.3.2009 | Dafiro | Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB UNITED KINGDOM | Novartis Europharm Limited | Wimblehurst Road, Horsham |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| UNITED KINGDOM | | | | |
| 27.3.2009 | Copalia | Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB UNITED KINGDOM | Novartis Europharm Limited | Wimblehurst Road, Horsham |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| UNITED KINGDOM | | | | |
| 27.3.2009 | Imprida | Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB UNITED KINGDOM | Novartis Europharm Limited | Wimblehurst Road, Horsham |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| UNITED KINGDOM | | | | |
| 27.3.2009 | Exforge | Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB UNITED KINGDOM | Novartis Europharm Limited | Wimblehurst Road, Horsham |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| UNITED KINGDOM | | | | |
| 27.3.2009 | Stalevo | Orion Corporation Orionintie 1 FIN-02200 Espoo SUOMI | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| SUOMI | | | | |
| 30.3.2009 | Cholestagel | Genzyme Europe B.V. Gooimeer 10 NL-1411 DD Naarden NEDERLAND | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| NL-1411 DD Naarden | | | | |
| NEDERLAND | | | | |
| 31.3.2009 | Rapilysin | Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 Hafnarfjordur ICELAND | Actavis Group PTC ehf. | Reykjavikurvegi 76-78 |
| Actavis Group PTC ehf. | | | | |
| Reykjavikurvegi 76-78 | | | | |
| 220 Hafnarfjordur | | | | |
| ICELAND | | | | |
| 31.3.2009 | Velcade | Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| B-2340 Beerse | | | | |
| BELGIË | | | | |
| 31.3.2009 | Aprovel | 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 | | | | |
| 31.3.2009 | Karvea | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road | | | | |
| Uxbridge UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 31.3.2009 | CoAprovel | 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 | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ------------------------------------------------------------ | ----------------------------- | --------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------------ |
| 17.3.2009 | Dynepo | Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke Hampshire RG24 8EP UNITED KINGDOM | Shire Pharmaceutical Contracts Ltd | Hampshire International Business Park, Chineham, Basingstoke |
| Shire Pharmaceutical Contracts Ltd | | | | |
| Hampshire International Business Park, Chineham, Basingstoke | | | | |
| Hampshire RG24 8EP | | | | |
| UNITED KINGDOM | | | | |

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No (2) 726/2004): Accepted

| Date of the decision | Name of the medicinal product | INN
(International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ---------------------- | ----------------------------- | ----------------------------------------- | ----------------------------------------------- | --------------------------------------------- | ---------------------- | ----------------------------------------------- | -------------------- |
| 17.3.2009 | BTVPUR Alsap 8 | Bluetongue virus Serotype 8 Antigen | MERIAL 29 avenue Tony Garnier 69007 LYON FRANCE | MERIAL | 29 avenue Tony Garnier | 69007 LYON | FRANCE |
| MERIAL | | | | | | | |
| 29 avenue Tony Garnier | | | | | | | |
| 69007 LYON | | | | | | | |
| FRANCE | | | | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ----------------------------------- | ----------------------------- | ----------------------------------------------------------------------------- | --------------------------------------------- | ------------------------- |
| 6.3.2009 | Econor | Novartis Animal Health Austria GmbH Biochemiestrasse 10 6250 Kundl ÖSTERREICH | Novartis Animal Health Austria GmbH | Biochemiestrasse 10 |
| Novartis Animal Health Austria GmbH | | | | |
| Biochemiestrasse 10 | | | | |
| 6250 Kundl | | | | |
| ÖSTERREICH | | | | |
| 12.3.2009 | Novem | 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 | | | | |
| 18.3.2009 | Aivlosin | ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS UNITED KINGDOM | ECO Animal Health Ltd | 78 Coombe Road New Malden |
| ECO Animal Health Ltd | | | | |
| 78 Coombe Road New Malden | | | | |
| Surrey KT3 4QS | | | | |
| UNITED KINGDOM | | | | |
| 23.3.2009 | Equilis Prequenza Te | 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 | | | | |
| 23.3.2009 | Equilis Prequenza | 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 | | | | |
| 25.3.2009 | Quadrisol | 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.

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

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