# C_2009146EN.01000601.xml

| 26.6.2009 | EN | Official Journal of the European Union | C 146/6 |
| --------- | -- | -------------------------------------- | ------- |

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2009 to 31 May 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 146/03

—   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 |
| --------------------------- | ----------------------------- | ----------------------------------------- | ------------------------------------------------------------------------ | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------- |
| 11.5.2009 | Nimvastid | Rivastigmine | 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 | | | | | | | |
| 15.5.2009 | Modigraf | Tacrolimus | Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp NEDERLAND | Astellas Pharma Europe B.V. | Elisabethhof 19 | 2353 EW Leiderdorp | NEDERLAND |
| Astellas Pharma Europe B.V. | | | | | | | |
| Elisabethhof 19 | | | | | | | |
| 2353 EW Leiderdorp | | | | | | | |
| NEDERLAND | | | | | | | |
| 15.5.2009 | Ellaone | Ulipristal acetate | Laboratoire HRA Pharma 15 rue Béranger 75003 Paris FRANCE | Laboratoire HRA Pharma | 15 rue Béranger | 75003 Paris | FRANCE |
| Laboratoire HRA Pharma | | | | | | | |
| 15 rue Béranger | | | | | | | |
| 75003 Paris | | | | | | | |
| FRANCE | | | | | | | |
| 15.5.2009 | Qutenza | Capsaicin | NeurogesX UK Limited 265 Strand London WC2R 1BH UNITED KINGDOM | NeurogesX UK Limited | 265 Strand | London | WC2R 1BH |
| NeurogesX UK Limited | | | | | | | |
| 265 Strand | | | | | | | |
| London | | | | | | | |
| WC2R 1BH | | | | | | | |
| UNITED KINGDOM | | | | | | | |

—   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 |
| --------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------- |
| 5.5.2009 | Kinzalkomb | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 5.5.2009 | Kinzalmono | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 6.5.2009 | Pritorplus | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 6.5.2009 | Pritor | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 7.5.2009 | Viramune | 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 | | | | |
| 7.5.2009 | Privigen | CSL Behring GmbH Emil von Behring Strasse 76 35041 Marburg DEUTSCHLAND | CSL Behring GmbH | Emil von Behring Strasse 76 |
| CSL Behring GmbH | | | | |
| Emil von Behring Strasse 76 | | | | |
| 35041 Marburg | | | | |
| DEUTSCHLAND | | | | |
| 7.5.2009 | Adenuric | Beaufour Ipsen Pharma 24, rue Erlanger 75781 Paris Cedex 16 FRANCE | Beaufour Ipsen Pharma | 24, rue Erlanger |
| Beaufour Ipsen Pharma | | | | |
| 24, rue Erlanger | | | | |
| 75781 Paris Cedex 16 | | | | |
| FRANCE | | | | |
| 11.5.2009 | 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 | | | | |
| 15.5.2009 | 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 | | | | |
| 15.5.2009 | Oprymea | KRKA, d.d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA | KRKA, d.d. | Novo mesto |
| KRKA, d.d. | | | | |
| Novo mesto | | | | |
| Šmarješka cesta 6 | | | | |
| SI-8501 Novo mesto | | | | |
| SLOVENIJA | | | | |
| 15.5.2009 | 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 | | | | |
| 15.5.2009 | Tredaptive | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | Merck Sharp & Dohme Ltd | Hertford Road |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire | | | | |
| EN11 9BU | | | | |
| UNITED KINGDOM | | | | |
| 15.5.2009 | Pelzont | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | Merck Sharp & Dohme Ltd | Hertford Road |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire | | | | |
| EN11 9BU | | | | |
| UNITED KINGDOM | | | | |
| 15.5.2009 | Trevaclyn | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | Merck Sharp & Dohme Ltd | Hertford Road |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire | | | | |
| EN11 9BU | | | | |
| UNITED KINGDOM | | | | |
| 19.5.2009 | Adenuric | Ipsen Pharma 65 quai Georges Gorse 92100 Boulogne-Billancourt FRANCE Beaufour Ipsen Pharma 24, rue Erlanger 75781 Paris Cedex 16 FRANCE | Ipsen Pharma | 65 quai Georges Gorse |
| Ipsen Pharma | | | | |
| 65 quai Georges Gorse | | | | |
| 92100 Boulogne-Billancourt | | | | |
| FRANCE | | | | |
| Beaufour Ipsen Pharma | | | | |
| 24, rue Erlanger | | | | |
| 75781 Paris Cedex 16 | | | | |
| FRANCE | | | | |
| 20.5.2009 | Pramipexole Teva | Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 NEDERLAND | Teva Pharma B.V. | Computerweg 10 |
| Teva Pharma B.V. | | | | |
| Computerweg 10 | | | | |
| DR Utrecht 3542 | | | | |
| NEDERLAND | | | | |
| 26.5.2009 | TORISEL | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM | Wyeth Europa Ltd | Huntercombe Lane South |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire | | | | |
| SL6 0PH | | | | |
| UNITED KINGDOM | | | | |
| 26.5.2009 | Luveris | 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 | | | | |
| 26.5.2009 | Tysabri | Elan Pharma International Ltd. Monksland, Athlone County Westmeath IRELAND | Elan Pharma International Ltd. | Monksland, Athlone |
| Elan Pharma International Ltd. | | | | |
| Monksland, Athlone | | | | |
| County Westmeath | | | | |
| IRELAND | | | | |
| 26.5.2009 | Pritor | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 26.5.2009 | Zavesca | Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL UNITED KINGDOM | Actelion Registration Ltd | BSI Building 13th Floor |
| Actelion Registration Ltd | | | | |
| BSI Building 13th Floor | | | | |
| 389 Chiswick High Road | | | | |
| London | | | | |
| W4 4AL | | | | |
| UNITED KINGDOM | | | | |
| 27.5.2009 | 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 | | | | |
| 27.5.2009 | Ventavis | Bayer Schering Pharma AG Müllerstrasse 170-178 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | Müllerstrasse 170-178 |
| Bayer Schering Pharma AG | | | | |
| Müllerstrasse 170-178 | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 27.5.2009 | Rilutek | 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 | | | | |
| 27.5.2009 | PritorPlus | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 28.5.2009 | TESAVEL | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | Merck Sharp & Dohme Ltd | Hertford Road |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire | | | | |
| EN11 9BU | | | | |
| UNITED KINGDOM | | | | |
| 28.5.2009 | 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 | | | | |
| 28.5.2009 | NovoSeven | Novo Nordisk A/S Novo Allé 2880 Bagsværd DANMARK | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| 2880 Bagsværd | | | | |
| DANMARK | | | | |
| 28.5.2009 | AVANDIA | SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM | SmithKline Beecham plc | 980 Great West Road |
| SmithKline Beecham plc | | | | |
| 980 Great West Road | | | | |
| Brentford | | | | |
| Middlesex | | | | |
| TW8 9GS | | | | |
| UNITED KINGDOM | | | | |
| 28.5.2009 | Soliris | Alexion Europe SAS 54-56 Avenue Hoche 75008 Paris FRANCE | Alexion Europe SAS | 54-56 Avenue Hoche |
| Alexion Europe SAS | | | | |
| 54-56 Avenue Hoche | | | | |
| 75008 Paris | | | | |
| FRANCE | | | | |
| 28.5.2009 | Tarceva | 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 | | | | |
| 28.5.2009 | Insulin Human Winthrop | 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 | | | | |
| 28.5.2009 | DepoCyte | Pacira Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ UNITED KINGDOM | Pacira Limited | West Forest Gate |
| Pacira Limited | | | | |
| West Forest Gate | | | | |
| Wellington Road | | | | |
| Wokingham | | | | |
| Berkshire | | | | |
| RG40 2AQ | | | | |
| UNITED KINGDOM | | | | |
| 28.5.2009 | 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 | | | | |
| 29.5.2009 | 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 | | | | |
| 29.5.2009 | 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 | | | | |
| 29.5.2009 | SUTENT | Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT 13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 29.5.2009 | Lyrica | Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT 13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 29.5.2009 | MicardisPlus | Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Strasse 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 | | | | |
| 55216 Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 29.5.2009 | Ziagen | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 29.5.2009 | CellCept | 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 | | | | |
| 29.5.2009 | Xelevia | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | Merck Sharp & Dohme Ltd | Hertford Road |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire | | | | |
| EN11 9BU | | | | |
| UNITED KINGDOM | | | | |
| 29.5.2009 | Viramune | 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 | | | | |
| 29.5.2009 | Zostavax | Sanofi Pasteur MSD SNC 8, rue Jonas Salk Lyon 69007 FRANCE | Sanofi Pasteur MSD SNC | 8, rue Jonas Salk |
| Sanofi Pasteur MSD SNC | | | | |
| 8, rue Jonas Salk | | | | |
| Lyon 69007 | | | | |
| FRANCE | | | | |
| 29.5.2009 | Replagal | 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 | | | | |
| 29.5.2009 | 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 | | | | |
| 29.5.2009 | 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 | | | | |
| 29.5.2009 | Kinzalkomb | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 29.5.2009 | ORENCIA | 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 | | | | |
| 29.5.2009 | Avastin | 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 | | | | |
| 29.5.2009 | Advate | Baxter AG Industriesstrasse 67 1220 Vienna ÖSTERREICH | Baxter AG | Industriesstrasse 67 |
| Baxter AG | | | | |
| Industriesstrasse 67 | | | | |
| 1220 Vienna | | | | |
| ÖSTERREICH | | | | |
| 29.5.2009 | Kinzalmono | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 29.5.2009 | 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 | | | | |
| 29.5.2009 | 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 | | | | |

—   Issuing of a marketing authorization (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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
(Anatomical Therapeutic Chemical Code) | Date of notification |
| -------------------- | ----------------------------- | ----------------------------------------------------------------------------------------------- | ------------------------------------------------------------------ | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------- |
| 11.5.2009 | Improvac | Synthetic peptide analogue of GnRF conjugated to a carrier protein of min. 300 μg per 2 ml dose | PFIZER Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | PFIZER Limited | Ramsgate Road | Sandwich | Kent |
| PFIZER Limited | | | | | | | |
| Ramsgate Road | | | | | | | |
| Sandwich | | | | | | | |
| Kent | | | | | | | |
| CT13 9NJ | | | | | | | |
| UNITED KINGDOM | | | | | | | |

—   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 |
| ----------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 8.5.2009 | 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 | | | | |
| 11.5.2009 | Aivlosin | ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS UNITED KINGDOM | ECO Animal Health Ltd | 78 Coombe Road |
| ECO Animal Health Ltd | | | | |
| 78 Coombe Road | | | | |
| New Malden | | | | |
| Surrey | | | | |
| KT3 4QS | | | | |
| UNITED KINGDOM | | | | |
| 19.5.2009 | Onsior | Novartis Animal Health UK Ltd Frimley Business Park Frimley/Camberley Surrey GU16 7SR UNITED KINGDOM | Novartis Animal Health UK Ltd | Frimley Business Park |
| Novartis Animal Health UK Ltd | | | | |
| Frimley Business Park | | | | |
| Frimley/Camberley | | | | |
| Surrey | | | | |
| GU16 7SR | | | | |
| UNITED KINGDOM | | | | |
| 25.5.2009 | Advocate | Bayer Animal Health GmbH 51368 Leverkusen DEUTSCHLAND | Bayer Animal Health GmbH | 51368 Leverkusen |
| Bayer Animal Health GmbH | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 29.5.2009 | Previcox | Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 Avenue Tony Garnier |
| Merial | | | | |
| 29 Avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |

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

| 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 |
| -------------------------------- | ----------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 7.5.2009 | Porcilis Porcoli | Intervet International B.V. (NL) Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND | Intervet International B.V. (NL) | Wim de Körverstraat 35 |
| Intervet International B.V. (NL) | | | | |
| 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 of 30.4.2004, p. 1.

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