EN Official Journal of the European Union C 111/2

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010

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

2010/C 111/02

— 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 8.1.2010 Leflunomide Winthrop leflunomide Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/09/604/001-010 Film-coated tablet L04AA13 12.1.2010 11.1.2010 Scintimun besilesomab CIS bio international 32 Boite Postale 91192 Gif-sur-Yvette FRANCE EU/1/09/602/001-002 Kit for radiopharmaceutical preparation V09HA03 15.1.2010 25.1.2010 Elonva corifollitropin alfa N.V. Organon Kloosterstraat 6 5349 AB Oss NEDERLAND EU/1/09/609/001-002 Solution for injection GO3GA09 27.1.2010 25.1.2010 Temomedac temozolomide ALFRED E. TIEFENBACHER (GmbH & Co. KG) Van-der-Smissen-Straße 1 22767 Hamburg DEUTSCHLAND EU/1/09/605/001-012 Capsule, hard L01AX03 27.1.2010 26.1.2010 Docetaxel Teva Docetaxel Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/611/001-002 Concentrate and solvent for solution for infusion L01CD02 28.1.2010 26.1.2010 Telmisartan Teva telmisartan Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/610/001-030 Tablet C09CA07 28.1.2010 28.1.2010 Temozolomide Teva temozolomide Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/606/001-012 Capsule, hard L01AX03 1.2.2010 29.1.2010 Silodyx silodosin Recordati Ireland Ltd Raheens East Ringaskiddy Co. Cork IRELAND EU/1/09/607/001-014 Capsule, hard G04CA04 2.2.2010 29.1.2010 Urorec silodosin Recordati Ireland Ltd Raheens East Ringaskiddy Co. Cork IRELAND EU/1/09/608/001-014 Capsule, hard G04CA04 2.2.2010





— Issuing of a marketing authorization (Article 13 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 29.1.2010 Gemesis BioMimetic Therapeutics Ltd Arnold & Porter Tower 42 25 Old Broad Street London EC2N 1HQ UNITED KINGDOM 2.2.2010





— 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 7.1.2010 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road Westport Co. Mayo IRELAND EU/1/02/205/001-004 11.1.2010 8.1.2010 Kaletra Abbott Laboratories Ltd Abbott House Vanwall Business Park Vanwall Road Maidenhead Berkshire SL6 4XE UNITED KINGDOM EU/1/01/172/001-007 12.1.2010 8.1.2010 Osseor Les Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE EU/1/04/287/001-006 12.1.2010 8.1.2010 Protelos Les Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE EU/1/04/288/001-006 12.1.2010 8.1.2010 Ratiograstim ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm DEUTSCHLAND EU/1/08/444/001-012 13.1.2010 8.1.2010 Revlimid Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA UNITED KINGDOM EU/1/07/391/001-004 12.1.2010 11.1.2010 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France 75013 Paris FRANCE EU/1/98/086/001-034 13.1.2010 11.1.2010 Nplate Amgen Europe B.V. Minervum 7061 4817 ZK Breda NEDERLAND EU/1/08/497/001-008 13.1.2010 12.1.2010 Apidra Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/04/285/001-004 14.1.2010 12.1.2010 EMEND Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/03/262/001-008 14.1.2010 12.1.2010 Prialt Eisai Limited European Knowledge Centre Mosquito Way Hatfield Herts AL10 9SN UNITED KINGDOM EU/1/04/302/001-004 14.1.2010 12.1.2010 Revlimid Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA UNITED KINGDOM EU/1/07/391/001-004 14.1.2010 15.1.2010 Thyrogen Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/99/122/001-002 19.1.2010 19.1.2010 Gardasil Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/06/357/001-021 21.1.2010 19.1.2010 Herceptin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/00/145/001 21.1.2010 19.1.2010 IRESSA AstraZeneca AB SE-151 85 Sodertalje SVERIGE EU/1/09/526/001-002 21.1.2010 19.1.2010 M-M-RVAXPRO Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/06/337/001-013 21.1.2010 19.1.2010 Orfadin Swedish Orphan International AB Drottninggatan 98 SE-111 60 Stockholm SVERIGE EU/1/04/303/001-003 21.1.2010 19.1.2010 ProQuad Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/05/323/001-013 21.1.2010 20.1.2010 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn DEUTSCHLAND EU/1/07/412/001-020 22.1.2010 20.1.2010 Arixtra Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/02/206/001-035 22.1.2010 20.1.2010 Atriance Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/07/403/001 22.1.2010 20.1.2010 Avaglim SmithKline Beecham Ltd 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM EU/1/06/349/001-010 22.1.2010 20.1.2010 Avandamet SmithKline Beecham Ltd 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM EU/1/03/258/001-022 22.1.2010 20.1.2010 AVANDIA SmithKline Beecham Ltd 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM EU/1/00/137/002-018 22.1.2010 20.1.2010 Binocrit Sandoz GmbH Biochemiestrasse 10 6250 Kundl ÖSTERREICH EU/1/07/410/001-026 22.1.2010 20.1.2010 Elaprase Shire Human Genetic Therapies AB Svärdvägen 11D SE-182 33 Danderyd SVERIGE EU/1/06/365/001-003 25.1.2010 20.1.2010 Epoetin alfa Hexal Hexal AG. Industriestraße 25 83607 Holzkirchen DEUTSCHLAND EU/1/07/411/001-026 25.1.2010 20.1.2010 HBVAXPRO Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/01/183/001 EU/1/01/183/004-005 EU/1/01/183/007-008 EU/1/01/183/011 EU/1/01/183/013 EU/1/01/183/015 EU/1/01/183/018-032 22.1.2010 20.1.2010 Hycamtin SmithKline Beecham Ltd 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM EU/1/96/027/001 EU/1/96/027/003-007 22.1.2010 20.1.2010 Integrilin Glaxo Group Ltd Greenford Middlesex UB6 ONN UNITED KINGDOM EU/1/99/109/001-002 22.1.2010 20.1.2010 NeoRecormon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/97/031/019-046 22.1.2010 20.1.2010 ORENCIA Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/07/389/001-003 22.1.2010 20.1.2010 Orgalutran N.V. Organon P.O. Box 20 Kloosterstraat 6 5340 BH Oss NEDERLAND EU/1/00/130/001-002 22.1.2010 20.1.2010 RotaTeq Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/06/348/001-002 22.1.2010 20.1.2010 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/02/222/001-004 22.1.2010 20.1.2010 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/04/282/001-002 22.1.2010 20.1.2010 Thyrogen Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/99/122/001-002 22.1.2010 20.1.2010 Tracleer Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High London W4 4AL UNITED KINGDOM EU/1/02/220/001-006 22.1.2010 20.1.2010 Truvada Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM EU/1/04/305/001-002 22.1.2010 20.1.2010 Tyverb Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/07/440/001-002 22.1.2010 20.1.2010 Viracept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/97/054/001 EU/1/97/054/004-005 22.1.2010 20.1.2010 Volibris Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/08/451/001-004 22.1.2010 20.1.2010 Ziagen Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/99/112/001-002 22.1.2010 20.1.2010 Zostavax Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/06/341/001-013 22.1.2010 25.1.2010 Alisade Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/08/474/001-003 28.1.2010 25.1.2010 Altargo Glaxo Group Limited Glaxo Wellcome House Berkeley Avenue Greenford, Middlesex UB6 0NN UNITED KINGDOM EU/1/07/390/001-004 28.1.2010 25.1.2010 Avamys Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/07/434/001-003 28.1.2010 25.1.2010 Betaferon Bayer Schering Pharma AG Müllerstraße 170—178 13342 Berlin DEUTSCHLAND EU/1/95/003/003-010 27.1.2010 25.1.2010 Bondronat Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/96/012/004 EU/1/96/012/009-013 27.1.2010 25.1.2010 Combivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN UNITED KINGDOM EU/1/98/058/001-002 28.1.2010 25.1.2010 Fabrazyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/01/188/001-006 27.1.2010 25.1.2010 Kiovig Baxter AG Industriesstrasse 67 1220 Wien ÖSTERREICH EU/1/05/329/001-005 27.1.2010 25.1.2010 Norvir Abbott Laboratories Ltd Abbott House Vanwall Business Park Vanwall Road Maidenhead Berkshire SL6 4XE UNITED KINGDOM EU/1/96/016/001 EU/1/96/016/003-006 27.1.2010 25.1.2010 Pelzont Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/460/001-014 27.1.2010 25.1.2010 Qutenza Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp NEDERLAND EU/1/09/524/001-002 27.1.2010 25.1.2010 Sebivo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/388/001-003 27.1.2010 25.1.2010 Somavert Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/02/240/001-004 27.1.2010 25.1.2010 TORISEL Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/07/424/001 27.1.2010 25.1.2010 Tredaptive Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/459/001-014 27.1.2010 25.1.2010 Trevaclyn Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/458/001-014 27.1.2010 25.1.2010 Xolair Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/05/319/001-010 27.1.2010 25.1.2010 Zometa Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/01/176/001-006 27.1.2010 27.1.2010 Arava Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/99/118/001-010 29.1.2010 27.1.2010 Privigen CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg DEUTSCHLAND EU/1/08/446/001-006 29.1.2010 27.1.2010 Rivastigmine Teva Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/513/001-020 29.1.2010 27.1.2010 Sonata Meda AB Pipers väg 2A SE-170 09 Solna SVERIGE EU/1/99/102/001-006 29.1.2010 27.1.2010 Zerene Meda AB Pipers väg 2A SE-170 09 Solna SVERIGE EU/1/99/099/001-006 29.1.2010 28.1.2010 Rapamune Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/01/171/001 EU/1/01/171/007-010 1.2.2010 29.1.2010 Azopt Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD UNITED KINGDOM EU/1/00/129/001-003 2.2.2010 29.1.2010 Clopidogrel Winthrop Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France 75013 Paris FRANCE EU/1/08/465/001-020 2.2.2010 29.1.2010 INTANZA Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/08/505/001-006 3.2.2010 2.2.2010 Yttriga Eckert & Ziegler Nuclitec GmbH Gieselweg 1 38110 Braunschweig DEUTSCHLAND EU/1/05/322/001 4.2.2010 3.2.2010 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France 75013 Paris FRANCE EU/1/98/086/001-034 5.2.2010 3.2.2010 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/98/085/001-034 5.2.2010 3.2.2010 Temodal Schering Plough Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË EU/1/98/096/001-025 5.2.2010 4.2.2010 Irbesartan HCT Winthrop SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France 75013 Paris FRANCE EU/1/06/377/001-028 8.2.2010 8.2.2010 Bondenza (Ibandronic Acid Roche) Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/03/266/003-004 10.2.2010 8.2.2010 Bonviva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/03/265/003-004 10.2.2010 8.2.2010 Pandemrix GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/08/452/001 10.2.2010 8.2.2010 ReFacto AF Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/99/103/001-004 10.2.2010 8.2.2010 TOVIAZ Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/07/386/017-018 10.2.2010 9.2.2010 Bridion N.V. Organon Kloosterstraat 6 5349 AB Oss NEDERLAND EU/1/08/466/001-002 11.2.2010 9.2.2010 Cialis Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/02/237/001-008 11.2.2010 9.2.2010 Clopidogrel 1A Pharma Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND EU/1/09/542/001-007 11.2.2010 9.2.2010 Exforge Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/370/001-036 11.2.2010 9.2.2010 Fertavid SP Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE EU/1/09/510/001-019 11.2.2010 9.2.2010 Imprida Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/373/001-036 11.2.2010 9.2.2010 Kaletra Abbott Laboratories Limited Abbott House Vanwall Business Park Vanwall Road Maidenhead Berkshire SL6 4XE UNITED KINGDOM EU/1/01/172/001-007 11.2.2010 9.2.2010 Kineret Biovitrum AB (publ) SE-112 76 Stockholm SVERIGE EU/1/02/203/001-004 11.2.2010 9.2.2010 NovoSeven Novo Nordisk A/S Novo Allé 2880 Bagsvaerd DANMARK EU/1/96/006/001-006 11.2.2010 9.2.2010 Temodal Schering Plough Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË EU/1/98/096/001-025 11.2.2010





— Modification of a marketing authorization (Article 13 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 20.1.2010 Avastin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/04/300/001-002 22.1.2010 20.1.2010 Erbitux Merck KGaA Frankfurter Straße 250 64271 Darmstadt DEUTSCHLAND EU/1/04/281/001-005 22.1.2010 9.2.2010 EVICEL OMRIX biopharmaceuticals S.A./N.V. Chaussée de Waterloo/Waterloosesteenweg 200 1640 Rhode-St-Genèse/Sint-Genesius-Rode BELGIQUE/BELGIË EU/1/08/473/001-003 15.2.2010





— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 (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 14.1.2010 Gripovac 3 Inactivated vaccine against swine influenza in pigs MERIAL 29 avenue Tony Garnier 69007 Lyon FRANCE EU/2/09/102/001-006 Suspension for injection QI09AA03 18.1.2010 14.1.2010 RESPIPORC FLU3 Inactivated vaccine against swine influenza in pigs IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau DEUTSCHLAND EU/2/09/103/001-006 Suspension for injection QI09AA03 18.1.2010 15.1.2010 Zulvac 8 Bovis Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02 Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH UNITED KINGDOM EU/2/09/105/001-002 Suspension for injection QI02AA08(cattle) 19.1.2010 15.1.2010 Zulvac 8 Ovis Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02 Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH UNITED KINGDOM EU/2/09/104/001-002 Suspension for injection QIO4AA02 19.1.2010





— 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 12.1.2010 BTVPUR Alsap 8 Merial 29 avenue Tony Garnier 69007 Lyon FRANCE EU/2/09/094/001-005 14.1.2010 12.1.2010 METACAM Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein DEUTSCHLAND EU/2/97/004/035-038 14.1.2010 12.1.2010 Porcilis PCV Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/08/091/001-010 14.1.2010 12.1.2010 Previcox Merial 29 avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/045/001-006 14.1.2010 14.1.2010 Poulvac FluFend H5N3 RG Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH UNITED KINGDOM EU/2/06/060/001-002 18.1.2010 14.1.2010 Purevax RCPCh Merial 29 avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/050/001-002 15.1.2010 15.1.2010 Convenia Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ UNITED KINGDOM EU/2/06/059/001 19.1.2010 15.1.2010 Purevax RC Merial 29 avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/051/001-002 19.1.2010 15.1.2010 Purevax RCCh Merial 29 avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/049/001-002 19.1.2010 15.1.2010 Purevax RCPCh FeLV Merial 29 avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/047/001-002 19.1.2010 15.1.2010 Purevax RCP FeLV Merial 29 avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/048/001-002 19.1.2010 25.1.2010 Purevax RCP Merial 29 avenue Tony Garnier 69007 Lyon FRANCE EU/2/04/052/001-002 27.1.2010 29.1.2010 Quadrisol Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/97/005/001 EU/2/97/005/005 2.2.2010

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 4H UNITED KINGDOM

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

(2) See footnote 1.