EN Official Journal of the European Union C 231/3

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 July 2009 to 31 July 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 231/03

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

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 1.7.2009 Ribavirin Teva Pharma BV Ribavirin Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/527/001-016 Film-coated tablet J05A B04 3.7.2009 2.7.2009 Nymusa Caffeine citrate CHIESI FARMACEUTICI SpA Via Palermo 26/A 43100 Parma PR ITALIA EU/1/09/528/001 Solution for infusion and oral solution N06BC01 6.7.2009 20.7.2009 Instanyl Fentanyl Nycomed Danmark ApS Langebjerg 1 4000 Roskilde DANMARK EU/1/09/531/001-009 Nasal spray, solution N02AB03 23.7.2009 24.7.2009 Vedrop Tocofersolan Orphan Europe SARL Immeuble Le Wilson 70 Avenue du Général de Gaulle 92800 Puteaux FRANCE EU/1/09/533/001-003 Oral solution A11HA08 30.7.2009 24.7.2009 Topotecan Actavis Topotecan Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 Hafnarfjordur ICELAND EU/1/09/536/001-002 Powder for concentrate for solution for infusion L01XX17 30.7.2009 28.7.2009 Clopidogrel Acino Clopidogrel Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND EU/1/09/532/001-007 Film-coated tablet BO1AC04 31.7.2009 28.7.2009 Clopidogrel ratiopharm GmbH Clopidogrel Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND EU/1/09/541/001-007 Film-coated tablet BO1AC04 31.7.2009 28.7.2009 Clopidogrel 1A Pharma Clopidogrel Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND EU/1/09/542/001-007 Film-coated tablet BO1AC04 31.7.2009 28.7.2009 Clopidogrel Hexal Clopidogrel Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND EU/1/09/534/001-007 Film-coated tablet BO1AC04 31.7.2009 28.7.2009 Grepid Clopidogrel Pharmathen S.A. 6 Dervenakion 15351 Pallini Attiki ΕΛΛAΔΑ EU/1/09/535/001-014 Film-coated tablet B01AC-04 31.7.2009 28.7.2009 Clopidogrel Teva Clopidogrel Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/09/540/001-009 Film-coated tablet B01AC04 31.7.2009 31.7.2009 Mozobil Plerixafor Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/09/537/001 Solution for injection L03AX16 4.8.2009

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

Date of the decision Name of the medicinal product Holder of the marketing authorisation Number of the entry in the Community Register Date of notification 1.7.2009 ReFacto AF Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/99/103/001-004 2.7.2009 1.7.2009 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/296/001-009 3.7.2009 1.7.2009 Cancidas Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/01/196/001 EU/1/01/196/003 3.7.2009 1.7.2009 Naglazyme BioMarin Europe Ltd 164 Shaftesbury Avenue London WC2H 8HL UNITED KINGDOM EU/1/05/324/001-002 3.7.2009 1.7.2009 Integrilin Glaxo Group Ltd Greenford Middlesex UB6 ONN UNITED KINGDOM EU/1/99/109/001-002 3.7.2009 1.7.2009 Rebif Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM EU/1/98/063/008-010 3.7.2009 1.7.2009 ProQuad Sanofi Pasteur MSD, SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/05/323/001-013 3.7.2009 1.7.2009 Liprolog Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/01/195/001-027 3.7.2009 1.7.2009 Norvir Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM EU/1/96/016/001 EU/1/96/016/003-004 3.7.2009 1.7.2009 Humalog Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010 EU/1/96/007/015-021 EU/1/96/007/023-038 3.7.2009 1.7.2009 Xeristar Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/04/297/001-008 3.7.2009 1.7.2009 Tracleer Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL UNITED KINGDOM EU/1/02/220/006 3.7.2009 1.7.2009 Tracleer Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL UNITED KINGDOM EU/1/02/220/001-006 3.7.2009 1.7.2009 Arava Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND EU/1/99/118/001-010 3.7.2009 2.7.2009 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden NEDERLAND EU/1/99/116/001-005 7.7.2009 2.7.2009 Alimta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/290/001-002 7.7.2009 2.7.2009 Mimpara Amgen Europe B.V. Minervum 7061 4817 ZK Breda NEDERLAND EU/1/04/292/001-012 7.7.2009 2.7.2009 ADROVANCE Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/06/364/001-009 7.7.2009 2.7.2009 Bonviva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/03/265/003-006 7.7.2009 2.7.2009 Bondenza Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/03/266/003-006 7.7.2009 2.7.2009 Aldurazyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/03/253/001-003 7.7.2009 2.7.2009 Angiox The Medicines Company UK Ltd 115 L Milton Park Abingdon Oxfordshire OX14 4SA UNITED KINGDOM EU/1/04/289/001-002 8.7.2009 3.7.2009 Prevenar Wyeth-Lederle Vaccines S.A. Rue du Bosquet 15 1348 Louvain-La-Neuve BELGIQUE EU/1/00/167/001-008 7.7.2009 3.7.2009 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden NEDERLAND EU/1/99/116/001-005 7.7.2009 3.7.2009 Zyprexa Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/96/022/002 EU/1/96/022/004 EU/1/96/022/006 EU/1/96/022/008-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-034 7.7.2009 3.7.2009 RELISTOR Wyeth Europa Limited Huntercombe Lane South, Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/08/463/001-003 7.7.2009 7.7.2009 Tracleer Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL UNITED KINGDOM EU/1/02/220/001-006 9.7.2009 7.7.2009 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/99/125/001-016 9.7.2009 7.7.2009 Prepandrix GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/08/453/001 9.7.2009 7.7.2009 Pre-pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/08/478/001 9.7.2009 7.7.2009 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/343/005 9.7.2009 7.7.2009 YENTREVE Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/04/280/001-008 9.7.2009 7.7.2009 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU UNITED KINGDOM EU/1/04/276/001-020 EU/1/04/276/024-036 9.7.2009 7.7.2009 Zonegran Eisai Limited European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN UNITED KINGDOM EU/1/04/307/001-013 9.7.2009 7.7.2009 CELSENTRI Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/07/418/001-010 9.7.2009 7.7.2009 Invega Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/07/395/001-095 9.7.2009 7.7.2009 Tygacil Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/06/336/001 9.7.2009 7.7.2009 FOSAVANCE Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/05/310/001-009 9.7.2009 7.7.2009 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/03/267/001-010 9.7.2009 7.7.2009 Revatio Pfizer Limited Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/05/318/001 9.7.2009 10.7.2009 Binocrit Sandoz GmbH Biochemiestrasse 10 6250 Kundl ÖSTERREICH EU/1/07/410/001-020 14.7.2009 10.7.2009 Pandemrix GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/08/452/001 14.7.2009 10.7.2009 Epoetin alfa Hexal Hexal AG. Industriestrasse 25 83607 Holzkirchen DEUTSCHLAND EU/1/07/411/001-020 14.7.2009 14.7.2009 INCRELEX Ipsen Pharma 65 quai Georges Gorse 92100 Boulogne-Billancourt FRANCE Tercica Europe Limited Riverside One, Sir John Rogerson's Quay Dublin 2 IRELAND EU/1/07/402/001 16.7.2009 14.7.2009 Zometa Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/01/176/001-006 16.7.2009 14.7.2009 Exjade Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/06/356/001-009 16.7.2009 14.7.2009 ISENTRESS Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/436/001-002 16.7.2009 14.7.2009 Thelin Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ UNITED KINGDOM EU/1/06/353/001-005 16.7.2009 14.7.2009 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn DEUTSCHLAND EU/1/07/412/001-020 16.7.2009 14.7.2009 Dynastat Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/02/209/001-008 16.7.2009 14.7.2009 DULOXETINE BOEHRINGER INGELHEIM Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND EU/1/08/471/001-012 16.7.2009 14.7.2009 Doribax Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË EU/1/08/467/001 16.7.2009 14.7.2009 Crixivan Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/96/024/001-005 EU/1/96/024/008 EU/1/96/024/010 16.7.2009 14.7.2009 Paxene Norton Healthcare Limited Albert Basin Royal Docks London E16 2QJ UNITED KINGDOM EU/1/99/113/001-004 16.7.2009 16.7.2009 Neupro Schwarz Pharma Ltd Shannon Industrial Estate Co. Clare IRELAND EU/1/05/331/001-055 21.7.2009 16.7.2009 Opgenra Howmedica International S. de R. L. Raheen Business Park Limerick IRELAND EU/1/08/489/001-002 21.7.2009 16.7.2009 ADROVANCE Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/06/364/001-009 21.7.2009 16.7.2009 ECALTA Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/07/416/001 21.7.2009 16.7.2009 ISENTRESS Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/436/001-002 21.7.2009 16.7.2009 CUBICIN Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/05/328/001-002 21.7.2009 16.7.2009 Olanzapine Neopharma Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF UNITED KINGDOM EU/1/07/426/001-011 21.7.2009 16.7.2009 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM EU/1/99/126/001-021 21.7.2009 17.7.2009 Zalasta Krka d.d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA EU/1/07/415/001-056 21.7.2009 17.7.2009 Stocrin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/99/111/001-005 EU/1/99/111/008-011 21.7.2009 17.7.2009 Olanzapine Mylan Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL UNITED KINGDOM EU/1/08/475/001-034 21.7.2009 20.7.2009 Olanzapine Teva Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND EU/1/07/427/001-057 23.7.2009 23.7.2009 Dynastat Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/02/209/001-008 28.7.2009 23.7.2009 NeuroBloc Eisai Limited European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN UNITED KINGDOM EU/1/00/166/001-003 28.7.2009 23.7.2009 Xelevia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/382/001-018 28.7.2009 23.7.2009 Cancidas Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/01/196/001 EU/1/01/196/003 28.7.2009 23.7.2009 Invanz Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/02/216/001-002 28.7.2009 23.7.2009 ATryn GTC Biotherapeutics UK Limited 10 Norwich Street London EC4A 1BD UNITED KINGDOM LEO Pharma A/S Industriparken 55 2750 Ballerup DANMARK EU/1/06/355/001-003 28.7.2009 23.7.2009 Avastin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM EU/1/04/300/001-002 28.7.2009 23.7.2009 Vistide Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM EU/1/97/037/001 28.7.2009 23.7.2009 ECALTA Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/07/416/002 28.7.2009 24.7.2009 Vimpat UCB Pharma S.A. Allée de la Recherche 60 1070 Bruxelles BELGIQUE EU/1/08/470/001-017 31.7.2009 24.7.2009 Humira Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM EU/1/03/256/001-010 30.7.2009 24.7.2009 ZYPADHERA Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND EU/1/08/479/001-003 30.7.2009 24.7.2009 Macugen Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/05/325/002 30.7.2009 24.7.2009 Silgard Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/06/358/001-021 30.7.2009 24.7.2009 Flebogammadif Instituto Grifols S.A. Can Guasch Parets del Vallès 08150 Barcelona ESPAÑA EU/1/07/404/001-005 30.7.2009 24.7.2009 FABLYN Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/08/500/001-004 30.7.2009 24.7.2009 Nexavar Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/06/342/001 30.7.2009 24.7.2009 FIRMAGON Ferring Pharmaceuticals A/S Kay Fiskers Plads 11 2300 København S DANMARK EU/1/08/504/001-002 30.7.2009 24.7.2009 GONAL-f Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM EU/1/95/001/001 EU/1/95/001/003-005 EU/1/95/001/009 EU/1/95/001/012 EU/1/95/001/021-022 EU/1/95/001/025-028 EU/1/95/001/031-035 30.7.2009 24.7.2009 Cervarix GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE EU/1/07/419/001-012 30.7.2009 24.7.2009 Kuvan Merck KGaA Frankfurter Straße 250 64293 Darmstadt DEUTSCHLAND EU/1/08/481/001-003 30.7.2009 24.7.2009 Gardasil Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE EU/1/06/357/001-021 30.7.2009 24.7.2009 Pedea Orphan Europe SARL Immeuble Le Wilson 70 Avenue du Général de Gaulle 92800 Puteaux FRANCE EU/1/04/284/001 30.7.2009 27.7.2009 Synagis Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM EU/1/99/117/001-002 30.7.2009 27.7.2009 Tasigna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/07/422/001-004 30.7.2009 27.7.2009 Luminity Lantheus MI UK Limited One South Place London EC2M 2WG UNITED KINGDOM Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe/Terhulpsesteenweg 185 1170 Brussels/Brussel BELGIQUE/BELGIË EU/1/06/361/001-002 30.7.2009 27.7.2009 NovoRapid Novo Nordisk A/S Novo Allé 2880 Bagsværd DANMARK EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-015 30.7.2009 27.7.2009 Xolair Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/05/319/001-010 30.7.2009 27.7.2009 Prevenar Wyeth-Lederle Vaccines S.A. Rue du Bosquet 15 1348 Louvain-La-Neuve BELGIQUE EU/1/00/167/001-008 30.7.2009 27.7.2009 Helixate NexGen Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/00/144/001-004 30.7.2009 27.7.2009 KOGENATE Bayer Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND EU/1/00/143/001-011 30.7.2009 27.7.2009 ViraferonPeg Schering Plough Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË EU/1/00/132/001-050 30.7.2009 27.7.2009 Renagel Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND EU/1/99/123/005-013 30.7.2009 28.7.2009 Osseor Les Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE EU/1/04/287/001-006 31.7.2009 28.7.2009 Protelos Les Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE EU/1/04/288/001-006 31.7.2009 28.7.2009 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM EU/1/06/363/001-011 31.7.2009 29.7.2009 Ebixa H.Lundbeck A/S Ottiliavej 9 2500 Valby DANMARK EU/1/02/219/005-006 EU/1/02/219/013 31.7.2009 29.7.2009 Januvia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/383/001-018 31.7.2009 29.7.2009 Firazyr Jerini AG Invalidenstr. 130 10115 Berlin DEUTSCHLAND EU/1/08/461/001 31.7.2009 29.7.2009 NutropinAq Ipsen Pharma 65 quai Georges Gorse 92100 Boulogne-Billancourt FRANCE IPSEN Limited 190 Bath Road Slough Berkshire SLI 3XE UNITED KINGDOM EU/1/00/164/003-005 31.7.2009 29.7.2009 Abraxane Abraxis BioScience Limited Hatfield AL10 9NA UNITED KINGDOM EU/1/07/428/001 31.7.2009 29.7.2009 Janumet Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/455/001-016 31.7.2009 29.7.2009 Velmetia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/456/001-016 31.7.2009 29.7.2009 Efficib Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/08/457/001-016 31.7.2009 29.7.2009 IVEMEND Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/07/437/001-002 31.7.2009 29.7.2009 TOVIAZ Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM EU/1/07/386/001-016 31.7.2009 31.7.2009 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 60318 Frankfurt/Main DEUTSCHLAND EU/1/02/218/004-006 4.8.2009 31.7.2009 Emselex Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM EU/1/04/294/001-028 4.8.2009 31.7.2009 Kepivance Biovitrum AB (publ) SE-112 76 Stockholm SVERIGE EU/1/05/314/001 4.8.2009 31.7.2009 EMEND Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM EU/1/03/262/001-008 4.8.2009

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

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 7.7.2009 Melovem Meloxicam Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer NEDERLAND EU/2/09/098/001 Solution for injection QM01AC06 9.7.2009 24.7.2009 Suvaxyn PCV Porcine Circovirus recombinant virus (cPCV) 1-2, inactivated Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH UNITED KINGDOM EU/2/09/099/001-006 Suspension for injection QI09AA07 30.7.2009

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

Date of the decision Name of the medicinal product Holder of the marketing authorisation Number of the entry in the Community Register Date of notification 14.7.2009 Meloxivet Janssen Pharmaceutica N.V. Turnhoutseweg 30 2340 Beerse BELGIË EU/2/07/077/001-005 16.7.2009 16.7.2009 Nobivac Piro Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/04/046/001-003 21.7.2009 20.7.2009 PRILACTONE Ceva sante animale Z.I. la Ballastière 33500 Libourne FRANCE EU/2/07/074/001-006 23.7.2009 20.7.2009 ZACTRAN Merial 29 avenue Tony Garnier 69007 Lyon FRANCE EU/2/08/082/001-006 23.7.2009 31.7.2009 Nobilis Influenza H7N1 Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND EU/2/07/073/001-004 4.8.2009

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

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