EN Official Journal of the European Union C 359/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2010 to 31 October 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 359/01

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 1.9.2010 Brinavess vernakalant hydrochloride Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom EU/1/10/645/001-002 Concentrate for solution for infusion C01BG11 6.9.2010 1.9.2010 Sycrest Asenapine N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/10/640/001-006 Sublingual tablet N05AH05 6.9.2010 6.9.2010 Rapiscan regadenoson Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/10/643/001 Solution for injection C01EB21 8.9.2010 17.9.2010 Ibandronic Acid Teva Ibandronic acid Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/642/001-004 Film-coated tablet M05BA06 21.9.2010 30.9.2010 Telmisartan Actavis telmisartan Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland EU/1/10/639/001-030 Tablet C09CA07 5.10.2010 7.10.2010 Myclausen mycophenolate mofetil Herbert J. Passauer GmbH & Co. KG Stubenrauchstrasse 33, 14167 Berlin, Deutschland EU/1/10/647/001-002 Film-coated tablet L04AA06 11.10.2010 7.10.2010 Twynsta telmisartan/amlodipine Boehringer Ingelheim International GmbH Binger Strasse 173 - D - 55216 Ingelheim am Rhein, Deutschland EU/1/10/648/001-028 Tablet C09DB04 11.10.2010 28.10.2010 Clopidogrel HCS Clopidogrel HCS bvba H. Kennisstraat 53, B 2650 Edegem, Belgïe EU/1/10/651/001-015 Film-coated tablet B01AC04 2.11.2010 28.10.2010 Clopidogrel Teva Generics B.V. Clopidogrel Teva Generics B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/650/001-015 Film-coated tablet B01AC04 4.11.2010 28.10.2010 Ruconest Conestat alfa Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland EU/1/10/641/001 Powder for solution for injection Pending 4.11.2010





— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 16.9.2010 Zeftera Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België 20.9.2010





— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 1.9.2010 Altargo Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/390/001-004 8.9.2010 1.9.2010 Ecalta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/416/001-002 6.9.2010 1.9.2010 Keppra UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/00/146/001-032 6.9.2010 1.9.2010 Levitra Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/03/248/001-015 6.9.2010 1.9.2010 Prevenar 13 Wyeth Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-la-Neuve, Belgique EU/1/09/590/001-006 6.9.2010 1.9.2010 Regranex Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/99/101/001 6.9.2010 1.9.2010 Relistor Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/08/463/001-003 6.9.2010 1.9.2010 Vfend Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/212/001-026 6.9.2010 1.9.2010 Zypadhera Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA, Houten, Nederland EU/1/08/479/001-003 6.9.2010 6.9.2010 Abraxane Abraxis BioScience Limited Rosanne House, Parkway, Welwyn Garden City, Herts, AL8 6HG, United Kingdom EU/1/07/428/001 9.9.2010 6.9.2010 Apidra Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/04/285/001-036 9.9.2010 6.9.2010 Cialis Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/02/237/001-009 9.9.2010 6.9.2010 Clopidogrel Winthrop Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/08/465/001-020 9.9.2010 6.9.2010 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/296/001-009 8.9.2010 6.9.2010 Dynastat Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/209/001-008 8.9.2010 6.9.2010 Emadine Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/98/095/001-004 9.9.2010 6.9.2010 Insuman Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/97/030/028-195 9.9.2010 6.9.2010 Menveo Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/614/001 9.9.2010 6.9.2010 M-M-RVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/337/001-013 9.9.2010 6.9.2010 Onglyza Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/09/545/001-010 9.9.2010 6.9.2010 Oslif Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/09/586/001-010 9.9.2010 6.9.2010 ProQuad Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/05/323/001-013 9.9.2010 6.9.2010 Relistor Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/08/463/001-011 8.9.2010 6.9.2010 Renvela Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland EU/1/09/521/001-007 9.9.2010 6.9.2010 Thyrogen Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/99/122/001-002 9.9.2010 6.9.2010 Vimpat UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/08/470/001-017 8.9.2010 6.9.2010 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 9.9.2010 6.9.2010 Xeristar Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/297/001-008 8.9.2010 6.9.2010 Xolair Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/319/001-010 8.9.2010 6.9.2010 Zerit Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/96/009/001-009 9.9.2010 6.9.2010 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/1/96/022/009-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-034 8.9.2010 6.9.2010 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/99/125/001-016 8.9.2010 10.9.2010 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/08/452/001 14.9.2010 10.9.2010 Siklos ADDMEDICA 101, rue Saint Lazare, Paris 75009, FRANCE EU/1/07/397/001 14.9.2010 16.9.2010 Alimta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/290/001 20.9.2010 16.9.2010 Tracleer Actelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220/001-006 20.9.2010 17.9.2010 Xyrem UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom EU/1/05/312/001 21.9.2010 23.9.2010 Kepivance Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/05/314/001 27.9.2010 23.9.2010 Levemir Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278/001-011 27.9.2010 23.9.2010 Revatio Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/05/318/001-002 27.9.2010 27.9.2010 Caelyx Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/96/011/001-004 29.9.2010 27.9.2010 Panretin Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom EU/1/00/149/001 29.9.2010 30.9.2010 Clopidogrel Apotex Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland EU/1/09/568/001-018 5.10.2010 30.9.2010 Mepact IDM PHARMA SAS 11-15 Quai De Dion Bouton, 92816 Puteaux Cedex, France EU/1/08/502/001 6.10.2010 30.9.2010 Noxafil SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/05/320/001 5.10.2010 30.9.2010 Rotarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/05/330/001-011 5.10.2010 30.9.2010 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363/001-015 5.10.2010 30.9.2010 Thalidomide Celgene Celgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom EU/1/08/443/001 5.10.2010 5.10.2010 APTIVUS Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/05/315/001-002 7.10.2010 5.10.2010 Mircera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/07/400/001-024 7.10.2010 5.10.2010 Revlimid Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom EU/1/07/391/001-004 7.10.2010 7.10.2010 Cyanokit Merck Santé s.a.s. 37, rue Saint-Romain, 69379 Lyon Cedex 08, France EU/1/07/420/001-002 11.10.2010 7.10.2010 DuoTrav Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/06/338/001-003 11.10.2010 7.10.2010 Soliris Alexion Europe S.A.S. 25, Boulevard de l'Amiral Bruix, 75016 Paris, France EU/1/07/393/001 11.10.2010 11.10.2010 Retacrit HOSPIRA Enterprises B.V. Randstad 22-11, 1316 BN, Almere, Nederland EU/1/07/431/001-025 13.10.2010 14.10.2010 Alisade Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United Kingdom EU/1/08/474/001-003 19.10.2010 14.10.2010 Avamys Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/434/001-003 19.10.2010 14.10.2010 Biograstim CT Arzneimittel GmbH Lengeder Straße 42a, D-13407 Berlin, Deutschland EU/1/08/450/001-010 18.10.2010 14.10.2010 Firmagon Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, Copenhagen S 2300, Danmark EU/1/08/504/001-003 18.10.2010 14.10.2010 Multaq Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/09/591/001-004 18.10.2010 14.10.2010 Ratiograstim ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/444/001-012 18.10.2010 14.10.2010 Vidaza Celgene Europe Ltd Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom EU/1/08/488/001 18.10.2010 14.10.2010 Xarelto Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/08/472/001-010 18.10.2010 15.10.2010 Riprazo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/409/001-020 19.10.2010 15.10.2010 Silapo STADA Arzneimittel AG Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland EU/1/07/432/001-022 19.10.2010 15.10.2010 Sprimeo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/407/001-020 19.10.2010 25.10.2010 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland EU/1/02/218/001-003 EU/1/02/218/005-030 27.10.2010 25.10.2010 Azilect Teva Pharma GmbH Kandelstrasse 10, Kirchzarten 79199, Deutschland EU/1/04/304/001-007 29.10.2010 25.10.2010 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/343/001-007 27.10.2010 25.10.2010 Cerezyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/97/053/001-005 27.10.2010 25.10.2010 Champix Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/360/001-013 27.10.2010 25.10.2010 Ebixa H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/02/219/001-049 27.10.2010 25.10.2010 Epivir ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/96/015/001-005 27.10.2010 25.10.2010 Faslodex AstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom EU/1/03/269/001-002 27.10.2010 25.10.2010 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/03/247/001-002 27.10.2010 25.10.2010 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145/001 27.10.2010 25.10.2010 Irbesartan/Hydrochlorothiazide Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/583/001-072 27.10.2010 25.10.2010 Karvea Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/97/049/001-039 27.10.2010 25.10.2010 Mabthera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/067/001-002 27.10.2010 25.10.2010 Mirapexin Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/97/051/001-006 EU/1/97/051/009-033 27.10.2010 25.10.2010 M-M-RVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/337/001-013 27.10.2010 25.10.2010 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442/001-008 27.10.2010 25.10.2010 ProQuad Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/05/323/001-013 27.10.2010 25.10.2010 Puregon Organon N.V. Kloosterstraat 6, Postbus 20, 5340 BH Oss, Nederland EU/1/96/008/001-041 27.10.2010 25.10.2010 Revlimid Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom EU/1/07/391/001-004 27.10.2010 25.10.2010 Sifrol Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/050/001-006 EU/1/97/050/009-033 27.10.2010 25.10.2010 Simponi Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/09/546/001-004 27.10.2010 25.10.2010 Sprimeo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/407/001-020 27.10.2010 25.10.2010 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363/001-015 27.10.2010 25.10.2010 Toviaz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/386/001-018 27.10.2010 25.10.2010 Vantavo Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/572/001-009 27.10.2010 25.10.2010 Vasovist TMC Pharma Services Ltd. Finchampstead, Berks, RG40 4LJ, UK EU/1/05/313/001-009 27.10.2010 25.10.2010 Vimpat UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/08/470/001-017 27.10.2010 25.10.2010 Zonegran Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom EU/1/04/307/001-013 27.10.2010 25.10.2010 Zostavax Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/341/001-013 27.10.2010 28.10.2010 Ambirix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/02/224/001-005 2.11.2010 28.10.2010 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/97/046/001-039 2.11.2010 28.10.2010 Fertavid SP Europe Rue de Stalle, 73 B-1180 Bruxelles, Belgique EU/1/09/510/001-019 2.11.2010 28.10.2010 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 4.11.2010 28.10.2010 Mimpara Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/04/292/001-012 4.11.2010 28.10.2010 NovoSeven Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/96/006/001-007 4.11.2010 28.10.2010 Olanzapine Neopharma Neopharma Limited 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom EU/1/07/426/001-011 1.11.2010 28.10.2010 Olanzapine Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/07/427/001-057 1.11.2010 28.10.2010 PegIntron Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/131/001-050 4.11.2010 28.10.2010 Travatan Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/01/199/001-002 4.11.2010 28.10.2010 ViraferonPeg Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/132/001-050 4.11.2010 29.10.2010 Mycamine Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/08/448/001-002 5.11.2010





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

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 6.9.2010 ImmunoGam Cangene Europe Limited Parkshot House, 5 Kew Road, Richmond, Surrey TW9 2PR, United Kingdom EU/1/10/613/001-002 9.9.2010 27.9.2010 Enviage Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/406/001-020 29.9.2010 28.10.2010 NeoSpect CIS bio international Boite Postale 32 - F-91192 Gif-sur-Yvette – France EU/1/00/154/001-002 5.11.2010





— Suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 16.9.2010 Clopidogrel 1A Pharma Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/542/001-007 20.9.2010 16.9.2010 Clopidogrel Acino Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/532/001-007 20.9.2010 16.9.2010 Clopidogrel Acino Pharma Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/549/001-007 20.9.2010 16.9.2010 Clopidogrel Acino Pharma GmbH Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/548/001-007 20.9.2010 16.9.2010 Clopidogrel Hexal Acino Pharma GmbH Am Windfeld 35, Miesbach 83714, Deutschland EU/1/09/534/001-007 20.9.2010 16.9.2010 Clopidogrel ratiopharm Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/554/001-008 20.9.2010 16.9.2010 Clopidogrel ratiopharm GmbH Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/541/001-008 20.9.2010 16.9.2010 Clopidogrel Sandoz Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/547/001-007 20.9.2010





— 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 6.9.2010 Bovilis BTV8 Inactivated Bluetongue virus Intervet International B.V. Wim de Körverstraat 35, NL - 5831 Boxmeer, Nederland EU/2/10/106/001-014 Suspension for injection QI02AA08(cattle) QI04AA02(sheep) 8.9.2010 16.9.2010 Rhiniseng inactivated vaccine against atrophic rhinitis in pigs Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170- Amer (Girona), España EU/2/10/109/001-009 Suspension for injection QI09AB04 21.9.2010 30.9.2010 Coxevac Inactivated Coxiella burnetii vaccine CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France EU/2/10/110/001-002 Suspension for injection QI03AB ngi 5.10.2010





— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 1.9.2010 Acticam Ecuphar NV Legeweg 157-I, B-8020 Oostkamp, Belgïe EU/2/08/088/001-004 6.9.2010 17.9.2010 Porcilis AR-T DF Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/00/026/001-004 21.9.2010 23.9.2010 Porcilis AR-T DF Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/00/026/001-006 27.9.2010 30.9.2010 Poulvac FluFend H5N3 RG Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom EU/2/06/060/001-002 13.10.2010 30.9.2010 Prac-Tic Novartis Sanidad Animal S.L. Calle de la Marina, 206, E - Barcelona 08013, ESPANA EU/2/06/066/001-012 5.10.2010 5.10.2010 Nobilis Influenza H5N2 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/06/061/001-004 7.10.2010 11.10.2010 Equioxx MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/08/083/001-005 13.10.2010 14.10.2010 Cerenia Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/06/062/005 18.10.2010 14.10.2010 Improvac Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/09/095/001-006 18.10.2010 14.10.2010 Novem Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/04/042/001-002 EU/2/04/042/007-010 18.10.2010 14.10.2010 Posatex Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/08/081/001-003 18.10.2010 14.10.2010 Quadrisol Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/97/005/001 EU/2/97/005/005 18.10.2010 28.10.2010 Trocoxil Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/08/084/001-005 4.11.2010 28.10.2010 Zactran MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/08/082/001-006 4.11.2010





— Suspension of a marketing authorization (Article 45 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 27.9.2010 Flexicam Dechra Veterinary Products A/S Mekuvej 9, 7171 Uldum, Danmark EU/2/06/058/001-003 29.9.2010





— Lift of suspension of a marketing authorization (Article 45 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 1.9.2010 Porcilis Pesti Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/99/016/001-006 6.9.2010

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 UK - LONDON E14 4H

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

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