EN Official Journal of the European Union C 383/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2011 to 31 October 2011

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

2011/C 383/01

— 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 2.9.2011 Vibativ telavancin Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland EU/1/11/705/001-002 powder for concentrate for solution for infusion J01XA03 6.9.2011 2.9.2011 Votubia Everolimus Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/710/001-007 Tablet L01XE10 6.9.2011 5.9.2011 Zytiga abiraterone Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/714/001 Tablet L02BX03 7.9.2011 16.9.2011 Dexdor dexmedetomidine Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/718/001-006 Concentrate for solution for infusion N05CM18 21.9.2011 19.9.2011 Incivo telaprevir Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720/001 Film-coated tablet Pending 22.9.2011 30.9.2011 Pramipexole Accord pramipexole Accord Healthcare Limited 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom EU/1/11/728/001-010 Tablet N04BC05 4.10.2011 3.10.2011 Levetiracetam Accord levetiracetam Accord Healthcare Limited 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom EU/1/11/712/001-028 Film-coated tablet N03AX14 5.1.2011 3.10.2011 Levetiracetam Actavis levetiracetam Actavis Group PTC ehf. Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland EU/1/11/713/001-040 Film-coated tablet N03AX14 5.10.2011 3.10.2011 Matever levetiracetam Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/11/711/001-030 Concentrate for solution for infusion Film-coated tablet N03AX14 6.10.2011 3.10.2011 Telmisartan Teva Pharma telmisartan Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/719/001-060 Tablet C09CA07 5.10.2011 27.10.2011 Eurartesim dihydroartemisinin/piperaquine tetraphosphate Sigma-Tau Industrie Farmaceutiche Riunite S.p.A Viale Shakespeare 47, 00144 Rome, Italia EU/1/11/716/001-005 Film-coated tablet P01BF05 2.11.2011





— 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 2.9.2011 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/98/086/001-034 6.9.2011 2.9.2011 Lucentis Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/374/001 6.9.2011 2.9.2011 Torisel Wyeth Europa Ltd Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom EU/1/07/424/001 6.9.2011 5.9.2011 Advagraf Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland EU/1/07/387/001-026 7.9.2011 5.9.2011 Aflunov Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/658/001-002 7.9.2011 5.9.2011 Apidra Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/04/285/001-036 7.9.2011 5.9.2011 Cayston Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom EU/1/09/543/001-002 7.9.2011 5.9.2011 Insuman Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/97/030/028-195 7.9.2011 5.9.2011 ProQuad Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/05/323/001-013 7.9.2011 5.9.2011 Removab Fresenius Biotech GmbH Am Haag 6-7, D-82166 Graefelfing, Deutschland EU/1/09/512/001-002 7.9.2011 5.9.2011 Simponi Janssen Biologics B.V. Einsteinweg 101, CB Leiden 2333, Nederland EU/1/09/546/001-004 7.9.2011 5.9.2011 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 7.9.2011 7.9.2011 CANCIDAS Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/01/196/001 EU/1/01/196/003 9.9.2011 7.9.2011 Circadin RAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom EU/1/07/392/003 13.9.2011 7.9.2011 Irbesartan HCT Winthrop Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/06/377/001-028 9.9.2011 13.9.2011 Ammonaps Swedish Orphan Biovitrum International AB SE-11276 Stockholm, Sverige EU/1/99/120/003-004 15.9.2011 13.9.2011 Luminity Lantheus MI UK Limited Festival House - 39 Oxford Street - Newbury - Berkshire RG14 1JG - United Kingdom EU/1/06/361/001-002 15.9.2011 13.9.2011 Raloxifene Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/627/001-003 15.9.2011 13.9.2011 Synagis Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/99/117/001-002 15.9.2011 13.9.2011 Xelevia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382/001-018 15.9.2011 13.9.2011 Zypadhera Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/479/001-003 16.9.2011 16.9.2011 Aerius Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/160/001-013 EU/1/00/160/022-034 EU/1/00/160/036-069 21.9.2011 16.9.2011 Angiox The Medicines Company UK Ltd 115 L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom EU/1/04/289/001 20.9.2011 16.9.2011 Azomyr Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/157/001-013 EU/1/00/157/022-067 21.9.2011 16.9.2011 Azopt Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/00/129/001-003 20.9.2011 16.9.2011 Ilaris Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/564/001-003 20.9.2011 16.9.2011 Myclausen Herbert J. Passauer GmbH & Co. KG Stubenrauchstrasse 33, 14167 Berlin, Deutschland EU/1/10/647/001-004 20.9.2011 16.9.2011 Neoclarityn Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/161/001-013 EU/1/00/161/022-067 21.9.2011 16.9.2011 NeuroBloc Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom EU/1/00/166/001-003 20.9.2011 16.9.2011 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/08/452/001 21.9.2011 16.9.2011 Resolor Shire-Movetis NV Veedjik 58 (1004), B-2300 Turnhout, Belgium EU/1/09/581/001-008 21.9.2011 16.9.2011 Suboxone RB Pharmaceuticals Limited 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom EU/1/06/359/001-004 20.9.2011 16.9.2011 Viramune Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/97/055/001-009 26.9.2011 19.9.2011 Byetta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/06/362/001-004 22.9.2011 19.9.2011 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/07/384/001-005 22.9.2011 19.9.2011 Ifirmasta KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/480/001-018 22.9.2011 19.9.2011 Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg – Deutschland EU/1/09/605/001-012 22.9.2011 19.9.2011 Zonegran Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom EU/1/04/307/001-021 22.9.2011 22.9.2011 Clopidogrel DURA Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland EU/1/09/560/001-009 26.9.2011 22.9.2011 Ixiaro Intercell AG Campus Vienna Biocenter 3 A-1030 Wien, Österreich EU/1/08/501/001-002 26.9.2011 22.9.2011 Leflunomide ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/10/654/001-004 26.9.2011 22.9.2011 Pergoveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/07/396/001-003 26.9.2011 22.9.2011 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492/001-006 26.9.2011 22.9.2011 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/95/002/001-005 27.9.2011 30.9.2011 Aerinaze SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/07/399/001-006 4.10.2011 3.10.2011 Elaprase Shire Human Genetic Therapies AB Svärdvägen 11D, 18233 Danderyd, Sverige EU/1/06/365/001-003 5.10.2011 3.10.2011 Lysodren Laboratoire HRA Pharma 15, rue Béranger, 75003 Paris, France EU/1/04/273/001 5.10.2011 3.10.2011 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363/001-015 5.10.2011 3.10.2011 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295/001 5.10.2011 6.10.2011 NeoRecormon Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/97/031/001-046 10.10.2011 6.10.2011 Noxafil SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/05/320/001 10.10.2011 6.10.2011 Sildenafil Actavis Actavis Group PTC ehf. Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland EU/1/09/595/001-015 10.10.2011 6.10.2011 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/99/110/001-005 EU/1/99/110/008-010 10.10.2011 6.10.2011 Topotecan Hospira Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/633/001-002 10.10.2011 12.10.2011 Celsentri ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/418/001-010 13.10.2011 12.10.2011 Galvus Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/414/001-010 EU/1/07/414/018 14.10.2011 12.10.2011 Invega Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse – België EU/1/07/395/001-095 14.10.2011 12.10.2011 Jalra Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/485/001-011 14.10.2011 12.10.2011 Rilonacept Regeneron Regeneron UK Limited 40 Bank Street, London, E14 5DS United Kingdom EU/1/09/582/001 14.10.2011 12.10.2011 Stelara Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse – België EU/1/08/494/001-004 14.10.2011 12.10.2011 Teysuno Taiho Pharma Europe, Limited 55 Colmore Row, Birmingham, West Midlands, B3 2AS, United Kingdom EU/1/11/669/001-004 14.1.2011 12.10.2011 Xeplion Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/672/001-006 14.10.2011 12.10.2011 Xiliarx Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/486/001-011 14.10.2011 17.10.2011 Docetaxel Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/611/001-002 19.10.2011 20.10.2011 Arixtra Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/02/206/001-035 24.10.2011 20.10.2011 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/98/085/001-034 24.10.2011 20.10.2011 Mircera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/07/400/008-013 EU/1/07/400/017-024 24.10.2011 20.10.2011 Naglazyme BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/05/324/001-002 24.10.2011 20.10.2011 Zypadhera Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/479/001-003 24.10.2011 20.10.2011 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/1/96/022/019-040 28.9.2011 20.10.2011 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/99/125/001-020 28.9.2011 24.10.2011 Alimta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/290/001-002 26.10.2011 24.10.2011 Avonex Biogen Idec Ltd Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/97/033/002-006 26.10.2011 24.10.2011 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/98/086/001-034 26.10.2011 24.10.2011 Daxas Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/10/636/001-007 26.10.2011 24.10.2011 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/07/384/001-005 26.10.2011 24.10.2011 Ebixa H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/02/219/001-049 26.10.2011 24.10.2011 Efient Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/08/503/001-016 26.10.2011 24.10.2011 Emend Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262/001-008 27.10.2011 24.10.2011 Erbitux Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland EU/1/04/281/001-005 26.10.2011 24.10.2011 Humira Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/03/256/001-010 26.10.2011 24.10.2011 Icandra Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/484/001-018 26.10.2011 24.10.2011 IntronA Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/99/127/011-039 EU/1/99/127/041-044 27.10.2011 24.10.2011 Irbesartan HCT Winthrop Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/06/377/001-028 26.10.2011 24.10.2011 Keppra UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/ Researchdreef, 60, Brussel 1070, België EU/1/00/146/001-032 26.10.2011 24.10.2011 Kivexa ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/04/298/001-003 26.10.2011 24.10.2011 Levemir Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278/001-016 26.10.2011 24.10.2011 Lyrica Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 139NJ, United Kingdom EU/1/04/279/001-044 26.10.2011 24.10.2011 Nexavar Bayer Pharma AG Berlin 13342, Deutschland EU/1/06/342/001 26.10.2011 24.10.2011 Onglyza Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/09/545/001-015 26.10.2011 24.10.2011 Prevenar 13 Wyeth-Lederle Vaccines S.A. Pleinlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgïe-Belgique EU/1/09/590/001-006 26.10.2011 24.10.2011 Revatio Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/05/318/001 26.10.2011 24.10.2011 Rotarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/05/330/001-011 26.10.2011 24.10.2011 Starlix Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/174/001-021 26.10.2011 24.10.2011 Sycrest N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/10/640/001-006 26.10.2011 24.10.2011 Toviaz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/386/001-018 26.10.2011 24.10.2011 Votrient Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/628/001-004 26.10.2011 24.10.2011 Ziagen ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/99/112/001-002 26.10.2011 27.10.2011 Advagraf Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland EU/1/07/387/001-026 4.11.2011 27.10.2011 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100, D-60318 Frankfurt/Main – Deutschland EU/1/02/218/001-003 EU/1/02/218/005-030 4.11.2011 27.10.2011 Ceprotin Baxter AG Industriestraße 67, A - 1221 Wien, Österreich EU/1/01/190/001-002 4.11.2011 27.10.2011 Eucreas Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/425/001-018 4.11.2011 27.10.2011 Exalief BIAL - Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado – Portugal EU/1/09/520/001-020 4.11.2011 27.10.2011 Galvus Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/414/001-010 EU/1/07/414/018 4.11.2011 27.10.2011 Jalra Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/485/001-011 4.11.2011 27.10.2011 Leflunomide Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/09/604/001-010 1.11.2011 27.10.2011 Mixtard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/231/030-032 1.11.2011 27.10.2011 Rapiscan Rapidscan Pharma Solutions EU Ltd. Regent's Place, 338 Euston Road, London NW1 3BT, UK EU/1/10/643/001 4.11.2011 27.10.2011 Rasilamlo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/686/001-056 4.11.2011 27.10.2011 Riprazo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/409/001-040 1.11.2011 27.10.2011 Riprazo HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/680/001-080 4.11.2011 27.10.2011 Sprimeo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/407/001-040 1.11.2011 27.10.2011 Sprimeo HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/683/001-080 4.11.2011 27.10.2011 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/95/002/001-005 4.11.2011 27.10.2011 Tygacil Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/06/336/001 4.11.2011 27.10.2011 Xiliarx Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/486/001-011 4.11.2011





— 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 3.10.2011 Prepandemic 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 5.10.2011 17.10.2011 Ablavar TMC Pharma Services Ltd. Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire, RG27 8AS, United Kingdom EU/1/05/313/001-009 19.10.2011





— 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 Décision 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 7.9.2011 Nobivac Myxo-RHD Live myxoma vectored RHD virus strain 009 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/11/132/001-004 Lyophilisate and solvent for suspension for injection QI08AD 9.9.2011 13.9.2011 Recocam Meloxicam CF Pharma Limited Unit 622, Northern Extension, Waterford, Ireland EU/2/11/133/001-003 Solution for injection QM01AC06 15.9.2011 6.10.2011 Recuvyra Fentanyl Nexcyon Pharmaceuticals Ltd. Bank Barn, How Mill, Brampton, Cumbria CA8 9JY, UNITED KINGDOM EU/2/11/127/001 Transdermal solution QN02AB03 11.10.2011





— 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 5.9.2011 Improvac Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/09/095/001-006 7.9.2011 13.9.2011 Cortavance VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros – France EU/2/06/069/001 15.9.2011 16.9.2011 Loxicom Norbrook Laboratories Limited Station Works, Newry, Co. Down, BT35 6JP, United Kindgom EU/2/08/090/001-026 20.9.2011 16.9.2011 Porcilis Pesti Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/99/016/001-006 21.9.2011 19.9.2011 ZULVAC 1+8 Ovis Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/11/120/001-003 22.9.2011 20.10.2011 Suprelorin VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros – France EU/2/07/072/003-004 24.10.2011 24.10.2011 Meloxoral Le Vet B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/10/111/001-007 26.10.2011

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.