PT Jornal Oficial da União Europeia C 316/1

Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de Julho de 2011 para 31 de Agosto de 2011

[Publicado nos termos do artigo 13.o ou do artigo 38.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho (1) ]

2011/C 316/01

— Concessão de uma autorização de introdução no mercado (Artigo 13 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho): Autorizado

Data da decisão Nome do medicamento DCI (Denominação Comum Internacional) Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Forma farmacêutica Código ATC (código anatómico-terapêutico-químico) Data de notificação 13.7.2011 Benlysta belimumab Glaxo Group Limited Glaxo Wellcome House, Berkely Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/11/700/001-002 Pó para concentrado para solução para perfusão L04AA26 15.7.2011 13.7.2011 Temozolomide Sun temozolamida Sun Pharmaceuticals Industries Europe B.V. Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/11/697/001-012 Cápsula L01AX03 18.7.2011 13.7.2011 Xgeva denosumab Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/11/703/001-002 Solução injectável M05BX04 15.7.2011 13.7.2011 Yervoy ipilimumab Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698/001-002 Concentrado para solução para perfusão L01XC11 15.7.2011 18.7.2011 Victrelis boceprevir Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704/001 Cápsula J05AE 20.7.2011 20.7.2011 Fampyra fampridina Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/11/699/001-002 Comprimido de acção prolongada N07XX07 25.7.2011 20.7.2011 TOBI Podhaler Tobramicina Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/10/652/001-003 Pó para inalação, cápsula J01GB01 25.7.2011 26.7.2011 Ibandronic acid Sandoz Ácido ibandrónico Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland EU/1/11/685/001-005 Comprimido revestido por película M05BA06 28.7.2011 27.7.2011 Zoely nomegestrol/estradiol Merck Serono Europe Limited 56 Marsh Wall, London E14 9TP, United Kingdom EU/1/11/690/001-002 Comprimido revestido por película G03AA14 1.8.2011 18.8.2011 Entacapone Orion entacapona Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/708/001-004 Comprimido revestido por película N04BX02 22.8.2011 24.8.2011 Levodopa/Carbidopa/Entacapone Orion levodopa, carbidopa, entacapona Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/706/001-033 Comprimido revestido por película N04BA03 29.8.2011 24.8.2011 Trajenta linagliptina Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/11/707/001-011 Comprimido revestido por película A10BH05 30.8.2011 26.8.2011 Levetiracetam ratiopharm Levetiracetam ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/11/702/001-031 Comprimido revestido por película Solução oral N03AX14 31.8.2011 26.8.2011 Levetiracetam Teva Levetiracetam Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/701/001-028 Comprimido revestido por película N03AX14 31.8.2011





— Alteração de uma autorização de introdução no mercado (Artigo 13 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho): Autorizado

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 5.7.2011 Irbesartan Winthrop Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/06/376/001-033 7.7.2011 5.7.2011 Relistor Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/08/463/001-011 7.7.2011 7.7.2011 Adrovance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/364/005 EU/1/06/364/009 11.7.2011 7.7.2011 Ammonaps Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sverige EU/1/99/120/001-004 12.7.2011 7.7.2011 Hirobriz Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/09/594/001-010 11.7.2011 7.7.2011 Modigraf Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/09/523/001-002 11.7.2011 7.7.2011 Removab Fresenius Biotech GmbH Am Haag 6-7, D-82166 Graefelfing, Deutschland EU/1/09/512/001-002 11.7.2011 11.7.2011 NovoRapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-015 EU/1/99/119/017-023 13.7.2011 11.7.2011 Onbrez Breezhaler Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/593/001-010 13.7.2011 11.7.2011 Optaflu Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland EU/1/07/394/001-009 13.7.2011 13.7.2011 Sildenafil ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/603/001-015 18.7.2011 13.7.2011 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 18.7.2011 13.7.2011 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 18.7.2011 13.7.2011 ViraferonPeg Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/132/001-050 18.7.2011 13.7.2011 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 18.7.2011 18.7.2011 Crixivan Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/96/024/001-005 EU/1/96/024/010 20.7.2011 18.7.2011 Intrinsa Warner Chilcott UK Ltd Old Belfast Road, Millbrook, Larne, County Antrim BT40 2SH, United Kingdom EU/1/06/352/001-003 20.7.2011 18.7.2011 Livensa Warner Chilcott Deutschland Gmbh Dr.-Otto-Röhm-Strasse 2-4, Weiterstadt 64331, Deutschland EU/1/06/351/001-003 20.7.2011 18.7.2011 Multaq Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/09/591/001-004 20.7.2011 18.7.2011 ReFacto AF Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/103/001-008 20.7.2011 18.7.2011 Savene SpePharm Holding BV Kingsfordweg 151, GR Amsterdam 1043, Nederland EU/1/06/350/001 20.7.2011 20.7.2011 Atriance Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/403/001 25.7.2011 20.7.2011 Betaferon Bayer Schering Pharma AG Müllerstrasse 170-178, D - 13342 Berlin, Deutschland EU/1/95/003/003-012 25.7.2011 20.7.2011 Esbriet InterMune UK Ltd 4th Floor, One Victoria Street, Bristol, BS1 6AA, United Kingdom EU/1/11/667/001-003 26.7.2011 20.7.2011 Intelence Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/468/001 25.7.2011 20.7.2011 Ratiograstim ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/444/001-012 25.7.2011 20.7.2011 Rivastigmine 1 A Pharma 1 A Pharma GmbH Keltenring 1+3, Oberhaching 82041, Deutschland EU/1/09/585/001-018 25.7.2011 20.7.2011 Rivastigmine Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland EU/1/09/599/001-018 25.7.2011 20.7.2011 Silgard Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358/001-008 EU/1/06/358/018-021 25.7.2011 20.7.2011 Zalasta KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/07/415/001-056 25.7.2011 26.7.2011 Avaglim SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/06/349/001-010 28.7.2011 26.7.2011 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 28.7.2011 26.7.2011 Busilvex Pierre Fabre Médicament 45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France EU/1/03/254/002 28.7.2011 26.7.2011 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/296/001-009 28.7.2011 26.7.2011 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/03/247/001-002 28.7.2011 26.7.2011 Infanrix hexa GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/00/152/001-008 EU/1/00/152/019-020 28.7.2011 26.7.2011 Kuvan Merck Serono Europe Limited 56 Marsh Wall, London E14 9TP, United Kingdom EU/1/08/481/001-003 28.7.2011 26.7.2011 Menveo Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/614/001-003 28.7.2011 26.7.2011 Remicade Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 28.7.2011 26.7.2011 Retacrit Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/07/431/001-025 28.7.2011 26.7.2011 Stelara Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/494/001-004 28.7.2011 26.7.2011 Xeristar Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/297/001-008 28.7.2011 27.7.2011 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 2.8.2011 27.7.2011 Beromun Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/99/097/001 1.8.2011 27.7.2011 Bondenza Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/266/003-006 29.7.2011 27.7.2011 Bonviva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/265/003-006 29.7.2011 27.7.2011 Copalia Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/372/001-039 1.8.2011 27.7.2011 Dafiro Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/371/001-039 1.8.2011 27.7.2011 Ecalta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/416/001-002 29.7.2011 27.7.2011 Emtriva Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/261/001-003 3.8.2011 27.7.2011 Eporatio ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/573/001-028 29.7.2011 27.7.2011 Exforge Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/370/001-039 29.7.2011 27.7.2011 Exjade Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/356/001-009 1.8.2011 27.7.2011 Faslodex AstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom EU/1/03/269/001-002 1.8.2011 27.7.2011 Fosavance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/310/005 EU/1/05/310/009 29.7.2011 27.7.2011 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/357/001-008 EU/1/06/357/018-021 29.7.2011 27.7.2011 Imprida Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/373/001-039 29.7.2011 27.7.2011 Integrilin Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United Kingdom EU/1/99/109/001-002 1.8.2011 27.7.2011 Kiovig Baxter AG Industriestraße 67, A - 1221 Wien, Österreich EU/1/05/329/001-006 29.7.2011 27.7.2011 Leflunomide Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/09/604/001-010 2.8.2011 27.7.2011 Nevanac Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/07/433/001 29.7.2011 27.7.2011 PhotoBarr Axcan Pharma International BV Engelenkampstraat 72, 6131 JJ Sittard, Nederland EU/1/04/272/001-002 2.8.2011 27.7.2011 PREZISTA Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/06/380/001-005 2.8.2011 27.7.2011 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 EU/1/01/171/013-014 1.8.2011 27.7.2011 Relistor TMC Pharma Services Ltd. Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire, RG27 8AS, United Kingdom EU/1/08/463/001-011 1.8.2011 27.7.2011 Silgard Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358/001-021 2.8.2011 27.7.2011 Sycrest N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/10/640/001-006 2.8.2011 27.7.2011 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498/001-008 29.7.2011 27.7.2011 Truvada Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/04/305/001-002 3.8.2011 27.7.2011 Valdoxan Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/08/499/001-008 1.8.2011 27.7.2011 Vantavo Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/572/005 EU/1/09/572/009 1.8.2011 27.7.2011 Yentreve Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/280/001-008 29.7.2011 1.8.2011 alli Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/401/007-016 3.8.2011 1.8.2011 Doribax Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/467/001-002 3.8.2011 1.8.2011 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/357/001-021 3.8.2011 1.8.2011 Iressa AstraZeneca AB Sodertalje S 151 85, Sverige EU/1/09/526/001-002 3.8.2011 1.8.2011 Nexavar Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/06/342/001 2.8.2011 1.8.2011 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442/001-014 3.8.2011 1.8.2011 Rivastigmine Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/513/001-020 3.8.2011 1.8.2011 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492/001-006 3.8.2011 5.8.2011 ATryn GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom EU/1/06/355/001-003 10.8.2011 5.8.2011 Biograstim CT Arzneimittel GmbH Lengeder Straße 42a, D-13407 Berlin, Deutschland EU/1/08/450/001-010 10.8.2011 5.8.2011 Biopoin CT Arzneimittel GmbH Lengeder Straße 42a, D-13407 Berlin, Deutschland EU/1/09/565/001-028 10.8.2011 5.8.2011 Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-022 10.8.2011 5.8.2011 Focetria Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/07/385/001-002 EU/1/07/385/004 10.8.2011 5.8.2011 Hepsera Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom EU/1/03/251/001-002 10.8.2011 5.8.2011 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 10.8.2011 5.8.2011 InductOs Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/02/226/001 10.8.2011 5.8.2011 Silapo STADA Arzneimittel AG Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland EU/1/07/432/001-022 10.8.2011 5.8.2011 Synflorix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/508/001-010 10.8.2011 5.8.2011 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 10.8.2011 10.8.2011 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/99/118/001-010 12.8.2011 10.8.2011 Cholestagel Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/03/268/001-004 12.8.2011 10.8.2011 Filgrastim Hexal HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/08/496/001-016 12.8.2011 10.8.2011 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134/001-037 12.8.2011 10.8.2011 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133/001-032 12.8.2011 10.8.2011 Oslif Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/09/586/001-010 12.8.2011 10.8.2011 Vidaza Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom EU/1/08/488/001 12.8.2011 10.8.2011 Zarzio Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/08/495/001-016 12.8.2011 18.8.2011 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/283/008-012 22.8.2011 18.8.2011 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/98/085/001-034 22.8.2011 18.8.2011 Osseor Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/04/287/001-006 22.8.2011 18.8.2011 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/08/452/001 22.8.2011 18.8.2011 Protelos Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/04/288/001-006 22.8.2011 18.8.2011 Sutent Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/347/001-008 22.8.2011 18.8.2011 Volibris Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/08/451/001-004 22.8.2011 19.8.2011 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430/001-002 23.8.2011 24.8.2011 Afinitor Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538/001-008 30.8.2011 24.8.2011 Efficib Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457/001-016 30.8.2011 24.8.2011 Enbrel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/99/126/001-022 9.9.2011 24.8.2011 Intelence Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/468/001 30.8.2011 24.8.2011 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 30.8.2011 24.8.2011 Janumet Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455/001-016 30.8.2011 24.8.2011 Januvia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383/001-018 30.8.2011 24.8.2011 Kentera Nicobrand Limited 189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP EU/1/03/270/001-005 30.8.2011 24.8.2011 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134/001-037 30.8.2011 24.8.2011 Mepact IDM PHARMA SAS 11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France EU/1/08/502/001 30.8.2011 24.8.2011 Micardis Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/98/090/017-022 29.8.2011 24.8.2011 Modigraf Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/09/523/001-002 29.8.2011 24.8.2011 Multaq Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/09/591/001-004 26.8.2011 24.8.2011 Mycamine Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/08/448/001-002 26.8.2011 24.8.2011 Neupro Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland EU/1/05/331/001-055 26.8.2011 24.8.2011 Nplate Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/08/497/001-008 30.8.2011 24.8.2011 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133/001-032 29.8.2011 24.8.2011 Osigraft Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland EU/1/01/179/001 30.8.2011 24.8.2011 PegIntron Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/131/001-050 26.8.2011 24.8.2011 Pelzont Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/460/001-014 26.8.2011 24.8.2011 Rebetol Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/99/107/001-005 29.8.2011 24.8.2011 Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/03/267/001-010 30.8.2011 24.8.2011 Ristaben Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621/001-018 30.8.2011 24.8.2011 Ristfor Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620/001-016 30.8.2011 24.8.2011 Stalevo Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi EU/1/03/260/001-038 30.8.2011 24.8.2011 Starlix Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/174/001-021 30.8.2011 24.8.2011 Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311/001-003 26.8.2011 24.8.2011 Tesavel Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435/001-018 30.8.2011 24.8.2011 Thyrogen Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/99/122/001-002 30.8.2011 24.8.2011 Tredaptive Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/459/001-014 30.8.2011 24.8.2011 Trevaclyn Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/458/001-014 30.8.2011 24.8.2011 Tygacil Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/06/336/001 30.8.2011 24.8.2011 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274/001-002 30.8.2011 24.8.2011 Velmetia Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456/001-016 30.8.2011 24.8.2011 Vfend Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/212/001-026 30.8.2011 24.8.2011 ViraferonPeg Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/132/001-050 30.8.2011 24.8.2011 Yttriga Eckert & Ziegler Nuclitec GmbH Gieselweg 1, Braunschweig 38110, Deutschland EU/1/05/322/001-002 29.8.2011 24.8.2011 Zevalin Bayer Schering Pharma AG D-13342 Berlin, Deutschland EU/1/03/264/001 30.8.2011 24.8.2011 Zometa Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/176/001-009 30.8.2011 26.8.2011 Alisade Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United Kingdom EU/1/08/474/001-003 31.8.2011 26.8.2011 Avamys Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/434/001-003 31.8.2011 26.8.2011 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/07/419/001-012 31.8.2011 26.8.2011 Corlentor Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/05/317/001-014 31.8.2011 26.8.2011 Fertavid SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/09/510/001-019 31.8.2011 26.8.2011 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 31.8.2011 26.8.2011 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/06/368/001-168 31.8.2011 26.8.2011 Procoralan Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/05/316/001-014 31.8.2011 26.8.2011 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618/001-004 31.8.2011 26.8.2011 Sebivo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/388/001-003 31.8.2011 26.8.2011 Tepadina ADIENNE S.r.l. via Broseta, 64/B, 24128 Bergamo, Italia EU/1/10/622/001-002 31.8.2011 26.8.2011 Topotecan Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/09/552/001-004 31.8.2011





— Concessão de uma autorização de introdução no mercado (Artigo 38 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho (2) ): Autorizado

Data da decisão Nome do medicamento DCI (Denominação Comum Internacional) Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Forma farmacêutica Código ATC (código anatómico-terapêutico-químico) Data de notificação 5.8.2011 Proteq West Nile Vírus recombinante canarypox da Febre do Nilo Ocidental (vCP 2017) MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/11/129/001-004 Suspensão injectável QI05AX 10.8.2011 5.8.2011 Zulvac 1 Bovis Vírus da Língua Azul inactivado, serotipo 1, estirpe BTV-1/ALG2006/01 E1 PR ≥ 1 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/11/130/001-003 Suspensão injectável QI02AA08 10.8.2011 5.8.2011 Zulvac 1 Ovis Vírus da Língua Azul inactivado, serotipo 1, estirpe BTV-1/ALG2006/01 E1 PR ≥ 1 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/11/131/001-006 Suspensão injectável QI04AA02 10.8.2011 18.8.2011 Emdocam Meloxicam Emdoka bvba J. Lijsenstraat 16, B-2321 Hoogstraten, Belgïe EU/2/11/128/001-003 Solução injectável QM01AC06 22.8.2011





— Alteração de uma autorização de introdução no mercado (Artigo 38 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho): Autorizado

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 7.7.2011 Leucofeligen FeLV/RCP VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros Cedex France EU/2/09/097/001-002 11.7.2011 7.7.2011 Palladia Pfizer Ltd Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/09/100/001-003 12.7.2011 7.7.2011 ProMeris Duo Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/06/065/001-010 11.7.2011 11.7.2011 Trocoxil Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/08/084/001-005 13.7.2011 13.7.2011 Loxicom Norbrook Laboratories Limited Station Works, Newry, Co. Down, BT35 6JP, United Kindgom EU/2/08/090/001-018 18.7.2011 20.7.2011 Posatex Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/08/081/001-003 25.7.2011 27.7.2011 Poulvac FluFend H5N3 RG Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/06/060/001-002 1.8.2011 27.7.2011 ProMeris Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/06/064/001-004 1.8.2011 27.7.2011 Slentrol Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/07/071/001-003 2.8.2011 5.8.2011 Cerenia Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/06/062/001-005 10.8.2011 5.8.2011 Virbagen Omega VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros - France EU/2/01/030/001-004 10.8.2011 19.8.2011 Nobilis Influenza H5N2 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/06/061/001-004 23.8.2011 19.8.2011 Zolvix Novartis Healthcare A/S Lyngbyvej 172, DK-2100 Copenhagen, Danmark EU/2/09/101/001-010 23.8.2011 24.8.2011 Suvaxyn Aujeszky 783 +O/W Fort Dodge Animal Health Holland C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland EU/2/98/009/001-006 30.8.2011





— Retirada de uma autorização de introdução no mercado (Artigo 38 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho)

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 10.8.2011 Yarvitan Janssen Pharmaceutica N.V. Turnhoutseweg 30, B-2340 Beerse, België EU/2/06/063/001-003 12.8.2011

Os interessados podem solicitar o acesso ao relatório público dos medicamentos em questão e das decisões correspondentes junto de:

The European Medicines Agency 7, Westferry Circus, Canary Wharf UK - LONDON E14 4H

(1) JO L 136 de 30.4.2004, p. 1.

(2) JO L 136 de 30.4.2004, p. 1.