(Oplysninger) EUROPA-KOMMISSIONEN

Transkript

1 Den Europæiske Unions Tidende C 316/1 IV (Oplysninger) OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER EUROPA-KOMMISSIONEN Oversigt over EU- om tilladelse til markedsføring af lægemidler fra 1. juli 2011 til 31. august 2011 (Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 ( 1 )) (2011/C 316/01) ( 1 ) EUT L 136 af , s. 1.

2 Udstedelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt Lægemidlets navn INN-navn (International Non-Proprietary Name) Benlysta belimumab Glaxo Group Limited Glaxo Wellcome House, Berkely Avenue, Greenford, Middlesex UB6 0NN, United Temozolomide Sun temozolomid Sun Pharmaceuticals Industries Europe B.V. Polarisavenue 87, 2132 JH Hoofddorp, Nederland Xgeva denosumab Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland Yervoy ipilimumab Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Victrelis boceprevir Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Fampyra fampridin Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United TOBI Podhaler Tobramycin Novartis Europharm Limited Sussex, RH12 5AB, United Ibandronic acid Sandoz Ibandronsyre Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, Holzkirchen, Zoely Nomegestrol/estradiol Merck Serono Europe Limited 56 Marsh Wall, London E14 9TP, United Indehaver af markedsføringstilladelsen Nummer i EF-registret Lægemiddelform EU/1/11/700/ Pulver til koncentrat til infusionsvæske, opløsning ATC-kode (Anatomical Therapeutic Chemical Code) L04AA EU/1/11/697/ Kapsler, hårde L01AX EU/1/11/703/ EU/1/11/698/ Injektionsvœske, opløsning Koncentrat till infusionsvaeske, opløsning M05BX L01XC EU/1/11/704/001 Kapsler, hårde J05AE EU/1/11/699/ Depottablet N07XX EU/1/10/652/ Inhalationspulver i kapsel J01GB EU/1/11/685/ Filmovertrukket tablet M05BA EU/1/11/690/ Filmovertrukket tablet G03AA C 316/2 Den Europæiske Unions Tidende

3 Lægemidlets navn INN-navn (International Non-Proprietary Name) Entacapone Orion entacapon Orion Corporation Orionintie 1, FI Espoo, Suomi Levodopa/Carbidopa/Entacapone Orion Levodopa, carbidopa, entacapone Indehaver af markedsføringstilladelsen Nummer i EF-registret Lægemiddelform Orion Corporation Orionintie 1, FI Espoo, Suomi Trajenta linagliptin Boehringer Ingelheim International GmbH Binger Strasse 173- D Ingelheim am Rhein, Levetiracetam ratiopharm Levetiracetam ratiopharm GmbH Graf-Arco-Straße 3, D Ulm, Levetiracetam Teva Levetiracetam Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland ATC-kode (Anatomical Therapeutic Chemical Code) EU/1/11/708/ Filmovertrukket tablet N04BX EU/1/11/706/ Filmovertrukket tablet N04BA EU/1/11/707/ Filmovertrukket tablet A10BH EU/1/11/702/ Filmovertrukket tablet Oral opløsning N03AX EU/1/11/701/ Filmovertrukket tablet N03AX Den Europæiske Unions Tidende C 316/3

4 C 316/4 Den Europæiske Unions Tidende Ændring af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt Irbesartan Winthrop Sanofi-Aventis 174, avenue de France, F Paris, France Relistor Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United EU/1/06/376/ EU/1/08/463/ Adrovance Merck Sharp & Dohme Ltd EU/1/06/364/005 EU/1/06/364/ Ammonaps Swedish Orphan Biovitrum International AB SE Stockholm, Sverige Hirobriz Breezhaler Novartis Europharm Limited Sussex, RH12 5AB, United Modigraf Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland Removab Fresenius Biotech GmbH Am Haag 6-7, D Graefelfing, EU/1/99/120/ EU/1/09/594/ EU/1/09/523/ EU/1/09/512/ 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/ EU/1/99/119/ Onbrez Breezhaler Novartis Europharm Ltd Optaflu Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Strasse 76, D Marburg, Sildenafil ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D Ulm, EU/1/09/593/ EU/1/07/394/ EU/1/09/603/ Stocrin Merck Sharp & Dohme Ltd Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United EU/1/99/111/ EU/1/99/111/ EU/1/99/110/ EU/1/99/110/ ViraferonPeg Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, Brussel, België EU/1/00/132/

5 Den Europæiske Unions Tidende C 316/ Viread Gilead Sciences International Limited Cambridge CB21 6GT United EU/1/01/200/ Crixivan Merck Sharp & Dohme Ltd EU/1/96/024/ EU/1/96/024/ Intrinsa Warner Chilcott UK Ltd Old Belfast Road, Millbrook, Larne, County Antrim BT40 2SH, United Livensa Warner Chilcott Gmbh Dr.-Otto-Röhm-Strasse 2-4, Weiterstadt 64331, Multaq Sanofi-Aventis 174, avenue de France, F Paris, France ReFacto AF Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Savene SpePharm Holding BV Kingsfordweg 151, GR Amsterdam 1043, Nederland Atriance Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Betaferon Bayer Schering Pharma AG Müllerstrasse , D Berlin, Esbriet InterMune UK Ltd 4th Floor, One Victoria Street, Bristol, BS1 6AA, United Intelence Janssen-Cilag International NV Turnhoutseweg, Beerse - België Ratiograstim ratiopharm GmbH Graf-Arco-Straße 3, D Ulm, EU/1/06/352/ EU/1/06/351/ EU/1/09/591/ EU/1/99/103/ EU/1/06/350/ EU/1/07/403/ EU/1/95/003/ EU/1/11/667/ EU/1/08/468/ EU/1/08/444/ Rivastigmine 1 A Pharma 1 A Pharma GmbH Keltenring 1+3, Oberhaching 82041, EU/1/09/585/ Rivastigmine Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, Holzkirchen, EU/1/09/599/ Silgard Merck Sharp & Dohme Ltd EU/1/06/358/ EU/1/06/358/

6 C 316/6 Den Europæiske Unions Tidende Zalasta KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija Avaglim SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United EU/1/07/415/ EU/1/06/349/ Bondronat Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United EU/1/96/012/004 EU/1/96/012/ Busilvex Pierre Fabre Médicament 45, Place Abel Gance, Boulogne Billancourt Cedex, France Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland Forsteo Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/03/254/ EU/1/04/296/ EU/1/03/247/ Infanrix hexa GlaxoSmithKline Biologicals S.A. rue de l'institut 89, Rixensart, B-1330 Belgique EU/1/00/152/ EU/1/00/152/ Kuvan Merck Serono Europe Limited 56 Marsh Wall, London E14 9TP, United Menveo Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, Siena, Italia Remicade Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland Retacrit Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Stelara Janssen-Cilag International NV Turnhoutseweg, Beerse - België Xeristar Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Beromun Boehringer Ingelheim International GmbH Binger Strasse 173- D Ingelheim am Rhein, EU/1/08/481/ EU/1/10/614/ EU/1/99/116/ EU/1/07/431/ EU/1/08/494/ EU/1/04/297/ EU/1/04/300/ EU/1/99/097/

7 Den Europæiske Unions Tidende C 316/ Bondenza Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Bonviva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Copalia Novartis Europharm Ltd Dafiro Novartis Europharm Ltd Ecalta Pfizer Limited CT13 9NJ, United Emtriva Gilead Sciences International Limited Cambridge CB21 6GT United Eporatio ratiopharm GmbH Graf-Arco-Straße 3, D Ulm, Exforge Novartis Europharm Ltd Exjade Novartis Europharm Ltd Faslodex AstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United EU/1/03/266/ EU/1/03/265/ EU/1/06/372/ EU/1/06/371/ EU/1/07/416/ EU/1/03/261/ EU/1/09/573/ EU/1/06/370/ EU/1/06/356/ EU/1/03/269/ Fosavance Merck Sharp & Dohme Ltd EU/1/05/310/005 EU/1/05/310/ Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon, France EU/1/06/357/ EU/1/06/357/ Imprida Novartis Europharm Ltd Integrilin Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United EU/1/06/373/ EU/1/99/109/

8 C 316/8 Den Europæiske Unions Tidende Kiovig Baxter AG Industriestraße 67, A Wien, Österreich EU/1/05/329/ Leflunomide Winthrop Sanofi-Aventis GmbH D Frankfurt am Main, EU/1/09/604/ Nevanac Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United PhotoBarr Axcan Pharma International BV Engelenkampstraat 72, 6131 JJ Sittard, Nederland PREZISTA Janssen-Cilag International NV Turnhoutseweg, Beerse - België EU/1/07/433/ EU/1/04/272/ EU/1/06/380/ Rapamune Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United EU/1/01/171/001 EU/1/01/171/ EU/1/01/171/ Relistor TMC Pharma Services Ltd. Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire, RG27 8AS, United Silgard Merck Sharp & Dohme Ltd Sycrest N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland Truvada Gilead Sciences International Limited Cambridge CB21 6GT United Valdoxan Les Laboratoires Servier 22, rue Garnier, Neuilly-sur-Seine, France EU/1/08/463/ EU/1/06/358/ EU/1/10/640/ EU/1/08/498/ EU/1/04/305/ EU/1/08/499/ Vantavo Merck Sharp & Dohme Ltd. EU/1/09/572/005 EU/1/09/572/ Yentreve Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland alli Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United EU/1/04/280/ EU/1/07/401/

9 Den Europæiske Unions Tidende C 316/ Doribax Janssen-Cilag International NV Turnhoutseweg, Beerse - België Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon, France Iressa AstraZeneca AB Sodertalje S , Sverige Nexavar Bayer Schering Pharma AG Berlin, Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D Ingelheim am Rhein, Rivastigmine Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United ATryn GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Biograstim CT Arzneimittel GmbH Lengeder Straße 42a, D Berlin, Biopoin CT Arzneimittel GmbH Lengeder Straße 42a, D Berlin, Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United EU/1/08/467/ EU/1/06/357/ EU/1/09/526/ EU/1/06/342/ EU/1/08/442/ EU/1/09/513/ EU/1/08/492/ EU/1/06/355/ EU/1/08/450/ EU/1/09/565/ EU/1/99/126/ Focetria Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, Siena, Italia EU/1/07/385/ EU/1/07/385/ Hepsera Gilead Sciences International Limited Cambridge, CB21 6GT, United EU/1/03/251/ Hycamtin SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United EU/1/96/027/001 EU/1/96/027/ InductOs Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United EU/1/02/226/

10 C 316/10 Den Europæiske Unions Tidende Silapo STA Arzneimittel AG Stadastrasse 2-18, Bad Vilbel, Synflorix GlaxoSmithKline Biologicals S.A. rue de l'institut 89, 1330 Rixensart, Belgique Viread Gilead Sciences International Limited Cambridge CB21 6GT United Arava Sanofi-Aventis GmbH D Frankfurt am Main, Cholestagel Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland Filgrastim Hexal HEXAL AG Industriestrasse 25, D Holzkirchen, Lantus Sanofi-Aventis GmbH D Frankfurt am Main, Optisulin Sanofi-Aventis GmbH D Frankfurt am Main, Oslif Breezhaler Novartis Europharm Limited Sussex, RH12 5AB, United Vidaza Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Zarzio Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Osseor Les Laboratoires Servier 22, rue Garnier, Neuilly-sur-Seine, France Pandemrix GlaxoSmithKline Biologicals S.A. rue de l'institut 89, Rixensart, B-1330 Belgique Protelos Les Laboratoires Servier 22, rue Garnier, Neuilly-sur-Seine, France EU/1/07/432/ EU/1/09/508/ EU/1/01/200/ EU/1/99/118/ EU/1/03/268/ EU/1/08/496/ EU/1/00/134/ EU/1/00/133/ EU/1/09/586/ EU/1/08/488/ EU/1/08/495/ EU/1/04/283/ EU/1/98/085/ EU/1/04/287/ EU/1/08/452/ EU/1/04/288/

11 Den Europæiske Unions Tidende C 316/ Sutent Pfizer Ltd CT 13 9NJ, United Volibris Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Atripla Bristol-Myers Squibb and Gilead Sciences Limited I Business & Technology Park, Carrigtohill, Co. Cork, Ireland Afinitor Novartis Europharm Ltd Efficib Merck Sharp & Dohme Ltd Enbrel Pfizer Limited CT13 9NJ, United Intelence Janssen-Cilag International NV Turnhoutseweg, Beerse - België EU/1/06/347/ EU/1/08/451/ EU/1/07/430/ EU/1/09/538/ EU/1/08/457/ EU/1/99/126/ EU/1/08/468/ IntronA Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, Brussel, België EU/1/99/127/ EU/1/99/127/ Janumet Merck Sharp & Dohme Ltd Januvia Merck Sharp & Dohme Ltd Kentera Nicobrand Limited 189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP Lantus Sanofi-Aventis GmbH D Frankfurt am Main, Mepact IDM PHARMA SAS quai De Dion Bouton, Puteaux Cedex, France Micardis Boehringer Ingelheim International GmbH Binger Strasse 173- D Ingelheim am Rhein, Modigraf Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/08/455/ EU/1/07/383/ EU/1/03/270/ EU/1/00/134/ EU/1/08/502/ EU/1/98/090/ EU/1/09/523/

12 C 316/12 Den Europæiske Unions Tidende Multaq Sanofi-Aventis 174, avenue de France, F Paris, France Mycamine Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland Neupro Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland Nplate Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/09/591/ EU/1/08/448/ EU/1/05/331/ EU/1/08/497/ Optisulin Sanofi-Aventis GmbH D Frankfurt am Main, EU/1/00/133/ Osigraft Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland EU/1/01/179/ PegIntron Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, Brussel, België EU/1/00/131/ Pelzont Merck Sharp & Dohme Ltd Rebetol Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, Brussel, België Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Ristaben Merck Sharp & Dohme Ltd Ristfor Merck Sharp & Dohme Ltd Stalevo Orion Corporation Orionintie 1, FIN Espoo, Suomi Starlix Novartis Europharm Ltd EU/1/08/460/ EU/1/99/107/ EU/1/03/267/ EU/1/10/621/ EU/1/10/620/ EU/1/03/260/ EU/1/01/174/

13 Den Europæiske Unions Tidende C 316/ Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Tesavel Merck Sharp & Dohme Ltd Thyrogen Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland Tredaptive Merck Sharp & Dohme Ltd Trevaclyn Merck Sharp & Dohme Ltd Tygacil Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België Velmetia Merck Sharp & Dohme Ltd Vfend Pfizer Ltd CT 13 9NJ, United ViraferonPeg Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, Brussel, België Yttriga Eckert & Ziegler Nuclitec GmbH Gieselweg 1, Braunschweig 38110, Zevalin Bayer Schering Pharma AG D Berlin, Zometa Novartis Europharm Ltd Alisade Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United Avamys Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United EU/1/05/311/ EU/1/07/435/ EU/1/99/122/ EU/1/08/459/ EU/1/08/458/ EU/1/06/336/ EU/1/04/274/ EU/1/08/456/ EU/1/02/212/ EU/1/00/132/ EU/1/05/322/ EU/1/03/264/ EU/1/01/176/ EU/1/08/474/ EU/1/07/434/

14 C 316/14 Den Europæiske Unions Tidende Cervarix GlaxoSmithKline Biologicals S.A. rue de l'institut 89, 1330 Rixensart, Belgique Corlentor Les Laboratoires Servier 22, rue Garnier, Neuilly-sur-Seine, France Fertavid SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, Brussel, België EU/1/07/419/ EU/1/05/317/ EU/1/09/510/ HBVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon, France EU/1/01/183/001 EU/1/01/183/ EU/1/01/183/ EU/1/01/183/011 EU/1/01/183/013 EU/1/01/183/015 EU/1/01/183/ Insulin Human Winthrop Sanofi-Aventis GmbH D Frankfurt am Main, EU/1/06/368/ Procoralan Les Laboratoires Servier 22, rue Garnier, Neuilly-sur-Seine, France Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland Sebivo Novartis Europharm Ltd Tepadina ADIENNE S.r.l. via Broseta, 64/B, Bergamo, Italia Topotecan Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/05/316/ EU/1/10/618/ EU/1/07/388/ EU/1/10/622/ EU/1/09/552/

15 Udstedelse af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 ( 1 )): Godkendt Lægemidlets navn INN-navn (International Non-Proprietary Name) Proteq West Nile West Nile rekombinant canarypox virus (vcp2017) Zulvac 1 Bovis Inaktiveret bluetonguevirus, serotype 1, stamme BTV-1/ALG2006/01 E1 RP Zulvac 1 Ovis Inaktiveret bluetonguevirus, serotype 1, stamme BTV-1/ALG2006/01 E1 RP 1 Indehaver af markedsføringstilladelsen Nummer i EF-registret Lægemiddelform MERIAL 29 avenue Tony Garnier, LYON, France Pfizer Limited CT13 9NJ, United Pfizer Limited CT13 9NJ, United Emdocam Meloxicam Emdoka bvba J. Lijsenstraat 16, B-2321 Hoogstraten, Belgïe ( 1 ) EUT L 136 af , s. 1. EU/2/11/129/ EU/2/11/130/ EU/2/11/131/ EU/2/11/128/ Suspension til injektion Suspension til injektion Suspension til injektion Injektionsvœske, opløsning ATC-kode (Anatomical Therapeutic Chemical Code) QI05AX QI02AA QI04AA QM01AC Den Europæiske Unions Tidende C 316/15

16 C 316/16 Den Europæiske Unions Tidende Ændring af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt Leucofeligen FeLV/RCP VIRBAC S.A. 1ère Avenue 2065 m L.I.D Carros Cedex France EU/2/09/097/ Palladia Pfizer Ltd CT13 9NJ, United EU/2/09/100/ ProMeris Duo Pfizer Limited CT13 9NJ, United EU/2/06/065/ Trocoxil Pfizer Limited CT13 9NJ United EU/2/08/084/ Loxicom Norbrook Laboratories Limited Station Works, Newry, Co. Down, BT35 6JP, United Kindgom EU/2/08/090/ Posatex Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/08/081/ Poulvac FluFend H5N3 RG Pfizer Limited CT13 9NJ United EU/2/06/060/ ProMeris Pfizer Limited CT13 9NJ United EU/2/06/064/ Slentrol Pfizer Ltd CT 13 9NJ, United EU/2/07/071/ Cerenia Pfizer Ltd CT 13 9NJ, United EU/2/06/062/ Virbagen Omega VIRBAC S.A. 1ère Avenue 2065 m L.I.D Carros - France EU/2/01/030/ Nobilis Influenza H5N2 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/06/061/ Zolvix Novartis Healthcare A/S Lyngbyvej 172, DK-2100 Copenhagen, Danmark EU/2/09/101/ Suvaxyn Aujeszky 783 +O/W Fort Dodge Animal Health Holland C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland EU/2/98/009/

17 Den Europæiske Unions Tidende C 316/17 Tilbagekaldelse af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004) Yarvitan Janssen Pharmaceutica N.V. Turnhoutseweg 30, B-2340 Beerse, België EU/2/06/063/ Alle interesserede kan ved henvendelse på nedenstående adresse få tilsendt den offentlige evalueringsrapport om de pågældende lægemidler og de, der er truffet vedrørende disse: The European Medicines Agency 7, Westferry Circus, Canary Wharf UK - LONDON E14 4H