Official Journal of the European Union C 401/3
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1 Official Journal of the European Union C 401/3 Summary of European Union s on marketing authorisations in respect of medicinal s from 1 November 2012 to 30 November 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council ( 1 )) (2012/C 401/02) ( 1 ) OJ L 136, , p. 1.
2 Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted the INN (International Non-Proprietary Name) Forxiga dapagliflozin Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, Picato ingenol mebutate LEO Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark Capecitabine medac capecitabine medac Gesellschaft für klinische Spezialpräparate mbh Fehlandtstrasse 3, D Hamburg - Deutschland Ibandronic acid Accord Ibandronic acid Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF Zoledronic acid Hospira zoledronic acid Hospira UK Ltd. Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, Eylea aflibercept Bayer Pharma AG D Berlin, Deutschland Memantine Merz Memantine Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100, D Frankfurt/Main - Deutschland Constella linaclotide Almirall, S.A. Ronda General Mitre, 151, Barcelona, España entry in the Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) EU/1/12/795 Film-coated tablet A10BX EU/1/12/796 Gel D06BX EU/1/12/802 Film-coated tablet L01BC EU/1/12/798 EU/1/12/800 Concentrate for solution for infusion Concentrate for solution for infusion Solution for infusion M05BA M05BA EU/1/12/797 Solution for injection S01LA EU/1/12/799 Film-coated tablet Oral solution N06DX EU/1/12/801 Capsule, hard Pending C 401/4 EN Official Journal of the European Union
3 Official Journal of the European Union C 401/5 Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted the Enyglid KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/ Rivastigmine 1 A Pharma 1 A Pharma GmbH Keltenring 1 + 3, Oberhaching 82041, Deutschland EU/1/09/ Ivemend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, EU/1/07/ Olanzapine Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/07/ Naglazyme BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, EU/1/05/ Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/ Retacrit Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, EU/1/07/ Sutent Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, EU/1/06/ Xaluprine Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, EU/1/11/ Xarelto Bayer Pharma AG Berlin, Deutschland EU/1/08/ Abilify Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, EU/1/04/ Actraphane Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, Siena, Italia EU/1/02/ Actrapid Novo Nordisk A/S EU/1/02/ Apidra Sanofi-Aventis Deutschland GmbH D Frankfurt am Main, Deutschland EU/1/04/ Champix Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, EU/1/06/
4 C 401/6 Official Journal of the European Union the Eliquis Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, EU/1/11/ Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/ Insulatard Novo Nordisk A/S EU/1/02/ Ketek Aventis Pharma S.A. 20 avenue Raymond Aron, F Antony, France EU/1/01/ Lumigan Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland EU/1/02/ Mirapexin Boehringer Ingelheim International GmbH Binger Strasse 173- D Ingelheim am Rhein, Deutschland EU/1/97/ Mixtard Novo Nordisk A/S EU/1/02/ Mycophenolate mofetil Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/07/ Myfenax Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/07/ Protaphane Novo Nordisk A/S EU/1/02/ Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, EU/1/07/ Sifrol Boehringer Ingelheim International GmbH Binger Strasse 173, D Ingelheim am Rhein, Deutschland EU/1/97/ Simponi Janssen Biologics B.V. Einsteinweg 101, CB Leiden 2333, Nederland EU/1/09/ Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, EU/1/06/ Tysabri Elan Pharma International Ltd. Treasury Building, Lower Grand Canal Street, Dublin 2, IRELAND EU/1/06/ Diacomit Biocodex 7 avenue Gallieni, Gentilly, France EU/1/06/
5 Official Journal of the European Union C 401/7 the GILENYA Novartis Europharm Ltd RH12 5AB, EU/1/11/ Humira AbbVie Ltd. Maidenhead, SL6 4XE, EU/1/03/ Olanzapine Apotex Apotex Europe B.V. Darwinweg 20, 2333 CR Leiden, Nederland EU/1/10/ Prevenar 13 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, EU/1/09/ Rasilez Novartis Europharm Ltd RH12 5AB, EU/1/07/ Rasilez HCT Novartis Europharm Ltd RH12 5AB, EU/1/08/ Rasitrio Novartis Europharm Limited, RH12 5AB, EU/1/11/ Remicade Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/ Riprazo Novartis Europharm Ltd RH12 5AB, EU/1/07/ Rivastigmine HEXAL HEXAL AG Industriestrasse 25, D Holzkirchen, Deutschland EU/1/09/ RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, EU/1/08/ Thyrogen Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/99/ Tracleer Actelion Registration Ltd Chiswick Tower 13th Floor, 389 Chiswick High Road, London W4 4AL, EU/1/02/ Vimpat UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/08/ Viread Gilead Sciences International Limited Cambridge CB21 6GT EU/1/01/
6 C 401/8 Official Journal of the European Union the Temodal Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon, France Olazax Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, Praha 4, Česká republika Silgard Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Tygacil Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, Zevalin Spectrum Pharmaceuticals B.V. Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland EU/1/98/ EU/1/06/ EU/1/09/ EU/1/06/ EU/1/06/ EU/1/03/ Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted the Inflacam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND Meloxivet Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND EU/2/11/ EU/2/07/ EU/2/07/ Anyone wishing to consult the public assessment report on the medicinal s in question and the s relating thereto is invited to contact: The European Medicines Agency 7, Westferry Circus, Canary Wharf UK - LONDON E14 4H
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