EN Official Journal of the European Union C 401/3

Summary of European Union decisions on marketing authorisations in respect of medicinal products 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

— 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 12.11.2012 Forxiga dapagliflozin Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/12/795 Film-coated tablet A10BX09 14.11.2012 15.11.2012 Picato ingenol mebutate LEO Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark EU/1/12/796 Gel D06BX02 19.11.2012 19.11.2012 Capecitabine medac capecitabine medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland EU/1/12/802 Film-coated tablet L01BC06 23.11.2012 19.11.2012 Ibandronic acid Accord Ibandronic acid Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom EU/1/12/798 Concentrate for solution for infusion M05BA06 23.11.2012 19.11.2012 Zoledronic acid Hospira zoledronic acid Hospira UK Ltd. Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/12/800 Concentrate for solution for infusion Solution for infusion M05BA 23.11.2012 22.11.2012 Eylea aflibercept Bayer Pharma AG D - 13342 Berlin, Deutschland EU/1/12/797 Solution for injection S01LA05 26.11.2012 22.11.2012 Memantine Merz Memantine Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland EU/1/12/799 Film-coated tablet Oral solution N06DX01 26.11.2012 26.11.2012 Constella linaclotide Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/12/801 Capsule, hard Pending 28.11.2012





— 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 8.11.2012 Enyglid KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/580 12.11.2012 8.11.2012 Rivastigmine 1 A Pharma 1 A Pharma GmbH Keltenring 1 + 3, Oberhaching 82041, Deutschland EU/1/09/585 12.11.2012 12.11.2012 Ivemend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/437 14.11.2012 12.11.2012 Olanzapine Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/07/427 14.11.2012 15.11.2012 Naglazyme BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/05/324 19.11.2012 15.11.2012 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618 19.11.2012 15.11.2012 Retacrit Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/07/431 19.11.2012 15.11.2012 Sutent Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/347 19.11.2012 15.11.2012 Xaluprine Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom EU/1/11/727 19.11.2012 15.11.2012 Xarelto Bayer Pharma AG 13342 Berlin, Deutschland EU/1/08/472 19.11.2012 19.11.2012 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom EU/1/04/276 22.11.2012 19.11.2012 Actraphane Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/02/229 22.11.2012 19.11.2012 Actrapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/230 22.11.2012 19.11.2012 Apidra Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/04/285 23.11.2012 19.11.2012 Champix Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/360 22.11.2012 19.11.2012 Eliquis Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/691 23.11.2012 19.11.2012 Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720 22.11.2012 19.11.2012 Insulatard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/233 22.11.2012 19.11.2012 Ketek Aventis Pharma S.A. 20 avenue Raymond Aron, F-92160 Antony, France EU/1/01/191 22.11.2012 19.11.2012 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland EU/1/02/205 23.11.2012 19.11.2012 Mirapexin Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/97/051 23.11.2012 19.11.2012 Mixtard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/231 22.11.2012 19.11.2012 Mycophenolate mofetil Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/07/439 22.11.2012 19.11.2012 Myfenax Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/07/438 22.11.2012 19.11.2012 Protaphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/234 22.11.2012 19.11.2012 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom EU/1/07/391 22.11.2012 19.11.2012 Sifrol Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/050 22.11.2012 19.11.2012 Simponi Janssen Biologics B.V. Einsteinweg 101, CB Leiden 2333, Nederland EU/1/09/546 23.11.2012 19.11.2012 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363 22.11.2012 19.11.2012 Tysabri Elan Pharma International Ltd. Treasury Building, Lower Grand Canal Street, Dublin 2, IRELAND EU/1/06/346 23.11.2012 22.11.2012 Diacomit Biocodex 7 avenue Gallieni, 94250 Gentilly, France EU/1/06/367 26.11.2012 22.11.2012 GILENYA Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/677 26.11.2012 22.11.2012 Humira AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom EU/1/03/256 26.11.2012 22.11.2012 Olanzapine Apotex Apotex Europe B.V. Darwinweg 20, 2333 CR Leiden, Nederland EU/1/10/635 26.11.2012 22.11.2012 Prevenar 13 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/590 27.11.2012 22.11.2012 Rasilez Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405 26.11.2012 22.11.2012 Rasilez HCT Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491 26.11.2012 22.11.2012 Rasitrio Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/730 26.11.2012 22.11.2012 Remicade Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116 27.11.2012 22.11.2012 Riprazo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/409 26.11.2012 22.11.2012 Rivastigmine HEXAL HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/09/589 27.11.2012 22.11.2012 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492 27.11.2012 22.11.2012 Thyrogen Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/99/122 27.11.2012 22.11.2012 Tracleer Actelion Registration Ltd Chiswick Tower 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220 27.11.2012 22.11.2012 Vimpat UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/08/470 27.11.2012 22.11.2012 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200 27.11.2012 26.11.2012 Temodal Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom EU/1/98/096 28.11.2012 30.11.2012 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/357 30.11.2012 30.11.2012 Olazax Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika EU/1/09/597 4.12.2012 30.11.2012 Silgard Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358 4.12.2012 30.11.2012 Tygacil Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/06/336 4.12.2012 30.11.2012 Zevalin Spectrum Pharmaceuticals B.V. Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland EU/1/03/264 4.12.2012





— 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 8.11.2012 Inflacam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND EU/2/11/134 12.11.2012 8.11.2012 Meloxivet Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom EU/2/07/077 12.11.2012 12.11.2012 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND EU/2/07/078 14.11.2012

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.