EN Official Journal of the European Union C 121/2

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2013 to 31 March 2013

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

2013/C 121/02

— 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 4.3.2013 Perjeta pertuzumab Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/813 Concentrate for solution for infusion L01XC13 6.3.2013 13.3.2013 Actelsar HCT telmisartan/hydrochlorothiazide Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/13/817 Tablet C09DA07 15.3.2013 13.3.2013 JETREA OCRIPLASMIN ThromboGenics NV Gaston Geenslaan 1, B-3001 Leuven, België EU/1/13/819 Concentrate for solution for injection Pending 15.3.2013 13.3.2013 Tolucombi telmisartan/hydrochlorothiazide Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/13/821 Tablet C09DA07 15.3.2013 22.3.2013 Bexsero Meningococcal group B Vaccine (rDNA, component, adsorbed) Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/12/812 Suspension for injection J07AH09 26.3.2013 27.3.2013 Bosulif Bosutinib Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/13/818 Film-coated tablet L01XE14 2.4.2013





— 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 6.3.2013 Byetta Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/06/362 8.3.2013 6.3.2013 Intelence Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/468 8.3.2013 6.3.2013 Ozurdex Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland EU/1/10/638 8.3.2013 6.3.2013 Ranexa Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/462 8.3.2013 11.3.2013 Champix Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/360 13.3.2013 11.3.2013 Qutenza Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/09/524 13.3.2013 11.3.2013 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529 13.3.2013 13.3.2013 BYDUREON Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/696 15.3.2013 13.3.2013 Efficib Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457 15.3.2013 13.3.2013 Firazyr Shire Orphan Therapies GmbH Friedrichstrasse 149, D-10117 Berlin, Deutschland EU/1/08/461 15.3.2013 13.3.2013 Firdapse BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/09/601 15.3.2013 13.3.2013 Ganfort Allergan Pharmaceuticals Ireland, (514125) Castlebar Road, Westport, County Mayo, Ireland EU/1/06/340 15.3.2013 13.3.2013 Iscover Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/98/070 15.3.2013 13.3.2013 Janumet Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455 15.3.2013 13.3.2013 Optimark Mallinckrodt Deutschland GmbH Josef-Dietzgen-Strasse 1, 53773 Hennef, Deutschland EU/1/07/398 15.3.2013 13.3.2013 Pegasys Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221 15.3.2013 13.3.2013 Privigen CSL Behring GmbH Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland EU/1/08/446 15.3.2013 13.3.2013 Velmetia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456 15.3.2013 13.3.2013 Vidaza Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/08/488 15.3.2013 22.3.2013 Daliresp Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/11/668 26.3.2013 22.3.2013 DaTSCAN GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom EU/1/00/135 26.3.2013 22.3.2013 Daxas Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/10/636 26.3.2013 22.3.2013 Emend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262 26.3.2013 22.3.2013 Ivemend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/437 26.3.2013 22.3.2013 Libertek Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/11/666 26.3.2013 22.3.2013 Pixuvri CTI Life Sciences Ltd Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom EU/1/12/764 26.3.2013 26.3.2013 Combivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/98/058 28.3.2013 26.3.2013 Daliresp Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/11/668 28.3.2013 26.3.2013 Daxas Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/10/636 28.3.2013 26.3.2013 Epivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/96/015 28.3.2013 26.3.2013 Kivexa ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/04/298 28.3.2013 26.3.2013 Libertek Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/11/666 28.3.2012 26.3.2013 Privigen CSL Behring GmbH Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland EU/1/08/446 28.3.2013 26.3.2013 Telzir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/04/282 28.3.2013 26.3.2013 Trizivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/00/156 28.3.2013 26.3.2013 Ziagen ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/99/112 28.3.2013 27.3.2013 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/07/419 29.3.2013





— 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 27.3.2013 Bondenza Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/266 2.4.2013 27.3.2013 Possia AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/10/656 2.4.2013





— Suspension of a marketing authorization (Article 20 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 22.3.2013 Pelzont Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/460 26.3.2013 22.3.2013 Tredaptive Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/459 26.3.2013 22.3.2013 Trevaclyn Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/458 26.3.2013





— 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 6.3.2013 Loxicom Norbrook Laboratories Ltd Station Works, Newry, Co. Down, BT35 6JP, United Kindgom EU/2/08/090 8.3.2013 6.3.2013 ProteqFlu Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/03/037 8.3.2013 6.3.2013 ProteqFlu-Te Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/03/038 8.3.2013

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.