EN Official Journal of the European Union C 154/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 April 2013

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

2013/C 154/01

— 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 17.4.2013 Hexacima Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France EU/1/13/828 Suspension for injection J07CA09 19.4.2013 17.4.2013 Hexyon diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France EU/1/13/829 Suspension for injection J07CA09 19.4.2013 17.4.2013 Imatinib Actavis Imatinib Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/13/825 Capsule, hard Film-coated tablet L01XE01 19.4.2013 22.4.2013 Memantine LEK Memantine Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/13/826 Film-coated tablet N06DX01 24.4.2013 22.4.2013 Memantine Mylan Memantine Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/13/827 Film-coated tablet N06DX01 24.4.2013 22.4.2013 Nemdatine Memantine Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/13/824 Film-coated tablet N06DX01 24.4.2013 29.4.2013 Maruxa Memantine Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/13/820 Film-coated tablet N06DX01 6.5.2013





— 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 9.4.2013 NULOJIX Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/694 11.4.2013 9.4.2013 Oprymea Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/469 11.4.2013 9.4.2013 Thalidomide Celgene Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/08/443 11.4.2013 9.4.2013 Xiapex Auxilium UK Limited Orchard Lea, Winkfield Lane, Windsor, Berks SL4 4RU, United Kingdom EU/1/11/671 11.4.2013 10.4.2013 Rasitrio Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/730 12.4.2013 17.4.2013 Competact Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/06/354 19.4.2013 17.4.2013 Doribax Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/467 19.4.2013 17.4.2013 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405 19.4.2013 17.4.2013 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491 19.4.2013 17.4.2013 Rivastigmine Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/11/693 19.4.2013 17.4.2013 Tyverb Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/440 19.4.2013 17.4.2013 Viagra Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/98/077 19.4.2013 22.4.2013 Emselex Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/04/294 24.4.2013 22.4.2013 Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720 24.4.2013 22.4.2013 INCRELEX Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France EU/1/07/402 24.4.2013 22.4.2013 Jentadueto Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/12/780 24.4.2013 22.4.2013 Mabthera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/067 24.4.2013 22.4.2013 Rasilamlo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/686 24.4.2013 22.4.2013 Tandemact Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/06/366 24.4.2013 22.4.2013 Trajenta Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/11/707 24.4.2013 22.4.2013 Vedrop Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France EU/1/09/533 24.4.2013 29.4.2013 Actos Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/00/150 1.5.2013 29.4.2013 Glubrava Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/07/421 1.5.2013 29.4.2013 Glustin Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/00/151 1.5.2013 29.4.2013 Soliris Alexion Europe SAS 25 boulevard de l'Amiral Bruix, F-75016 Paris, France EU/1/07/393 2.5.2013 29.4.2013 Stocrin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/111 1.5.2013 29.4.2013 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/99/110 1.5.2013 29.4.2013 Viread Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/01/200 1.5.2013





— 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 10.4.2013 Pelzont Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/460 12.4.2013 10.4.2013 Tredaptive Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/459 12.4.2013 10.4.2013 Trevaclyn Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/458 12.4.2013





— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2) ): Accepted

Date of the Décision 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 10.4.2013 ECOPORC SHIGA Genetically modified recombinant Stx2e antigen IDT Biologika GmbH Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland EU/2/13/149 Suspension for injection QI09AB02 12.4.2013 22.4.2013 Meloxidolor Meloxicam Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland EU/2/13/148 Solution for injection QM01AC06 24.4.2013





— 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 10.4.2013 Equilis Prequenza Te Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/05/057 12.4.2013

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.

(2) OJ L 136, 30.4.2004, p. 1.