Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2015 to 30 April 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2015-05-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015176EN.01000401.xml










29.5.2015   


EN


Official Journal of the European Union


C 176/4





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2015 to 30 April 2015
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2015/C 176/02)
—   Issuing of a marketing authorisation (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




13.4.2015


Ristempa


pegfilgrastim


Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland


EU/1/15/996


Solution for injection


L03AA13


15.4.2015




24.4.2015


Arzerra


Ofatumumab


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/10/625


Concentrate for solution for infusion


L01XC10


28.4.2015




—   Modification of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




8.4.2015


Adenuric


Menarini International Operations Luxembourg S.A.
1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg


EU/1/08/447


10.4.2015




8.4.2015


Ammonaps


Swedish Orphan International AB
SE-112 76 Stockholm, Sverige


EU/1/99/120


10.4.2015




8.4.2015


Daxas


Takeda GmbH
Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland


EU/1/10/636


10.4.2015




8.4.2015


Dukoral


Valneva Sweden AB
SE-105 21 Stockholm, Sverige


EU/1/03/263


13.4.2015




8.4.2015


Invokana


Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België


EU/1/13/884


10.4.2015




8.4.2015


ReFacto AF


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/99/103


10.4.2015




8.4.2015


Rivastigmine Sandoz


Sandoz Pharmaceuticals GmbH
Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland


EU/1/09/599


10.4.2015




8.4.2015


Rotarix


GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique


EU/1/05/330


10.4.2015




8.4.2015


Sustiva


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/99/110


10.4.2015




9.4.2015


Capecitabine medac


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6, D-22880 Wedel, Deutschland


EU/1/12/802


13.4.2015




9.4.2015


Clopidogrel Acino


Acino AG
Am Windfeld 35, 83714 Miesbach, Deutschland


EU/1/09/532


13.4.2015




9.4.2015


Clopidogrel DURA


Mylan dura GmbH
Wittichstraße 6, D-64295 Darmstadt, Deutschland


EU/1/09/560


13.4.2015




9.4.2015


Clopidogrel Mylan


Mylan S.A.S
117 allée des Parcs, F-69800 Saint Priest, France


EU/1/09/559


13.4.2015




9.4.2015


Cubicin


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/05/328


14.4.2015




9.4.2015


Eucreas


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/07/425


14.4.2015




9.4.2015


Forsteo


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland


EU/1/03/247


13.4.2015




9.4.2015


Glybera


uniQure biopharma B.V.
Meibergdreef 61, NL-1105 BA Amsterdam, Nederland


EU/1/12/791


13.4.2015




9.4.2015


GONAL-f


Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/95/001


13.4.2015




9.4.2015


Levitra


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/03/248


13.4.2015




9.4.2015


M-M-RVAXPRO


Sanofi Pasteur MSD, SNC
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/06/337


13.4.2015




9.4.2015


Olanzapine Teva


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/07/427


13.4.2015




13.4.2015


Axura


Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland


EU/1/02/218


15.4.2015




13.4.2015


Azopt


Alcon Laboratories (UK) Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom


EU/1/00/129


15.4.2015




13.4.2015


Capecitabine Accord


Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom


EU/1/12/762


15.4.2015




13.4.2015


Clopidogrel ratiopharm GmbH


Archie Samuel s.r.o.
Slunná 16, CZ-61700 Brno, Česká republika


EU/1/09/541


15.4.2015




13.4.2015


Ecansya


Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/12/763


15.4.2015




13.4.2015


Icandra


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/08/484


16.4.2015




13.4.2015


SonoVue


Bracco International B.V.
Strawinskylaan 3051, NL-1077 ZX Amsterdam, Nederland


EU/1/01/177


15.4.2015




13.4.2015


Targretin


Eisai Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom


EU/1/01/178


15.4.2015




13.4.2015


Taxotere


Aventis Pharma S.A.
20 avenue Raymond Aron, F-92165 Antony CEDEX, France


EU/1/95/002


15.4.2015




13.4.2015


Tecfidera


Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom


EU/1/13/837


15.4.2015




13.4.2015


Zomarist


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/08/483


16.4.2015




13.4.2015


Zyllt


Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/09/553


15.4.2015




13.4.2015


Zyprexa


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland


EU/1/96/022


15.4.2015




13.4.2015


Zyprexa Velotab


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland


EU/1/99/125


15.4.2015




15.4.2015


Zevalin


Spectrum Pharmaceuticals B.V.
Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland


EU/1/03/264


17.4.2015




20.4.2015


Combivir


ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom


EU/1/98/058


22.4.2015




20.4.2015


Mekinist


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/14/931


22.4.2015




24.4.2015


Abilify


Otsuka Pharmaceutical Europe Ltd.
Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom


EU/1/04/276


28.4.2015




24.4.2015


ABILIFY MAINTENA


Otsuka Pharmaceutical Europe Ltd.
Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom


EU/1/13/882


28.4.2015




24.4.2015


Atriance


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/07/403


28.4.2015




24.4.2015


Benlysta


Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/11/700


28.4.2015




24.4.2015


Bretaris Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/781


28.4.2015




24.4.2015


Daliresp


Takeda GmbH
Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland


EU/1/11/668


28.4.2015




24.4.2015


Daxas


Takeda GmbH
Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland


EU/1/10/636


28.4.2015




24.4.2015


Deltyba


Otsuka Novel Products GmbH
Erika-Mann-Straße 21, D-80636 München, Deutschland


EU/1/13/875


28.4.2015




24.4.2015


Docetaxel Winthrop


Aventis Pharma S.A.
20 avenue Raymond Aron, F-92165 Antony CEDEX, France


EU/1/07/384


28.4.2015




24.4.2015


Eklira Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/778


28.4.2015




24.4.2015


Fosavance


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/05/310


28.4.2015




24.4.2015


Galvus


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/07/414


28.4.2015




24.4.2015


Hycamtin


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/96/027


28.4.2015




24.4.2015


Imatinib Medac


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6, D-22880 Wedel, Deutschland


EU/1/13/876


28.4.2015




24.4.2015


Jalra


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/08/485


28.4.2015




24.4.2015


JETREA


ThromboGenics NV
Gaston Geenslaan 1, B-3001 Leuven, België


EU/1/13/819


28.4.2015




24.4.2015


Libertek


Takeda GmbH
Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland


EU/1/11/666


28.4.2015




24.4.2015


Luveris


Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/00/155


28.4.2015




24.4.2015


Onglyza


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/09/545


28.4.2015




24.4.2015


Rapiscan


Rapidscan Pharma Solutions EU Ltd
Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom


EU/1/10/643


28.4.2015




24.4.2015


Tivicay


ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom


EU/1/13/892


28.4.2015




24.4.2015


Toujeo


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/00/133


28.4.2015




24.4.2015


Trobalt


Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/11/681


28.4.2015




24.4.2015


Xiapex


Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm, Sverige


EU/1/11/671


28.4.2015




24.4.2015


Xiliarx


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/08/486


28.4.2015




—   Withdrawal of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




13.4.2015


Rienso


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/12/774


15.4.2015




—   Modification of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




9.4.2015


Metacam


Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland


EU/2/97/004


13.4.2015




13.4.2015


BROADLINE


Merial
29 avenue Tony Garnier, F-69007 Lyon, France


EU/2/13/157


15.4.2015




13.4.2015


Draxxin


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/03/041


15.4.2015




13.4.2015


Porcilis Porcoli


Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland


EU/2/96/001


15.4.2015




24.4.2015


Porcilis ColiClos


Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland


EU/2/12/141


28.4.2015




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




30, Churchill Place, Canary Wharf




UK — LONDON E14 5EU






(1)  OJ L 136, 30.4.2004, p. 1.