Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2014 to 31 January 2014 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2014-02-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014059EN.01000101.xml










28.2.2014   


EN


Official Journal of the European Union


C 59/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2014 to 31 January 2014
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2014/C 59/01)
—   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




08.01.2014


Diacomit


Stiripentol







Biocodex




7 avenue Gallieni, F-94250 Gentilly, France






EU/1/06/367


Capsule, hard
Powder for oral suspension


N03AX17


10.01.2014




08.01.2014


Levetiracetam Hospira


levetiracetam







Hospira UK Limited




Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom






EU/1/13/889


Concentrate for solution for infusion


N03AX14


10.01.2014




16.01.2014


Sovaldi


sofosbuvir







Gilead Sciences International Limited




Cambridge CB21 6GT, United Kingdom






EU/1/13/894


Film-coated tablet


Pending


17.01.2014




16.01.2014


Tivicay


dolutegravir







ViiV Healthcare UK Limited




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






EU/1/13/892


Film-coated tablet


J05AX12


21.01.2014




16.01.2014


Xigduo


dapagliflozin/metformin







Bristol-Myers Squibb/AstraZeneca EEIG




Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom






EU/1/13/900


Film-coated tablet


A10BD15


21.01.2014




16.01.2014


Zoledronic acid Accord


zoledronic acid







Accord Healthcare Limited




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






EU/1/13/834


Concentrate for solution for infusion


M05BA08


21.01.2014




30.01.2014


Tecfidera


Dimethyl fumarate







Biogen Idec Limited




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






EU/1/13/837


Gastro-resistant capsule, hard


N07XX09


03.02.2014







—   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




08.01.2014


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


10.01.2014




08.01.2014


Ibandronic acid Accord







Accord Healthcare Limited




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






EU/1/12/798


10.01.2014




08.01.2014


Intelence







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/08/468


10.01.2014




08.01.2014


Pramipexole Accord







Accord Healthcare Limited




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






EU/1/11/728


10.01.2014




09.01.2014


Tractocile







Ferring Pharmaceuticals A/S




Kay Fiskers Plads 11, DK-2300 København S, Danmark






EU/1/99/124


10.01.2014




10.01.2014


NovoRapid







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/99/119


14.01.2014




10.01.2014


VELCADE







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/04/274


14.01.2014




10.01.2014


Zeffix







Glaxo Group Ltd




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






EU/1/99/114


14.01.2014




16.01.2014


Adenuric







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg






EU/1/08/447


21.01.2014




16.01.2014


Arzerra







Glaxo Group Ltd




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






EU/1/10/625


21.01.2014




16.01.2014


Dacogen







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/12/792


21.01.2014




16.01.2014


Evra







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/02/223


21.01.2014




16.01.2014


Firdapse







BioMarin Europe Ltd




164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom






EU/1/09/601


21.01.2014




16.01.2014


INOmax







Linde Healthcare AB




SE-181 81 Lidingö, Sverige






EU/1/01/194


21.01.2014




16.01.2014


IOA







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/11/689


21.01.2014




16.01.2014


Nimvastid







Krka, d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/525


21.01.2014




16.01.2014


Rapiscan







Rapidscan Pharma Solutions EU Ltd.




Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom






EU/1/10/643


21.01.2014




16.01.2014


Ribavirin Teva







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/09/509


23.01.2014




16.01.2014


Ribavirin Teva Pharma BV







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/09/527


22.01.2014




16.01.2014


Zoely







Theramex S.r.l.




Via Messina 38, 20154 Milano, Italia






EU/1/11/690


23.01.2014




16.01.2014


Zytiga







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/11/714


21.01.2014




17.01.2014


Ameluz







Biofrontera Bioscience GmbH




Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland






EU/1/11/740


21.01.2014




17.01.2014


Prialt







Eisai Limited




European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom






EU/1/04/302


21.01.2014




22.01.2014


Clopidogrel DURA







Mylan dura GmbH




Wittichstraße 6, D-64295 Darmstadt, Deutschland






EU/1/09/560


24.01.2014




22.01.2014


Insulatard







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/233


24.01.2014




22.01.2014


Kaletra







AbbVie Ltd




Maidenhead, SL6 4XE, United Kingdom






EU/1/01/172


24.01.2014




22.01.2014


Leflunomide ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, D-89079 Ulm, Deutschland






EU/1/10/654


24.01.2014




22.01.2014


Temozolomide Sandoz







Sandoz Pharmaceuticals GmbH




Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland






EU/1/10/617


24.01.2014




22.01.2014


Victrelis







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/11/704


24.01.2014




22.01.2014


Zebinix







BIAL — Portela & Ca, SA




A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal






EU/1/09/514


24.01.2014




24.01.2014


Jentadueto







Boehringer Ingelheim International GmbH




Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/12/780


28.01.2014




29.01.2014


Levemir







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/04/278


31.01.2014




29.01.2014


Levetiracetam Accord







Accord Healthcare Limited




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






EU/1/11/712


31.01.2014




29.01.2014


Rienso







Takeda Pharma A/S




PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/12/774


31.01.2014




29.01.2014


RotaTeq







Sanofi Pasteur MSD, SNC




8 rue Jonas Salk, F-69007 Lyon, France






EU/1/06/348


31.01.2014




29.01.2014


Wilzin







Orphan Europe S.A.R.L.




Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France






EU/1/04/286


31.01.2014




29.01.2014


XALKORI







Pfizer Limited




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






EU/1/12/793


31.01.2014




31.01.2014


Crixivan







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/96/024


04.02.2014




31.01.2014


Docetaxel Winthrop







Aventis Pharma S.A.




20 avenue Raymond Aron, F-92165 Antony CEDEX, France






EU/1/07/384


04.02.2014




31.01.2014


Nexavar







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/06/342


04.02.2014




31.01.2014


Sildenafil Teva







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/09/584


05.02.2014




31.01.2014


Travatan







Alcon Laboratories (UK) Ltd.




Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom






EU/1/01/199


04.02.2014




31.01.2014


Zoledronic acid Hospira







Hospira UK Limited




Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom






EU/1/12/800


04.02.2014







—   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




16.01.2014


BLUEVAC BTV8







CZ Veterinaria, S.A.




La Relva s/n, P.O. Box 16, E-36400 Porriño, España






EU/2/11/122


21.01.2014




16.01.2014


Contacera







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/12/144


21.01.2014




24.01.2014


Proteq West Nile







Merial




29 avenue Tony Garnier, F-69007 Lyon, France






EU/2/11/129


28.01.2014




29.01.2014


Suvaxyn PCV







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/09/099


31.01.2014




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, 30.4.04, p. 1.