Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2014 to 31 March 2014 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2014-04-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014123EN.01000101.xml










25.4.2014   


EN


Official Journal of the European Union


C 123/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2014 to 31 March 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 123/01
—   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




5.3.2014


Sirturo


bedaquiline


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


EU/1/13/901


Tablet


J04A


7.3.2014




21.3.2014


Cometriq


cabozantinib


TMC Pharma Services Ltd.
Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom


EU/1/13/890


Capsule, hard


Pending


26.3.2014




21.3.2014


Eperzan


albiglutide


GlaxoSmithKline Trading Services Limited
6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland


EU/1/13/908


Powder and solvent for solution for injection


A10BX13


26.3.2014




21.3.2014


Latuda


lurasidone


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


EU/1/14/913


Film-coated tablet


N05AE05


27.3.2014




27.3.2014


Adempas


riociguat


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/13/907


Film-coated tablet


C02KX05


31.3.2014




27.3.2014


Bemfola


follitropin alfa


FINOX Biotech AG
Gärten 71 FL-9496 Balzers Liechtenstein


EU/1/13/909


Solution for injection in pre-filled pen


G03GA05


31.3.2014




27.3.2014


Zoledronic acid Teva Generics


Zoledronic Acid


Teva Generics B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland


EU/1/14/912


Solution for infusion


M05BA08


1.4.2014




—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected










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




21.3.2014


Winfuran


Toray International U.K. Limited
Verulam Gardens, 70 Gray’s Inn Road, London, WC1X 8NH, United Kingdom


—


25.3.2014




—   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




3.3.2014


Opatanol


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


EU/1/02/217


5.3.2014




3.3.2014


Peyona


Chiesi Farmaceutici S.P.A.
Via Palermo 26/A, 43122 Parma, Italia


EU/1/09/528


5.3.2014




3.3.2014


Sildenafil Actavis


Actavis Group PTC ehf.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland


EU/1/09/595


5.3.2014




5.3.2014


Azopt


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


EU/1/00/129


10.3.2014




5.3.2014


Emadine


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


EU/1/98/095


10.3.2014




5.3.2014


Forxiga


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


EU/1/12/795


7.3.2014




5.3.2014


IntronA


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


EU/1/99/127


7.3.2014




5.3.2014


Tasmar


Meda AB
Pipers väg 2A, S-170 09 Solna, Sverige


EU/1/97/044


7.3.2014




10.3.2014


Osigraft


Olympus Biotech International Limited
Block 2, International Science Centre, National Technology Park, Castletroy, Limerick, Ireland


EU/1/01/179


12.3.2014




10.3.2014


Pedea


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France


EU/1/04/284


12.3.2014




10.3.2014


Ruconest


Pharming Group N.V.
Darwinweg 24, NL-2333 CR Leiden, Nederland


EU/1/10/641


12.3.2014




12.3.2014


Qutenza


Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, Nederland


EU/1/09/524


14.3.2014




12.3.2014


Tyverb


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


EU/1/07/440


14.3.2014




12.3.2014


Vibativ


Clinigen Healthcare Limited
Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom


EU/1/11/705


14.3.2014




14.3.2014


Cialis


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


EU/1/02/237


18.3.2014




14.3.2014


Pandemrix


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


EU/1/08/452


18.3.2014




14.3.2014


Zevalin


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


EU/1/03/264


18.3.2014




21.3.2014


Abseamed


Medice Arzneimittel Pütter GmbH & Co KG
Kuhloweg 37, D-58638 Iserlohn, Deutschland


EU/1/07/412


26.3.2014




21.3.2014


Binocrit


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/07/410


26.3.2014




21.3.2014


Ceplene


Meda AB
Box 906, SE-170 09 Solna, Sverige


EU/1/08/477


26.3.2014




21.3.2014


Clopidogrel Acino


Acino AG
Am Windfeld 35, 83714 Miesbach, Deutschland


EU/1/09/532


26.3.2014




21.3.2014


Dificlir


Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, Nederland


EU/1/11/733


26.3.2014




21.3.2014


DuoTrav


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


EU/1/06/338


25.3.2014




21.3.2014


ellaOne


Laboratoire HRA Pharma
15 rue Béranger, F-75003 Paris, France


EU/1/09/522


26.3.2014




21.3.2014


Elonva


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


EU/1/09/609


25.3.2014




21.3.2014


Entacapone Teva


Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland


EU/1/10/665


25.3.2014




21.3.2014


Epoetin alfa Hexal


Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, Deutschland


EU/1/07/411


26.3.2014




21.3.2014


Mabthera


Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/98/067


26.3.2014




21.3.2014


Nexium Control


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


EU/1/13/860


25.3.2014




21.3.2014


Renvela


Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland


EU/1/09/521


26.3.2014




21.3.2014


Replagal


Shire Human Genetic Therapies AB
Svärdvägen 11D, SE-182 33 Danderyd, Sverige


EU/1/01/189


26.3.2014




21.3.2014


Soliris


Alexion Europe SAS
25 boulevard de l'Amiral Bruix, F-75016 Paris, France


EU/1/07/393


28.3.2014




21.3.2014


TachoSil


Takeda Austria GmbH
St.-Peter-Strasse 25, A-4020 Linz, Österreich


EU/1/04/277


25.3.2014




21.3.2014


Temozolomide SUN


Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland


EU/1/11/697


25.3.2014




21.3.2014


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


26.3.2014




21.3.2014


Victrelis


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


EU/1/11/704


25.3.2014




21.3.2014


XALKORI


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


EU/1/12/793


25.3.2014




21.3.2014


Ziagen


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


EU/1/99/112


26.3.2014




27.3.2014


Altargo


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


EU/1/07/390


31.3.2014




27.3.2014


Gardasil


Sanofi Pasteur MSD, SNC
8 rue Jonas Salk, F-69007 Lyon, France


EU/1/06/357


31.3.2014




27.3.2014


Silgard


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


EU/1/06/358


31.3.2014




31.3.2014


Temomedac


medac Gesellschaft für klinische Spezialpräparate mbH
Fehlandtstraße 3, D-20354 Hamburg, Deutschland


EU/1/09/605


2.4.2014




—   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 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




12.3.2014


Equisolon


Prednisolone


Le Vet B.V.
Wilgenweg 7, NL-3421 TV Oudewater, Nederland


EU/2/14/161


Oral powder


QH02AB06


14.3.2014




12.3.2014


Fungitraxx


Itraconazole


Avimedical B.V.
Abbinkdijk 1, 7255 LX Hengelo (Gld), Nederland


EU/2/13/160


Oral solution


QJ02AC02


17.3.2014




—   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




12.3.2014


BTVPUR AlSap 8


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


EU/2/09/094


14.3.2014




12.3.2014


Loxicom


Norbrook Laboratories Ltd
Station Works, Newry, Co. Down, BT35 6JP, United Kindgom


EU/2/08/090


14.3.2014




12.3.2014


RevitaCAM


Abbott Laboratories Ltd
Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom


EU/2/12/138


14.3.2014




14.3.2014


Bovilis BTV8


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


EU/2/10/106


18.3.2014




14.3.2014


Panacur AquaSol


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


EU/2/11/135


18.3.2014




31.3.2014


Meloxidyl


CEVA SANTE ANIMALE
10 avenue de la Ballastière, F-33500 Libourne, France


EU/2/06/070


2.4.2014




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.

(2)  OJ L 136, 30.4.04, p. 1.