Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2015 to 31 January 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2015-02-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015071EN.01000201.xml










27.2.2015   


EN


Official Journal of the European Union


C 71/2





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2015 to 31 January 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 071/02)
—   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 authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




12.1.2015


Rasagiline ratiopharm


rasagiline


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


EU/1/14/977


Tablet


N04BD02


14.1.2015




15.1.2015


Cosentyx


secukinumab


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


EU/1/14/980


Powder and solution for injection
Solution for injection in a pre-filled syringe
Solution for injection in pre-filled pen


L04AC10


19.1.2015




15.1.2015


Exviera


dasabuvir


AbbVie Ltd
Maidenhead, SL6 4XE, United Kingdom


EU/1/14/983


Film-coated tablet


Pending


19.1.2015




15.1.2015


Ofev


Nintedanib


Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland


EU/1/14/979


Capsule, soft


L01XE31


19.1.2015




15.1.2015


Otezla


apremilast


Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom


EU/1/14/981


Film-coated tablet


L04AA32


16.1.2015




15.1.2015


Senshio


ospemifene


Shionogi Limited
33 Kingsway, London WC2B 6UF, United Kingdom


EU/1/14/978


Film-coated tablet


G03XC05


19.1.2015




15.1.2015


Sevelamer carbonate Zentiva


Sevelamer carbonate


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


EU/1/14/952


Film-coated tablet
Powder for oral suspension


V03AE02


19.1.2015




15.1.2015


Vectibix


panitumumab


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


EU/1/07/423


Concentrate for solution for infusion


L01XC08


19.1.2015




15.1.2015


Viekirax


ombitasvir/paritaprevir/ritonavir


AbbVie Ltd
Maidenhead, SL6 4XE, United Kingdom


EU/1/14/982


Film-coated tablet


Pending


19.1.2015




19.1.2015


Cerdelga


eliglustat


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


EU/1/14/974


Capsule, hard


A16AX10


21.1.2015




19.1.2015


Zontivity


vorapaxar


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


EU/1/14/976


Film-coated tablet


Pending


21.1.2015




—   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




7.1.2015


ellaOne


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


EU/1/09/522


9.1.2015




12.1.2015


Defitelio


Gentium S.p.A.
Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia


EU/1/13/878


14.1.2015




12.1.2015


Emselex


Merus Labs Luxco S.à R.L.
26-28, rue Edward Steichen, L-2540 Luxembourg


EU/1/04/294


14.1.2015




12.1.2015


ProQuad


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


EU/1/05/323


14.1.2015




12.1.2015


Savene


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


EU/1/06/350


14.1.2015




12.1.2015


Temozolomide Hospira


Hospira UK Limited
Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom


EU/1/10/615


14.1.2015




12.1.2015


Tracleer


Actelion Registration Ltd
Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom


EU/1/02/220


14.1.2015




12.1.2015


Zostavax


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


EU/1/06/341


14.1.2015




15.1.2015


Advate


Baxter AG
Industriestraße 67, A-1221 Wien, Österreich


EU/1/03/271


19.1.2015




15.1.2015


Byetta


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/06/362


19.1.2015




15.1.2015


Caprelsa


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/749


19.1.2015




15.1.2015


Cholib


Abbott Healthcare Products Ltd
Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom


EU/1/13/866


19.1.2015




15.1.2015


Corlentor


Les Laboratoires Servier
50 rue Carnot, F-92284 Suresnes CEDEX, France


EU/1/05/317


19.1.2015




15.1.2015


Focetria


Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1, 53100 Siena, Italia


EU/1/07/385


19.1.2015




15.1.2015


Iclusig


ARIAD Pharma Ltd
Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom


EU/1/13/839


19.1.2015




15.1.2015


Incresync


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


EU/1/13/842


19.1.2015




15.1.2015


Latuda


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


EU/1/14/913


19.1.2015




15.1.2015


Matever


Pharmathen S.A.
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα


EU/1/11/711


19.1.2015




15.1.2015


Memantine ratiopharm


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


EU/1/13/836


19.1.2015




15.1.2015


Nivestim


Hospira UK Limited
Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom


EU/1/10/631


19.1.2015




15.1.2015


Opsumit


Actelion Registration Ltd
Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom


EU/1/13/893


17.1.2015




15.1.2015


Picato


Leo Pharma A/S
Industriparken 55, DK-2750 Ballerup, Danmark


EU/1/12/796


19.1.2015




15.1.2015


Procoralan


Les Laboratoires Servier
50 rue Carnot, F-92284 Suresnes CEDEX, France


EU/1/05/316


19.1.2015




15.1.2015


Prolia


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


EU/1/10/618


19.1.2015




15.1.2015


Revolade


GlaxoSmithKline Trading Services Limited
Currabinny, Carrigaline, County Cork, Ireland


EU/1/10/612


19.1.2015




15.1.2015


SANCUSO


ProStrakan Limited
Galabank Business Park, Galashiels TD1 1QH, United Kingdom


EU/1/12/766


19.1.2015




15.1.2015


Simponi


Janssen Biologics B.V.
Einsteinweg 101, NL-2333 CB Leiden, Nederland


EU/1/09/546


19.1.2015




15.1.2015


TOBI Podhaler


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


EU/1/10/652


19.1.2015




15.1.2015


Vipdomet


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


EU/1/13/843


19.1.2015




15.1.2015


Vipidia


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


EU/1/13/844


19.1.2015




15.1.2015


Votrient


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


EU/1/10/628


19.1.2015




15.1.2015


Zoledronic acid medac


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


EU/1/12/779


19.1.2015




19.1.2015


Aclasta


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


EU/1/05/308


21.1.2015




19.1.2015


BYDUREON


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/696


21.1.2015




19.1.2015


Cometriq


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


EU/1/13/890


21.1.2015




19.1.2015


Gliolan


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


EU/1/07/413


21.1.2015




19.1.2015


Optaflu


Novartis Vaccines and Diagnostics GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland


EU/1/07/394


21.1.2015




19.1.2015


Sirturo


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


EU/1/13/901


21.1.2015




22.1.2015


Atripla


Bristol-Myers Squibb and Gilead Sciences Limited
IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland


EU/1/07/430


26.1.2015




22.1.2015


Incivo


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


EU/1/11/720


26.1.2015




22.1.2015


Lyrica


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


EU/1/04/279


26.1.2015




22.1.2015


Spedra


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


EU/1/13/841


26.1.2015




27.1.2015


Evicel


Omrix Biopharmaceuticals N.V.
Leonardo Da Vincilaan 15, B-1831 Diegem, België


EU/1/08/473


29.1.2015




27.1.2015


Levetiracetam Teva


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


EU/1/11/701


30.1.2015




27.1.2015


Myfenax


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


EU/1/07/438


30.1.2015




27.1.2015


Myocet


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


EU/1/00/141


30.1.2015




27.1.2015


Pramipexole Teva


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


EU/1/08/490


30.1.2015




27.1.2015


VPRIV


Shire Pharmaceuticals Ireland Limited
5 River Walk, Citywest Business Campus, Dublin 24, Ireland


EU/1/10/646


29.1.2015




27.1.2015


Yellox


PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c 17000 Praha 7 Czech Republic


EU/1/11/692


29.1.2015




30.1.2015


Clopidogrel Teva


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


EU/1/09/540


3.2.2015




30.1.2015


Pioglitazone Teva


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


EU/1/12/757


3.2.2015




30.1.2015


Pioglitazone Teva Pharma


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


EU/1/12/758


3.2.2015




30.1.2015


Tresiba


Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/12/807


3.2.2015




30.1.2015


Trisenox


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


EU/1/02/204


5.2.2015




30.1.2015


VELCADE


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


EU/1/04/274


3.2.2015




30.1.2015


Xiapex


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


EU/1/11/671


3.2.2015




—   Issuing 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


INN (International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




15.1.2015


NEXGARD SPECTRA


Afoxolaner/milbemycin oxime


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


EU/2/14/177


Chewable tablet


QP54AB51


19.1.2015




—   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




12.1.2015


Coxevac


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


EU/2/10/110


14.1.2015




15.1.2015


BLUEVAC BTV8


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


EU/2/11/122


19.1.2015




30.1.2015


Emdocam


Emdoka bvba
J. Lijsenstraat 16, B-2321 Hoogstraten, België


EU/2/11/128


3.2.2015




—   Withdrawal of a marketing authorisation (Article 38 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




15.1.2015


Slentrol


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


EU/2/07/071


19.1.2015




15.1.2015


TruScient


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


EU/2/11/136


19.1.2015




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.