Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2015 to 30 September 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2015-10-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015361EN.01000101.xml










30.10.2015   


EN


Official Journal of the European Union


C 361/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2015 to 30 September 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 361/01)
—   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




8.9.2015


Ivabradine Anpharm


ivabradine


ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
ul. Annopol 6B, 03-236 Warszawa, Polska


EU/1/15/1041


Film-coated tablet


C01EB17


10.9.2015




8.9.2015


Raxone


idebenone


Santhera Pharmaceuticals (Deutschland) GmbH
Marie-Curie Strasse 8, 79539 Lörrach, Deutschland


EU/1/15/1020


Film-coated tablet


N07


10.9.2015




14.9.2015


Pemetrexed Lilly


pemetrexed


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


EU/1/15/1034


Intravenous use


L01BA04


16.9.2015




17.9.2015


Intuniv


guanfacine


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


EU/1/15/1040


Prolonged-release tablet


C02AC02


21.9.2015




18.9.2015


Pemetrexed Sandoz


pemetrexed


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/15/1037


Powder for concentrate for solution for infusion


L01BA04


23.9.2015




18.9.2015


Zalviso


Sufentanil


Grünenthal GmbH
Zieglerstrasse 6, D-52078, Aachen, Deutschland


EU/1/15/1042


Sublingual tablet


N01AH03


22.9.2015




18.9.2015


Zerbaxa


ceftolozane/tazobactam


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


EU/1/15/1032


Powder for concentrate for solution for infusion


J01DI54


22.9.2015




23.9.2015


Fexeric


ferric citrate coordination complex


Keryx Biopharma UK Ltd
Riverbank House, 2 Swan Lane, London, EC4R 3TT, United Kingdom


EU/1/15/1039


Film-coated tablet


V03AE


28.9.2015




23.9.2015


Praluent


alirocumab


Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France


EU/1/15/1031


Solution for injection


C10


25.9.2015




—   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




8.9.2015


ATryn


GTC Biotherapeutics UK Limited
10 Norwich Street, London EC4A 1BD, United Kingdom


EU/1/06/355


10.9.2015




8.9.2015


Daklinza


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


EU/1/14/939


10.9.2015




8.9.2015


Ebixa


H. Lundbeck A/S
Ottiliavej 9, DK-2500 Valby, Danmark


EU/1/02/219


10.9.2015




8.9.2015


Enbrel


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


EU/1/99/126


10.9.2015




8.9.2015


Esbriet


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


EU/1/11/667


10.9.2015




8.9.2015


Extavia


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


EU/1/08/454


10.9.2015




8.9.2015


Grastofil


Apotex Europe B.V.
Darwinweg 20, NL- 2333 CR Leiden, Nederland


EU/1/13/877


10.9.2015




8.9.2015


Hirobriz Breezhaler


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


EU/1/09/594


10.9.2015




8.9.2015


Plegridy


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


EU/1/14/934


10.9.2015




8.9.2015


Xofigo


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/13/873


10.9.2015




8.9.2015


Xyrem


UCB Pharma Ltd
208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom


EU/1/05/312


10.9.2015




10.9.2015


ADCETRIS


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


EU/1/12/794


14.9.2015




14.9.2015


Betmiga


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


EU/1/12/809


16.9.2015




14.9.2015


Elaprase


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


EU/1/06/365


16.9.2015




14.9.2015


Quinsair


Aptalis Pharma SAS
Route de Bû, F-78550 Houdan, France


EU/1/14/973


16.9.2015




18.9.2015


Evoltra


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


EU/1/06/334


22.9.2015




18.9.2015


Iclusig


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


EU/1/13/839


22.9.2015




18.9.2015


Imvanex


Bavarian Nordic A/S
Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark


EU/1/13/855


22.9.2015




18.9.2015


INOmax


Linde Healthcare AB
SE-181 81 Lidingö, Sverige


EU/1/01/194


22.9.2015




18.9.2015


Metalyse


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


EU/1/00/169


22.9.2015




18.9.2015


Perjeta


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


EU/1/13/813


22.9.2015




18.9.2015


Ruconest


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


EU/1/10/641


22.9.2015




18.9.2015


Sebivo


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


EU/1/07/388


22.9.2015




18.9.2015


Spedra


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


EU/1/13/841


22.9.2015




18.9.2015


TachoSil


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


EU/1/04/277


22.9.2015




18.9.2015


Visudyne


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


EU/1/00/140


22.9.2015




23.9.2015


Ilaris


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


EU/1/09/564


28.10.2015




23.9.2015


Inflectra


Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom


EU/1/13/854


25.9.2015




23.9.2015


Toviaz


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


EU/1/07/386


25.9.2015




23.9.2015


Trajenta


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


EU/1/11/707


25.9.2015




23.9.2015


Viagra


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


EU/1/98/077


28.9.2015




30.9.2015


Arixtra


Aspen Pharma Trading Limited
3016 Lake Drive Citywest Business Campus Dublin 24 Ireland


EU/1/02/206


2.10.2015




30.9.2015


Iasibon


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


EU/1/10/659


2.10.2015




30.9.2015


Sifrol


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


EU/1/97/050


2.10.2015




30.9.2015


Vibativ


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


EU/1/11/705


2.10.2015




—   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




23.9.2015


Biograstim


AbZ-Pharma GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland


EU/1/08/450


25.9.2015




—   Issuing 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


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




8.9.2015


FORTEKOR PLUS


pimobendan/benazepril


Elanco Europe Ltd
Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, United Kingdom


EU/2/15/185


Tablet


QC09BX90


10.9.2015




8.9.2015


Novaquin


meloxicam


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


EU/2/15/186


Oral suspension


QM01AC06


10.9.2015




8.9.2015


Vectormune ND


Cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain


CEVA-Phylaxia Co. Ltd
Budapest, Szállás u. 5, 1107 MAGYARORSZÁG


EU/2/15/188


Suspension and solvent for suspension for injection


QI01AD


10.9.2015




—   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




8.9.2015


BTVPUR AlSap 1


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


EU/2/10/112


10.9.2015




8.9.2015


BTVPUR AlSap 1-8


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


EU/2/10/113


10.9.2015




8.9.2015


Meloxoral


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


EU/2/10/111


10.9.2015




18.9.2015


Onsior


Elanco Europe Ltd
Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, United Kingdom


EU/2/08/089


22.9.2015




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




7, Westferry Circus, Canary Wharf




UK — LONDON E14 4H






(1)  OJ L 136, 30.4.2004, p. 1.