Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2015 to 31 May 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2015-06-26
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015211EN.01000101.xml










26.6.2015   


EN


Official Journal of the European Union


C 211/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2015 to 31 May 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 211/01)
—   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




6.5.2015


Zykadia


ceritinib


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


EU/1/15/999


Capsule, hard


L01XE


8.5.2015




27.5.2015


Akynzeo


netupitant/palonosetron


Helsinn Birex Pharmaceuticals Ltd
Damastown, Mulhuddart, Dublin 15, Ireland


EU/1/15/1001


Capsule, hard


A04AA55


29.5.2015




27.5.2015


Jinarc


tolvaptan


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


EU/1/15/1000


Tablet


Pending


29.5.2015




27.5.2015


Synjardy


empagliflozin/metformin


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


EU/1/15/1003


Film-coated tablet


A10BD20


29.5.2015




27.5.2015


Voriconazole Hospira


voriconazole


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


EU/1/15/1004


Powder for solution for infusion


J02AC03


29.5.2015




28.5.2015


Lenvima


lenvatinib


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


EU/1/15/1002


Capsule, hard


L01XE29


1.6.2015




—   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




5.5.2015


Copalia


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


EU/1/06/372


7.5.2015




5.5.2015


Copalia HCT


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


EU/1/09/575


7.5.2015




5.5.2015


Dafiro


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


EU/1/06/371


7.5.2015




5.5.2015


Dafiro HCT


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


EU/1/09/574


7.5.2015




5.5.2015


Erivedge


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


EU/1/13/848


8.5.2015




5.5.2015


Exforge


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


EU/1/06/370


7.5.2015




5.5.2015


Exforge HCT


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


EU/1/09/569


7.5.2015




5.5.2015


Imprida


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


EU/1/06/373


7.5.2015




5.5.2015


INCRELEX


Ipsen Pharma
65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France


EU/1/07/402


7.5.2015




5.5.2015


Irbesartan/Hydrochlorothiazide Teva


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


EU/1/09/583


8.5.2015




5.5.2015


Orfadin


Swedish Orphan Biovitrum International AB
SE-112 76 Stockholm, Sverige


EU/1/04/303


8.5.2015




5.5.2015


Sycrest


Organon N.V.
Kloosterstraat 6, NL-5349 AB Oss, Nederland


EU/1/10/640


7.5.2015




5.5.2015


Tamiflu


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


EU/1/02/222


8.5.2015




5.5.2015


Telzir


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


EU/1/04/282


7.5.2015




5.5.2015


Tyverb


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


EU/1/07/440


7.5.2015




5.5.2015


Voncento


CSL Behring GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland


EU/1/13/857


7.5.2015




5.5.2015


Votrient


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


EU/1/10/628


7.5.2015




5.5.2015


Zoledronic acid Teva Pharma


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


EU/1/12/772


7.5.2015




5.5.2015


Zypadhera


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


EU/1/08/479


7.5.2015




6.5.2015


Arzerra


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


EU/1/10/625


8.5.2015




6.5.2015


Celsentri


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


EU/1/07/418


8.5.2015




6.5.2015


Celvapan


Baxter AG
Industriestraße 67, A-1221 Wien, Österreich


EU/1/08/506


8.5.2015




6.5.2015


Clopidogrel Krka


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


EU/1/09/556


8.5.2015




6.5.2015


Imatinib Teva


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


EU/1/12/808


8.5.2015




6.5.2015


Optaflu


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


EU/1/07/394


8.5.2015




6.5.2015


Revolade


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


EU/1/10/612


8.5.2015




6.5.2015


Tafinlar


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


EU/1/13/865


8.5.2015




13.5.2015


Cayston


Gilead Sciences International Limited
Granta Park, Abington, Cambridge CB21 6GT, United Kingdom


EU/1/09/543


19.5.2015




13.5.2015


Efficib


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


EU/1/08/457


19.5.2015




13.5.2015


Granupas


Lucane Pharma
172 rue de Charonne, 75011 Paris, France


EU/1/13/896


19.5.2015




13.5.2015


Janumet


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


EU/1/08/455


19.5.2015




13.5.2015


Leflunomide ratiopharm


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


EU/1/10/654


19.5.2015




13.5.2015


Luminity


Lantheus MI UK Limited
Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom


EU/1/06/361


19.5.2015




13.5.2015


Memantine Merz


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


EU/1/12/799


19.5.2015




13.5.2015


Ovitrelle


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


EU/1/00/165


19.5.2015




13.5.2015


Trizivir


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


EU/1/00/156


19.5.2015




13.5.2015


Velmetia


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


EU/1/08/456


19.5.2015




13.5.2015


Vyndaqel


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


EU/1/11/717


19.5.2015




27.5.2015


Aflunov


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


EU/1/10/658


29.5.2015




27.5.2015


Ariclaim


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


EU/1/04/283


29.5.2015




27.5.2015


Brinavess


Cardiome UK Limited
Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom


EU/1/10/645


29.5.2015




27.5.2015


Clopidogrel TAD


TAD Pharma GmbH
Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland


EU/1/09/555


29.5.2015




27.5.2015


Cometriq


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


EU/1/13/890


29.5.2015




27.5.2015


Cymbalta


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


EU/1/04/296


29.5.2015




27.5.2015


Erivedge


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


EU/1/13/848


29.5.2015




27.5.2015


Esmya


Gedeon Richter Plc.
Gyömrői út 19-21., H-1103 Budapest, Magyarország


EU/1/12/750


29.5.2015




27.5.2015


Foclivia


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


EU/1/09/577


29.5.2015




27.5.2015


Gardasil


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


EU/1/06/357


29.5.2015




27.5.2015


Imnovid


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


EU/1/13/850


29.5.2015




27.5.2015


INCRELEX


Ipsen Pharma
65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France


EU/1/07/402


29.5.2015




27.5.2015


Jentadueto


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


EU/1/12/780


29.5.2015




27.5.2015


Levemir


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


EU/1/04/278


29.5.2015




27.5.2015


Levetiracetam Accord


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


EU/1/11/712


29.5.2015




27.5.2015


Myclausen


Herbert J. Passauer GmbH & Co. KG
Stubenrauchstrasse 33, D-14167 Berlin, Deutschland


EU/1/10/647


29.5.2015




27.5.2015


Nexium Control


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


EU/1/13/860


29.5.2015




27.5.2015


Nivestim


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


EU/1/10/631


29.5.2015




27.5.2015


Prepandrix


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


EU/1/08/453


29.5.2015




27.5.2015


Raloxifene Teva


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


EU/1/10/627


29.6.2015




27.5.2015


Relistor


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


EU/1/08/463


29.5.2015




27.5.2015


Resolor


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


EU/1/09/581


29.5.2015




27.5.2015


Selincro


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


EU/1/12/815


29.5.2015




27.5.2015


Silgard


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


EU/1/06/358


29.5.2015




27.5.2015


Sonata


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


EU/1/99/102


29.5.2015




27.5.2015


Sovaldi


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/894


29.5.2015




27.5.2015


Targretin


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


EU/1/01/178


29.5.2015




27.5.2015


Temodal


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


EU/1/98/096


29.5.2015




27.5.2015


Temozolomide Accord


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


EU/1/10/615


29.5.2015




27.5.2015


Thalidomide Celgene


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


EU/1/08/443


29.5.2015




27.5.2015


Tolucombi


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


EU/1/13/821


29.5.2015




27.5.2015


Volibris


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


EU/1/08/451


29.5.2015




27.5.2015


Xeristar


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


EU/1/04/297


29.5.2015




27.5.2015


Xtandi


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


EU/1/13/846


29.5.2015




27.5.2015


Yentreve


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


EU/1/04/280


29.5.2015




27.5.2015


Yondelis


Pharma Mar S.A.
Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España


EU/1/07/417


29.5.2015




28.5.2015


Aclasta


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


EU/1/05/308


1.6.2015




28.5.2015


alli


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


EU/1/07/401


1.6.2015




28.5.2015


Dificlir


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


EU/1/11/733


1.6.2015




28.5.2015


Invega


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


EU/1/07/395


1.6.2015




28.5.2015


Januvia


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


EU/1/07/383


1.6.2015




28.5.2015


Lonquex


UAB ‘Sicor Biotech’
Molėtų pl. 5, LT-08409 Vilnius, Lietuva


EU/1/13/856


1.6.2015




28.5.2015


Ristaben


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


EU/1/10/621


1.6.2015




28.5.2015


Topotecan Hospira


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


EU/1/10/633


1.6.2015




28.5.2015


Tygacil


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


EU/1/06/336


1.6.2015




—   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




5.5.2015


Clopidogrel DURA


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


EU/1/09/560


7.5.2015




6.5.2015


Provenge


Dendreon UK Limited
41 Chalton Street, London NW1 1JD, United Kingdom


EU/1/13/867


8.5.2015




—   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




5.5.2015


MS-H vaccine


Pharmsure International Ltd
Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom


EU/2/11/126


7.5.2015




5.5.2015


Purevax RCP


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


EU/2/04/052


7.5.2015




13.5.2015


Nobilis IB 4-91


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


EU/2/98/006


19.5.2015




13.5.2015


Rheumocam


Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland


EU/2/07/078


19.5.2015




27.5.2015


Meloxivet


Eli Lilly and Company Limited
Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom


EU/2/07/077


29.5.2015




27.5.2015


Purevax FeLV


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


EU/2/00/019


29.5.2015




27.5.2015


Purevax RCPCh


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


EU/2/04/050


29.5.2015




27.5.2015


Suprelorin


VIRBAC S.A.
1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France


EU/2/07/072


29.5.2015




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.