Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2015 to 31 December 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-01-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, withdrawal from the market








C_2016035EN.01000101.xml










29.1.2016   


EN


Official Journal of the European Union


C 35/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2015 to 31 December 2015
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 035/01)
—   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




2.12.2015


Ciambra


pemetrexed


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


EU/1/15/1055


Powder for concentrate for solution for infusion


L01BA04


4.12.2015




2.12.2015


Nucala


mepolizumab


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


EU/1/15/1043


Powder for solution for injection


Pending


7.12.2015




16.12.2015


Imlygic


talimogene laherparepvec


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


EU/1/15/1064


Solution for injection


Pending


18.12.2015




—   Issuing of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




21.12.2015


Heparesc


Cytonet GmbH & Co. KG
Albert-Ludwig-Grimm Straße 20, D-69469 Weinheim, Deutschland


—


23.12.2015




—   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




2.12.2015


Tadalafil Mylan


Generics [UK] Limited
Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom


EU/1/14/961


4.12.2015




2.12.2015


Twinrix Adult


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


EU/1/96/020


4.12.2015




2.12.2015


Twinrix Paediatric


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


EU/1/97/029


4.12.2015




2.12.2015


Zyclara


Meda AB
Pipers väg 2A, SE-170 73 Solna, Sverige


EU/1/12/783


4.12.2015




9.12.2015


Abasaglar


Eli Lilly Regional Operations GmbH.
Kölblgasse 8-10, 1030 Wien, Österreich


EU/1/14/944


11.12.2015




9.12.2015


Voriconazole Accord


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


EU/1/13/835


11.12.2015




10.12.2015


Accofil


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


EU/1/14/946


14.12.2015




10.12.2015


Amyvid


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


EU/1/12/805


14.12.2015




10.12.2015


Cervarix


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


EU/1/07/419


14.12.2015




10.12.2015


Efient


DAIICHI SANKYO EUROPE GmbH
Zielstattstrasse 48, D-81379 München, Deutschland


EU/1/08/503


14.12.2015




10.12.2015


Gardasil


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


EU/1/06/357


14.12.2015




10.12.2015


Holoclar


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


EU/1/14/987


14.12.2015




10.12.2015


Ifirmasta


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


EU/1/08/480


14.12.2015




10.12.2015


Remsima


Celltrion Healthcare Hungary Kft.
Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország


EU/1/13/853


14.12.2015




10.12.2015


Silgard


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


EU/1/06/358


14.12.2015




10.12.2015


Starlix


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


EU/1/01/174


14.12.2015




10.12.2015


Synagis


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/99/117


14.12.2015




10.12.2015


Vipidia


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


EU/1/13/844


14.12.2015




10.12.2015


Votubia


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


EU/1/11/710


14.12.2015




10.12.2015


Zoledronic acid Actavis


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


EU/1/12/759


14.12.2015




14.12.2015


Atripla


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


EU/1/07/430


16.12.2015




14.12.2015


Envarsus


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


EU/1/14/935


16.12.2015




14.12.2015


Incruse


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


EU/1/14/922


16.12.2015




14.12.2015


Jardiance


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


EU/1/14/930


16.12.2015




14.12.2015


Pandemrix


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


EU/1/08/452


16.12.2015




14.12.2015


Yervoy


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


EU/1/11/698


16.12.2015




16.12.2015


Aldurazyme


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


EU/1/03/253


18.12.2015




16.12.2015


Angiox


The Medicines Company UK Ltd
115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom


EU/1/04/289


18.12.2015




16.12.2015


AUBAGIO


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


EU/1/13/838


18.12.2015




16.12.2015


BYDUREON


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/696


18.12.2015




16.12.2015


Byetta


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/06/362


18.12.2015




16.12.2015


Caprelsa


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/749


18.12.2015




16.12.2015


Cholestagel


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


EU/1/03/268


18.12.2015




16.12.2015


Cimzia


UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België


EU/1/09/544


18.12.2015




16.12.2015


Emend


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


EU/1/03/262


18.12.2015




16.12.2015


Eucreas


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


EU/1/07/425


18.12.2015




16.12.2015


Fuzeon


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


EU/1/03/252


18.12.2015




16.12.2015


Galvus


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


EU/1/07/414


18.12.2015




16.12.2015


Icandra


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


EU/1/08/484


18.12.2015




16.12.2015


Invokana


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


EU/1/13/884


18.12.2015




16.12.2015


Jalra


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


EU/1/08/485


18.12.2015




16.12.2015


Kentera


Nicobrand Limited
189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP, United Kindom


EU/1/03/270


21.12.2015




16.12.2015


Lyrica


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


EU/1/04/279


18.12.2015




16.12.2015


Nimenrix


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


EU/1/12/767


18.12.2015




16.12.2015


ProQuad


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


EU/1/05/323


18.12.2015




16.12.2015


Protopic


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


EU/1/02/201


18.12.2015




16.12.2015


Stivarga


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/13/858


18.12.2015




16.12.2015


Tecfidera


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


EU/1/13/837


22.12.2015




16.12.2015


Vfend


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


EU/1/02/212


18.12.2015




16.12.2015


Vokanamet


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


EU/1/14/918


18.12.2015




16.12.2015


Xeplion


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


EU/1/11/672


18.12.2015




16.12.2015


Xiliarx


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


EU/1/08/486


18.12.2015




16.12.2015


Zomarist


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


EU/1/08/483


18.12.2015




16.12.2015


Zutectra


Biotest Pharma GmbH
Landsteinerstrasse 5, D-63303 Dreieich, Deutschland


EU/1/09/600


18.12.2015




18.12.2015


Harvoni


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/14/958


22.12.2015




18.12.2015


Zostavax


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


EU/1/06/341


22.12.2015




—   Withdrawal of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




16.12.2015


Osigraft


Olympus Biotech International Limited
40 Upper Mount Street, Dublin 2, Ireland


EU/1/01/179


21.12.2015




—   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




9.12.2015


Imrestor


pegbovigrastim


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


EU/2/15/193


Solution for injection


QL03AA90


11.12.2015




9.12.2015


Velactis


Cabergoline


Ceva Santé Animale
10 av. de La Ballastière, 33500 Libourne, France


EU/2/15/192


Solution for injection


QG02CB03


11.12.2015




—   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




2.12.2015


Easotic


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


EU/2/08/085


4.12.2015




2.12.2015


Inflacam


Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland


EU/2/11/134


4.12.2015




2.12.2015


Purevax Rabies


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


EU/2/10/117


4.12.2015




18.12.2015


Equip WNV


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


EU/2/08/086


21.12.2015




18.12.2015


Novem


Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland


EU/2/04/042


22.12.2015




18.12.2015


Purevax RC


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


EU/2/04/051


22.12.2015




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.