Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2016 to 31 January 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-02-26
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2016076EN.01000101.xml










26.2.2016   


EN


Official Journal of the European Union


C 76/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2016 to 31 January 2016
(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 076/01)
—   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




11.1.2016


Eptifibatide Accord


eptifibatide


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


EU/1/15/1065


Solution for infusion
Solution for injection


B01AC16


13.1.2016




14.1.2016


Benepali


etanercept


Samsung Bioepis UK Limited
3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom


EU/1/15/1074


Solution for injection


L04AB01


18.1.2016




14.1.2016


Briviact


brivaracetam


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


EU/1/15/1073


Film-coated tablet
Oral solution
Solution for injection or infusion


N03AX23


18.1.2016




14.1.2016


Episalvan


birch bark extract


Birken AG
Streiflingsweg 11, D-75223 Niefern-Öschelbronn, Deutschland


EU/1/15/1069


Gel


Pending


18.1.2016




14.1.2016


Lopinavir/Ritonavir Mylan


lopinavir/ritonavir


Mylan S.A.S
117 allée des Parcs, F-69800 Saint Priest, France


EU/1/15/1067


Film-coated tablet


J05AR10


18.1.2016




14.1.2016


Oncaspar


pegaspargase


Baxalta Innovations GmbH
Industriestrasse 67, A-1221 Vienna, Österreich


EU/1/15/1070


Powder and solvent for solution for injection/infusion


L01XX24


18.1.2016




14.1.2016


Spectrila


asparaginase


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


EU/1/15/1072


Powder for concentrate for solution for infusion


L01XX02


18.1.2016




18.1.2016


Pemetrexed Accord


pemetrexed


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


EU/1/15/1071


Powder for concentrate for solution for infusion


L01BA04


20.1.2016




18.1.2016


Pemetrexed Actavis


pemetrexed


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


EU/1/15/1063


Concentrate for solution for infusion


L01BA04


21.1.2016




—   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




7.1.2016


Bosulif


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


EU/1/13/818


11.1.2016




7.1.2016


Kuvan


BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, Ireland


EU/1/08/481


11.1.2016




7.1.2016


Sildenafil Teva


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


EU/1/09/584


11.1.2016




7.1.2016


Sirturo


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


EU/1/13/901


11.1.2016




11.1.2016


Cometriq


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


EU/1/13/890


13.1.2016




11.1.2016


Latuda


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


EU/1/14/913


13.1.2016




11.1.2016


Sivextro


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


EU/1/15/991


13.1.2016




11.1.2016


Yellox


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


EU/1/11/692


13.1.2016




11.1.2016


Zinforo


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/785


13.1.2016




12.1.2016


Atriance


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


EU/1/07/403


14.1.2016




12.1.2016


Cervarix


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


EU/1/07/419


14.1.2016




12.1.2016


Gardasil


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


EU/1/06/357


14.1.2016




12.1.2016


Gardasil 9


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


EU/1/15/1007


14.1.2016




12.1.2016


Silgard


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


EU/1/06/358


14.1.2016




14.1.2016


Bronchitol


Pharmaxis Pharmaceuticals Limited
25 Moorgate, London, EC2R 6AY, United Kingdom.


EU/1/12/760


18.1.2016




14.1.2016


Caprelsa


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/749


18.1.2016




14.1.2016


Eliquis


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


EU/1/11/691


18.1.2016




14.1.2016


Evoltra


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


EU/1/06/334


18.1.2016




14.1.2016


Glivec


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


EU/1/01/198


18.1.2016




14.1.2016


Leganto


UCB Manufacturing Ireland Ltd
Shannon Industrial Estate, Co, Clare, Ireland


EU/1/11/695


19.1.2016




14.1.2016


Lumigan


Allergan Pharmaceuticals Ireland
Castlebar Road, Westport, County Mayo, Ireland


EU/1/02/205


18.1.2016




14.1.2016


Pravafenix


LABORATOIRES SMB SA
26-28 rue de la Pastorale/26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België


EU/1/11/679


18.1.2016




14.1.2016


Rotarix


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


EU/1/05/330


18.1.2016




14.1.2016


Torisel


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


EU/1/07/424


18.1.2016




14.1.2016


Trobalt


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


EU/1/11/681


18.1.2016




14.1.2016


VELCADE


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


EU/1/04/274


18.1.2016




14.1.2016


Xeloda


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


EU/1/00/163


18.1.2016




18.1.2016


Repso


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


EU/1/11/674


20.1.2016




18.1.2016


Xagrid


Shire Pharmaceutical Contracts Ltd
Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom


EU/1/04/295


20.1.2016




18.1.2016


Xiapex


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


EU/1/11/671


20.1.2016




22.1.2016


Clopidogrel Teva Pharma


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


EU/1/09/561


26.1.2016




22.1.2016


Kadcyla


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


EU/1/13/885


26.1.2016




22.1.2016


Levitra


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/03/248


26.1.2016




22.1.2016


Levodopa/Carbidopa/Entacapone Orion


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/1/11/706


26.1.2016




22.1.2016


Neupro


UCB Manufacturing Ireland Ltd
Shannon Industrial Estate, Co, Clare, Ireland


EU/1/05/331


26.1.2016




22.1.2016


Nplate


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


EU/1/08/497


26.1.2016




22.1.2016


Ofev


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


EU/1/14/979


26.1.2016




22.1.2016


Optaflu


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


EU/1/07/394


26.1.2016




22.1.2016


Topotecan Actavis


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


EU/1/09/536


27.1.2016




22.1.2016


Ulunar Breezhaler


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


EU/1/14/917


26.1.2016




22.1.2016


Viagra


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


EU/1/98/077


26.1.2016




22.1.2016


Vivanza


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/03/249


26.1.2016




25.1.2016


Corlentor


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


EU/1/05/317


27.1.2016




25.1.2016


Cyramza


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


EU/1/14/957


27.1.2016




25.1.2016


Entacapone Orion


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/1/11/708


27.1.2016




25.1.2016


Exviera


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/14/983


27.1.2016




25.1.2016


GILENYA


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


EU/1/11/677


27.1.2016




25.1.2016


NovoRapid


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


EU/1/99/119


27.1.2016




25.1.2016


Procoralan


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


EU/1/05/316


27.1.2016




25.1.2016


SANCUSO


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


EU/1/12/766


27.1.2016




25.1.2016


Sildenafil Actavis


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


EU/1/09/595


27.1.2016




25.1.2016


Sildenafil ratiopharm


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


EU/1/09/603


28.1.2016




25.1.2016


Stalevo


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/1/03/260


27.1.2016




25.1.2016


Tarceva


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


EU/1/05/311


27.1.2016




25.1.2016


Travatan


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


EU/1/01/199


27.1.2016




25.1.2016


VELCADE


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


EU/1/04/274


27.1.2016




25.1.2016


Viekirax


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/14/982


27.1.2016




28.1.2016


Bexsero


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


EU/1/12/812


1.2.2016




28.1.2016


Clopidogrel Acino


Acino AG
Am Windfeld 35, 83714 D-Miesbach, Deutschland


EU/1/09/532


1.2.2016




28.1.2016


Comtess


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/1/98/082


1.2.2016




28.1.2016


Daklinza


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


EU/1/14/939


1.2.2016




28.1.2016


Defitelio


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


EU/1/13/878


1.2.2016




28.1.2016


Nonafact


Sanquin Plasma Products B.V.
Plesmanlaan 125, NL-1066 CX Amsterdam, Nederland


EU/1/01/186


1.2.2016




28.1.2016


Relistor


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


EU/1/08/463


1.2.2016




28.1.2016


Revolade


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


EU/1/10/612


1.2.2016




28.1.2016


Sovaldi


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/894


1.2.2016




28.1.2016


Ultibro Breezhaler


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


EU/1/13/862


1.2.2016




28.1.2016


Voriconazole Hospira


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


EU/1/15/1004


1.2.2016




28.1.2016


Xoterna Breezhaler


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


EU/1/13/863


1.2.2016




—   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




7.1.2016


Activyl


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


EU/2/10/118


11.1.2016




7.1.2016


CaniLeish


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


EU/2/11/121


11.1.2016




7.1.2016


Cimalgex


Vétoquinol SA
Magny-Vernois, F-70200 Lure, France


EU/2/10/119


11.1.2016




7.1.2016


Comfortis


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


EU/2/10/115


11.1.2016




7.1.2016


Melosus


CP-Pharma Handelsgesellschaft mbH
Ostlandring 13, D-31303 Burgdorf, Deutschland


EU/2/10/116


11.1.2016




7.1.2016


Neocolipor


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


EU/2/98/008


11.1.2016




7.1.2016


Veraflox


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/10/107


11.1.2016




7.1.2016


Zulvac 1 + 8 Ovis


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


EU/2/11/120


11.1.2016




14.1.2016


Procox


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/11/123


18.1.2016




22.1.2016


ERYSENG PARVO


Laboratorios Hipra, S.A.
Avda. La Selva, 135, E-17170 Amer (Girona), España


EU/2/14/167


26.1.2016




22.1.2016


Purevax RCPCh FeLV


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


EU/2/04/047


26.1.2016




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.