Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2017 to 31 December 2017 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2018-01-26
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2018030EN.01000101.xml










26.1.2018   


EN


Official Journal of the European Union


C 30/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2017 to 31 December 2017
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2018/C 030/01)
—   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




8.12.2017


Tacforius


tacrolimus


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


EU/1/17/1244


Prolonged release capsule, hard


L04AD02


12.12.2017




18.12.2017


Alecensa


alectinib


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


EU/1/16/1169


Capsule, hard


L01XE36


20.12.2017




—   Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




8.12.2017


Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech


XBiotech Germany GmbH
Lyoner Straße 14, 60528 Frankfurt am Main, Deutschland


—


12.12.2017




18.12.2017


Masipro


AB Science
3 avenue George V, 75008 Paris, France


—


20.12.2017




—   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




1.12.2017


Alecensa


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


EU/1/16/1169


5.12.2017




1.12.2017


Hetlioz


Vanda Pharmaceuticals Limited
25 Old Broad Street, level 21a, London EC2N 1HQ, United Kingdom


EU/1/15/1008


5.12.2017




1.12.2017


Jakavi


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


EU/1/12/773


5.12.2017




1.12.2017


OCALIVA


Intercept Pharma Ltd
2 Pancras Square, London N1C 4AG, United Kingdom


EU/1/16/1139


5.12.2017




1.12.2017


Thymanax


Servier (Ireland) Industries Limited
Gorey Road, Arklow, Co. Wicklow, Ireland


EU/1/08/498


5.12.2017




8.12.2017


Ceplene


Noventia Pharma Srl
Via Carlo Pisacane 31, 47121 Forli, Italia


EU/1/08/477


12.12.2017




8.12.2017


Dexdor


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/1/11/718


12.12.2017




8.12.2017


Esbriet


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


EU/1/11/667


13.12.2017




8.12.2017


Esmya


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


EU/1/12/750


12.12.2017




8.12.2017


Genvoya


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/15/1061


12.12.2017




8.12.2017


GILENYA


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


EU/1/11/677


13.12.2017




8.12.2017


Humira


AbbVie Ltd
Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom


EU/1/03/256


12.12.2017




8.12.2017


Januvia


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


EU/1/07/383


13.12.2017




8.12.2017


JETREA


ThromboGenics NV
Gaston Geenslaan 1, 3001 Leuven, België


EU/1/13/819


12.12.2017




8.12.2017


KEYTRUDA


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


EU/1/15/1024


13.12.2017




8.12.2017


Leganto


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


EU/1/11/695


12.12.2017




8.12.2017


Lemtrada


Genzyme Therapeutics Ltd
4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom


EU/1/13/869


13.12.2017




8.12.2017


Moventig


Kyowa Kirin Limited
Galabank Business Park, Galashiels, TD1 1QH, United Kingdom


EU/1/14/962


12.12.2017




8.12.2017


Mysimba


Orexigen Therapeutics Ireland Limited
2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland


EU/1/14/988


12.12.2017




8.12.2017


Oncaspar


Baxalta Innovations GmbH
Industriestraße 67, 1221 Wien, Österreich


EU/1/15/1070


14.12.2017




8.12.2017


Perjeta


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


EU/1/13/813


13.12.2017




8.12.2017


Selincro


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


EU/1/12/815


12.12.2017




8.12.2017


Taltz


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/15/1085


12.12.2017




8.12.2017


Tesavel


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


EU/1/07/435


13.12.2017




8.12.2017


Truberzi


Allergan Pharmaceuticals International Limited
Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland


EU/1/16/1126


12.12.2017




8.12.2017


Xiapex


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


EU/1/11/671


12.12.2017




8.12.2017


Zevalin


Spectrum Pharmaceuticals B.V.
Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland


EU/1/03/264


12.12.2017




11.12.2017


EVOTAZ


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


EU/1/15/1025


13.12.2017




11.12.2017


Holoclar


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


EU/1/14/987


13.12.2017




11.12.2017


Neupro


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


EU/1/05/331


13.12.2017




11.12.2017


Odefsey


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/16/1112


13.12.2017




11.12.2017


Rapiscan


GE Healthcare AS
Nycoveien 1, 0485, Oslo, Norge


EU/1/10/643


15.12.2017




11.12.2017


Reyataz


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


EU/1/03/267


13.12.2017




11.12.2017


Strensiq


Alexion Europe SAS
1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France


EU/1/15/1015


13.12.2017




11.12.2017


Tarceva


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


EU/1/05/311


13.12.2017




11.12.2017


Zyclara


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


EU/1/12/783


13.12.2017




15.12.2017


Actelsar HCT


Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland


EU/1/13/817


19.12.2017




15.12.2017


ADCETRIS


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


EU/1/12/794


19.12.2017




15.12.2017


Efficib


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


EU/1/08/457


19.12.2017




15.12.2017


Eviplera


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/11/737


19.12.2017




15.12.2017


Janumet


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


EU/1/08/455


19.12.2017




15.12.2017


M-M-RVAXPRO


MSD VACCINS
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/06/337


19.12.2017




15.12.2017


Procysbi


Chiesi Orphan B.V.
Graadt van Roggenweg 340, 3531 AH Utrecht, Nederland


EU/1/13/861


19.12.2017




15.12.2017


Ristaben


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


EU/1/10/621


19.12.2017




15.12.2017


Ristfor


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


EU/1/10/620


19.12.2017




15.12.2017


Stocrin


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


EU/1/99/111


19.12.2017




15.12.2017


Sustiva


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


EU/1/99/110


19.12.2017




15.12.2017


Velmetia


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


EU/1/08/456


19.12.2017




18.12.2017


Daklinza


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


EU/1/14/939


20.12.2017




18.12.2017


Enbrel


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


EU/1/99/126


20.12.2017




18.12.2017


HBVAXPRO


MSD VACCINS
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/01/183


20.12.2017




18.12.2017


NovoMix


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


EU/1/00/142


20.12.2017




18.12.2017


ProQuad


MSD VACCINS
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/05/323


20.12.2017




18.12.2017


Xelevia


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


EU/1/07/382


20.12.2017




20.12.2017


Azilect


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


EU/1/04/304


22.12.2017




20.12.2017


Duloxetine Lilly


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/14/972


22.12.2017




20.12.2017


Ebymect


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/15/1051


22.12.2017




20.12.2017


Efient


Daiichi Sankyo Europe GmbH
Zielstattstraße 48, 81379 München, Deutschland


EU/1/08/503


22.12.2017




20.12.2017


Fabrazyme


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


EU/1/01/188


22.12.2017




20.12.2017


Gardasil


MSD VACCINS
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/06/357


22.12.2017




20.12.2017


Incresync


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


EU/1/13/842


20.12.2017




20.12.2017


Insulin Human Winthrop


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/06/368


2.1.2018




20.12.2017


Levetiracetam ratiopharm


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


EU/1/11/702


22.12.2017




20.12.2017


Levetiracetam SUN


Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, 2132 JH Hoofddorp, Nederland


EU/1/11/741


22.12.2017




20.12.2017


Qtern


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/16/1108


22.12.2017




20.12.2017


Ranexa


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


EU/1/08/462


22.12.2017




20.12.2017


Tivicay


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


EU/1/13/892


22.12.2017




20.12.2017


Xigduo


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/13/900


22.12.2017




—   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




1.12.2017


Rabitec


Rabies vaccine (live, oral) for foxes and raccoon dogs


IDT Biologika GmbH
Am Pharmapark, 06861 Dessau-Rosslau, Deutschland


EU/2/17/219


Oral suspension


QI07BD


5.12.2017




—   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




6.12.2017


Kexxtone


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


EU/2/12/145


8.12.2017




6.12.2017


Spironolactone Ceva


Ceva Santé Animale
10 avenue de la Ballastière, 33500 Libourne, France


EU/2/07/074


8.12.2017




18.12.2017


Sedadex


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


EU/2/16/198


20.12.2017




20.12.2017


Easotic


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


EU/2/08/085


22.12.2017




20.12.2017


Leucogen


Virbac
1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France


EU/2/09/096


22.12.2017




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.