Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2016 to 31 October 2016 (Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-11-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2016438EN.01000101.xml










25.11.2016   


EN


Official Journal of the European Union


C 438/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2016 to 31 October 2016
(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 438/01)
—   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




14.10.2016


Onivyde


irinotecan


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


EU/1/16/1130


Concentrate for solution for infusion


L01XX19


18.10.2016




—   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




6.10.2016


Imatinib Teva


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


EU/1/12/808


10.10.2016




6.10.2016


Pregabalin Sandoz


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/15/1011


10.10.2016




6.10.2016


Replagal


Shire Human Genetic Therapies AB
Vasagatan 7, 111 20 Stockholm, Sverige


EU/1/01/189


10.10.2016




14.10.2016


Leflunomide Winthrop


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


EU/1/09/604


18.10.2016




14.10.2016


Lixiana


Daiichi Sankyo Europe GmbH
Zielstattstrasse 48, D-81379 München, Deutschland


EU/1/15/993


18.10.2016




14.10.2016


Pegasys


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


EU/1/02/221


26.10.2016




14.10.2016


Ristempa


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


EU/1/15/996


18.10.2016




14.10.2016


Stivarga


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/13/858


18.10.2016




14.10.2016


Zerbaxa


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


EU/1/15/1032


18.10.2016




21.10.2016


ADCETRIS


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


EU/1/12/794


25.10.2016




21.10.2016


BeneFIX


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


EU/1/97/047


25.10.2016




21.10.2016


Blincyto


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


EU/1/15/1047


25.10.2016




21.10.2016


Cholib


Mylan Products Limited
20 Station Close, Potters Bar, EN6 ITL, United Kingdom


EU/1/13/866


25.10.2016




21.10.2016


Lynparza


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/14/959


25.10.2016




21.10.2016


Metalyse


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


EU/1/00/169


25.10.2016




21.10.2016


NovoRapid


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


EU/1/99/119


25.10.2016




21.10.2016


Olanzapine Teva


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


EU/1/07/427


25.10.2016




21.10.2016


Prevenar 13


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


EU/1/09/590


25.10.2016




24.10.2016


Evicel


Omrix Biopharmaceuticals N.V.
Leonardo Da Vincilaan 15, B-1831 Diegem, België


EU/1/08/473


26.10.2016




24.10.2016


Raplixa


ProFibrix BV (Mallinckrodt Pharmaceuticals)
Darwinweg 24 2333 CR Leiden, Nederland


EU/1/14/985


26.10.2016




24.10.2016


Somatropin Biopartners


BioPartners GmbH
Kaiserpassage 11, D-72764 Reutlingen, Deutschland


EU/1/13/849


26.10.2016




24.10.2016


ZALTRAP


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


EU/1/12/814


26.10.2016




27.10.2016


Perjeta


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


EU/1/13/813


31.10.2016




27.10.2016


Privigen


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


EU/1/08/446


31.10.2016




27.10.2016


Vitekta


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/883


31.10.2016




27.10.2016


Volibris


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


EU/1/08/451


31.10.2016




—   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




3.10.2016


Hiprabovis IBR Marker Live


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


EU/2/10/114


5.10.2016




3.10.2016


Meloxidyl


CEVA SANTE ANIMALE
10 avenue de la Ballastière, F-33500 Libourne, France


EU/2/06/070


5.10.2016




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.