Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2017 to 31 October 2017 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2017-12-01
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2017410EN.01000101.xml










1.12.2017   


EN


Official Journal of the European Union


C 410/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2017 to 31 October 2017
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2017/C 410/01)






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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




3.10.2017


Beromun


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


EU/1/99/097


5.10.2017




3.10.2017


Lantus


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


EU/1/00/134


5.10.2017




3.10.2017


Ristaben


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


EU/1/10/621


5.10.2017




3.10.2017


Synflorix


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


EU/1/09/508


5.10.2017




3.10.2017


Toujeo


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


EU/1/00/133


5.10.2017




3.10.2017


Zoely


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


EU/1/11/690


5.10.2017




4.10.2017


Empliciti


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


EU/1/16/1088


6.10.2017




4.10.2017


Twinrix Adult


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


EU/1/96/020


6.10.2017




9.10.2017


Ambirix


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


EU/1/02/224


11.10.2017




9.10.2017


Erivedge


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


EU/1/13/848


11.10.2017




13.10.2017


Amlodipine/Valsartan Mylan


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


EU/1/16/1092


17.10.2017




13.10.2017


Emtricitabine/Tenofovir disoproxil Zentiva


Zentiva, k.s.
U Kabelovny 130, 102 37 Praha 10, Česká republika


EU/1/16/1148


17.10.2017




13.10.2017


JETREA


ThromboGenics NV
Gaston Geenslaan 1, 3001 Leuven, België


EU/1/13/819


17.10.2017




13.10.2017


Twinrix Paediatric


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


EU/1/97/029


17.10.2017




13.10.2017


Ulunar Breezhaler


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


EU/1/14/917


17.10.2017




13.10.2017


Wakix


Bioprojet Pharma
9 rue Rameau, 75002 Paris, France


EU/1/15/1068


17.10.2017




19.10.2017


Emend


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


EU/1/03/262


24.10.2017




19.10.2017


Firazyr


Shire Orphan Therapies GmbH
Friedrichstraße 149, 10117 Berlin, Deutschland


EU/1/08/461


23.10.2017




19.10.2017


Humalog


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


EU/1/96/007


23.10.2017




19.10.2017


Mozobil


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


EU/1/09/537


23.10.2017




19.10.2017


Opdivo


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


EU/1/15/1014


23.10.2017




19.10.2017


Pradaxa


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


EU/1/08/442


23.10.2017




19.10.2017


Revestive


Shire Pharmaceuticals Ireland Limited
5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/12/787


23.10.2017




19.10.2017


Stribild


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/830


23.10.2017




19.10.2017


Xarelto


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/08/472


23.10.2017




19.10.2017


Yondelis


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


EU/1/07/417


23.10.2017




23.10.2017


Giotrif


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


EU/1/13/879


25.10.2017




23.10.2017


Instanyl


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


EU/1/09/531


25.10.2017




23.10.2017


Levetiracetam Actavis Group


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


EU/1/11/738


25.10.2017




23.10.2017


Liprolog


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


EU/1/01/195


25.10.2017




23.10.2017


Olanzapine Glenmark


Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue, Kenton, Harrow, Middlesex, HA3 0BU, United Kingdom


EU/1/09/587


25.10.2017




23.10.2017


Olanzapine Glenmark Europe


Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue, Kenton, Harrow, Middlesex, HA3 0BU, United Kingdom


EU/1/09/588


25.10.2017




23.10.2017


Prevenar 13


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


EU/1/09/590


25.10.2017




30.10.2017


Competact


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


EU/1/06/354


1.11.2017




30.10.2017


Epclusa


Gilead Sciences International Ltd
Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom


EU/1/16/1116


1.11.2017




30.10.2017


Firdapse


BioMarin Europe Ltd
10 Bloomsbury Way, London WC1A 2SL, United Kingdom


EU/1/09/601


1.11.2017




30.10.2017


Fortacin


Recordati Ireland Ltd
Raheens East, Ringaskiddy, Co. Cork, Ireland


EU/1/13/881


1.11.2017




30.10.2017


Ibandronic Acid Teva


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


EU/1/10/642


2.11.2017




30.10.2017


Multaq


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


EU/1/09/591


2.11.2017




30.10.2017


Tarceva


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


EU/1/05/311


1.11.2017




30.10.2017


Ultibro Breezhaler


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


EU/1/13/862


1.11.2017




30.10.2017


Venclyxto


AbbVie Ltd
Vanwall Road, Maidenhead, SL6 4UB, United Kingdom


EU/1/16/1138


1.11.2017










—



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




5.10.2017


Equisolon


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


EU/2/14/161


10.10.2017




10.10.2017


Simparica


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


EU/2/15/191


12.10.2017




19.10.2017


Bovela


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


EU/2/14/176


23.10.2017




24.10.2017


Inflacam


Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland


EU/2/11/134


26.10.2017




24.10.2017


Ingelvac CircoFLEX


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


EU/2/07/079


26.10.2017




31.10.2017


Pexion


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


EU/2/12/147


6.11.2017




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.