Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2017 to 30 September 2017 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2017-10-27
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug, withdrawal from the market








C_2017367EN.01000101.xml










27.10.2017   


EN


Official Journal of the European Union


C 367/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2017 to 30 September 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 367/01)






—



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




5.9.2017


Cuprior


trientine


gmp-orphan SA
Pépinière Paris Santé Cochin, 27-29 rue Faubourg Saint-Jacques, 75014 Paris, France


EU/1/17/1199


Tablet


A16AX12


7.9.2017




5.9.2017


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan


Efavirenz/emtricitabine/tenofovir disoproxil


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


EU/1/17/1222


Film-coated tablet


J05AR06


7.9.2017




18.9.2017


Bavencio


avelumab


Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/17/1214


Concentrate for solution for infusion


Pending


20.9.2017




18.9.2017


Entecavir Mylan


entecavir


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


EU/1/17/1227


Film-coated tablet


J05AF10


20.9.2017




18.9.2017


Lacosamide Accord


lacosamide


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


EU/1/17/1230


Film-coated tablet


N03AX18


20.9.2017




18.9.2017


Rydapt


Midostaurin


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


EU/1/17/1218


Capsule, soft


L01XE39


20.9.2017




18.9.2017


Xermelo


telotristat


Ipsen Pharma
65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France


EU/1/17/1224


Film-coated tablet


Pending


20.9.2017




21.9.2017


Symtuza


darunavir/cobicistat/emtricitabine/tenofovir alafenamide


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


EU/1/17/1225


Film-coated tablet


Pending


25.9.2017




21.9.2017


Tecentriq


atezolizumab


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


EU/1/17/1220


Concentrate for solution for infusion


Pending


25.9.2017




26.9.2017


Dupixent


dupilumab


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


EU/1/17/1229


Solution for injection


Pending


28.9.2017




26.9.2017


Entecavir Accord


entecavir


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


EU/1/17/1211


Film-coated tablet


J05AF10


28.9.2017




26.9.2017


Lutathera


lutetium (177Lu) oxodotreotide


Advanced Accelerator Applications
20 rue Diesel, F-01630 Saint-Genis-Pouilly, France


EU/1/17/1226


Solution for infusion


V10XX04


28.9.2017










—



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




5.9.2017


Humira


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/03/256


7.9.2017




5.9.2017


Olazax


Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b, 140 78 Praha 4, Česká republika.


EU/1/09/597


7.9.2017




5.9.2017


Thorinane


Techdow Pharma Netherlands B.V.
Strawinskylaan 1143, Toren C-11, 1077XX Amsterdam, Nederland


EU/1/16/1131


7.9.2017




7.9.2017


Binocrit


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/07/410


11.9.2017




7.9.2017


Epoetin alfa Hexal


Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, Deutschland


EU/1/07/411


11.9.2017




7.9.2017


Fexeric


Keryx Biopharma UK Ltd.
Riverbank House, 2 Swan Lane, London, EC4R 3TT, United Kingdom


EU/1/15/1039


11.9.2017




7.9.2017


Intanza


Sanofi Pasteur Europe
2 Avenue Pont Pasteur, 69007 Lyon, France


EU/1/08/505


11.9.2017




7.9.2017


Taltz


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


EU/1/15/1085


11.9.2017




11.9.2017


Infanrix hexa


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


EU/1/00/152


13.9.2017




11.9.2017


Januvia


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


EU/1/07/383


13.9.2017




11.9.2017


Jinarc


Otsuka Pharmaceutical Europe Ltd.
Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom


EU/1/15/1000


13.9.2017




11.9.2017


Methylthioninium chloride Proveblue


Provepharm S.A.S.
22 Rue Marc Donadille, 13013 Marseille, France


EU/1/11/682


14.9.2017




11.9.2017


Neparvis


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


EU/1/16/1103


13.9.2017




11.9.2017


Osseor


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


EU/1/04/287


13.9.2017




11.9.2017


Protelos


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


EU/1/04/288


13.9.2017




11.9.2017


Simponi


Janssen Biologics B.V.
Einsteinweg 101, NL-2333 CB Leiden, Nederland


EU/1/09/546


13.9.2017




11.9.2017


Tesavel


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


EU/1/07/435


13.9.2017




11.9.2017


Tysabri


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


EU/1/06/346


13.9.2017




11.9.2017


Ventavis


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/03/255


13.9.2017




11.9.2017


Votrient


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


EU/1/10/628


13.9.2017




11.9.2017


Xelevia


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


EU/1/07/382


13.9.2017




11.9.2017


Zerit


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


EU/1/96/009


13.9.2017




11.9.2017


Zyprexa


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


EU/1/96/022


13.9.2017




14.9.2017


Angiox


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


EU/1/04/289


18.9.2017




14.9.2017


Ebixa


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


EU/1/02/219


18.9.2017




14.9.2017


Eurartesim


Alfasigma S.p.A.
Viale Sarca, n. 223, 20126 Milano, Italia


EU/1/11/716


21.9.2017




14.9.2017


Glidipion


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


EU/1/12/756


18.9.2017




14.9.2017


Ifirmasta


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


EU/1/08/480


18.9.2017




14.9.2017


Olanzapine Apotex


Apotex Europe B.V.
Darwinweg 20, NL-2333 CR Leiden, Nederland


EU/1/10/635


18.9.2017




14.9.2017


Olazax Disperzi


Glenmark Pharmaceuticals s.r.o.
City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika


EU/1/09/592


18.9.2017




14.9.2017


Sovaldi


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/894


18.9.2017




14.9.2017


Trevicta


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


EU/1/14/971


18.9.2017




14.9.2017


Vimpat


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


EU/1/08/470


18.9.2017




14.9.2017


Wakix


Bioprojet Pharma
9 rue Rameau, F-75002 Paris, France


EU/1/15/1068


18.9.2017




18.9.2017


Abseamed


Medice Arzneimittel Pütter GmbH & Co KG
Kuhloweg 37, D-58638 Iserlohn, Deutschland


EU/1/07/412


20.9.2017




18.9.2017


Betmiga


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


EU/1/12/809


20.9.2017




18.9.2017


Bexsero


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


EU/1/12/812


20.9.2017




18.9.2017


Blincyto


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


EU/1/15/1047


20.9.2017




18.9.2017


Gazyvaro


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


EU/1/14/937


20.9.2017




18.9.2017


Ibandronic acid Accord


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


EU/1/12/798


20.9.2017




18.9.2017


Imatinib Teva


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


EU/1/12/808


20.9.2017




18.9.2017


Lumark


IDB Holland B.V.
Weverstraat 17, 5111 PV Baarle-Nassau, Nederland


EU/1/15/1013


20.9.2017




18.9.2017


Lynparza


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/14/959


20.9.2017




18.9.2017


Lyxumia


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


EU/1/12/811


20.9.2017




18.9.2017


Mozobil


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


EU/1/09/537


20.9.2017




18.9.2017


NexoBrid


MediWound Germany GmbH
Eisenstr. 5, D-65428 Ruesselsheim, Deutschland


EU/1/12/803


20.9.2017




18.9.2017


Ninlaro


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


EU/1/16/1094


20.9.2017




18.9.2017


Nivestim


Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom


EU/1/10/631


20.9.2017




18.9.2017


NovoRapid


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


EU/1/99/119


20.9.2017




18.9.2017


Opdivo


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


EU/1/15/1014


20.9.2017




18.9.2017


Oslif Breezhaler


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


EU/1/09/586


20.9.2017




18.9.2017


Prolia


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


EU/1/10/618


20.9.2017




18.9.2017


Retacrit


Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom


EU/1/07/431


20.9.2017




18.9.2017


Revlimid


Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom


EU/1/07/391


20.9.2017




18.9.2017


RoActemra


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


EU/1/08/492


20.9.2017




18.9.2017


RotaTeq


MSD VACCINS
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/06/348


20.9.2017




18.9.2017


Samsca


Otsuka Pharmaceutical Europe Ltd.
Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom


EU/1/09/539


21.9.2017




18.9.2017


Signifor


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


EU/1/12/753


20.9.2017




18.9.2017


Xgeva


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


EU/1/11/703


20.9.2017




18.9.2017


Zebinix


Bial — Portela & Ca, SA
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal


EU/1/09/514


28.7.2017




18.9.2017


Zebinix


Bial — Portela & Ca, SA
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal


EU/1/09/514


20.9.2017




18.9.2017


Zypadhera


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


EU/1/08/479


20.9.2017




21.9.2017


Amyvid


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


EU/1/12/805


25.9.2017




21.9.2017


EndolucinBeta


ITG Isotope Technologies Garching GmbH
Lichtenbergstr. 1, D-85748 Garching, Deutschland


EU/1/16/1105


25.9.2017




21.9.2017


Iclusig


Incyte Biosciences UK Ltd
Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom


EU/1/13/839


25.9.2017




21.9.2017


Lartruvo


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


EU/1/16/1143


25.9.2017




21.9.2017


Lenvima


Eisai Europe Limited
European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom


EU/1/15/1002


25.9.2017




21.9.2017


Plenadren


Shire Services BVBA
rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België


EU/1/11/715


25.9.2017




21.9.2017


Relvar Ellipta


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


EU/1/13/886


25.9.2017




21.9.2017


Revinty Ellipta


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


EU/1/14/929


25.9.2017




21.9.2017


Ryzodeg


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


EU/1/12/806


25.9.2017




21.9.2017


Tresiba


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


EU/1/12/807


25.9.2017




21.9.2017


Xtandi


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


EU/1/13/846


25.9.2017




21.9.2017


ZALTRAP


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


EU/1/12/814


25.9.2017




26.9.2017


Hirobriz Breezhaler


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


EU/1/09/594


28.9.2017




26.9.2017


Onbrez Breezhaler


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


EU/1/09/593


28.9.2017




26.9.2017


Ristempa


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


EU/1/15/996


28.9.2017




26.9.2017


Stayveer


Marklas Nederland B.V.
Beneluxlaan 2b, NL-3446 GR Woerden, Nederland


EU/1/13/832


28.9.2017




26.9.2017


TachoSil


Takeda Austria GmbH
St.-Peter-Strasse 25, A-4020 Linz, Österreich


EU/1/04/277


28.9.2017




26.9.2017


Tracleer


Actelion Registration Ltd
Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom


EU/1/02/220


28.9.2017




26.9.2017


Xoterna Breezhaler


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


EU/1/13/863


28.9.2017




28.9.2017


Neupro


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


EU/1/05/331


2.10.2017




28.9.2017


Revolade


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


EU/1/10/612


29.9.2017










—



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




28.9.2017


Ristempa


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


EU/1/15/996


2.10.2017










—



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




7.9.2017


SevoFlo


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


EU/2/02/035


11.9.2017




14.9.2017


Equilis Te


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


EU/2/05/055


18.9.2017




14.9.2017


LETIFEND


Laboratorios LETI, S.L.unipersonal
C/Del Sol 5, Polígono Industrial Norte Tres Cantos, 28760 Madrid, España


EU/2/16/195


18.9.2017




14.9.2017


Nobivac Myxo-RHD


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


EU/2/11/132


18.9.2017




14.9.2017


Rheumocam


Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland


EU/2/07/078


19.9.2017




21.9.2017


Bovalto Ibraxion


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


EU/2/99/017


25.9.2017




21.9.2017


Pirsue


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


EU/2/00/027


25.9.2017




21.9.2017


Sevohale


Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland


EU/2/16/196


25.9.2017




25.9.2017


Equilis Prequenza Te


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


EU/2/05/057


27.9.2017




25.9.2017


Metacam


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


EU/2/97/004


27.9.2017




28.9.2017


ProZinc


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


EU/2/13/152


2.10.2017




28.9.2017


Versican Plus L4


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


EU/2/14/171


2.10.2017




28.9.2017


Versican Plus Pi


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


EU/2/14/168


2.10.2017




28.9.2017


Versican Plus Pi/L4


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


EU/2/14/172


2.10.2017




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.