Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2017 to 30 April 2017 (Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2017-05-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug, withdrawal from the market








C_2017171EN.01000101.xml










30.5.2017   


EN


Official Journal of the European Union


C 171/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2017 to 30 April 2017
(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2017/C 171/01)






—



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




10.4.2017


Chenodeoxycholic acid sigma-tau


chenodeoxycholic acid


sigma-tau Arzeimittel GmbH
Liebherrstr. 22, 80538 München, Deutschland


EU/1/16/1110


Capsule, hard


A05AA01


12.4.2017




20.4.2017


Roteas


edoxaban


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


EU/1/16/1152


Film-coated tablet


B01AF03


24.4.2017




20.4.2017


Varuby


rolapitant


TESARO UK LIMITED
55 Baker Street, London W1U 7EU, United Kingdom


EU/1/17/1180


Film-coated tablet


A04AD14


24.4.2017




24.4.2017


Natpar


parathyroid hormone


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


EU/1/15/1078


Powder and solution for injection


H05AA03


26.4.2017




24.4.2017


Pemetrexed Hospira UK Limited


pemetrexed


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


EU/1/17/1183


Powder for concentrate for solution for infusion


L01BA04


26.4.2017




24.4.2017


TAGRISSO


osimertinib


AstraZeneca AB
Gärtunavägen, SE-151 85 Södertälje, Sverige


EU/1/16/1086


Film-coated tablet


L01XE35


26.4.2017




28.4.2017


Darzalex


daratumumab


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


EU/1/16/1101


Concentrate for solution for infusion


L01XC24


3.5.2017




28.4.2017


Emtricitabine/Tenofovir disoproxil Krka d.d.


emtricitabine/tenofovir disoproxil


KRKA, d.d.
Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/17/1182


Film-coated tablet


J05AR03


3.5.2017










—



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




3.4.2017


Clopidogrel Zentiva


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


EU/1/08/465


5.4.2017




3.4.2017


Corlentor


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


EU/1/05/317


5.4.2017




3.4.2017


DuoPlavin


Sanofi Clir SNC
54 rue La Boétie, F-75008 Paris, France


EU/1/10/619


5.4.2017




3.4.2017


JEVTANA


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


EU/1/11/676


5.4.2017




3.4.2017


Procoralan


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


EU/1/05/316


5.4.2017




3.4.2017


Vepacel


Nanotherapeutics UK Limited
10 Chiswell Street, 2nd Floor London, EC1Y 4UQ, United Kingdom


EU/1/12/752


5.4.2017




3.4.2017


Xofigo


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/13/873


5.4.2017




6.4.2017


Evra


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


EU/1/02/223


10.4.2017




6.4.2017


Fycompa


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


EU/1/12/776


10.4.2017




6.4.2017


Irbesartan Teva


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


EU/1/09/576


10.4.2017




6.4.2017


Levetiracetam Hospira


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


EU/1/13/889


10.4.2017




6.4.2017


Vivanza


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/03/249


10.4.2017




6.4.2017


Zalviso


Grünenthal GmbH
Zieglerstrasse 6, D-52078, Aachen, Deutschland


EU/1/15/1042


10.4.2017




11.4.2017


Abasaglar


Eli Lilly Regional Operations GmbH.
Kölblgasse 8-10, 1030 Wien, Österreich


EU/1/14/944


13.4.2017




11.4.2017


Constella


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


EU/1/12/801


13.4.2017




11.4.2017


Envarsus


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


EU/1/14/935


13.4.2017




11.4.2017


Helixate NexGen


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/00/144


13.4.2017




11.4.2017


Hexacima


Sanofi Pasteur SA
2 avenue Pont Pasteur, F-69007 Lyon, France


EU/1/13/828


13.4.2017




11.4.2017


Iblias


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/15/1077


13.4.2017




11.4.2017


KOGENATE Bayer


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/00/143


13.4.2017




11.4.2017


Kovaltry


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/15/1076


13.4.2017




11.4.2017


Optimark


Guerbet
15, rue des Vanesses, 93420, Villepinte, France


EU/1/07/398


13.4.2017




11.4.2017


Orgalutran


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


EU/1/00/130


13.4.2017




11.4.2017


Sylvant


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


EU/1/14/928


13.4.2017




12.4.2017


Eylea


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/12/797


19.4.2017




12.4.2017


Myfenax


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


EU/1/07/438


19.4.2017




12.4.2017


Ovaleap


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


EU/1/13/871


19.4.2017




12.4.2017


Tecfidera


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


EU/1/13/837


19.4.2017




20.4.2017


Bretaris Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/781


24.4.2017




20.4.2017


Briviact


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


EU/1/15/1073


24.4.2017




20.4.2017


Cetrotide


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


EU/1/99/100


25.4.2017




20.4.2017


Edistride


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/15/1052


24.4.2017




20.4.2017


Eklira Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/778


24.4.2017




20.4.2017


Forxiga


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/795


24.4.2017




20.4.2017


Glybera


uniQure biopharma B.V.
Meibergdreef 61, NL-1105 BA Amsterdam, Nederland


EU/1/12/791


24.4.2017




20.4.2017


Invokana


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


EU/1/13/884


24.4.2017




20.4.2017


Izba


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


EU/1/13/905


24.4.2017




20.4.2017


Jardiance


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


EU/1/14/930


24.4.2017




20.4.2017


Lonquex


UAB ‘Sicor Biotech’
Molėtų pl. 5, LT-08409 Vilnius, Lietuva


EU/1/13/856


24.4.2017




20.4.2017


Mycophenolate mofetil Teva


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


EU/1/07/439


24.4.2017




20.4.2017


Pandemic influenza vaccine H5N1 MedImmune


MedImmune, LLC
Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland


EU/1/16/1089


24.4.2017




20.4.2017


Picato


LEO Laboratories Ltd.
285 Cashel Road, Crumlin, Dublin 12, Ireland


EU/1/12/796


24.4.2017




20.4.2017


Rotarix


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


EU/1/05/330


24.4.2017




20.4.2017


Synjardy


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


EU/1/15/1003


24.4.2017




20.4.2017


Tamiflu


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


EU/1/02/222


24.4.2017




20.4.2017


Travatan


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


EU/1/01/199


24.4.2017




20.4.2017


Vokanamet


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


EU/1/14/918


24.4.2017




20.4.2017


Xigduo


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/13/900


24.4.2017




24.4.2017


CANCIDAS


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


EU/1/01/196


26.4.2017




24.4.2017


Darzalex


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


EU/1/16/1101


26.4.2017




24.4.2017


Docetaxel Winthrop


Aventis Pharma S.A.
20 avenue Raymond Aron, F-92165 Antony CEDEX, France


EU/1/07/384


26.4.2017




24.4.2017


Esbriet


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


EU/1/11/667


26.4.2017




24.4.2017


Flebogamma DIF


Instituto Grifols, S.A.
Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa


EU/1/07/404


26.4.2017




24.4.2017


Imatinib Actavis


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


EU/1/13/825


26.4.2017




24.4.2017


Jakavi


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


EU/1/12/773


26.4.2017




24.4.2017


Opatanol


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


EU/1/02/217


26.4.2017




24.4.2017


Siklos


Addmedica
101 rue Saint Lazare, F-75009 Paris, France


EU/1/07/397


26.4.2017




24.4.2017


Zinforo


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/785


26.4.2017




28.4.2017


Actos


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


EU/1/00/150


3.5.2017




28.4.2017


Cholestagel


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


EU/1/03/268


3.5.2017




28.4.2017


Cimzia


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


EU/1/09/544


4.5.2017




28.4.2017


Cinqaero


Teva Pharmaceuticals Limited
Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom


EU/1/16/1125


3.5.2017




28.4.2017


CONTROLOC Control


Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


EU/1/09/515


3.5.2017




28.4.2017


Fertavid


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


EU/1/09/510


3.5.2017




28.4.2017


Glustin


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


EU/1/00/151


3.5.2017




28.4.2017


Imatinib Medac


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


EU/1/13/876


3.5.2017




28.4.2017


Invokana


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


EU/1/13/884


3.5.2017




28.4.2017


Ixiaro


Valneva Austria GmbH
Campus Vienna Biocenter 3, A-1030 Wien, Österreich


EU/1/08/501


3.5.2017




28.4.2017


Kalydeco


Vertex Pharmaceuticals (Europe) Limited
2 Kingdom Street, London W2 6BD, United Kingdom


EU/1/12/782


3.5.2017




28.4.2017


NovoNorm


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


EU/1/98/076


3.5.2017




28.4.2017


Opdivo


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


EU/1/15/1014


3.5.2017




28.4.2017


PANTOLOC Control


Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


EU/1/09/519


3.5.2017




28.4.2017


PANTOZOL Control


Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


EU/1/09/517


3.5.2017




28.4.2017


Prandin


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


EU/1/00/162


3.5.2017




28.4.2017


Puregon


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


EU/1/96/008


3.5.2017




28.4.2017


Repaglinide Teva


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


EU/1/09/530


3.5.2017




28.4.2017


SOMAC Control


Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


EU/1/09/516


3.5.2017




28.4.2017


Temozolomide Teva


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


EU/1/09/606


3.5.2017




28.4.2017


Tresiba


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


EU/1/12/807


3.5.2017




28.4.2017


Trobalt


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


EU/1/11/681


3.5.2017




28.4.2017


Vizarsin


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


EU/1/09/551


3.5.2017




28.4.2017


Vokanamet


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


EU/1/14/918


3.5.2017




28.4.2017


Xeplion


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


EU/1/11/672


3.5.2017




28.4.2017


Zebinix


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


EU/1/09/514


3.5.2017




28.4.2017


Zoledronic acid medac


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


EU/1/12/779


3.5.2017










—



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




3.4.2017


Imprida


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


EU/1/06/373


5.4.2017




24.4.2017


DUTREBIS


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


EU/1/15/995


26.4.2017










—



Issuing 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


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




25.4.2017


Credelio


lotilaner


Elanco Europe Ltd.
Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom


EU/2/17/206


Chewable tablet


QP53BE04


27.4.2017




25.4.2017


CYTOPOINT


lokivetmab


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


EU/2/17/205


solution for injection in a vial


QD11AH91


27.4.2017




25.4.2017


Zulvac BTV Ovis


Bluetongue vaccine (inactivated): serotype 1, 4, 8


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


EU/2/17/207


Suspension for injection


QI04AA02


27.4.2017










—



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




11.4.2017


Procox


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/11/123


19.4.2017




12.4.2017


FORTEKOR PLUS


Elanco Europe Ltd.
Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom


EU/2/15/185


19.4.2017




25.4.2017


Cerenia


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


EU/2/06/062


27.4.2017




25.4.2017


Quadrisol


VETCOOL B.V.
Otto Hahnweg 24, 3542 AX Utrecht, Nederland


EU/2/97/005


28.4.2017




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.