Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2017 to 28 February 2017 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2017-03-31
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2017102EN.01000101.xml










31.3.2017   


EN


Official Journal of the European Union


C 102/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2017 to 28 February 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 102/01)






—



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




13.2.2017


LIFMIOR


etanercept


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


EU/1/16/1165


Powder and solvent for solution for injection


L04AB01


15.2.2017




13.2.2017


Olumiant


baricitinib


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


EU/1/16/1170


Film-coated tablet


L04AA37


15.2.2017




13.2.2017


Vihuma


simoctocog alfa


Octapharma AB
Lars Forssells gata 23, 112 75 Stockholm, Sverige


EU/1/16/1168


Powder and solvent for solution for injection


B02BD02


15.2.2017




16.2.2017


Alecensa


alectinib


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


EU/1/16/1169


Capsule, hard


L01XE36


20.2.2017




17.2.2017


Truxima


rituximab


Celltrion Healthcare Hungary Kft.
1051 Budapest Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország


EU/1/16/1167


Concentrate for solution for infusion


L01XC02


22.2.2017




27.2.2017


Pregabalin Zentiva k.s


pregabalin


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


EU/1/16/1166


Capsule, hard


N03AX16


1.3.2017










—



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




6.2.2017


Alimta


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


EU/1/04/290


8.2.2017




6.2.2017


Amyvid


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


EU/1/12/805


8.2.2017




6.2.2017


APTIVUS


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


EU/1/05/315


8.2.2017




6.2.2017


Gardasil


MSD VACCINS
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/06/357


8.2.2017




6.2.2017


Imvanex


Bavarian Nordic A/S
Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark


EU/1/13/855


8.2.2017




6.2.2017


Scintimun


CIS bio international
Boîte postale 32, F-91192 Gif-sur-Yvette, France


EU/1/09/602


8.2.2017




6.2.2017


Silgard


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


EU/1/06/358


8.2.2017




6.2.2017


Stribild


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/830


8.2.2017




6.2.2017


Tolucombi


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


EU/1/13/821


9.2.2017




6.2.2017


Victrelis


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


EU/1/11/704


8.2.2017




8.2.2017


Optruma


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


EU/1/98/074


10.2.2017




13.2.2017


Aripiprazole Zentiva


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


EU/1/15/1009


15.2.2017




13.2.2017


Senshio


Shionogi Limited
33 Kingsway, London WC2B 6UF, United Kingdom


EU/1/14/978


15.2.2017




13.2.2017


Sustiva


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


EU/1/99/110


15.2.2017




16.2.2017


Aripiprazole Sandoz


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/15/1029


20.2.2017




16.2.2017


Armisarte


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


EU/1/15/1063


20.2.2017




16.2.2017


Brimica Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/14/963


20.2.2017




16.2.2017


Docetaxel Teva


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


EU/1/09/611


20.2.2017




16.2.2017


Duaklir Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/14/964


20.2.2017




16.2.2017


Enyglid


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


EU/1/09/580


20.2.2017




16.2.2017


EVOTAZ


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


EU/1/15/1025


20.2.2017




16.2.2017


Farydak


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


EU/1/15/1023


20.2.2017




16.2.2017


Forsteo


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


EU/1/03/247


20.2.2017




16.2.2017


Genvoya


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/15/1061


20.2.2017




16.2.2017


INOmax


Linde Healthcare AB
SE-181 81 Lidingö, Sverige


EU/1/01/194


22.2.2017




16.2.2017


Irbesartan/Hydrochlorothiazide Teva


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


EU/1/09/583


20.2.2017




16.2.2017


Kadcyla


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


EU/1/13/885


20.2.2017




16.2.2017


Kalydeco


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


EU/1/12/782


20.2.2017




16.2.2017


Leganto


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


EU/1/11/695


20.2.2017




16.2.2017


Mirapexin


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


EU/1/97/051


20.2.2017




16.2.2017


Neupro


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


EU/1/05/331


20.2.2017




16.2.2017


Nimenrix


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


EU/1/12/767


20.2.2017




16.2.2017


Nonafact


Sanquin Plasma Products B.V.
Plesmanlaan 125, NL-1066 CX Amsterdam, Nederland


EU/1/01/186


20.2.2017




16.2.2017


Nucala


GlaxoSmithKline Trading Services Limited
Currabinny, Carrigaline, County Cork, Ireland


EU/1/15/1043


20.2.2017




16.2.2017


Optimark


Mallinckrodt Deutschland GmbH
Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland


EU/1/07/398


20.2.2017




16.2.2017


Portrazza


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


EU/1/15/1084


20.2.2017




16.2.2017


Quinsair


Horizon Pharma Europe B.V.
Naritaweg 165, NL-1043 BW Amsterdam, Nederland


EU/1/14/973


20.2.2017




16.2.2017


Ravicti


Horizon Pharma Ireland Limited
Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland


EU/1/15/1062


20.2.2017




16.2.2017


Repaglinide Krka


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


EU/1/09/579


20.2.2017




16.2.2017


Revlimid


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


EU/1/07/391


20.2.2017




16.2.2017


Revolade


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


EU/1/10/612


20.2.2017




16.2.2017


Rivastigmine Actavis


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


EU/1/11/693


20.2.2017




16.2.2017


Sifrol


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


EU/1/97/050


20.2.2017




16.2.2017


Stocrin


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


EU/1/99/111


20.2.2017




16.2.2017


Twynsta


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


EU/1/10/648


20.2.2017




16.2.2017


Viread


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/01/200


20.2.2017




16.2.2017


Zyprexa Velotab


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


EU/1/99/125


20.2.2017




17.2.2017


Caprelsa


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


EU/1/11/749


21.2.2017




17.2.2017


Cyramza


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


EU/1/14/957


21.2.2017




17.2.2017


Emend


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


EU/1/03/262


21.2.2017




17.2.2017


IMBRUVICA


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


EU/1/14/945


21.2.2017




17.2.2017


Pioglitazone Teva


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


EU/1/12/757


21.2.2017




17.2.2017


Pioglitazone Teva Pharma


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


EU/1/12/758


21.2.2017




17.2.2017


Repatha


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


EU/1/15/1016


21.2.2017




23.2.2017


Dacogen


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


EU/1/12/792


27.2.2017




23.2.2017


Daklinza


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


EU/1/14/939


27.2.2017




23.2.2017


Docetaxel Accord


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


EU/1/12/769


27.2.2017




23.2.2017


Docetaxel Kabi


Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom


EU/1/12/770


27.2.2017




23.2.2017


Exviera


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/14/983


27.2.2017




23.2.2017


Harvoni


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/14/958


27.2.2017




23.2.2017


Ilaris


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


EU/1/09/564


27.2.2017




23.2.2017


Ketoconazole HRA


Laboratoire HRA Pharma
15 rue Béranger, F-75003 Paris, France


EU/1/14/965


27.2.2017




23.2.2017


Lamivudine Teva


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


EU/1/09/566


27.2.2017




23.2.2017


OLYSIO


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


EU/1/14/924


27.2.2017




23.2.2017


Revlimid


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


EU/1/07/391


27.2.2017




23.2.2017


Sovaldi


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/894


27.2.2017




23.2.2017


Tivicay


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


EU/1/13/892


27.2.2017




23.2.2017


Vargatef


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


EU/1/14/954


27.2.2017




23.2.2017


Viekirax


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/14/982


27.2.2017




23.2.2017


Zinforo


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/785


27.2.2017




27.2.2017


Adcirca


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


EU/1/08/476


1.3.2017




27.2.2017


Kisplyx


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


EU/1/16/1128


1.3.2017




27.2.2017


Vectibix


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


EU/1/07/423


1.3.2017










—



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




2.2.2017


VarroMed


oxalic acid dihydrate/formic acid


BeeVital GmbH
Wiesenbergstrasse 19, 5164, Seeham, Österreich


EU/2/16/203


Bee-hive dispersion


Pending


6.2.2017




9.2.2017


Stronghold Plus


selamectin/sarolaner


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


EU/2/16/204


Spot-on solution


QP54AA55


13.2.2017










—



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




9.2.2017


EQUIOXX


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


EU/2/08/083


13.2.2017




10.2.2017


Vectormune ND


CEVA-Phylaxia Co. Ltd
Budapest, Szállás u. 5, 1107 MAGYARORSZÁG


EU/2/15/188


14.2.2017




17.2.2017


ERYSENG PARVO


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


EU/2/14/167


21.2.2017




17.2.2017


Trifexis


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


EU/2/13/155


21.2.2017




17.2.2017


Vectra 3D


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


EU/2/13/156


21.2.2017




27.2.2017


Equip WNV


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


EU/2/08/086


1.3.2017




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.