Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2018 to 28 February 2018 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2018-03-28
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2018115EN.01000101.xml










28.3.2018   


EN


Official Journal of the European Union


C 115/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2018 to 28 February 2018
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2018/C 115/01)






—



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




8.2.2018


Efavirenz/Emtricitabine/Tenofovir disoproxil Krka


efavirenz/emtricitabine/tenofovir disoproxil


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


EU/1/17/1263


Film-coated tablet


J05AR06


12.2.2018




8.2.2018


Ozempic


semaglutide


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


EU/1/17/1251


Solution for injection


A10BJ06


12.2.2018




9.2.2018


Alkindi


hydrocortisone


Diurnal Ltd
Cardiff Medicentre, Heath Park, Cardiff CF14 4UJ, United Kingdom


EU/1/17/1260


Granules in capsules for opening


H02AB09


13.2.2018




9.2.2018


Herzuma


trastuzumab


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


EU/1/17/1257


Powder for concentrate for solution for infusion


L01XC03


13.2.2018




15.2.2018


Anagrelide Mylan


anagrelide


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


EU/1/17/1256


Capsule, hard


L01XX35


19.2.2018




19.2.2018


CRYSVITA


Burosumab


Kyowa Kirin Limited
Galabank Business Park, Galashiels, TD1 1QH, United Kingdom


EU/1/17/1262


Solution for injection


M05BX


21.2.2018




23.2.2018


Hemlibra


emicizumab


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


EU/1/18/1271


Solution for injection


B02BX06


27.2.2018










—



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




5.2.2018


Ebilfumin


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


EU/1/14/915


7.2.2018




5.2.2018


Episalvan


Amryt AG
Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland


EU/1/15/1069


8.2.2018




5.2.2018


NULOJIX


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


EU/1/11/694


7.2.2018




5.2.2018


Pedea


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France


EU/1/04/284


8.2.2018




5.2.2018


Pregabalin Sandoz


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/15/1011


7.2.2018




5.2.2018


Pregabalin Sandoz GmbH


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/15/1012


7.2.2018




5.2.2018


PREZISTA


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


EU/1/06/380


7.2.2018




5.2.2018


Truvada


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/04/305


7.2.2018




5.2.2018


Vedrop


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France


EU/1/09/533


8.2.2018




8.2.2018


Bosulif


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


EU/1/13/818


12.2.2018




8.2.2018


Daptomycin Hospira


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


EU/1/17/1175


12.2.2018




8.2.2018


Esbriet


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


EU/1/11/667


12.2.2018




8.2.2018


Exforge


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


EU/1/06/370


12.2.2018




8.2.2018


Iclusig


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


EU/1/13/839


12.2.2018




8.2.2018


Methylthioninium chloride Proveblue


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


EU/1/11/682


15.2.2018




8.2.2018


OLYSIO


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


EU/1/14/924


12.2.2018




8.2.2018


Rezolsta


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


EU/1/14/967


12.2.2018




8.2.2018


Thalidomide Celgene


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


EU/1/08/443


12.2.2018




8.2.2018


VELCADE


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


EU/1/04/274


12.2.2018




8.2.2018


Victrelis


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


EU/1/11/704


12.2.2018




8.2.2018


Voriconazole Accord


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


EU/1/13/835


12.2.2018




8.2.2018


Xtandi


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


EU/1/13/846


12.2.2018




9.2.2018


Caprelsa


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


EU/1/11/749


13.2.2018




9.2.2018


Cymbalta


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


EU/1/04/296


13.2.2018




9.2.2018


Cystadane


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France


EU/1/06/379


13.2.2018




9.2.2018


Entyvio


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


EU/1/14/923


13.2.2018




9.2.2018


IMBRUVICA


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


EU/1/14/945


13.2.2018




9.2.2018


Neuraceq


Piramal Imaging Limited
Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom


EU/1/13/906


13.2.2018




9.2.2018


Ventavis


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/03/255


13.2.2018




15.2.2018


Emselex


Merus Labs Luxco II S.à R.L.
26-28, rue Edward Steichen, 2540 Luxembourg


EU/1/04/294


19.2.2018




15.2.2018


Fosavance


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


EU/1/05/310


19.2.2018




15.2.2018


Vantavo


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


EU/1/09/572


19.2.2018




16.2.2018


Esmya


Gedeon Richter Plc.
Gyömrői út 19-21., 1103 Budapest, Magyarország


EU/1/12/750


20.2.2018




19.2.2018


Adcirca


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


EU/1/08/476


21.2.2018




19.2.2018


Aerivio Spiromax


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


EU/1/16/1122


21.2.2018




19.2.2018


Airexar Spiromax


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


EU/1/16/1123


21.2.2018




19.2.2018


Anoro


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


EU/1/14/898


21.2.2018




19.2.2018


Gardasil 9


MSD VACCINS
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/15/1007


21.2.2018




19.2.2018


Icandra


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


EU/1/08/484


21.2.2018




19.2.2018


Lyrica


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


EU/1/04/279


21.2.2018




19.2.2018


Mycamine


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


EU/1/08/448


21.2.2018




19.2.2018


Neulasta


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


EU/1/02/227


21.2.2018




19.2.2018


Nucala


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


EU/1/15/1043


21.2.2018




19.2.2018


Olanzapine Teva


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


EU/1/07/427


21.2.2018




19.2.2018


Ongentys


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


EU/1/15/1066


22.2.2018




19.2.2018


Orkambi


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


EU/1/15/1059


21.2.2018




19.2.2018


PegIntron


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


EU/1/00/131


21.2.2018




19.2.2018


Rebetol


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


EU/1/99/107


21.2.2018




19.2.2018


Senshio


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


EU/1/14/978


21.2.2018




19.2.2018


Simulect


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


EU/1/98/084


21.2.2018




19.2.2018


Talmanco


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


EU/1/16/1153


21.2.2018




19.2.2018


Tenofovir disoproxil Mylan


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


EU/1/16/1129


21.2.2018




19.2.2018


Vfend


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


EU/1/02/212


21.2.2018




19.2.2018


ViraferonPeg


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


EU/1/00/132


21.2.2018




19.2.2018


Wilzin


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France


EU/1/04/286


21.2.2018




19.2.2018


Zyprexa Velotab


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


EU/1/99/125


21.2.2018




22.2.2018


Dynastat


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


EU/1/02/209


26.2.2018




22.2.2018


Eucreas


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


EU/1/07/425


26.2.2018




22.2.2018


NutropinAq


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


EU/1/00/164


26.2.2018




22.2.2018


Trulicity


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


EU/1/14/956


26.2.2018




22.2.2018


Zurampic


Grünenthal GmbH
Zieglerstraße 6, 52078, Aachen, Deutschland


EU/1/15/1080


26.2.2018




27.2.2018


Abasaglar


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


EU/1/14/944


1.3.2018




27.2.2018


Omnitrope


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/06/332


1.3.2018










—



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




7.2.2018


Suvaxyn Circo


Porcine circovirus vaccine (inactivated, recombinant)


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


EU/2/17/223


Emulsion for injection


QI09AA07


9.2.2018










—



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




20.2.2018


Advocate


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/03/039


22.2.2018




20.2.2018


Porcilis PCV


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


EU/2/08/091


22.2.2018




20.2.2018


Porcilis PCV M Hyo


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


EU/2/14/175


22.2.2018




20.2.2018


Vectormune ND


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


EU/2/15/188


22.2.2018




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.