Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2018 to 30 June 2018 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2018-07-27
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2018266EN.01000101.xml










27.7.2018   


EN


Official Journal of the European Union


C 266/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2018 to 30 June 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 266/01)






—



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




18.6.2018


Blincyto


blinatumomab


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


EU/1/15/1047


Powder for concentrate for solution for infusion


L01XC19


20.6.2018




21.6.2018


Biktarvy


bictegravir / emtricitabine / tenofovir alafenamide


Gilead Sciences International Limited
Cambridge CB21 6GT United Kingdom


EU/1/18/1289


Film-coated tablet


J05AR20


25.6.2018




25.6.2018


Dzuveo


sufentanil


FGK Representative Service GmbH
Heimeranstraße 35, 80339 München, Deutschland


EU/1/18/1284


Sublingual tablet


N01AH03


27.6.2018










—



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




4.6.2018


Copalia


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/06/372


6.6.2018




4.6.2018


Emtriva


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/03/261


6.6.2018




4.6.2018


Iclusig


Incyte Biosciences Distribution B.V.
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland


EU/1/13/839


6.6.2018




4.6.2018


Prolia


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


EU/1/10/618


6.6.2018




4.6.2018


Stocrin


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/99/111


6.6.2018




4.6.2018


Stribild


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/13/830


6.6.2018




4.6.2018


Truvada


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/04/305


6.6.2018




4.6.2018


Tybost


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/13/872


6.6.2018




4.6.2018


Zinbryta


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


EU/1/16/1107


6.6.2018




7.6.2018


ALPROLIX


Swedish Orphan Biovitrum AB (publ)
112 76 Stockholm, Sverige


EU/1/16/1098


11.6.2018




7.6.2018


BeneFIX


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


EU/1/97/047


11.6.2018




7.6.2018


Bexsero


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


EU/1/12/812


11.6.2018




7.6.2018


Cerdelga


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


EU/1/14/974


11.6.2018




7.6.2018


Cimzia


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


EU/1/09/544


11.6.2018




7.6.2018


Constella


Allergan Pharmaceuticals International Limited
Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland


EU/1/12/801


11.6.2018




7.6.2018


Dafiro


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/06/371


11.6.2018




7.6.2018


Exforge HCT


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/09/569


11.6.2018




7.6.2018


Genvoya


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/15/1061


11.6.2018




7.6.2018


Harvoni


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/14/958


11.6.2018




7.6.2018


Isentress


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/07/436


11.6.2018




7.6.2018


Pemetrexed Accord


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


EU/1/15/1071


11.6.2018




7.6.2018


Pradaxa


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


EU/1/08/442


11.6.2018




7.6.2018


Quinsair


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


EU/1/14/973


11.6.2018




7.6.2018


SomaKit TOC


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


EU/1/16/1141


11.6.2018




7.6.2018


TAGRISSO


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/16/1086


11.6.2018




7.6.2018


Uptravi


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


EU/1/15/1083


11.6.2018




7.6.2018


Viekirax


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/14/982


11.6.2018




7.6.2018


Vosevi


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/17/1223


11.6.2018




7.6.2018


Votubia


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/11/710


11.6.2018




7.6.2018


Xultophy


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


EU/1/14/947


11.6.2018




7.6.2018


Zydelig


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/14/938


11.6.2018




7.6.2018


Zykadia


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/15/999


11.6.2018




12.6.2018


Emtricitabine/Tenofovir disoproxil Mylan


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


EU/1/16/1133


14.6.2018




12.6.2018


Fareston


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/1/96/004


14.6.2018




12.6.2018


Incruse


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


EU/1/14/922


14.6.2018




12.6.2018


Kuvan


BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, Ireland


EU/1/08/481


14.6.2018




14.6.2018


Insuman


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


EU/1/97/030


19.6.2018




14.6.2018


Iscover


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


EU/1/98/070


19.6.2018




14.6.2018


SOLYMBIC


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


EU/1/16/1163


19.6.2018




15.6.2018


Aerinaze


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


EU/1/07/399


19.6.2018




15.6.2018


Lusduna


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/16/1162


19.6.2018




15.6.2018


Maviret


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/17/1213


19.6.2018




15.6.2018


Neoclarityn


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


EU/1/00/161


19.6.2018




15.6.2018


Xyrem


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


EU/1/05/312


19.6.2018




15.6.2018


Zepatier


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/16/1119


19.6.2018




15.6.2018


Zerbaxa


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/15/1032


19.6.2018




15.6.2018


ZINPLAVA


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/16/1156


19.6.2018




21.6.2018


Inflectra


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


EU/1/13/854


25.6.2018




21.6.2018


KEYTRUDA


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/15/1024


25.6.2018




21.6.2018


Leflunomide medac


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6, 22880 Wedel, Deutschland


EU/1/10/637


25.6.2018




21.6.2018


Panretin


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


EU/1/00/149


25.6.2018




21.6.2018


Remsima


Celltrion Healthcare Hungary Kft.
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország


EU/1/13/853


25.6.2018




21.6.2018


Rolufta


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


EU/1/17/1174


25.6.2018




21.6.2018


Targretin


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


EU/1/01/178


25.6.2018




21.6.2018


Xeljanz


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


EU/1/17/1178


25.6.2018




21.6.2018


Xofigo


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/13/873


25.6.2018




25.6.2018


Copalia HCT


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/09/575


27.6.2018




25.6.2018


Cubicin


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


EU/1/05/328


27.6.2018




25.6.2018


Dafiro HCT


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/09/574


27.6.2018




25.6.2018


Darzalex


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


EU/1/16/1101


27.6.2018




25.6.2018


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan


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


EU/1/17/1222


27.6.2018




25.6.2018


Exforge


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/06/370


27.6.2018




25.6.2018


Glivec


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/01/198


27.6.2018




25.6.2018


Leflunomide Winthrop


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


EU/1/09/604


27.6.2018




25.6.2018


Nexium Control


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


EU/1/13/860


27.6.2018




25.6.2018


Orbactiv


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


EU/1/15/989


27.6.2018




25.6.2018


PANTOLOC Control


Takeda GmbH
Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland


EU/1/09/519


27.6.2018




25.6.2018


pantoprazole


 


 


26.6.2018




25.6.2018


Stivarga


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/13/858


27.6.2018




25.6.2018


Xeljanz


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


EU/1/17/1178


27.6.2018




25.6.2018


Xgeva


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


EU/1/11/703


27.6.2018




25.6.2018


Yondelis


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


EU/1/07/417


27.6.2018




29.6.2018


Aerius


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/00/160


3.7.2018




29.6.2018


Azomyr


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/00/157


3.7.2018




29.6.2018


Edistride


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/15/1052


3.7.2018




29.6.2018


Efficib


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/08/457


3.7.2018




29.6.2018


Granupas


Eurocept International B.V.
Trapgans 5, 1244 RL Ankeveen, Nederland


EU/1/13/896


3.7.2018




29.6.2018


IMBRUVICA


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


EU/1/14/945


3.7.2018




29.6.2018


Janumet


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/08/455


3.7.2018




29.6.2018


Jinarc


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


EU/1/15/1000


3.7.2018




29.6.2018


Olumiant


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


EU/1/16/1170


3.7.2018




29.6.2018


Orgalutran


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


EU/1/00/130


3.7.2018




29.6.2018


Revlimid


Celgene Europe B.V.
Winthonlaan 6N, 3526 KV Utrecht, Nederland


EU/1/07/391


3.7.2018




29.6.2018


Rezolsta


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


EU/1/14/967


3.7.2018




29.6.2018


Ristfor


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/10/620


3.7.2018




29.6.2018


Samsca


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


EU/1/09/539


3.7.2018




29.6.2018


Spectrila


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6, 22880 Wedel, Deutschland


EU/1/15/1072


3.7.2018




29.6.2018


Temozolomide Accord


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


EU/1/10/615


3.7.2018




29.6.2018


Velmetia


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/08/456


3.7.2018










—



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




15.6.2018


SOLYMBIC


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


EU/1/16/1163


19.6.2018




21.6.2018


Angiox


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


EU/1/04/289


25.6.2018




29.6.2018


Victrelis


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


EU/1/11/704


3.7.2018










—



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




14.6.2018


Dany's BienenWohl


oxalic acid dihydrate


Dany Bienenwohl GmbH
Geyerspergerstraße 27, 80689 München, Deutschland


EU/2/18/225


Powder and solution for bee-hive dispersion


QP53AG03


19.6.2018










—



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




4.6.2018


Activyl


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


EU/2/10/118


6.6.2018




4.6.2018


Cepedex


CP-Pharma Handelsgesellschaft mbH
Ostlandring 13, 31303 Burgdorf, Deutschland


EU/2/16/200


6.6.2018




11.6.2018


Veraflox


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/10/107


13.6.2018




14.6.2018


Aftovaxpur Doe


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/13/153


19.6.2018




18.6.2018


Rhiniseng


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


EU/2/10/109


20.6.2018




27.6.2018


BROADLINE


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/13/157


29.6.2018




27.6.2018


Evalon


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


EU/2/16/194


29.6.2018




27.6.2018


Porcilis PCV M Hyo


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


EU/2/14/175


29.6.2018




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.