Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2020 to 31 January 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2020-02-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2020066EN.01000101.xml










28.2.2020   


EN


Official Journal of the European Union


C 66/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2020 to 31 January 2020
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2020/C 66/01)






—



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




9.1.2020


Clopidogrel/Acetylsalicylic acid Mylan


clopidogrel/acetylsalicylic acid







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest,




France






EU/1/19/1395


Film-coated tablet


B01AC30


13.1.2020




9.1.2020


Deferasirox Accord


deferasirox







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona,




España






EU/1/19/1412


Film-coated tablet


V03AC03


13.1.2020




9.1.2020


Isturisa


osilodrostat







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4,




Ireland






EU/1/19/1407


Film-coated tablet


H02CA02


13.1.2020




9.1.2020


TAVLESSE


fostamatinib







Rigel Pharmaceuticals B.V.




Avenue Ceramique 223, 6621 KX Maastricht,




Nederland






EU/1/19/1405


Film-coated tablet


B02BX09


13.1.2020




13.1.2020


Mayzent


siponimod







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4,




Ireland






EU/1/19/1414


Film-coated tablet


L04AA42


15.1.2020




16.1.2020


Polivy


polatuzumab vedotin







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen,




Deutschland






EU/1/19/1388


Powder for concentrate for solution for infusion


L01XC37


20.1.2020




16.1.2020


Sunosi


solriamfetol







Jazz Pharmaceuticals Ireland Ltd




5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7,




Ireland






EU/1/19/1408


Film-coated tablet


N06BA14


20.1.2020










—



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




9.1.2020


Akynzeo







Helsinn Birex Pharmaceuticals Ltd




Damastown, Mulhuddart, Dublin 15,




Ireland






EU/1/15/1001


13.1.2020




9.1.2020


Clopidogrel ratiopharm GmbH







Archie Samuel s.r.o.




Slunná 16, 61700 Brno,




Česká republika






EU/1/09/541


13.1.2020




9.1.2020


Cymbalta







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht,




Nederland






EU/1/04/296


13.1.2020




9.1.2020


Elebrato Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24,




Ireland






EU/1/17/1237


13.1.2020




9.1.2020


Kigabeq







ORPHELIA Pharma SAS




85 boulevard Saint-Michel, 75005 Paris,




France






EU/1/18/1302


13.1.2020




9.1.2020


Sirturo







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse,




België






EU/1/13/901


13.1.2020




9.1.2020


Sivextro







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem,




Nederland






EU/1/15/991


13.1.2020




9.1.2020


Taxotere







Sanofi Mature IP




54 Rue de la Boetie, 75008, Paris,




FRANCE






EU/1/95/002


13.1.2020




9.1.2020


Tecfidera







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp,




Nederland






EU/1/13/837


13.1.2020




13.1.2020


Abasaglar







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht,




Nederland






EU/1/14/944


15.1.2020




13.1.2020


Caprelsa







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam,




Nederland






EU/1/11/749


15.1.2020




13.1.2020


Darunavir Krka d.d.







Krka d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto,




Slovenija






EU/1/17/1248


15.1.2020




13.1.2020


Dexdor







Orion Corporation




Orionintie 1, 02200 Espoo,




Suomi






EU/1/11/718


15.1.2020




13.1.2020


Hizentra







CSL Behring GmbH




Emil-von-Behring-Straße 76, 35041 Marburg,




Deutschland






EU/1/11/687


15.1.2020




13.1.2020


Infanrix hexa







GlaxoSmithKline Biologicals S.A.




rue de l’Institut 89, 1330 Rixensart,




Belgique






EU/1/00/152


15.1.2020




13.1.2020


Invokana







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse,




België






EU/1/13/884


15.1.2020




13.1.2020


Orbactiv







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg,




Grand-Duché de Luxembourg






EU/1/15/989


15.1.2020




13.1.2020


Tenofovir disoproxil Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest,




France






EU/1/16/1129


15.1.2020




13.1.2020


Tenofovir disoproxil Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10,




Česká republika






EU/1/16/1127


15.1.2020




13.1.2020


Vaxelis







MCM Vaccine B.V.




Robert Boyleweg 4, 2333 CG Leiden,




Nederland






EU/1/15/1079


16.1.2020




13.1.2020


Yescarta







Kite Pharma EU B.V.




Science Park 408, 1098 XH Amsterdam,




Nederland






EU/1/18/1299


15.1.2020




13.1.2020


Zepatier







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem,




Nederland






EU/1/16/1119


15.1.2020




16.1.2020


Gardasil 9







MSD VACCINS




162 avenue Jean Jaurès, 69007 Lyon,




France






EU/1/15/1007


20.1.2020




16.1.2020


Humalog







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht,




Nederland






EU/1/96/007


20.1.2020




16.1.2020


Lantus







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/00/134


20.1.2020




16.1.2020


Lemtrada







Sanofi Belgium




Leonardo Da Vincilaan 19, B-1831 Diegem,




België






EU/1/13/869


20.1.2020




16.1.2020


Liprolog







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht,




Nederland






EU/1/01/195


20.1.2020




16.1.2020


Mysimba







Orexigen Therapeutics Ireland Limited




2nd Floor, Palmerston House, Fenian Street, Dublin 2,




Ireland






EU/1/14/988


20.1.2020




16.1.2020


Prolia







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda,




Nederland






EU/1/10/618


20.1.2020




16.1.2020


Semglee







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest,




France






EU/1/18/1270


20.1.2020




16.1.2020


Toujeo







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/00/133


20.1.2020




16.1.2020


Viread







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77,




Ireland






EU/1/01/200


20.1.2020




16.1.2020


Zirabev







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel,




België






EU/1/18/1344


20.2.2020




17.1.2020


Verzenios







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht,




Nederland






EU/1/18/1307


21.1.2020




20.1.2020


Darzalex







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse,




België






EU/1/16/1101


22.1.2020




20.1.2020


Eurartesim







Alfasigma S.p.A.




Via Ragazzi del ‘99, n.5, 40133 Bologna,




Italia






EU/1/11/716


22.1.2020




20.1.2020


Fertavid







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem,




Nederland






EU/1/09/510


22.1.2020




20.1.2020


OPDIVO







Bristol-Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15,




Ireland






EU/1/15/1014


22.1.2020




20.1.2020


Stelara







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse,




België






EU/1/08/494


22.1.2020




20.1.2020


YERVOY







Bristol-Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15,




Ireland






EU/1/11/698


22.1.2020




23.1.2020


Bydureon







AstraZeneca AB




151 85 Södertälje,




Sverige






EU/1/11/696


27.1.2020




23.1.2020


Cyramza







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht,




Nederland






EU/1/14/957


27.1.2020




23.1.2020


Hemlibra







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen,




Deutschland






EU/1/18/1271


28.1.2020




23.1.2020


Ketoconazole HRA







HRA Pharma Rare Diseases




200 avenue de Paris, 92320 Chatillon,




France






EU/1/14/965


27.1.2020




23.1.2020


Menveo







GSK Vaccines S.r.l.




Via Fiorentina 1, 53100 Siena,




Italia






EU/1/10/614


27.1.2020




23.1.2020


Sirturo







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse,




België






EU/1/13/901


27.1.2020




23.1.2020


Xeristar







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht,




Nederland






EU/1/04/297


27.1.2020




23.1.2020


Zynquista







Navigant Germany GmbH




Albrechtstrasse 10c, 10117 Berlin,




Deutschland






EU/1/19/1363


27.1.2020




27.1.2020


Delstrigo







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem,




Nederland






EU/1/18/1333


29.1.2020




27.1.2020


Erleada







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse,




België






EU/1/18/1342


29.1.2020




27.1.2020


Rubraca







Clovis Oncology Ireland Limited




Regus Dublin Airport, Skybridge House – Dublin Airport, Swords, Co. Dublin, K67 P6K2,




Ireland






EU/1/17/1250


29.1.2020




31.1.2020


Otezla







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda,




Nederland






EU/1/14/981


4.2.2020




31.1.2020


Panretin







Eisai GmbH




Lyoner Straße 36, 60528 Frankfurt am Main,




Deutschland






EU/1/00/149


4.2.2020




31.1.2020


Xeljanz







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel,




België






EU/1/17/1178


4.2.2020




31.1.2020


Zejula







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24,




Ireland






EU/1/17/1235


4.2.2020










—



Withdrawal of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




13.1.2020


Clopidogrel ratiopharm GmbH







Archie Samuel s.r.o.




Slunná 16, 61700 Brno,




Česká republika






EU/1/09/541


15.1.2020




23.1.2020


Fertavid







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem,




Nederland






EU/1/09/510


27.1.2020




23.1.2020


Varuby







TESARO Bio Netherlands B.V.




Joop Geeskinkweg 901, 1114AB Amsterdam-Duisvendrecht,




Nederland






EU/1/17/1180


27.1.2020










—



Suspension of a marketing authorization (Article 20 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 authorization


Number of the entry in the Community Register


Date of notification




17.1.2020


Picato







LEO Laboratories Ltd




285 Cashel Road, Crumlin, Dublin 12,




Ireland






EU/1/12/796


21.1.2020










—



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




15.1.2020


Stelfonta


tigilanol tiglate







QBiotics Netherlands B.V.




Prinses Margrietplantsoen 33, 2595 AM Den Haag,




Nederland






EU/2/19/248


Solution for injection


QL01XX91


17.1.2020




28.1.2020


Aservo EquiHaler


ciclesonide







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein,




Deutschland






EU/2/19/249


Inhalation solution


QR03BA08


30.1.2020










—



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




15.1.2020


BTVPUR







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173, 55216 Ingelheim am Rhein,




Deutschland






EU/2/10/113


17.1.2020




15.1.2020


Coliprotec F4







Prevtec Microbia GmbH




Geyerspergerstr 27, 80689 München,




Deutschland






EU/2/14/180


17.1.2020




15.1.2020


Nobilis IB 4-91







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer,




Nederland






EU/2/98/006


17.1.2020




15.1.2020


Pirsue







Zoetis Belgium S.A.




rue Laid Burniat 1, 1348 Louvain-la-Neuve,




Belgique






EU/2/00/027


17.1.2020




15.1.2020


ProteqFlu







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein,




Deutschland






EU/2/03/037


17.1.2020




15.1.2020


ProteqFlu-Te







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein,




Deutschland






EU/2/03/038


17.1.2020




15.1.2020


Proteq West Nile







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173, 55216 Ingelheim am Rhein,




Deutschland






EU/2/11/129


17.1.2020




15.1.2020


Purevax Rabies







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173, 55216 Ingelheim am Rhein,




Deutschland






EU/2/10/117


17.1.2020




15.1.2020


Semintra







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein,




Deutschland






EU/2/12/146


17.1.2020




15.1.2020


Zulvac SBV







Zoetis Belgium S.A.




rue Laid Burniat 1, 1348 Louvain-la-Neuve,




Belgique






EU/2/14/178


17.1.2020




20.1.2020


Onsior







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven,




Deutschland






EU/2/08/089


22.1.2020




27.1.2020


ERAVAC







Laboratorios Hipra, S.A.




Avda. La Selva, 135, 17170 Amer (Girona),




España






EU/2/16/199


29.1.2020




27.1.2020


Kexxtone







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven,




Deutschland






EU/2/12/145


29.1.2020




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




Domenico Scarlattilaan 6




1083 HS Amsterdam




NETHERLANDS






(1)  OJ L 136, 30.4.2004, p. 1.