Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2020 to 31 August 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2020-09-25
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_2020318EN.01000101.xml










25.9.2020   


EN


Official Journal of the European Union


C 318/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2020 to 31 August 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 318/01)
—   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




19.8.2020


Aybintio


bevacizumab







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/20/1454


Concentrate for solution for infusion


L01XC07


20.8.2020




19.8.2020


Bavencio


avelumab







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/17/1214


Concentrate for solution for infusion


L01XC31


25.8.2020




19.8.2020


Gencebok


caffeine citrate







Gennisium Pharma




Faculté Cochin — Paris Biotech Santé, 24 rue du Faubourg St Jacques, 75014 Paris, France






EU/1/20/1465


Solution for infusion


N06BC01


20.8.2020




19.8.2020


Methylthioninium chloride Cosmo


methylthioninium chloride







Cosmo Technologies Ltd




Riverside II, Sir John Rogerson’s Quay, Dublin 2, Ireland






EU/1/20/1470


Prolonged-release tablet


V04CX


20.8.2020




21.8.2020


Kaftrio


ivacaftor / tezacaftor / elexacaftor







Vertex Pharmaceuticals (Ireland) Limited




28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland






EU/1/20/1468


Film-coated tablet


R07AX32


21.8.2020




25.8.2020


BLENREP


belantamab mafodotin







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/20/1474


Powder for concentrate for solution for infusion


L01XC39


26.8.2020




25.8.2020


Idefirix


imlifidase







Hansa Biopharma AB




P.O. Box 785, 220 07 Lund, Sverige






EU/1/20/1471


Powder for concentrate for solution for infusion


L04AA


1.9.2020




27.8.2020


Livogiva


teriparatide







Theramex Ireland Limited




3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland






EU/1/20/1462


Solution for injection


H05AA02


28.8.2020




27.8.2020


Qutavina


teriparatide







EuroGenerics Holdings BV




Locatellikade 1, 1076AZ Amsterdam, Nederland






EU/1/20/1463


Solution for injection


H05AA02.


31.8.2020




28.8.2020


Cabazitaxel Accord


cabazitaxel







Accord Healthcare S.L.U.




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






EU/1/20/1448


Concentrate for solution for infusion


L01CD04


31.8.2020




—   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




6.8.2020


Panretin







Amdipharm Limited




3 Burlington Road, Dublin 4, D04 RD68, IRELAND






EU/1/00/149


7.8.2020




6.8.2020


Pramipexole Accord







Accord Healthcare S.L.U.




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






EU/1/11/728


10.8.2020




6.8.2020


Raxone







Santhera Pharmaceuticals (Deutschland) GmbH




Marie-Curie Straße 8, 79539 Lörrach, Deutschland






EU/1/15/1020


12.8.2020




6.8.2020


Zavicefta







Pfizer Ireland Pharmaceuticals




Operations Support Group, Ringaskiddy, County Cork, Ireland






EU/1/16/1109


11.8.2020




10.8.2020


Colobreathe







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/11/747


14.8.2020




10.8.2020


Fotivda







EUSA Pharma (Netherlands) B.V.




Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland






EU/1/17/1215


3.9.2020




10.8.2020


Inflectra







Pfizer Europe MA EEIG




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






EU/1/13/854


11.8.2020




10.8.2020


Jylamvo







Therakind (Europe) Limited




3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland






EU/1/17/1172


24.8.2020




10.8.2020


Levetiracetam Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/11/701


17.8.2020




10.8.2020


Nucala







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/15/1043


14.8.2020




10.8.2020


Onivyde pegylated liposomal







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes Cedex, France






EU/1/16/1130


11.8.2020




10.8.2020


Pemetrexed Hospira







Pfizer Europe MA EEIG




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






EU/1/15/1057


10.8.2020




13.8.2020


Apealea







Oasmia Pharmaceutical AB




Vallongatan 1, 75228 Uppsala, Sverige






EU/1/18/1292


24.8.2020




13.8.2020


Armisarte







Actavis Group PTC ehf.




Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland






EU/1/15/1063


22.8.2020




13.8.2020


Cresemba







Basilea Pharmaceutica Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland






EU/1/15/1036


14.8.2020




13.8.2020


Duloxetine Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/15/1028


17.8.2020




13.8.2020


Imatinib Accord







Accord Healthcare S.L.U.




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






EU/1/13/845


17.8.2020




13.8.2020


Qtrilmet







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/19/1401


17.8.2020




13.8.2020


Twynsta







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/10/648


14.8.2020




17.8.2020


Circadin







RAD Neurim Pharmaceuticals EEC SARL




4 rue de Marivaux, 75002 Paris, France






EU/1/07/392


20.8.2020




19.8.2020


Elocta







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/15/1046


21.8.2020




19.8.2020


Emend







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/03/262


24.8.2020




19.8.2020


IDELVION







CSL Behring GmbH




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






EU/1/16/1095


24.8.2020




19.8.2020


IMBRUVICA







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/945


24.8.2020




19.8.2020


Pemetrexed medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/15/1038


20.8.2020




19.8.2020


Pemetrexed Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/15/1037


28.8.2020




19.8.2020


Praluent







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/15/1031


20.8.2020




19.8.2020


Skilarence







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/17/1201


26.8.2020




19.8.2020


Tecentriq







Roche Registration GmbH




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






EU/1/17/1220


20.8.2020




21.8.2020


Kalydeco







Vertex Pharmaceuticals (Ireland) Limited




28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland






EU/1/12/782


21.8.2020




25.8.2020


Aimovig







Novartis Europharm Limited




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






EU/1/18/1293


3.9.2020




25.8.2020


Axumin







Blue Earth Diagnostics Ireland Ltd




6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland






EU/1/17/1186


26.8.2020




25.8.2020


Ebymect







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/15/1051


1.9.2020




25.8.2020


Epclusa







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1116


26.8.2020




25.8.2020


Esperoct







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/19/1374


26.8.2020




25.8.2020


Latuda







Aziende Chimiche Riunite Angelini Francesco — A.C.R.A.F. S.p.A.




Viale Amelia 70, 00181 Roma, Italia






EU/1/14/913


4.9.2020




25.8.2020


Ninlaro







Takeda Pharma A/S




Dybendal Alle 10, 2630 Taastrup, Danmark






EU/1/16/1094


1.9.2020




25.8.2020


Ravicti







Immedica Pharma AB




SE-113 29 Stockholm, Sverige






EU/1/15/1062


26.8.2020




25.8.2020


RotaTeq







MSD VACCINS




162 avenue Jean Jaurès, 69007 Lyon, France






EU/1/06/348


27.8.2020




25.8.2020


Shingrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/18/1272


26.8.2020




25.8.2020


Vemlidy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1154


26.8.2020




25.8.2020


VITRAKVI







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/19/1385


26.8.2020




25.8.2020


Votubia







Novartis Europharm Limited




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






EU/1/11/710


25.8.2020




27.8.2020


Atriance







Novartis Europharm Limited




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






EU/1/07/403


27.8.2020




27.8.2020


Betaferon







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/95/003


28.8.2020




27.8.2020


Fortacin







Recordati Ireland Ltd




Raheens East, Ringaskiddy Co. Cork, Ireland






EU/1/13/881


3.9.2020




27.8.2020


Imatinib Actavis







Actavis Group PTC ehf.




Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland






EU/1/13/825


28.8.2020




27.8.2020


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


31.8.2020




27.8.2020


NovoThirteen







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/12/775


28.8.2020




27.8.2020


Skyrizi







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1361


28.8.2020




28.8.2020


Actraphane







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/02/229


31.8.2020




28.8.2020


Actrapid







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/02/230


31.8.2020




28.8.2020


Eurartesim







Alfasigma S.p.A.




Via Ragazzi del '99, n.5, 40133 Bologna, Italia






EU/1/11/716


31.8.2020




28.8.2020


IMBRUVICA







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/945


2.9.2020




28.8.2020


Olanzapine Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/08/475


31.8.2020




28.8.2020


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/06/380


1.9.2020




28.8.2020


Reyataz







Bristol-Myers Squibb Pharma EEIG




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






EU/1/03/267


31.8.2020




28.8.2020


Vyxeos liposomal







Jazz Pharmaceuticals Ireland Ltd




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






EU/1/18/1308


31.8.2020




28.8.2020


Xarelto







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/08/472


31.8.2020




—   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




14.8.2020


Qtrilmet







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/19/1401


17.8.2020




—   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




5.8.2020


Econor







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/98/010


6.8.2020




5.8.2020


Halocur







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/99/013


10.8.2020




12.8.2020


ECOPORC SHIGA







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/13/149


14.8.2020




12.8.2020


Nobilis IB Primo QX







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/14/174


14.8.2020




12.8.2020


Respiporc Flu3







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/09/103


31.8.2020




12.8.2020


RESPIPORC FLUpan H1N1







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/17/209


31.8.2020




12.8.2020


Simparica







Zoetis Belgium S.A.




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






EU/2/15/191


17.8.2020




18.8.2020


Suvaxyn PRRS MLV







Zoetis Belgium S.A.




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






EU/2/17/215


21.8.2020




20.8.2020


BLUEVAC BTV







CZ Veterinaria, S.A.




La Relva s/n — Torneiros, 36410 Porriño, España






EU/2/11/122


26.8.2020




20.8.2020


Zycortal







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/15/189


26.8.2020




28.8.2020


VEPURED







Laboratorios Hipra, S.A.




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






EU/2/17/214


1.9.2020




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.