Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2020 to 30 September 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2020-10-30
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2020367EN.01000501.xml










30.10.2020   


EN


Official Journal of the European Union


C 367/5






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2020 to 30 September 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 367/02)
—   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




17.9.2020


Arsenic trioxide medac


arsenic trioxide







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/20/1475


Concentrate and solvent for solution for infusion


L01XX27


18.9.2020




24.9.2020


AYVAKYT


avapritinib







Blueprint Medicines (Netherlands) B.V.




Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland






EU/1/20/1473


Film-coated tablet


L01EX18


25.9.2020




24.9.2020


Equidacent


bevacizumab







Centus Biotherapeutics Europe Limited




6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland






EU/1/20/1472


Concentrate for solution for infusion


L01XC07


25.9.2020




24.9.2020


Fampridine Accord


fampridine







Accord Healthcare S.L.U.




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






EU/1/20/1477


Prolonged-release tablet


N07XX07


29.9.2020




24.9.2020


Jyseleca


filgotinib







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1480


Film-coated tablet


L04AA45


25.9.2020




24.9.2020


Zynrelef


bupivacaine/meloxicam







Heron Therapeutics, B.V.




Herengracht 500, 1017 CB Amsterdam, Nederland






EU/1/20/1478


Prolonged-release solution for injection


Pending


25.9.2020




—   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




3.9.2020


HyQvia







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/13/840


5.9.2020




3.9.2020


Vimpat







UCB Pharma S.A.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België






EU/1/08/470


4.9.2020




15.9.2020


ADCETRIS







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/12/794


16.9.2020




15.9.2020


CellCept







Roche Registration GmbH




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






EU/1/96/005


16.9.2020




15.9.2020


Ervebo







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/19/1392


16.9.2020




15.9.2020


Hepsera







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/03/251


16.9.2020




15.9.2020


Herzuma







Celltrion Healthcare Hungary Kft.




Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország






EU/1/17/1257


16.9.2020




15.9.2020


JETREA







Inceptua AB




Gustavslundsv. 143, 16751 Bromma, Sverige






EU/1/13/819


16.9.2020




15.9.2020


Levetiracetam Accord







Accord Healthcare S.L.U.




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






EU/1/11/712


16.9.2020




15.9.2020


Levetiracetam Actavis







Actavis Group PTC ehf.




Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland






EU/1/11/713


16.9.2020




15.9.2020


Mvasi







Amgen Technology (Ireland) UC




Pottery Road, Dun Laoghaire, Co. Dublin, Ireland






EU/1/17/1246


17.9.2020




15.9.2020


Prasugrel Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/18/1273


16.9.2020




15.9.2020


Simbrinza







Novartis Europharm Limited




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






EU/1/14/933


16.9.2020




15.9.2020


Stayveer







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/832


16.9.2020




15.9.2020


Thalidomide Celgene







Celgene Europe B.V.




Winthontlaan 6 N, 3526 KV Utrecht, Nederland






EU/1/08/443


16.9.2020




15.9.2020


Tremfya







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/17/1234


16.9.2020




17.9.2020


Cosentyx







Novartis Europharm Limited




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






EU/1/14/980


18.9.2020




17.9.2020


Dengvaxia







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/18/1338


18.9.2020




17.9.2020


Episalvan







Amryt GMBH




Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland






EU/1/15/1069


29.9.2020




17.9.2020


Genvoya







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/15/1061


18.9.2020




17.9.2020


Hetlioz







Vanda Pharmaceuticals Netherlands B.V.,




Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland






EU/1/15/1008


19.9.2020




17.9.2020


Ivozall







ORPHELIA Pharma SAS




85 boulevard Saint-Michel, 75005 Paris, France






EU/1/19/1396


29.9.2020




17.9.2020


Kovaltry







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/15/1076


21.9.2020




17.9.2020


Lumark







IDB Holland B.V.




Weverstraat 17, 5111 PV Baarle-Nassau, Nederland






EU/1/15/1013


21.9.2020




17.9.2020


Tadalafil Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/14/961


18.9.2020




17.9.2020


Tyverb







Novartis Europharm Limited




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






EU/1/07/440


18.9.2020




17.9.2020


Zoledronic acid medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/12/779


21.9.2020




24.9.2020


Bavencio







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/17/1214


25.9.2020




24.9.2020


Cinacalcet Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/15/1054


28.9.2020




24.9.2020


Edistride







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/15/1052


28.9.2020




24.9.2020


EndolucinBeta







ITM Medical Isotopes GmbH




Lichtenbergstraße 1, 85748 Garching, Deutschland






EU/1/16/1105


28.9.2020




24.9.2020


Eylea







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/12/797


25.9.2020




24.9.2020


Inbrija







Acorda Therapeutics Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/19/1390


5.10.2020




24.9.2020


Incruse Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/14/922


2.10.2020




24.9.2020


Lenalidomide Accord







Accord Healthcare S.L.U.




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






EU/1/18/1316


28.9.2020




24.9.2020


Levetiracetam Actavis Group







Actavis Group PTC ehf.




Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland






EU/1/11/738


29.10.2020




24.9.2020


Lymphoseek







Navidea Biopharmaceuticals Europe Ltd.




Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland






EU/1/14/955


25.9.2020




24.9.2020


Lynparza







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/14/959


28.9.2020




24.9.2020


Olazax







Glenmark Pharmaceuticals s.r.o.




Hvězdova 1716/2b, 140 78 Praha 4, Česká republika






EU/1/09/597


29.9.2020




24.9.2020


Plegridy







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/14/934


28.9.2020




24.9.2020


Revlimid







Celgene Europe B.V.




Winthontlaan 6 N, 3526 KV Utrecht, Nederland






EU/1/07/391


28.9.2020




24.9.2020


Saxenda







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/15/992


28.9.2020




24.9.2020


Spectrila







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/15/1072


25.9.2020




24.9.2020


Vaxelis







MCM Vaccine B.V.




Robert Boyleweg 4, 2333 CG Leiden, Nederland






EU/1/15/1079


9.10.2020




24.9.2020


Victoza







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/09/529


28.9.2020




24.9.2020


Xermelo







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/17/1224


2.10.2020




24.9.2020


Yondelis







Pharma Mar S.A.




Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España






EU/1/07/417


28.9.2020




24.9.2020


Zalviso







Grünenthal GmbH




Zieglerstraße 6, 52078, Aachen, Deutschland






EU/1/15/1042


5.10.2020




30.9.2020


Aripiprazole Accord







Accord Healthcare S.L.U.




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






EU/1/15/1045


1.10.2020




30.9.2020


Blitzima







Celltrion Healthcare Hungary Kft.




Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország






EU/1/17/1205


1.10.2020




30.9.2020


CRYSVITA







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/17/1262


2.10.2020




30.9.2020


Eptifibatide Accord







Accord Healthcare S.L.U.




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






EU/1/15/1065


1.10.2020




30.9.2020


Erelzi







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1195


1.10.2020




30.9.2020


Extavia







Novartis Europharm Limited




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






EU/1/08/454


1.10.2020




30.9.2020


Exviera







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/14/983


2.10.2020




30.9.2020


Febuxostat Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/18/1347


1.10.2020




30.9.2020


Fiasp







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/16/1160


1.10.2020




30.9.2020


Herceptin







Roche Registration GmbH




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






EU/1/00/145


1.10.2020




30.9.2020


Icandra







Novartis Europharm Limited




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






EU/1/08/484


1.10.2020




30.9.2020


Kyntheum







Leo Pharma A/S




Industriparken 55, 2750 Ballerup, Danmark






EU/1/16/1155


2.10.2020




30.9.2020


Mepsevii







Ultragenyx Germany GmbH




Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland






EU/1/18/1301


1.10.2020




30.9.2020


Neparvis







Novartis Europharm Limited




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






EU/1/16/1103


1.10.2020




30.9.2020


Ozempic







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/17/1251


1.10.2020




30.9.2020


Pemetrexed Hospira







Pfizer Europe MA EEIG




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






EU/1/15/1057


2.10.2020




30.9.2020


ReFacto AF







Pfizer Europe MA EEIG




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






EU/1/99/103


1.10.2020




30.9.2020


Rolufta Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1174


2.10.2020




30.9.2020


Simulect







Novartis Europharm Limited




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






EU/1/98/084


1.10.2020




30.9.2020


Temozolomide HEXAL







Hexal AG




Industriestraße 25, 83607 Holzkirchen, Deutschland






EU/1/10/616


1.10.2020




30.9.2020


Temozolomide Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/10/617


1.10.2020




30.9.2020


Xigduo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/13/900


1.10.2020




30.9.2020


Zomarist







Novartis Europharm Limited




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






EU/1/08/483


1.10.2020




—   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




24.9.2020


Vepacel







Ology Bioservices Ireland LTD




Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland






EU/1/12/752


2.10.2020




—   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




16.9.2020


Increxxa


tulathromycin







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/20/258


Solution for injection


QJ01FA94


17.9.2020




16.9.2020


Innovax-ND-ILT


Marek's disease vaccine, Newcastle disease vaccine & infectious laryngotracheitis vaccine (live recombinant)







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/20/256


Concentrate and solvent for suspension for injection


QI01AD17


17.9.2020




16.9.2020


Tulinovet


tulathromycin







V.M.D.n.v.




Hoge Mauw 900, 2370 Arendonk, Belgïe






EU/2/20/257


Solution for injection


QJ01FA94


17.9.2020




18.9.2020


MHYOSPHERE PCV ID



Mycoplasma hyopneumoniae and porcine circovirus vaccine (inactivated, recombinant)







Laboratorios Hipra, S.A.




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






EU/2/20/259


Emulsion for injection


QI09AL08


21.9.2020




—   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




8.9.2020


Ingelvac CircoFLEX







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/07/079


22.9.2020




16.9.2020


Osurnia







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/14/170


17.9.2020




16.9.2020


Suvaxyn Circo + MH RTU







Zoetis Belgium S.A.




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






EU/2/15/190


17.9.2020




30.9.2020


Imrestor







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/15/193


1.10.2020




30.9.2020


Vectra Felis







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/14/165


1.10.2020




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.