Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2020 to 31 December 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2021-01-29
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_2021033EN.01000101.xml










29.1.2021   


EN


Official Journal of the European Union


C 33/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2020 to 31 December 2020
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2021/C 33/01)
—   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




9.12.2020


Leqvio


inclisiran







Novartis Europharm Limited




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






EU/1/20/1494


Solution for injection


C10AX16


10.12.2020




9.12.2020


TRIXEO AEROSPHERE


Formoterol / glycopyrronium bromide / budesonide







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/20/1498


Pressurised inhalation, suspension


R03AL11


10.12.2020




14.12.2020


Tecartus


autologous anti-CD19-transduced CD3+ cells







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/20/1492


Dispersion for infusion


L01X


15.12.2020




17.12.2020


Libmeldy


autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene







Orchard Therapeutics (Netherlands) B.V.




Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland






EU/1/20/1493


Dispersion for infusion


Pending


18.12.2020




17.12.2020


REKAMBYS


rilpivirine







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1482


Prolonged release suspension for injection


J05AG05


21.12.2020




17.12.2020


Vocabria


cabotegravir







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/20/1481


Film-coated tablet
Prolonged release suspension for injection


J05AJ04


21.12.2020




18.12.2020


Fintepla


fenfluramine







Zogenix ROI Limited




Trinity House, Charleston Road, Ranelagh, Dublin 6, D06 C8X4, Ireland






EU/1/20/1491


Oral solution


N03AX


21.12.2020




18.12.2020


Lenalidomide Mylan


lenalidomide







Mylan Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland






EU/1/20/1490


Capsule, hard


L04AX04


21.12.2020




21.12.2020


Phesgo


pertuzumab / trastuzumab







Roche Registration GmbH




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






EU/1/20/1497


Solution for injection


L01XY02


22.12.2020




—   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




1.12.2020


Vimpat







UCB Pharma S.A.




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






EU/1/08/470


2.12.2020




1.12.2020


Zonisamide Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1093


4.12.2020




9.12.2020


Aldara







Meda AB




Pipers väg 2A, 170 73 Solna, Sverige






EU/1/98/080


11.12.2020




9.12.2020


Caspofungin Accord







Accord Healthcare S.L.U.




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






EU/1/15/1081


11.12.2020




9.12.2020


Epidyolex







GW Pharma (International) B.V.




Databankweg 26, 3821AL Amersfoort, Nederland






EU/1/19/1389


11.12.2020




9.12.2020


Inlyta







Pfizer Europe MA EEIG




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






EU/1/12/777


11.12.2020




9.12.2020


Kadcyla







Roche Registration GmbH




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






EU/1/13/885


10.12.2020




9.12.2020


Lucentis







Novartis Europharm Limited




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






EU/1/06/374


10.12.2020




9.12.2020


MAVENCLAD







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/17/1212


11.1.2021




9.12.2020


Miglustat Dipharma







Dipharma B.V.




Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland






EU/1/18/1346


10.12.2020




9.12.2020


Neofordex







Laboratoires CTRS




63 rue de l'Est, 92100 Boulogne-Billancourt, France






EU/1/15/1053


11.12.2020




9.12.2020


Olazax Disperzi







Glenmark Pharmaceuticals s.r.o.




Hvězdova 1716/2b, 14078 Praha 4, Česká republika






EU/1/09/592


11.12.2020




9.12.2020


Onbrez Breezhaler







Novartis Europharm Limited




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






EU/1/09/593


10.12.2020




9.12.2020


Orbactiv







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/15/989


10.12.2020




9.12.2020


Orencia







Bristol-Myers Squibb Pharma EEIG




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






EU/1/07/389


10.12.2020




9.12.2020


Polivy







Roche Registration GmbH




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






EU/1/19/1388


10.12.2020




9.12.2020


SCENESSE







Clinuvel Europe Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/14/969


10.12.2020




9.12.2020


Seebri Breezhaler







Novartis Europharm Limited




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






EU/1/12/788


10.12.2020




9.12.2020


Tovanor Breezhaler







Novartis Europharm Limited




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






EU/1/12/790


6.1.2021




14.12.2020


ADCETRIS







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/12/794


15.12.2020




14.12.2020


Bosulif







Pfizer Europe MA EEIG




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






EU/1/13/818


15.12.2020




14.12.2020


Gilenya







Novartis Europharm Limited




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






EU/1/11/677


15.12.2020




14.12.2020


Hirobriz Breezhaler







Novartis Europharm Limited




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






EU/1/09/594


17.12.2020




14.12.2020


Jakavi







Novartis Europharm Limited




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






EU/1/12/773


17.12.2020




14.12.2020


JEVTANA







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/11/676


17.12.2020




14.12.2020


Lonsurf







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes CEDEX, France






EU/1/16/1096


15.12.2020




14.12.2020


Plegridy







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/14/934


15.12.2020




14.12.2020


Revatio







Upjohn EESV




Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland






EU/1/05/318


21.12.2020




14.12.2020


Uptravi







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/15/1083


16.12.2020




14.12.2020


Zyclara







Meda AB




Pipers väg 2A, 170 73 Solna, Sverige






EU/1/12/783


17.12.2020




17.12.2020


Empliciti







Bristol-Myers Squibb Pharma EEIG




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






EU/1/16/1088


19.12.2020




17.12.2020


Halimatoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1288


7.1.2021




17.12.2020


Keppra







UCB Pharma S.A.




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






EU/1/00/146


21.12.2020




17.12.2020


Kyprolis







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1060


18.12.2020




17.12.2020


Lorviqua







Pfizer Europe MA EEIG




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






EU/1/19/1355


18.12.2020




17.12.2020


Rubraca







Clovis Oncology Ireland Limited




Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland






EU/1/17/1250


21.12.2020




17.12.2020


Taltz







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/15/1085


22.12.2020




17.12.2020


Truberzi







Allergan Pharmaceuticals International Limited




Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland






EU/1/16/1126


30.12.2020




17.12.2020


Verzenios







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/18/1307


22.12.2020




17.12.2020


Votrient







Novartis Europharm Limited




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






EU/1/10/628


20.12.2020




17.12.2020


Wakix







Bioprojet Pharma




9 rue Rameau, 75002 Paris, France






EU/1/15/1068


6.1.2021




17.12.2020


Xyrem







UCB Pharma S.A.




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






EU/1/05/312


18.12.2020




17.12.2020


Ziextenzo







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1327


7.1.2021




18.12.2020


Cerezyme







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/97/053


21.12.2020




18.12.2020


Galvus







Novartis Europharm Limited




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






EU/1/07/414


6.1.2021




18.12.2020


Jalra







Novartis Europharm Limited




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






EU/1/08/485


6.1.2021




18.12.2020


Jivi







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/18/1324


22.12.2020




18.12.2020


Pixuvri







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes Cedex, France






EU/1/12/764


22.12.2020




18.12.2020


Rixubis







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/14/970


22.12.2020




18.12.2020


Veklury







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


21.12.2020




18.12.2020


Xiliarx







Novartis Europharm Limited




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






EU/1/08/486


6.1.2021




21.12.2020


Veklury







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


22.12.2020




22.12.2020


BLINCYTO







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1047


25.12.2020




22.12.2020


Zirabev







Pfizer Europe MA EEIG




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






EU/1/18/1344


23.12.2020




—   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




17.12.2020


Prepandrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/08/453


4.1.2021




18.12.2020


Halimatoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1288


8.1.2021




18.12.2020


Truberzi







Allergan Pharmaceuticals International Limited




Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland






EU/1/16/1126


5.1.2021




—   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




3.12.2020


REXXOLIDE


tulathromycin







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/20/263


Solution for injection


QJ01FA94


9.12.2020




9.12.2020


CircoMax Myco


Porcine circovirus vaccine (inactivated, recombinant) and Mycoplasma hyopneumoniae vaccine (inactivated)







Zoetis Belgium S.A.




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






EU/2/20/264


Emulsion for injection


QI09AL08


11.12.2020




9.12.2020


Enteroporc Coli AC


Neonatal piglet colibacillosis (recombinant, inactivated) and Clostridium perfringens vaccine (inactivated)







IDT Biologika GmbH




Am Pharmapark, 06861 Dessau-Rosslau, Deutschland






EU/2/20/262


Lyophilisate and suspension for suspension for injection


Pending


10.12.2020




9.12.2020


Nobivac DP Plus


Canine distemper vaccine (live) and canine parvovirus vaccine (live, recombinant)







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/20/265


Lyophilisate and solvent for suspension for injection


QI07AD03


10.12.2020




9.12.2020


Vectormune FP ILT


Fowlpox, avian infectious laryngotracheitis vaccine (live, recombinant)







Ceva-Phylaxia Co. Ltd.




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/20/266


Lyophilisate and solvent for suspension for injection


Pending


10.12.2020




—   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




3.12.2020


Bravecto Plus







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/18/224


4.12.2020




3.12.2020


Exzolt







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/17/212


4.12.2020




9.12.2020


Bravecto







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/13/158


10.12.2020




9.12.2020


Circovac







Ceva-Phylaxia Zrt.




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/07/075


11.12.2020




9.12.2020


Zulvac SBV







Zoetis Belgium S.A.




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






EU/2/14/178


11.12.2020




11.12.2020


Onsior







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/08/089


14.12.2020




17.12.2020


Nobilis IB 4-91







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/98/006


21.12.2020




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.