Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2020 to 30 November 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2020-12-30
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_2020453EN.01000101.xml










30.12.2020   


EN


Official Journal of the European Union


C 453/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2020 to 30 November 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 453/01)
—   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




5.11.2020


Calquence


acalabrutinib







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/20/1479


Capsule, hard


L01XE


6.11.2020




16.11.2020


EXPAREL liposomal


bupivacaine







Pacira Ireland Ltd




Unit 13, Classon House, Dundrum Business Park, Dundrum, Dublin 14, D14W9Y3, Ireland






EU/1/20/1489


Prolonged-release dispersion for injection


N01BB01


20.11.2020




16.11.2020


PHELINUN


melphalan







ADIENNE S.r.l.S.U.




Via Galileo Galilei 19, 20867 Caponago (MB), Italia






EU/1/20/1487


Powder and solvent for concentrate for solution for infusion


L01AA03


17.11.2020




16.11.2020


Rivaroxaban Accord


rivaroxaban







Accord Healthcare S.L.U.




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






EU/1/20/1488


Film-coated tablet


B01AF01


17.11.2020




16.11.2020


Supemtek


quadrivalent influenza vaccine (recombinant, prepared in cell culture)







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/20/1484


Solution for injection


J07BB02


17.11.2020




18.11.2020


MenQuadfi


Meningococcal group A, C, W and Y conjugate vaccine







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/20/1483


Solution for injection


J07AH08


20.11.2020




18.11.2020


Nyvepria


pegfilgrastim







Pfizer Europe MA EEIG




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






EU/1/20/1486


Solution for injection


L03AA13


19.11.2020




18.11.2020


Obiltoxaximab SFL


obiltoxaximab







SFL Pharmaceuticals Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland






EU/1/20/1485


Concentrate for solution for infusion


J06BB22


19.11.2020




19.11.2020


Oxlumo


lumasiran







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/20/1496


Solution for injection


A16AX


23.11.2020




24.11.2020


Trecondi


treosulfan







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/18/1351


Powder for solution for infusion


L01AB02


26.11.2020




—   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




3.11.2020


Edistride







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/15/1052


4.11.2020




3.11.2020


Forxiga







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/12/795


4.11.2020




3.11.2020


Kalydeco







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/12/782


4.11.2020




3.11.2020


Lynparza







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/14/959


4.11.2020




3.11.2020


Tegsedi







Akcea Therapeutics Ireland Ltd




Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland






EU/1/18/1296


4.11.2020




3.11.2020


Tepadina







ADIENNE S.r.l.




Via Galileo Galilei 19, 20867 Caponago (MB), Italia






EU/1/10/622


5.11.2020




5.11.2020


Cinqaero







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/16/1125


9.11.2020




5.11.2020


Giotrif







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/13/879


6.11.2020




5.11.2020


OPDIVO







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


9.11.2020




5.11.2020


Puregon







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/96/008


9.11.2020




5.11.2020


RXULTI







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland






EU/1/18/1294


9.11.2020




5.11.2020


Trumenba







Pfizer Europe MA EEIG




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






EU/1/17/1187


9.11.2020




5.11.2020


Visudyne







CHEPLAPHARM Arzneimittel GmbH




Ziegelhof 24, 17489 Greifswald, Deutschland






EU/1/00/140


9.11.2020




5.11.2020


YERVOY







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/698


9.11.2020




10.11.2020


Fycompa







Eisai GmbH




Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland






EU/1/12/776


11.11.2020




10.11.2020


Myozyme







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/06/333


30.11.2020




10.11.2020


Nexium Control







GlaxoSmithKline Dungarvan Limited




Dungarvan, Co. Waterford, Ireland






EU/1/13/860


11.11.2020




10.11.2020


Trecondi







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/18/1351


11.11.2020




16.11.2020


Anoro Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/14/898


18.11.2020




16.11.2020


Clopidogrel Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/08/465


17.11.2020




16.11.2020


DuoPlavin







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/10/619


17.11.2020




16.11.2020


EDURANT







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/11/736


17.11.2020




16.11.2020


Esbriet







Roche Registration GmbH




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






EU/1/11/667


17.11.2020




16.11.2020


Gilenya







Novartis Europharm Limited




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






EU/1/11/677


17.11.2020




16.11.2020


Instanyl







Takeda Pharma A/S




Dybendal Alle 10, 2630 Taastrup, Danmark






EU/1/09/531


18.11.2020




16.11.2020


Lopinavir/Ritonavir Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/15/1067


20.11.2020




16.11.2020


Obizur







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/15/1035


24.11.2020




16.11.2020


Pemetrexed Accord







Accord Healthcare S.L.U.




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






EU/1/15/1071


17.11.2020




16.11.2020


Recarbrio







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/19/1420


18.11.2020




16.11.2020


Revlimid







Bristol-Myers Squibb Pharma EEIG




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






EU/1/07/391


17.11.2020




16.11.2020


TachoSil







Takeda Austria GmbH




St.-Peter-Strasse 25, 4020 Linz, Österreich






EU/1/04/277


18.11.2020




16.11.2020


Talmanco







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1153


20.11.2020




16.11.2020


Tasigna







Novartis Europharm Limited




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






EU/1/07/422


17.11.2020




16.11.2020


Temodal







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/98/096


18.11.2020




16.11.2020


Temozolomide SUN







Sun Pharmaceutical Industries Europe BV




Polarisavenue 87, 2132 JH Hoofddorp, Nederland






EU/1/11/697


19.11.2020




16.11.2020


Temozolomide Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/606


19.11.2020




16.11.2020


Tivicay







ViiV Healthcare BV




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






EU/1/13/892


17.11.2020




16.11.2020


Velphoro







Vifor Fresenius Medical Care Renal Pharma France




100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France






EU/1/14/943


19.11.2020




16.11.2020


Vokanamet







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/918


18.11.2020




18.11.2020


AUBAGIO







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/13/838


19.11.2020




18.11.2020


Benepali







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/15/1074


23.11.2020




18.11.2020


Biktarvy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/18/1289


19.11.2020




18.11.2020


Brintellix







H. Lundbeck A/S




Ottiliavej 9, 2500 Valby, Danmark






EU/1/13/891


20.11.2020




18.11.2020


Cufence







Univar Solutions B.V.




Schouwburgplein 30, Rotterdam, 3012 CL, Nederland






EU/1/19/1365


20.11.2020




18.11.2020


Dovato







ViiV Healthcare B.V.




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






EU/1/19/1370


20.11.2020




18.11.2020


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/17/1222


20.11.2020




18.11.2020


Firdapse







SERB S.A.




Avenue Louise 480, 1050 Bruxelles, Belgique / Louizalaan 480, 1050 Brussel, België






EU/1/09/601


25.11.2020




18.11.2020


Hemangiol







Pierre Fabre Dermatologie




45 place Abel Gance, 92100 Boulogne, France






EU/1/14/919


18.11.2020




18.11.2020


Imlygic







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1064


20.11.2020




18.11.2020


Kisplyx







Eisai GmbH




Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland






EU/1/16/1128


23.11.2020




18.11.2020


Lenvima







Eisai GmbH




Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland






EU/1/15/1002


23.11.2020




18.11.2020


Myfenax







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/07/438


19.11.2020




18.11.2020


Nivestim







Pfizer Europe MA EEIG




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






EU/1/10/631


19.11.2020




18.11.2020


Orkambi







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/15/1059


19.11.2020




18.11.2020


Plavix







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/98/069


19.11.2020




18.11.2020


Pregabalin Pfizer







Upjohn EESV




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






EU/1/14/916


24.11.2020




18.11.2020


Synagis







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/99/117


19.11.2020




18.11.2020


Trulicity







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/14/956


1.12.2020




18.11.2020


Ultomiris







Alexion Europe SAS




103-105 Rue Anatole France, 92300 Levallois-Perret, France






EU/1/19/1371


19.11.2020




18.11.2020


VeraSeal







Instituto Grifols, S.A.




Can Guasc, 2 — Parets del Vallès, 08150 Barcelona, Espaňa






EU/1/17/1239


3.12.2020




18.11.2020


Viramune







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/97/055


23.11.2020




19.11.2020


Kevzara







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/17/1196


20.11.2020




20.11.2020


Bretaris Genuair







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/12/781


23.11.2020




20.11.2020


Cetrotide







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/99/100


23.11.2020




20.11.2020


Cosentyx







Novartis Europharm Limited




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






EU/1/14/980


23.11.2020




20.11.2020


Eklira Genuair







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/12/778


23.11.2020




20.11.2020


Enurev Breezhaler







Novartis Europharm Limited




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






EU/1/12/789


23.11.2020




20.11.2020


Flixabi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/16/1106


24.11.2020




20.11.2020


Kanuma







Alexion Europe SAS




103-105 rue Anatole France, 92300 Levallois-Perret, France






EU/1/15/1033


23.11.2020




20.11.2020


Luxturna







Novartis Europharm Limited




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






EU/1/18/1331


23.11.2020




20.11.2020


Lyrica







Upjohn EESV




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






EU/1/04/279


7.12.2020




20.11.2020


Ninlaro







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/16/1094


24.11.2020




20.11.2020


Olumiant







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/16/1170


23.11.2020




20.11.2020


Oncaspar







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes Cedex, France






EU/1/15/1070


24.11.2020




20.11.2020


Onpattro







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/18/1320


24.11.2020




20.11.2020


OPDIVO







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


23.11.2020




20.11.2020


Privigen







CSL Behring GmbH




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






EU/1/08/446


6.12.2020




20.11.2020


Rasagiline Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1090


24.11.2020




20.11.2020


Spherox







CO.DON AG




Warthestraße 21, 14513 Teltow, Deutschland






EU/1/17/1181


23.11.2020




20.11.2020


Tremfya







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/17/1234


24.11.2020




24.11.2020


Comtan







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/98/081


26.11.2020




24.11.2020


Desloratadine ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/11/746


3.12.2020




24.11.2020


Gardasil 9







MSD VACCINS




162 avenue Jean Jaurès, 69007 Lyon, France






EU/1/15/1007


26.11.2020




24.11.2020


GONAL-f







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/95/001


25.11.2020




24.11.2020


Irbesartan Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/576


25.11.2020




24.11.2020


Lacosamide UCB







UCB Pharma S.A.




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






EU/1/19/1383


25.11.2020




24.11.2020


Ongentys







Bial — Portela & Ca, SA




À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal






EU/1/15/1066


4.12.2020




24.11.2020


Strensiq







Alexion Europe SAS




103-105 rue Anatole France, 92300 Levallois-Perret, France






EU/1/15/1015


25.11.2020




24.11.2020


Tecfidera







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/13/837


3.12.2020




25.11.2020


Briviact







UCB Pharma S.A.




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






EU/1/15/1073


4.12.2020




25.11.2020


Dupixent







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/17/1229


26.11.2020




25.11.2020


Febuxostat Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/17/1194


27.11.2020




25.11.2020


Feraccru







Norgine B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/15/1075


26.11.2020




25.11.2020


Kalydeco







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/12/782


26.11.2020




25.11.2020


Prevenar 13







Pfizer Europe MA EEIG




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






EU/1/09/590


26.11.2020




25.11.2020


Symkevi







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/18/1306


26.11.2020




25.11.2020


Yescarta







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/18/1299


26.11.2020




—   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




3.11.2020


Panretin







Amdipharm Limited




3 Burlington Road, Dublin 4, D04 RD68, IRELAND






EU/1/00/149


4.11.2020




5.11.2020


Sebivo







Novartis Europharm Limited




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






EU/1/07/388


9.11.2020




20.11.2020


Alpivab







BioCryst Ireland Limited




Atlantic Avenue, Westpark Business Campus, Shannon, V14 YX01, Ireland






EU/1/18/1269


24.11.2020




24.11.2020


Qutavina







EuroGenerics Holdings BV




Locatellikade 1, 1076AZ Amsterdam, Nederland






EU/1/20/1463


26.11.2020




—   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




10.11.2020


Librela


bedinvetmab







Zoetis Belgium SA




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






EU/2/20/261


Solution for injection


QN02BG91


11.11.2020




10.11.2020


OvuGel


triptorelin acetate







Vetoquinol S.A.




Magny-Vernois, 70200 Lure, France






EU/2/20/260


Vaginal gel


QH01CA97


12.11.2020




—   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




4.11.2020


CYTOPOINT







Zoetis Belgium S.A.




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






EU/2/17/205


5.11.2020




4.11.2020


ReproCyc ParvoFLEX







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/19/237


6.11.2020




10.11.2020


ProZinc







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/2/13/152


26.11.2020




20.11.2020


Innovax-ND-IBD







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/17/213


29.11.2020




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.