Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2023 to 31 January 2023 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Date: 2023-02-28
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_2023076EN.01000501.xml










28.2.2023   


EN


Official Journal of the European Union


C 76/5






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2023 to 31 January 2023
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2))
(2023/C 76/02)
—   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




9.1.2023


JCOVDEN


COVID-19 vaccine (Ad26.COV2-S [recombinant])







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


Suspension for injection


J07BX03


9.1.2023




10.1.2023


Pirfenidone Viatris


pirfenidone







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/22/1707


Film-coated tablet


L04AX05


11.1.2023




10.1.2023


Sugammadex Amomed


sugammadex







AOP Orphan Pharmaceuticals GmbH,




Leopold-Ungar-Platz 2, 1190 Wien, Österreich






EU/1/22/1708


Solution for injection


V03AB35


11.1.2023




12.1.2023


Kauliv


teriparatide







Strides Pharma (Cyprus) Ltd.




Themistokli Dervi, 3, Julia House, 1st Floor, 1066, Nicosia, Κύπρος






EU/1/22/1710


Solution for injection


H05AA02


7.2.2023




—   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




5.1.2023


JCOVDEN







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


6.1.2023




5.1.2023


Nuvaxovid







Novavax CZ, a.s.




Bohumil 138, 281 63 Jevany, Česká republika






EU/1/21/1618


6.1.2023




5.1.2023


Veklury







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


6.1.2023




9.1.2023


Busilvex







PIERRE FABRE MEDICAMENT




Les Cauquillous, 81500 Lavaur, France






EU/1/03/254


11.1.2023




9.1.2023


ellaOne







Laboratoire HRA Pharma




200 avenue de Paris, 92320 Chatillon, France






EU/1/09/522


11.1.2023




9.1.2023


Mirapexin







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/97/051


11.1.2023




9.1.2023


Prasugrel Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/18/1273


11.1.2023




9.1.2023


Xevudy







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1562


11.1.2023




10.1.2023


Alofisel







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/17/1261


19.1.2023




10.1.2023


Biktarvy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/18/1289


11.1.2023




10.1.2023


Darzalex







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/16/1101


11.1.2023




10.1.2023


Fulvestrant Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/17/1253


11.1.2023




10.1.2023


Hemangiol







PIERRE FABRE MEDICAMENT




Les Cauquillous, 81500 Lavaur, France






EU/1/14/919


17.1.2023




10.1.2023


JEVTANA







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/11/676


12.1.2023




10.1.2023


Lokelma







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/17/1173


12.1.2023




10.1.2023


Lyxumia







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/12/811


17.1.2023




10.1.2023


Palonosetron Accord







Accord Healthcare S.L.U.




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






EU/1/16/1104


11.1.2023




10.1.2023


Skyrizi







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1361


11.1.2023




10.1.2023


Spherox







Rejuvenate GmbH




Deutscher Platz 5d, 04103 Leipzig, Deutschland






EU/1/17/1181


11.1.2023




10.1.2023


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


11.1.2023




10.1.2023


Vocabria







ViiV Healthcare BV




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






EU/1/20/1481


11.1.2023




10.1.2023


Xofluza







Roche Registration GmbH




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






EU/1/20/1500


11.1.2023




12.1.2023


Caprelsa







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/11/749


13.1.2023




12.1.2023


Dimethyl fumarate Neuraxpharm







Laboratorios Lesvi, S.L.




Avda. Barcelona 69, 08970 Sant Joan Despí — Barcelona, España






EU/1/22/1637


7.12.2022




12.1.2023


Dimethyl fumarate Neuraxpharm







Laboratorios Lesvi, S.L.




Avda. Barcelona 69, 08970 Sant Joan Despí — Barcelona, España






EU/1/22/1637


17.1.2023




12.1.2023


Juluca







ViiV Healthcare B.V.




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






EU/1/18/1282


13.1.2023




12.1.2023


Lopinavir/Ritonavir Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/15/1067


13.1.2023




12.1.2023


Mayzent







Novartis Europharm Limited




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






EU/1/19/1414


13.1.2023




12.1.2023


Ogivri







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/18/1341


13.1.2023




12.1.2023


Pregabalin Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/15/1021


13.1.2023




12.1.2023


Pregabalin Zentiva k.s







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1166


13.1.2023




12.1.2023


Twinrix Adult







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/96/020


17.1.2023




12.1.2023


Twinrix Paediatric







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/97/029


17.1.2023




13.1.2023


Holoclar







Holostem Terapie Avanzate S.r.l.




Via Glauco Gottardi 100, Modena, MO 41125, Italia






EU/1/14/987


16.1.2023




13.1.2023


Klisyri







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/21/1558


16.1.2023




13.1.2023


Lamzede







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/17/1258


16.1.2023




13.1.2023


Lojuxta







Amryt Pharmaceuticals DAC




45 Mespil Road, Dublin 4, Ireland






EU/1/13/851


18.1.2023




13.1.2023


Miglustat Dipharma







Dipharma Arzneimittel GmbH




Offheimer Weg 33, 65549 Limburg a. d. Lahn, Deutschland






EU/1/18/1346


18.1.2023




13.1.2023


Rotarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/05/330


18.1.2023




23.1.2023


Dupixent







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/17/1229


24.1.2023




23.1.2023


Edistride







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/15/1052


24.1.2023




23.1.2023


Efavirenz Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/11/742


24.1.2023




23.1.2023


Enhertu







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


24.1.2023




23.1.2023


Ferriprox







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/99/108


24.1.2023




23.1.2023


Fintepla







Zogenix ROI Limited




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






EU/1/20/1491


24.1.2023




23.1.2023


Glyxambi







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/16/1146


25.1.2023




23.1.2023


Hemlibra







Roche Registration GmbH




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






EU/1/18/1271


25.1.2023




23.1.2023


Mirvaso







Galderma International




Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France






EU/1/13/904


24.1.2023




23.1.2023


NULOJIX







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/694


29.1.2023




23.1.2023


Pioglitazone Accord







Accord Healthcare S.L.U.




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






EU/1/11/722


24.1.2023




23.1.2023


Qarziba







EUSA Pharma (Netherlands) B.V.




Beechavenue 54, 1119PW Schiphol-Rijk, Nederland






EU/1/17/1191


26.1.2023




23.1.2023


Reagila







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/17/1209


26.1.2023




23.1.2023


Remicade







Janssen Biologics B.V.




Einsteinweg 101, 2333 CB Leiden, Nederland






EU/1/99/116


24.1.2023




23.1.2023


Reyataz







Bristol-Myers Squibb Pharma EEIG




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






EU/1/03/267


29.1.2023




23.1.2023


RoActemra







Roche Registration GmbH




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






EU/1/08/492


24.1.2023




23.1.2023


Stalevo







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/03/260


1.2.2023




23.1.2023


Sunitinib Accord







Accord Healthcare S.L.U.




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






EU/1/20/1511


25.1.2023




23.1.2023


Synjardy







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/15/1003


25.1.2023




24.1.2023


Fintepla







Zogenix ROI Limited




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






EU/1/20/1491


31.1.2023




30.1.2023


Aprovel







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/97/046


2.2.2023




30.1.2023


Baraclude







Bristol-Myers Squibb Pharma EEIG




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






EU/1/06/343


31.1.2023




30.1.2023


CoAprovel







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/98/086


2.2.2023




30.1.2023


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


2.2.2023




30.1.2023


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


31.1.2023




30.1.2023


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


2.2.2023




30.1.2023


Memantine Accord







Accord Healthcare S.L.U.




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






EU/1/13/880


1.2.2023




30.1.2023


Repatha







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1016


1.2.2023




30.1.2023


Sapropterin Dipharma







Dipharma Arzneimittel GmbH




Offheimer Weg 33, 65549 Limburg a. d. Lahn, Deutschland






EU/1/21/1620


31.1.2023




30.1.2023


Sapropterin Dipharma







Dipharma Arzneimittel GmbH




Offheimer Weg 33, 65549 Limburg a. d. Lahn, Deutschland






EU/1/21/1620


8.2.2023




30.1.2023


Tyverb







Novartis Europharm Limited




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






EU/1/07/440


31.1.2023










—



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




9.1.2023


Busilvex







PIERRE FABRE MEDICAMENT




Les Cauquillous, 81500 Lavaur, France






EU/1/03/254


11.1.2023




—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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




26.1.2023


Brucellin Aquilon


Brucella abortus, strain AQ1302, protein extract







Aquilón CyL S.L.




Facultad de Veterinaria, Campus de Vegazana s/n, 24007 León, España






EU/2/22/291


Solution for injection


QI09AR


30.1.2023




—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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




9.1.2023


GALLIPRANT







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/17/221


10.1.2023




9.1.2023


Metacam







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/97/004


12.1.2023




9.1.2023


Novaquin







Le Vet Beheer B.V.




Wilgenweg 7, 3421 TV Oudewater, Nederland






EU/2/15/186


12.1.2023




9.1.2023


Oxybee







Dany Bienenwohl GmbH




Geyerspergerstraße 27, 80689 München, Deutschland






EU/2/17/216


12.1.2023




9.1.2023


Sedadex







Le Vet Beheer B.V.




Wilgenweg 7, 3421 TV Oudewater, Nederland






EU/2/16/198


10.1.2023




9.1.2023


Semintra







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/12/146


12.1.2023




9.1.2023


Vectra 3D







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/13/156


10.1.2023




9.1.2023


Versican Plus Pi/L4R







Zoetis Belgium




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






EU/2/14/173


12.1.2023




24.1.2023


BLUEVAC BTV







CZ Veterinaria, S.A.




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






EU/2/11/122


25.1.2023




24.1.2023


BTVPUR







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/10/113


27.1.2023




24.1.2023


Credelio Plus







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/21/271


25.1.2023




24.1.2023


ERYSENG PARVO







Laboratorios Hipra, S.A.




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






EU/2/14/167


27.1.2023




24.1.2023


Eurican Herpes 205







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/01/029


26.1.2023




24.1.2023


Fevaxyn Pentofel







Zoetis Belgium SA




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






EU/2/96/002


27.1.2023




24.1.2023


Improvac







Zoetis Belgium SA




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






EU/2/09/095


25.1.2023




24.1.2023


Mirataz







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/19/247


27.1.2023




24.1.2023


Panacur AquaSol







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/11/135


25.1.2023




24.1.2023


Porcilis PCV ID







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/15/187


26.1.2023




24.1.2023


Prevomax







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/17/211


30.1.2023




24.1.2023


Purevax RC







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/051


27.1.2023




24.1.2023


Purevax RCP







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/052


27.1.2023




24.1.2023


Purevax RCPCh FeLV







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/047


27.1.2023




26.1.2023


Imoxat







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/21/280


27.1.2023




26.1.2023


Meloxidolor







Le Vet Beheer B.V.




Wilgenweg 7, 3421 TV Oudewater, Nederland






EU/2/13/148


31.1.2023




26.1.2023


NexGard







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/13/159


27.1.2023




26.1.2023


NEXGARD SPECTRA







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/14/177


27.1.2023




26.1.2023


Purevax RCPCh







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/050


27.1.2023




26.1.2023


Purevax RCP FeLV







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/048


27.1.2023




26.1.2023


Solensia







Zoetis Belgium SA




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






EU/2/20/269


27.1.2023




26.1.2023


Suvaxyn CSF Marker







Zoetis Belgium




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






EU/2/14/179


30.1.2023




26.1.2023


Suvaxyn PRRS MLV







Zoetis Belgium SA




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






EU/2/17/215


27.1.2023




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.

(2)  OJ L 4, 7.1.2019, p. 43.