Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2024 to 31 January 2024 (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: 2024-02-29
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_202401495EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2024/1495


29.2.2024






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2024 to 31 January 2024
         
(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))
(C/2024/1495)

—   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




5.1.2024


Azacitidine Kabi


Azacitidine







Fresenius Kabi Deutschland GmbH




Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland






EU/1/23/1777


Powder for suspension for injection


L01BC07


9.1.2024




5.1.2024


Krazati


adagrasib







Mirati Therapeutics B.V.




Locatellikade 1, 1076 AZ Amsterdam, Nederland






EU/1/23/1744


Film-coated tablet


L01XX77


9.1.2024




5.1.2024


Naveruclif


paclitaxel







Accord Healthcare S.L.U.




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






EU/1/23/1778


Powder for dispersion for infusion


L01CD01


8.1.2024




5.1.2024


Rimmyrah


ranibizumab







QILU PHARMA SPAIN S.L.




Paseo de la Castellana 40, planta 8, 28046 Madrid, España






EU/1/23/1779


Solution for injection


S01LA04


9.1.2024




5.1.2024


Rystiggo


Rozanolixizumab







UCB Pharma S.A.




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






EU/1/23/1780


Solution for injection


L04AG16


8.1.2024




5.1.2024


Spexotras


trametinib







Novartis Europharm Limited




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






EU/1/23/1781


Powder for oral solution


L01EE01


8.1.2024




5.1.2024


Uzpruvo


ustekinumab







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/23/1784


Solution for injection


L04AC05


8.1.2024




25.1.2024


Omjjara


momelotinib







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/23/1782


Film-coated tablet


Pending


26.1.2024




—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected










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




5.1.2024


Albrioza







Amylyx Pharmaceuticals EMEA B.V.




Barbara Strozzilaan 201, Noord-Holland, 1083 HN Amsterdam, Nederland






—


9.1.2024




—   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




5.1.2024


ALPROLIX







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/16/1098


8.1.2024




5.1.2024


Bavencio







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/17/1214


9.1.2024




5.1.2024


Corbilta







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/13/859


9.1.2024




5.1.2024


Dectova







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/18/1349


10.1.2024




5.1.2024


Dexmedetomidine Accord







Accord Healthcare S.L.U.




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






EU/1/19/1418


9.1.2024




5.1.2024


Eylea







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/12/797


8.1.2024




5.1.2024


Ibandronic acid Accord







Accord Healthcare S.L.U.




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






EU/1/12/798


9.1.2024




5.1.2024


Jyseleca







Galapagos NV




Generaal De Wittelaan L11 A3, 2800 Mechelen, België






EU/1/20/1480


8.1.2024




5.1.2024


Libmyris







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/21/1590


9.1.2024




5.1.2024


LIVTENCITY







Takeda Pharmaceuticals International AG Ireland Branch




Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland






EU/1/22/1672


8.1.2024




5.1.2024


Mayzent







Novartis Europharm Limited




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






EU/1/19/1414


8.1.2024




5.1.2024


Mirapexin







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/97/051


8.1.2024




5.1.2024


Mulpleo







Shionogi B.V.




Herengracht 464, 1017 CA, Amsterdam, Nederland






EU/1/18/1348


8.1.2024




5.1.2024


Nivestim







Pfizer Europe MA EEIG




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






EU/1/10/631


8.1.2024




5.1.2024


Pazenir







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/18/1317


9.1.2024




5.1.2024


Retsevmo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


8.1.2024




5.1.2024


Sevelamer carbonate Winthrop







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/14/952


8.1.2024




5.1.2024


Sifrol







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/97/050


8.1.2024




5.1.2024


Skyrizi







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1361


8.1.2024




5.1.2024


Stivarga







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/13/858


9.1.2024




5.1.2024


Suboxone







Indivior Europe Limited




27 Windsor Place, Dublin 2, D02 DK44, Ireland






EU/1/06/359


9.1.2024




5.1.2024


Taltz







Eli Lilly and Company (Ireland) Limited




Dunderrow, Kinsale, Co. Cork, Ireland






EU/1/15/1085


9.1.2024




5.1.2024


Talzenna







Pfizer Europe MA EEIG




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






EU/1/19/1377


8.1.2024




5.1.2024


Trecondi







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/18/1351


8.1.2024




5.1.2024


Veltassa







Vifor Fresenius Medical Care Renal Pharma France




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






EU/1/17/1179


8.1.2024




9.1.2024


Lorviqua







Pfizer Europe MA EEIG




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






EU/1/19/1355


10.1.2024




11.1.2024


Grepid







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/09/535


12.1.2024




11.1.2024


Olanzapine Glenmark







Glenmark Arzneimittel GmbH




Industriestr. 31, D — 82194 Gröbenzell, Deutschland






EU/1/09/587


18.1.2024




11.1.2024


Olanzapine Glenmark Europe







Glenmark Arzneimittel GmbH




Industriestr. 31, D — 82194 Gröbenzell, Deutschland






EU/1/09/588


18.1.2024




11.1.2024


Oncaspar







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes Cedex, France






EU/1/15/1070


12.1.2024




11.1.2024


SIMBRINZA







Novartis Europharm Limited




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






EU/1/14/933


12.1.2024




11.1.2024


Tavneos







Vifor Fresenius Medical Care Renal Pharma France




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






EU/1/21/1605


12.1.2024




11.1.2024


Tecentriq







Roche Registration GmbH




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






EU/1/17/1220


12.1.2024




11.1.2024


Xenpozyme







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/22/1659


12.1.2024




12.1.2024


Clopidogrel TAD







TAD Pharma GmbH




Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland






EU/1/09/555


17.1.2024




12.1.2024


Cresemba







Basilea Pharmaceutica Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland






EU/1/15/1036


16.1.2024




12.1.2024


Elaprase







Takeda Pharmaceuticals International AG Ireland Branch




Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland






EU/1/06/365


15.1.2024




12.1.2024


Epivir







ViiV Healthcare B.V.




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






EU/1/96/015


15.1.2024




12.1.2024


GHRYVELIN







Atnahs Pharma Netherlands B.V.




Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark






EU/1/18/1337


15.1.2024




12.1.2024


Kisqali







Novartis Europharm Limited




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






EU/1/17/1221


15.1.2024




12.1.2024


Metalyse







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/00/169


16.1.2024




12.1.2024


Nucala







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/15/1043


19.1.2024




12.1.2024


Ontozry







Angelini Pharma S.p.A




Viale Amelia 70, 00181 Rome, Italia






EU/1/21/1530


15.1.2024




12.1.2024


Steglujan







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1266


17.1.2024




12.1.2024


Temodal







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/98/096


16.1.2024




12.1.2024


Tracleer







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/02/220


15.1.2024




23.1.2024


Lucentis







Novartis Europharm Limited




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






EU/1/06/374


24.1.2024




25.1.2024


Aerinaze







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/07/399


26.1.2024




25.1.2024


Alkindi







Diurnal Europe B.V.




Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland






EU/1/17/1260


29.1.2024




25.1.2024


Azacitidine Betapharm







betapharm Arzneimittel GmbH




Kobelweg 95, 86156 Augsburg, Deutschland






EU/1/19/1416


29.1.2024




25.1.2024


Byfavo







PAION Deutschland GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/20/1505


26.1.2024




25.1.2024


Cibinqo







Pfizer Europe MA EEIG




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






EU/1/21/1593


26.1.2024




25.1.2024


Darunavir Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/17/1249


31.1.2024




25.1.2024


Darzalex







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/16/1101


26.1.2024




25.1.2024


Elebrato Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1237


26.1.2024




25.1.2024


Feraccru







Norgine B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/15/1075


29.1.2024




25.1.2024


Filsuvez







Amryt Pharmaceuticals DAC




45 Mespil Road, Dublin 4, Ireland






EU/1/22/1652


26.1.2024




25.1.2024


HyQvia







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/13/840


26.1.2024




25.1.2024


Lenvima







Eisai GmbH




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






EU/1/15/1002


26.1.2024




25.1.2024


Levodopa/Carbidopa/Entacapone Orion







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/11/706


28.1.2024




25.1.2024


Lutathera







Advanced Accelerator Applications




8-10 Rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison, France






EU/1/17/1226


30.1.2024




25.1.2024


Lynparza







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/14/959


26.1.2024




25.1.2024


Myocet liposomal







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/00/141


5.2.2024




25.1.2024


Neofordex







THERAVIA




16 Rue Montrosier, 92200 Neuilly-sur-Seine, France






EU/1/15/1053


29.1.2024




25.1.2024


NovoSeven







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/96/006


29.1.2024




25.1.2024


Pregabalin Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/15/1021


27.1.2024




25.1.2024


Rapilysin







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/96/018


26.1.2024




25.1.2024


Rebif







Merck Europe B.V.




Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland






EU/1/98/063


26.1.2024




25.1.2024


SANCUSO







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/12/766


6.2.2024




25.1.2024


Spherox







CO.DON GmbH




Deutscher Platz 5d, 04103 Leipzig, Deutschland






EU/1/17/1181


29.1.2024




25.1.2024


Stalevo







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/03/260


26.1.2024




25.1.2024


Stribild







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/13/830


26.1.2024




25.1.2024


Terrosa







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/16/1159


5.2.2024




25.1.2024


Trajenta







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/11/707


26.1.2024




25.1.2024


Trelegy Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1236


26.1.2024




25.1.2024


Truvada







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/04/305


26.1.2024




25.1.2024


VeraSeal







Instituto Grifols, S.A.




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






EU/1/17/1239


29.1.2024




25.1.2024


ZALTRAP







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/12/814


26.1.2024




25.1.2024


Zyllt







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/553


26.1.2024




26.1.2024


Cyramza







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/14/957


29.1.2024




26.1.2024


NULOJIX







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/694


29.1.2024




26.1.2024


ZINPLAVA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/16/1156


29.1.2024




—   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




25.1.2024


Cuprymina







A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.




Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia






EU/1/12/784


26.1.2024




25.1.2024


Truvelog Mix 30







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/22/1639


26.1.2024




26.1.2024


Rapilysin







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/96/018


1.2.2024




—   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




5.1.2024


ERYSENG PARVO







Laboratorios Hipra, S.A.




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






EU/2/14/167


9.1.2024




5.1.2024


GALLIPRANT







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/17/221


8.1.2024




5.1.2024


NASYM







Laboratorios Hipra, S.A.




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






EU/2/19/241


8.1.2024




5.1.2024


Tulinovet







V.M.D.n.v.




Hoge Mauw 900, 2370 Arendonk, Belgïe






EU/2/20/257


8.1.2024




5.1.2024


VEPURED







Laboratorios Hipra, S.A.




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






EU/2/17/214


9.1.2024




25.1.2024


Bravecto







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/13/158


26.1.2024




25.1.2024


BROADLINE







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/13/157


29.1.2024




25.1.2024


FRONTPRO







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/19/240


29.1.2024




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.


ELI: http://data.europa.eu/eli/C/2024/1495/oj
ISSN 1977-091X (electronic edition)