Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2024 to 30 November 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: 2024-12-30
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_202407468EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/7468


30.12.2024






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2024 to 30 November 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/2024/7468)

—   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




13.11.2024


Afqlir


aflibercept







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/24/1867


Solution for injection


S01LA05


14.11.2024




13.11.2024


Opuviz


Aflibercept







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/24/1865


Solution for injection


S01LA05


18.11.2024




14.11.2024


ELAHERE


mirvetuximab soravtansine







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/24/1866


Concentrate for solution for infusion


L01FX26


15.11.2024




14.11.2024


Penbraya


Meningococcal groups A, C, W, Y conjugate and group B vaccine (recombinant, adsorbed)







Pfizer Europe MA EEIG




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






EU/1/24/1871


Powder and suspension for suspension for injection


J07AH11


15.11.2024




14.11.2024


Pomalidomide Teva


pomalidomide







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/24/1868


Capsule, hard


L04AX06


15.11.2024




15.11.2024


Fluad


influenza vaccine (surface antigen, inactivated, adjuvanted)


Seqirus Netherlands B.V.
Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland


EU/1/24/1878


Suspension for injection


J07BB02


19.11.2024




15.11.2024


Flucelvax


influenza vaccine (surface antigen, inactivated, prepared in cell cultures)







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/24/1879


Suspension for injection


J07BB02


26.11.2024




18.11.2024


Hympavzi


Marstacimab







Pfizer Europe MA EEIG




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






EU/1/24/1874


Solution for injection


B02BX11


19.11.2024




22.11.2024


Theralugand


lutetium (177Lu) chloride







Eckert & Ziegler Radiopharma GmbH




Robert-Rössle-Straße 10, 13125 Berlin, Deutschland






EU/1/24/1852


Radiopharmaceutical precursor, solution


V10X


27.11.2024




—   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




4.11.2024


Dupixent







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/17/1229


5.11.2024




4.11.2024


Farydak







pharmaand GmbH




Taborstrasse 1, 1020 Wien, Österreich






EU/1/15/1023


5.11.2024




4.11.2024


Hulio







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/18/1319


6.11.2024




4.11.2024


Inaqovi







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/23/1756


6.11.2024




4.11.2024


Remicade







Janssen Biologics B.V.




Einsteinweg 101, 2333 CB Leiden, Nederland






EU/1/99/116


5.11.2024




4.11.2024


Synjardy







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/15/1003


5.11.2024




4.11.2024


Vipdomet







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/13/843


5.11.2024




13.11.2024


Abevmy







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/20/1515


20.11.2024




13.11.2024


Eladynos







Theramex Ireland Limited




3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland






EU/1/22/1706


14.11.2024




13.11.2024


ELREXFIO







Pfizer Europe MA EEIG




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






EU/1/23/1770


15.11.2024




13.11.2024


MenQuadfi







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/20/1483


14.11.2024




13.11.2024


Ruxience







Pfizer Europe MA EEIG




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






EU/1/20/1431


15.11.2024




13.11.2024


TAVLESSE







Instituto Grifols, S.A.




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






EU/1/19/1405


18.11.2024




13.11.2024


Vaxelis







MCM Vaccine B.V.




Robert Boyleweg 4, 2333 CG Leiden, Nederland






EU/1/15/1079


14.11.2024




13.11.2024


Zynlonta







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/22/1695


14.11.2024




14.11.2024


Fingolimod Mylan







Mylan Pharmaceuticals Limited




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






EU/1/21/1573


15.11.2024




14.11.2024


Fulphila







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/18/1329


27.11.2024




14.11.2024


Givlaari







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/20/1428


19.11.2024




14.11.2024


Incruse Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/14/922


15.11.2024




14.11.2024


KIMMTRAK







Immunocore Ireland Limited




Unit 1 Sky Business Centres, Unit 21 Block Port Tunnel Business Park, Clonshaugh, Dublin 17, Dublin, D17 FY82, Ireland






EU/1/22/1630


18.11.2024




14.11.2024


Laventair Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/14/899


15.11.2024




14.11.2024


Lenalidomide Mylan







Mylan Pharmaceuticals Limited




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






EU/1/20/1490


15.11.2024




14.11.2024


Lumeblue







Cosmo Technologies Ltd




Riverside II, Sir John Rogerson’s Quay, Dublin 2, Ireland






EU/1/20/1470


15.11.2024




14.11.2024


Lumykras







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/21/1603


15.11.2024




14.11.2024


Rolufta Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1174


15.11.2024




14.11.2024


Spevigo







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/22/1688


15.11.2024




14.11.2024


Sugammadex Mylan







Mylan Pharmaceuticals Limited




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






EU/1/21/1583


15.11.2024




14.11.2024


Tarceva







CHEPLAPHARM Registration GmbH




Weiler Straße 5e, 79540 Lörrach, Deutschland






EU/1/05/311


20.11.2024




14.11.2024


Tecovirimat SIGA







SIGA Technologies Netherlands B.V.




Prinsenhil 29, Breda 4825 AX, Nederland






EU/1/21/1600


19.11.2024




14.11.2024


Uptravi







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/15/1083


15.11.2024




14.11.2024


Yescarta







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/18/1299


15.11.2024




18.11.2024


Akynzeo







Helsinn Birex Pharmaceuticals Ltd




Damastown, Mulhuddart, Dublin 15, Ireland






EU/1/15/1001


19.11.2024




18.11.2024


Apixaban Accord







Accord Healthcare S.L.U.




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






EU/1/20/1458


19.11.2024




18.11.2024


Cosentyx







Novartis Europharm Limited




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






EU/1/14/980


19.11.2024




18.11.2024


Erleada







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/18/1342


19.11.2024




18.11.2024


Isturisa







Recordati Rare Diseases




Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800  Puteaux, France






EU/1/19/1407


19.11.2024




18.11.2024


Krazati







Bristol Myers Squibb Pharma EEIG




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






EU/1/23/1744


19.11.2024




18.11.2024


Lupkynis







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/22/1678


19.11.2024




18.11.2024


Nevanac







Novartis Europharm Limited




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






EU/1/07/433


19.11.2024




18.11.2024


Nilemdo







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1425


27.11.2024




18.11.2024


Nustendi







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1424


27.11.2024




18.11.2024


Orgovyx







Accord Healthcare S.L.U.




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






EU/1/22/1642


19.11.2024




18.11.2024


Ozawade







Bioprojet Pharma




9 rue Rameau, 75002 Paris, France






EU/1/21/1546


19.11.2024




18.11.2024


Praluent







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/15/1031


19.11.2024




18.11.2024


Pylclari







CURIUM PET France




Biopole Clermont-Limagne, 3 rue Marie Curie, 63360 Saint-Beauzire, France






EU/1/23/1746


21.11.2024




18.11.2024


Simulect







Novartis Europharm Limited




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






EU/1/98/084


19.11.2024




18.11.2024


Xolair







Novartis Europharm Limited




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






EU/1/05/319


19.11.2024




19.11.2024


Victoza







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/09/529


26.11.2024




22.11.2024


Anoro Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/14/898


25.11.2024




22.11.2024


Beovu







Novartis Europharm Limited




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






EU/1/19/1417


25.11.2024




22.11.2024


Briviact







UCB Pharma S.A.




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






EU/1/15/1073


26.11.2024




22.11.2024


Bylvay







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/21/1566


29.11.2024




22.11.2024


Cablivi







Ablynx N.V.




Technologiepark 21, 9052 Zwijnaarde, België






EU/1/18/1305


25.11.2024




22.11.2024


Ebymect







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/15/1051


25.11.2024




22.11.2024


Rybelsus







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/20/1430


26.11.2024




22.11.2024


SANCUSO







Grünenthal GmbH




Zieglerstraße 6, 52078, Aachen, Deutschland






EU/1/12/766


28.11.2024




22.11.2024


Saxenda







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/15/992


26.11.2024




22.11.2024


Scintimun







CIS bio international




Boîte Postale 32, 91192 Gif-sur-Yvette, France






EU/1/09/602


27.11.2024




22.11.2024


Vaxneuvance







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/21/1591


26.11.2024




22.11.2024


Yselty







Theramex Ireland Limited




3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland






EU/1/21/1606


25.11.2024




25.11.2024


Hepcludex







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1446


26.11.2024




25.11.2024


Kevzara







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/17/1196


26.11.2024




25.11.2024


Kisqali







Novartis Europharm Limited




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






EU/1/17/1221


26.11.2024




25.11.2024


Menveo







GSK Vaccines S.r.l.




Via Fiorentina 1, 53100 Siena, Italia






EU/1/10/614


26.11.2024




25.11.2024


Orgalutran







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/130


27.11.2024




25.11.2024


Supemtek







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/20/1484


28.11.2024




25.11.2024


Tevimbra







BeiGene Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/23/1758


26.11.2024




25.11.2024


Tigecycline Accord







Accord Healthcare S.L.U.




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






EU/1/19/1394


26.11.2024




28.11.2024


Azacitidine Betapharm







betapharm Arzneimittel GmbH




Kobelweg 95, 86156 Augsburg, Deutschland






EU/1/19/1416


4.12.2024




28.11.2024


Besponsa







Pfizer Europe MA EEIG




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






EU/1/17/1200


29.11.2024




28.11.2024


Deferasirox Accord







Accord Healthcare S.L.U.




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






EU/1/19/1412


29.11.2024




28.11.2024


QUVIVIQ







Idorsia Pharmaceuticals Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Lörrach, Deutschland






EU/1/22/1638


3.12.2024




28.11.2024


Xigduo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/13/900


29.11.2024




29.11.2024


Ameluz







Biofrontera Bioscience GmbH




Hemmelrather Weg 201, 51377 Leverkusen, Deutschland






EU/1/11/740


4.12.2024




29.11.2024


Azacitidine Mylan







Mylan Ireland Limited




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






EU/1/20/1426


2.12.2024




29.11.2024


Mircera







Roche Registration GmbH




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






EU/1/07/400


3.12.2024




29.11.2024


Tasigna







Novartis Europharm Limited




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






EU/1/07/422


2.12.2024




—   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




25.11.2024


Extavia







Novartis Europharm Limited




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






EU/1/08/454


26.11.2024




25.11.2024


PreHevbri







VBI Vaccines B.V.




Delflandlaan 1, Queen’s Tower Office Number 714, 1062 EA Amsterdam, Nederland






EU/1/22/1641


27.11.2024




—   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




22.11.2024


BRAVECTO TriUNO


fluralaner / moxidectin / pyrantel







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/24/325


Chewable tablet


QP54AB52


28.11.2024




22.11.2024


DuOtic


Betamethasone acetate / Terbinafine







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/24/327


Ear gel


QS02CA90


25.11.2024




22.11.2024


VAXXON ND CLONE


Newcastle disease vaccine live







Vaxxinova International B.V




Transistorweg 5, 6534 AT Nijmegen,Nederland






EU/2/24/326


lyophilisate and solvent for oculonasal suspension for chickens


QI01AD06


27.11.2024




—   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




22.11.2024


Bovilis Nasalgen-C







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/23/294


25.11.2024




22.11.2024


Inflacam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/11/134


26.11.2024




22.11.2024


Poulvac Procerta HVT-IBD







Zoetis Belgium




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






EU/2/23/300


26.11.2024




25.11.2024


Eluracat







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/23/297


26.11.2024




25.11.2024


Enteroporc Coli AC







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/20/262


26.11.2024




25.11.2024


Mometamax Ultra







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/22/289


3.12.2024




25.11.2024


Rheumocam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/07/078


28.11.2024




28.11.2024


CLYNAV







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/16/197


29.11.2024




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, ELI: https://data.europa.eu/eli/reg/2004/726/oj.

(2)  
            OJ L 4, 7.1.2019, p. 43, ELI: https://data.europa.eu/eli/reg/2019/6/oj.


ELI: http://data.europa.eu/eli/C/2024/7468/oj
ISSN 1977-091X (electronic edition)