Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2024 to 30 September 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: 2024-10-21
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_202406277EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/6277


21.10.2024






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2024 to 30 September 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/2024/6277)

—   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




12.9.2024


Eksunbi


ustekinumab







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/24/1858


Concentrate for solution for infusion
Solution for injection


L04AC05


13.9.2024




19.9.2024


Anzupgo


delgocitinib







LEO Pharma A/S




Industriparken 55, DK-2750 Ballerup, Danmark






EU/1/24/1851


Cream


D11AH11


23.9.2024




19.9.2024


Axitinib Accord


axitinib







Accord Healthcare S.L.U.




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






EU/1/24/1847


Film-coated tablet


L01EK01


23.9.2024




19.9.2024


Iqirvo


elafibranor







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/24/1855


Film-coated tablet


A05AX06


23.9.2024




19.9.2024


Ituxredi


Rituximab







Reddy Holding GmbH




Kobelweg 95, Augsburg 86156, Deutschland






EU/1/24/1861


Concentrate for solution for infusion


L01X C02


23.9.2024




19.9.2024


KAYFANDA


Odevixibat







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/24/1854


Capsule, hard


A05AX


26.9.2024




19.9.2024


LOQTORZI


toripalimab







TMC Pharma (EU) Limited




G24 A Arclabs Research & Innovation Centre, SETU West Campus, Carriganore, Waterford, X91 P20H, Ireland






EU/1/24/1853


Concentrate for solution for infusion


L01FF13


23.9.2024




19.9.2024


Ranibizumab Midas


ranibizumab







Midas Pharma GmbH




Rheinstraße 49, D-55218 Ingelheim, Deutschland






EU/1/24/1860


Solution for injection


S01LA04


24.9.2024




19.9.2024


Tuznue


trastuzumab







Prestige Biopharma Belgium BVBA




Terhulpensesteenweg 449, 3090 Overijse, België






EU/1/24/1864


Powder for concentrate for solution for infusion


L01FD01


24.9.2024




19.9.2024


Vevizye


ciclosporin







Novaliq GmbH




Im Neuenheimer Feld 515, Neuenheim, 69120 Heidelberg, Deutschland






EU/1/24/1857


Eye drops, solution


S01XA18


23.9.2024




19.9.2024


Vyloy


zolbetuximab







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/24/1856


Powder for concentrate for solution for infusion


L01FX31


25.9.2024




25.9.2024


Fymskina


ustekinumab







Formycon AG




Fraunhoferstraße 15, 82152 Martinsried/Planegg, Deutschland






EU/1/24/1862


Concentrate for solution for infusion
Solution for injection


L04AC05


26.9.2024




25.9.2024


Otulfi


ustekinumab







Fresenius Kabi Deutschland GmbH




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






EU/1/24/1863


Concentrate for solution for infusion
Solution for injection


L04AC05


26.9.2024




27.9.2024


Yuvanci


Macitentan / Tadalafil







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/24/1859


Film-coated tablet


C02KX54


30.9.2024




—   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




6.9.2024


Abseamed







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37, 58638 Iserlohn, Deutschland






EU/1/07/412


17.9.2024




6.9.2024


Atectura Breezhaler







Novartis Europharm Limited




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






EU/1/20/1439


9.9.2024




6.9.2024


Dabigatran etexilate Leon Farma







Laboratorios Leon Farma S.A.




C/ La Vallina s/n, Poligono Industrial Navatejera, 24193 Villaquilambre León, España






EU/1/23/1769


17.9.2024




6.9.2024


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


9.9.2024




6.9.2024


Docetaxel Kabi







Fresenius Kabi Deutschland GmbH




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






EU/1/12/770


10.9.2024




6.9.2024


Entresto







Novartis Europharm Limited




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






EU/1/15/1058


9.9.2024




6.9.2024


Filgrastim Hexal







Hexal AG




Industriestraße 25, 83607 Holzkirchen, Deutschland






EU/1/08/496


9.9.2024




6.9.2024


Gazyvaro







Roche Registration GmbH




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






EU/1/14/937


9.9.2024




6.9.2024


Grastofil







Accord Healthcare S.L.U.




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






EU/1/13/877


9.9.2024




6.9.2024


Palforzia







STALLERGENES




6 rue Alexis de Tocqueville, 92160 Antony, France






EU/1/20/1495


13.9.2024




6.9.2024


Pritor







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/98/089


9.9.2024




6.9.2024


Rhokiinsa







Santen Oy




Niittyhaankatu 20, 33720 Tampere, Suomi






EU/1/19/1400


9.9.2024




6.9.2024


Riximyo







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1184


9.9.2024




6.9.2024


Trumenba







Pfizer Europe MA EEIG




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






EU/1/17/1187


9.9.2024




6.9.2024


Zarzio







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/08/495


9.9.2024




6.9.2024


Zessly







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1280


11.9.2024




6.9.2024


Ziagen







ViiV Healthcare BV




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






EU/1/99/112


9.9.2024




6.9.2024


Zimbus Breezhaler







Novartis Europharm Limited




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






EU/1/20/1440


9.9.2024




10.9.2024


Spikevax







MODERNA BIOTECH SPAIN, S.L.




C/ Julián Camarillo no 31, 28037 Madrid, España






EU/1/20/1507


11.9.2024




12.9.2024


Kinzalmono







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/98/091


13.9.2024




12.9.2024


Micardis







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/98/090


16.9.2024




12.9.2024


Pelgraz







Accord Healthcare S.L.U.




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






EU/1/18/1313


13.9.2024




12.9.2024


Rukobia







ViiV Healthcare BV




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






EU/1/20/1518


13.9.2024




12.9.2024


Xelevia







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/07/382


13.9.2024




16.9.2024


Adtralza







Leo Pharma A/S




Industriparken 55, 2750 Ballerup, Danmark






EU/1/21/1554


19.9.2024




16.9.2024


Bemrist Breezhaler







Novartis Europharm Limited




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






EU/1/20/1441


17.9.2024




16.9.2024


Binocrit







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/07/410


17.9.2024




16.9.2024


Enerzair Breezhaler







Novartis Europharm Limited




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






EU/1/20/1438


17.9.2024




16.9.2024


Enhertu







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


20.9.2024




16.9.2024


Irbesartan Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/576


17.10.2024




16.9.2024


Ledaga







Helsinn Birex Pharmaceuticals Ltd.




Damastown, Mulhuddart, Dublin 15, Ireland






EU/1/16/1171


18.9.2024




16.9.2024


Melatonin Neurim







RAD Neurim Pharmaceuticals EEC SARL




4 rue de Marivaux, 75002 Paris, France






EU/1/22/1694


17.9.2024




16.9.2024


Tezspire







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1677


17.9.2024




16.9.2024


Toviaz







Pfizer Europe MA EEIG




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






EU/1/07/386


17.9.2024




19.9.2024


Amsparity







Pfizer Europe MA EEIG




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






EU/1/19/1415


23.9.2024




19.9.2024


Arsenic Trioxide Accord







Accord Healthcare S.L.U.




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






EU/1/19/1398


23.9.2024




19.9.2024


Beovu







Novartis Europharm Limited




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






EU/1/19/1417


23.9.2024




19.9.2024


CABOMETYX







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/16/1136


23.9.2024




19.9.2024


EDURANT







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/11/736


23.9.2024




19.9.2024


Epoetin alfa Hexal







Hexal AG




Industriestraße 25, 83607 Holzkirchen, Deutschland






EU/1/07/411


23.9.2024




19.9.2024


Evrenzo







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/21/1574


24.9.2024




19.9.2024


GAVRETO







Blueprint Medicines (Netherlands) B.V.




Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland






EU/1/21/1555


26.9.2024




19.9.2024


Giapreza







PAION Pharma GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/19/1384


23.9.2024




19.9.2024


Imvanex







Bavarian Nordic A/S




Philip Heymans Allé 3, DK-2900 Hellerup, Danmark






EU/1/13/855


19.9.2024




19.9.2024


Ivabradine Accord







Accord Healthcare S.L.U.




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






EU/1/17/1190


23.9.2024




19.9.2024


Januvia







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/07/383


23.9.2024




19.9.2024


Lunsumio







Roche Registration GmbH




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






EU/1/22/1649


23.9.2024




19.9.2024


Mayzent







Novartis Europharm Limited




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






EU/1/19/1414


23.9.2024




19.9.2024


Neparvis







Novartis Europharm Limited




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






EU/1/16/1103


23.9.2024




19.9.2024


Opsumit







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/893


23.9.2024




19.9.2024


Orladeyo







Biocryst Ireland Limited




Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland






EU/1/21/1544


23.9.2024




19.9.2024


Paxlovid







Pfizer Europe MA EEIG




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






EU/1/22/1625


23.9.2024




19.9.2024


Recarbrio







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/19/1420


23.9.2024




19.9.2024


RINVOQ







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


23.9.2024




19.9.2024


Rybelsus







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/20/1430


24.9.2024




19.9.2024


Synagis







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/99/117


23.9.2024




19.9.2024


Ziextenzo







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1327


23.9.2024




25.9.2024


Kinpeygo







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/22/1657


30.9.2024




25.9.2024


Spevigo







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/22/1688


27.9.2024




25.9.2024


Stelara







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/08/494


26.9.2024




25.9.2024


Talmanco







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/16/1153


2.9.2024




25.9.2024


Talmanco







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/16/1153


26.9.2024




25.9.2024


Yuflyma







Celltrion Healthcare Hungary Kft.




Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország






EU/1/20/1513


27.9.2024




26.9.2024


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


26.9.2024




27.9.2024


Adrovance







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/06/364


3.10.2024




27.9.2024


Biopoin







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/09/565


2.10.2024




27.9.2024


Breyanzi







Bristol Myers Squibb Pharma EEIG




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






EU/1/22/1631


30.9.2024




27.9.2024


Cometriq







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/13/890


30.9.2024




27.9.2024


Dabigatran etexilate Teva







Laboratorios Leon Farma S.A.




C/ La Vallina s/n, Poligono Industrial Navatejera, 24193 Villaquilambre León, España






EU/1/23/1769


1.10.2024




27.9.2024


Fampyra







Acorda Therapeutics Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/11/699


1.10.2024




27.9.2024


GONAL-f







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/95/001


1.10.2024




27.9.2024


Ivabradine Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1144


3.10.2024




27.9.2024


Lacosamide Adroiq







Extrovis EU Ltd.




Pátriárka utca 14., 2000, Szentendre, Magyarország






EU/1/23/1732


2.10.2024




27.9.2024


MAVENCLAD







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/17/1212


30.9.2024




27.9.2024


Mylotarg







Pfizer Europe MA EEIG




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






EU/1/18/1277


30.9.2024




27.9.2024


Padcev







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/21/1615


30.9.2024




27.9.2024


Plerixafor Accord







Accord Healthcare S.L.U.




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






EU/1/22/1701


30.9.2024




27.9.2024


Shingrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/18/1272


30.9.2024




27.9.2024


Tenofovir disoproxil Viatris







Viatris Limited




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






EU/1/16/1129


30.9.2024




27.9.2024


Tesavel







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/07/435


30.9.2024




27.9.2024


Tolucombi







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/13/821


3.10.2024




27.9.2024


Tyruko







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/23/1745


30.9.2024




27.9.2024


Vantavo







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/09/572


30.9.2024




27.9.2024


YERVOY







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/698


30.9.2024




30.9.2024


Myozyme







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/06/333


1.10.2024




—   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




6.9.2024


Memantine LEK







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/13/826


10.9.2024




25.9.2024


Exviera







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/14/983


26.9.2024




25.9.2024


Viekirax







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/14/982


26.9.2024




27.9.2024


Gefitinib Mylan







Mylan Pharmaceuticals Limited




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






EU/1/18/1321


30.9.2024




—   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




12.9.2024


Cepeloron


Spironolactone







CP-Pharma Handelsgesellschaft mbH




Ostlandring 13, 31303 Burgdorf, Deutschland






EU/2/24/321


Chewable tablet


Pending


13.9.2024




—   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




6.9.2024


Posatex







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/08/081


9.9.2024




6.9.2024


Profender







Vetoquinol S.A.




Magny-Vernois, 70200 Lure, France






EU/2/05/054


9.9.2024




12.9.2024


Rabitec







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/17/219


13.9.2024




19.9.2024


Brucellin Aquilon







CZ Vaccines S.A.U.




A Relva s/n – Torneiros 36410 O Porriño Pontevedra, España






EU/2/22/291


25.9.2024




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/2024/6277/oj
ISSN 1977-091X (electronic edition)