Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2024 to 31 October 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: 2024-11-29
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_202406971EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/6971


29.11.2024






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2024 to 31 October 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/2024/6971)

—   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




1.10.2024


Brinavess







Correvio




15 rue du Bicentenaire, 92800 Puteaux, France






EU/1/10/645


23.10.2024




1.10.2024


Champix







Pfizer Europe MA EEIG




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






EU/1/06/360


2.10.2024




1.10.2024


Exjade







Novartis Europharm Limited




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






EU/1/06/356


2.10.2024




1.10.2024


Fosavance







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/05/310


2.10.2024




1.10.2024


Prialt







Esteve Pharmaceuticals GmbH




Hohenzollerndamm 150-151, 14199 Berlin, Deutschland






EU/1/04/302


15.10.2024




1.10.2024


Senshio







Shionogi B.V.




Herengracht 464, 1017 CA, Amsterdam, Nederland






EU/1/14/978


2.10.2024




4.10.2024


Bortezomib Fresenius Kabi







Fresenius Kabi Deutschland GmbH




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






EU/1/19/1397


7.10.2024




4.10.2024


EVUSHELD







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1651


7.10.2024




4.10.2024


Tadalafil Mylan







Mylan Pharmaceuticals Limited




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






EU/1/14/961


7.10.2024




4.10.2024


Tenofovir disoproxil Viatris







Viatris Limited




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






EU/1/16/1129


7.10.2024




7.10.2024


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


9.10.2024




7.10.2024


Isturisa







Recordati Rare Diseases




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






EU/1/19/1407


8.10.2024




8.10.2024


Nuvaxovid







Novavax CZ a.s.




Líbalova 2348/1, Chodov, 149 00 Praha 4, Česká republika






EU/1/21/1618


8.10.2024




9.10.2024


Dabigatran etexilate Teva







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/23/1769


11.10.2024




9.10.2024


Emselex







pharmaand GmbH




Taborstrasse 1, 1020 Wien, Österreich






EU/1/04/294


16.10.2024




9.10.2024


Fuzeon







Roche Registration GmbH




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






EU/1/03/252


11.10.2024




9.10.2024


Ganirelix Gedeon Richter







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/22/1658


11.10.2024




9.10.2024


Mycamine







Sandoz Pharmaceuticals d.d.




Verovškova ulica 57, 1000 Ljubljana, Slovenija






EU/1/08/448


10.10.2024




9.10.2024


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


10.10.2024




9.10.2024


Ponvory







LABORATOIRES JUVISE PHARMACEUTICALS




149 Boulevard Bataille de Stalingrad, 69100 Villeurbanne, France






EU/1/21/1550


10.10.2024




9.10.2024


Revlimid







Bristol-Myers Squibb Pharma EEIG




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






EU/1/07/391


14.10.2024




21.10.2024


Aflunov







Seqirus S.r.l.




Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia






EU/1/10/658


22.10.2024




21.10.2024


Aripiprazole Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/15/1009


23.10.2024




21.10.2024


Bortezomib Hospira







Pfizer Europe MA EEIG




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






EU/1/16/1114


22.10.2024




21.10.2024


Buccolam







Neuraxpharm Pharmaceuticals, S.L.




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






EU/1/11/709


22.10.2024




21.10.2024


Cholestagel







CHEPLAPHARM Arzneimittel GmbH




Ziegelhof 24, 17489 Greifswald, Deutschland






EU/1/03/268


25.10.2024




21.10.2024


Darzalex







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/16/1101


22.10.2024




21.10.2024


Esperoct







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/19/1374


23.10.2024




21.10.2024


Evrysdi







Roche Registration GmbH




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






EU/1/21/1531


22.10.2024




21.10.2024


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


23.10.2024




21.10.2024


Kirsty







Biosimilar Collaborations Ireland Limited




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






EU/1/20/1506


28.10.2024




21.10.2024


Lumykras







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/21/1603


22.10.2024




21.10.2024


Ngenla







Pfizer Europe MA EEIG




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






EU/1/21/1617


22.10.2024




21.10.2024


Otezla







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/14/981


22.10.2024




21.10.2024


Pravafenix







LABORATOIRES SMB SA




26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België






EU/1/11/679


22.10.2024




21.10.2024


Zavicefta







Pfizer Ireland Pharmaceuticals




Operations Support Group, Ringaskiddy, County Cork, Ireland






EU/1/16/1109


22.10.2024




21.10.2024


Zirabev







Pfizer Europe MA EEIG




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






EU/1/18/1344


22.10.2024




21.10.2024


Zokinvy







TMC Pharma (EU) Limited




G24 A Arclabs Research And Innovation Centre, Setu West Campus Carriganore, Waterford, X91 XD96, Ireland






EU/1/22/1660


22.10.2024




24.10.2024


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


25.10.2024




24.10.2024


Fasenra







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/17/1252


25.10.2024




24.10.2024


Jayempi







Lipomed GmbH




Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland






EU/1/21/1557


25.10.2024




24.10.2024


NUBEQA







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/20/1432


25.10.2024




24.10.2024


RINVOQ







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


28.10.2024




24.10.2024


Tecfidera







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/13/837


25.10.2024




24.10.2024


Xerava







PAION Pharma GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/18/1312


25.10.2024




25.10.2024


Inovelon







Eisai GmbH




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






EU/1/06/378


28.10.2024




28.10.2024


Enhertu







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


30.10.2024




28.10.2024


Somavert







Pfizer Europe MA EEIG




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






EU/1/02/240


30.10.2024




28.10.2024


Zejula







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1235


29.10.2024




—   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




9.10.2024


Pemetrexed Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/15/1037


14.10.2024




24.10.2024


Clopidogrel Taw Pharma







Taw Pharma (Ireland) Limited




104 Lower Baggot Street, Dublin 2, Ireland






EU/1/09/559


25.10.2024




24.10.2024


GAVRETO







Blueprint Medicines (Netherlands) B.V.




Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland






EU/1/21/1555


25.10.2024




—   Suspension of a marketing authorisation (Article 20 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




4.10.2024


Oxbryta







Pfizer Europe MA EEIG




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






EU/1/21/1622


4.10.2024




—   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




24.10.2024


ArthriCox


firocoxib







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, H62 FH90, Ireland






EU/2/24/323


Chewable tablet


QM01AH90


29.10.2024




24.10.2024


Cirbloc M Hyo


Porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)







Ceva-Phylaxia Co. Ltd.




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/24/322


Emulsion for injection


QI09AL08


25.10.2024




—   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




21.10.2024


RESPIVAC aMPV







Laboratorios Hipra, S.A.




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






EU/2/24/314


22.10.2024




24.10.2024


LETIFEND







LETI Pharma, S.L.U.




C/ Del Sol, 5, Poligono Industrial Norte,Tres Cantos, 28760 Madrid, España






EU/2/16/195


25.10.2024




24.10.2024


Purevax FeLV







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/00/019


29.10.2024




24.10.2024


Respiporc Flu3







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/09/103


30.10.2024




28.10.2024


Cimalgex







Vétoquinol SA




Magny-Vernois, 70200 Lure, France






EU/2/10/119


4.11.2024




31.10.2024


Equilis West Nile







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/13/151


4.11.2024




31.10.2024


Metacam







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/97/004


5.11.2024




31.10.2024


NexGard Combo







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/267


5.11.2024




31.10.2024


Novem







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/042


6.11.2024




31.10.2024


YURVAC RHD







Laboratorios Hipra, S.A.




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






EU/2/23/298


6.11.2024




—   Withdrawal 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)









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




4.10.2024


Fevaxyn Pentofel







Zoetis Belgium SA




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






EU/2/96/002


8.10.2024




4.10.2024


Suvaxyn Aujeszky 783 + O/W







Zoetis Belgium




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






EU/2/98/009


8.10.2024




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/2024/6971/oj
ISSN 1977-091X (electronic edition)