Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2023 to 30 December 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: 2024-05-31
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








C_202403356EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/3356


31.5.2024






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2023 to 30 December 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)
)


(C/2024/3356)

—   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




23.1.2023


Pradaxa







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/08/442


25.1.2023




30.1.2023


Fendrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/04/299


1.2.2023




24.2.2023


Jayempi







Nova Laboratories Ireland Limited




3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland






EU/1/21/1557


15.3.2023




24.4.2023


Revatio







Upjohn EESV




Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland






EU/1/05/318


12.5.2023




26.5.2023


Tecentriq







Roche Registration GmbH




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






EU/1/17/1220


30.5.2023




31.5.2023


Epidyolex







Jazz Pharmaceuticals Ireland Ltd




5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland






EU/1/19/1389


14.6.2023




23.6.2023


Delstrigo







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1333


12.7.2023




23.6.2023


Zynrelef







Heron Therapeutics, B.V.




Herengracht 500, 1017 CB Amsterdam, Nederland






EU/1/20/1478


12.7.2023




17.7.2023


Erelzi







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1195


18.7.2023




17.7.2023


Hukyndra







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/21/1589


19.7.2023




28.7.2023


Pylobactell







Richen Europe S.R.L




VIA San Cristoforo, 78-20090 Trezzano Sul Naviglio (Ml), Italia






EU/1/98/064


18.8.2023




15.9.2023


Norvir







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/96/016


18.9.2023




26.10.2023


Vihuma







Octapharma AB




Lars Forssells gata 23, 112 75 Stockholm, Sverige






EU/1/16/1168


17.11.2023




—   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




5.4.2023


Evanovo







Laboratorios Hipra, S.A.




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






EU/2/22/284


11.4.2023




5.4.2023


Procox







VETOQUINOL S.A.




Magny-Vernois, 70200 Lure, France






EU/2/11/123


12.4.2023




5.4.2023


Trocoxil







Zoetis Belgium




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






EU/2/08/084


11.5.2023




16.5.2023


Daxocox







Ecuphar NV




Legeweg 157-i, 8020 Oostkamp, België






EU/2/21/270


17.5.2023




16.5.2023


Purevax Rabies







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/10/117


19.5.2023




8.6.2023


Hydrocortisone aceponate Ecuphar







Ecuphar NV




Legeweg 157-i, 8020 Oostkamp, België






EU/2/18/230


13.6.2023




29.6.2023


MiPet Easecto







Zoetis Belgium




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






EU/2/17/220


4.7.2023




5.7.2023


Cardalis







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/12/142


7.7.2023




11.8.2023


Nobivac Myxo-RHD PLUS







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/19/244


14.8.2023




30.8.2023


Arti-Cell Forte







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/18/228


31.8.2023




20.11.2023


CircoMax Myco







Zoetis Belgium




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






EU/2/20/264


21.11.2023




23.11.2023


Neptra







Elanco Animal Health GmbH




Alfred-Nobel-Str. 50, 40789 Monheim, Deutschland






EU/2/19/246


4.12.2023




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.


ELI: http://data.europa.eu/eli/C/2024/3356/oj
ISSN 1977-091X (electronic edition)