Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products

26 July 2024

Human medicines European public assessment report (EPAR): Bylvay, odevixibat, Date of authorisation: 16/07/2021, Revision: 6, Status: Authorised

26 July 2024

Human medicines European public assessment report (EPAR): Fymskina, ustekinumab, Status: Opinion

26 July 2024

Dossier requirements for anticancer medicinal products for dogs and cats - Scientific guideline

26 July 2024

Concept paper on the revision of the guideline on dossier requirements for anticancer medicinal products for dogs and cats

26 July 2024

New fee regulation: webinar for veterinary marketing authorisation holders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 June 2024, 10:00 (CEST) to 20 June 2024, 11:00 (CEST)

26 July 2024

Records of data processing activity for digital business cards (QR code)

26 July 2024

Orphan designation: Acetylleucine Treatment of ataxia-oculomotor apraxia, 16/04/2024 Positive

26 July 2024

Orphan designation: annamycin Treatment of acute myeloid leukaemia, 16/04/2024 Positive

26 July 2024

Orphan designation: Humanised IgG1 (K322A) monoclonal antibody against disialoganglioside GD2 Treatment of neuroblastoma, 16/04/2024 Positive

26 July 2024