Agenda of the CVMP meeting 5-7 December 2023

Orphan designation: Dabrafenib mesylate Treatment of glioma, 09/12/2020 Positive

Second bilateral meeting between European Medicines Agency and Vaccines Europe, European Medicines Agency, Amsterdam, the Netherlands, 27 November 2023

Relaunched EMA website now live

Enalapril : List of nationally authorised medicinal products - PSUSA/00001211/202303

Human medicines European public assessment report (EPAR): Ryeqo, relugolix,estradiol,norethisterone acetate, Leiomyoma, Date of authorisation: 16/07/2021, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Macular Edema;Retinal Vein Occlusion;Diabetic Retinopathy;Myopia, Degenerative;Diabetes Complications, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Leflunomide medac, leflunomide, Arthritis, Rheumatoid, Date of authorisation: 27/07/2010, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR): Filgrastim Hexal, filgrastim, Neutropenia;Hematopoietic Stem Cell Transplantation;Cancer, Date of authorisation: 06/02/2009, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Opzelura, ruxolitinib, Vitiligo, Date of authorisation: 19/04/2023, Revision: 2, Status: Authorised