Orphan designation: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid Treatment of systemic sclerosis, 28/06/2024 Positive

Orphan designation: 4-[[[4-[5-Chloro-2-[[trans-4-[[(1R)-2-methoxy-1-methyl-ethyl]amino]cyclohexyl]amino]-4-pyridinyl]-2-thiazolyl]amino]methyl]tetrahydro-2H-pyran-4-carbonitrile Treatment of acute myeloid leukaemia, 28/06/2024 Positive

Orphan designation: Human IgG1 monoclonal antibody against hepatitis B virus, surface antigen Treatment of hepatitis D virus infection, 28/06/2024 Positive

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final revision 3 of Module XVI on risk minimisation measures and its Addendum II on their effectiveness evaluation, and revision 5 of Annex I on definitions

Joint Controllership Arrangement with regard to the Union product database (UPD)

Follow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma, Online, European Medicines Agency, Amsterdam, the Netherlands, 24 May 2024

Report - Follow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma

Human medicines European public assessment report (EPAR): Tizveni, tislelizumab, Date of authorisation: 19/04/2024, Status: Withdrawn (authorisation)

Human medicines European public assessment report (EPAR): Evicel, human fibrinogen,human thrombin, Date of authorisation: 05/10/2008, Revision: 18, Status: Withdrawn (authorisation)

Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Date of authorisation: 15/04/2005, Revision: 35, Status: Authorised