Orphan designation: bexmarilimab Treatment of myelodysplastic syndromes, 25/03/2025 Positive

Human medicines European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan, sitagliptin hydrochloride monohydrate,metformin hydrochloride, Date of authorisation: 16/02/2022, Revision: 5, Status: Authorised

Orphan designation: ixodes ricinus contact phase inhibitor Treatment of non-traumatic spontaneous intracerebral haemorrhage, 25/03/2025 Positive

Human medicines European public assessment report (EPAR): Rxulti, brexpiprazole, Date of authorisation: 26/07/2018, Revision: 7, Status: Authorised

Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains Treatment of multiple myeloma, 04/06/2020 Withdrawn

Orphan designation: Felzartamab Treatment of in solid organ transplantation, 13/12/2024 Positive

Orphan designation: deucrictibant monohydrate Treatment of bradykinin-mediated angioedema, 25/03/2025 Positive

Human medicines European public assessment report (EPAR): Reblozyl, luspatercept, Date of authorisation: 25/06/2020, Revision: 9, Status: Authorised

European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes

Human medicines European public assessment report (EPAR): Cejemly, sugemalimab, Date of authorisation: 24/07/2024, Revision: 4, Status: Authorised