Orphan designation: surovatamig Treatment of B-lymphoblastic leukaemia/lymphoma, 21/11/2025 Positive

Orphan designation: rezatapopt Treatment of ovarian cancer, 09/12/2025 Positive

Human medicines European public assessment report (EPAR): Wakix, pitolisant, Date of authorisation: 31/03/2016, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR): Atazanavir Krka, atazanavir, Date of authorisation: 25/03/2019, Revision: 3, Status: Withdrawn

Human medicines European public assessment report (EPAR): Duvyzat, givinostat, Date of authorisation: 06/06/2025, Revision: 1, Status: Authorised

Referral: Levamisole-containing medicinal products, levamisole, associated names: Decaris,Levamisol Arena Article 31 referrals CMDh final position, 27/03/2026

EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports

Human medicines European public assessment report (EPAR): Ziextenzo, pegfilgrastim, Date of authorisation: 22/11/2018, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR): Vevzuo, denosumab, Date of authorisation: 25/06/2025, Revision: 3, Status: Authorised

Transfer of marketing authorisation: questions and answers