EMA/PE/0000182245

Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto, venetoclax, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Blood and lymphatic system disorders, PIP number: EMA/PE/0000182075

EMA/PE/0000181243

Opinion/decision on a Paediatric investigation plan (PIP): Zegalogue, Dasiglucagon, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrine disorders, PIP number: EMA/PE/0000181174

EMA/PE/0000181050

Minutes of the HMPC meeting 19-21 January 2026

Opinion of the CVMP on the establishment of maximum residue limits: Fluralaner ( EMEA/V/MRL/004380/EXTN/0002)

Opinion of the CVMP on the establishment of maximum residue limits: Lidocaine (EMEA/V/MRL/003649/MODF/0004)

ICH E2D post-approval safety data management - scientific guideline

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