EMEA-002535-PIP04-21-M02

Human medicines European public assessment report (EPAR): Mynzepli, aflibercept, Date of authorisation: 18/08/2025, Status: Authorised

Human medicines European public assessment report (EPAR): Qoyvolma, ustekinumab, Date of authorisation: 02/06/2025, Revision: 2, Status: Authorised

Clinical Trial Information System (CTIS) structured data form - Notifications, Annual Safety Report (ASR) and results

Opinion/decision on a Paediatric investigation plan (PIP): Spevigo, spesolimab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0341/2024

Opinion/decision on a Paediatric investigation plan (PIP): Minjuvi, tafasitamab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0344/2024

Opinion/decision on a Paediatric investigation plan (PIP): Sotyktu, Deucravacitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Musculoskeletal and connective tissue disorders, PIP number: P/0319/2024

Opinion/decision on a Paediatric investigation plan (PIP): Ztalmy, ganaxolone, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0350/2024

Human medicines European public assessment report (EPAR): Polivy, polatuzumab vedotin, Date of authorisation: 16/01/2020, Revision: 7, Status: Authorised

Start of Union reviews adopted during the CHMP meeting of 13-16 October 2025