Pazenir
Pazenir
Pazenir
EMEA-002818-PIP01-20-M01
Opinion/decision on a Paediatric investigation plan (PIP): Vydura, rimegepant, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0320/2024
Opinion/decision on a Paediatric investigation plan (PIP): Aspaveli, pegcetacoplan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Renal and urinary disorders, PIP number: P/0348/2024
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