Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Blood and lymphatic system disorders, PIP number: P/0128/2023

Highlight report - Combination Products Operational Group (COMBO) - In Vitro Diagnostics stream - June 2026

Organisation chart: Information Management

Human medicines European public assessment report (EPAR): Elaprase, idursulfase, Date of authorisation: 08/01/2007, Revision: 27, Status: Authorised

EMA/PE/0000235658

EMA/PE/0000240018

Opinion/decision on a Paediatric investigation plan (PIP): Voxzogo, vosoritide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: EMA/PE/0000224087

Opinion/decision on a Paediatric investigation plan (PIP): Quviviq, Daridorexant, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: EMA/PE/0000233864

Human medicines European public assessment report (EPAR): Ontozry, cenobamate, Date of authorisation: 26/03/2021, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Ondibta, insulin glargine, Date of authorisation: 09/01/2026, Revision: 2, Status: Authorised