Opinion/decision on a Paediatric investigation plan (PIP): Inaqovi, cedazuridine,decitabine, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Blood and lymphatic system disorders, PIP number: P/0124/2024

EMEA-003453-PIP01-23

Opinion/decision on a Paediatric investigation plan (PIP): Akynzeo, netupitant,Palonosetron, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Surgical and medical procedures, PIP number: P/0132/2024

PSUSA/00010988/202410

EMEA-003439-PIP02-23

Human medicines European public assessment report (EPAR): Rozlytrek, entrectinib, Date of authorisation: 31/07/2020, Revision: 11, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Omvoh, Mirikizumab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Gastrointestinal disorders, PIP number: P/0129/2024

EMEA-003543-PIP01-23

Human medicines European public assessment report (EPAR): Vokanamet, canagliflozin,metformin, Date of authorisation: 23/04/2014, Revision: 25, Status: Authorised

EMEA-003542-PIP01-23