High-risk medical devices: consultation procedures

List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment

Human medicines European public assessment report (EPAR): Amversio, betaine anhydrous, Date of authorisation: 05/05/2022, Revision: 1, Status: Authorised

EMA/PE/0000228360

EMA/PE/0000228114

Opinion/decision on a Paediatric investigation plan (PIP): Trodelvy, sacituzumab govitecan, 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: EMA/PE/0000228097

EMA/PE/0000227674

Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: EMA/PE/0000228776

EMA/PE/0000228333

PSUSA/00000383/202506