Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group

QRD Appendix V - Adverse-drug-reaction reporting details

Human medicines European public assessment report (EPAR): Rivaroxaban Koanaa, rivaroxaban, Date of authorisation: 21/11/2025, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Obgemsa, vibegron, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Renal and urinary disorders, PIP number: EMA/PE/0000221175

Opinion/decision on a Paediatric investigation plan (PIP): Nexviadyme, avalglucosidase alfa, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0360/2021

EMA/PE/0000181294

EMA/PE/0000181238

EMA/PE/0000181236

EMA/PE/0000221419

Opinion/decision on a Paediatric investigation plan (PIP): Sirturo, bedaquiline fumarate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0470/2022