About

Periodic safety update report single assessments (PSUSAs) are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU). A PSUR is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation.

Key facts

Active substance(s) in scope of the PSUSA procedure
baclofen (oral use, for muscle spasticity indication)
Procedure number
PSUSA/00000294/202309
Regulatory outcome
Variation

Documents

Share this page