PSUSA/00010488/202405 - periodic safety update report single assessment

isotretinoin (oral formulations)
PSUSAHuman

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
isotretinoin (oral formulations)
Procedure number
PSUSA/00010488/202405
Regulatory outcome
Maintenance

Documents

Share this page