PSUSA/00002165/202306 - periodic safety update report single assessment

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

Procedure number
PSUSA/00002165/202306
Regulatory outcome
Variation

Documents

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