PSUSA/00002125/202008 - periodic safety update report single assessment | European Medicines Agency (EMA)

PSUSA/00002125/202008 - periodic safety update report single assessment

Naproxen
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
Naproxen
Procedure number
PSUSA/00002125/202008
Regulatory outcome
Maintenance

Documents

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