PSUSA/00000284/202211 - periodic safety update report single assessment

Bacillus clausii multi-antibioresistant spores
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
Bacillus clausii multi-antibioresistant spores
Procedure number
PSUSA/00000284/202211
Regulatory outcome
Maintenance

Documents

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