PSUSA/00000108/202412 - periodic safety update report single assessment

human alfa1-proteinase inhibitor (apart from the centrally authorised product)
PSUSA Human

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
human alfa1-proteinase inhibitor (apart from the centrally authorised product)
Procedure number
PSUSA/00000108/202412
Regulatory outcome
Maintenance

Documents

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