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
Aprotinin / calcium chloride / human factor XIII / ...
Procedure number
PSUSA/00010346/201611
Regulatory outcome
Maintenance

Documents

Aprotinin / calcium chloride / human factor XIII / ... - List of nationally authorised medicinal products - PSUSA/00010346/201611

Reference Number: EMA/530525/2017

English (EN) (154.81 KB - PDF)

First published: Last updated:
View

Share this page