PSUSA/00000444/202512 - periodic safety update report single assessment

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

brotizolam

Procedure number

PSUSA/00000444/202512

Regulatory outcome

Maintenance

Documents

PSUSA/00000444/202512 - List of nationally authorised medicinal products

Adopted

Reference Number:

EMADOC-1700519818-3330480

English (EN) (193.66 KB - PDF)

First published:

15/07/2026

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