PSUSA/00000485/202511 - 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

caffeine / ergotamine

Procedure number

PSUSA/00000485/202511

Regulatory outcome

Maintenance

Documents

Caffeine / ergotamine : List of nationally authorised medicinal products - PSUSA/00000485/202511

Reference Number:

EMADOC-1700519818-3328820

English (EN) (263.11 KB - PDF)

First published:

14/07/2026

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