PSUSA/00002298/202512 - 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

caffeine / paracetamol / propyphenazone, paracetamol / propyphenazone

Procedure number

PSUSA/00002298/202512

Regulatory outcome

Maintenance

Documents

Caffeine/paracetamol/propyphenazone, paracetamol/propyphenazone : List of nationally authorised medicinal products - PSUSA/00002298/202512

Reference Number:

EMADOC-1700519818-3321097

English (EN) (259.15 KB - PDF)

First published:

13/07/2026

View