PSUSA/00000967/202509 - 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

desogestrel / ethinylestradiol

Procedure number

PSUSA/00000967/202509

Regulatory outcome

Maintenance

Documents

Desogestrel / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000967/202509

Reference Number:

EMADOC-1700519818-3248282

English (EN) (270.07 KB - PDF)

First published:

16/06/2026

View