PharmacovigilanceOfficial

EMA publishes PSUSA outcome for ethosuximide, recommending maintenance of marketing authorisations

🇪🇺 EMA · Fri 30 Oct 2026

The EMA has published the periodic safety update report single assessment for ethosuximide, with a regulatory outcome of 'maintenance' and a list of nationally authorised products.

The European Medicines Agency published the outcome of a periodic safety update report single assessment (PSUSA) for ethosuximide on 30 October 2026. The procedure number is PSUSA/00001316/202603.

The regulatory outcome is listed as 'maintenance'. The source page does not give further detail on the assessment, such as any safety findings reviewed or changes to product information.

The published documents include a list of nationally authorised medicinal products covered by the procedure, reference number EMADOC-1700519818-3537119. It is available in English as a PDF of about 200 KB.

By way of context, a PSUSA is a single assessment of related periodic safety update reports for an active substance contained in medicines authorised in the EU. Marketing-authorisation holders submit these reports regularly at defined points after authorisation.

What it means for your team

  • Marketing-authorisation holders of nationally authorised ethosuximide products should check the published product list to confirm their products are included.
  • The 'maintenance' outcome indicates no change to the marketing authorisations is recorded on the page; teams should verify against the full documents for any other implications.
  • Pharmacovigilance teams should keep PSUR submission and tracking records for ethosuximide aligned with this procedure number.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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