PharmacovigilanceOfficial

EMA publishes PSUSA outcome for gliclazide: regulatory outcome is 'maintenance'

🇪🇺 EMA · Fri 30 Oct 2026

The EMA has published the single assessment outcome for gliclazide periodic safety update reports, with the marketing authorisations to be maintained, alongside a list of nationally authorised products.

The European Medicines Agency published the outcome of a periodic safety update report single assessment (PSUSA) for gliclazide on 30 October 2026. The procedure is numbered PSUSA/00001532/202602.

The regulatory outcome is listed as "maintenance". The EMA's page gives no further detail on the assessment, and the source text does not describe any safety findings or changes to product information.

The published documentation consists of a PDF titled "Gliclazide: List of nationally authorised medicinal products - PSUSA/00001532/202602" (reference EMADOC-1700519818-3540327). It is available in English and is about 490 KB in size.

By way of context, a PSUSA is a single assessment of related periodic safety update reports (PSURs) for an active substance contained in medicines authorised in the EU. A PSUR is a pharmacovigilance report that marketing-authorisation holders submit regularly at defined time points after a medicine is authorised.

What it means for your team

  • Marketing-authorisation holders for nationally authorised gliclazide products should check the published product list to confirm their products are included.
  • The outcome is recorded as maintenance, and the source text mentions no variation or other regulatory action.
  • Pharmacovigilance teams should review the EMA procedure page and its documents directly for any follow-up obligations, as the source text gives no further detail.

Official source: EMA ↗

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

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