PharmacovigilanceOfficial

EMA publishes nicorandil PSUSA outcome recommending maintenance of marketing authorisations

🇪🇺 EMA · Fri 30 Oct 2026

The EMA has published the outcome of the nicorandil periodic safety update report single assessment, PSUSA/00002152/202602, with a regulatory outcome of 'maintenance'.

The European Medicines Agency published the result of a periodic safety update report single assessment (PSUSA) for nicorandil on 30 October 2026. The procedure is numbered PSUSA/00002152/202602, and its regulatory outcome is listed as 'maintenance'.

The EMA's entry gives no further detail on the assessment. It does not describe any safety findings, changes to product information or follow-up measures, so the published information does not indicate what the assessment examined beyond the active substance.

The only document attached is a list of nationally authorised medicinal products in scope of the procedure (reference EMADOC-1700519818-3538865). It is an English-language PDF of 220.03 KB.

As general 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 at defined time points after authorisation.

What it means for your team

  • Marketing-authorisation holders for nationally authorised nicorandil products should check the published product list to confirm their products are included.
  • The outcome is recorded as 'maintenance'; the published entry does not announce any change to the authorisations.
  • Pharmacovigilance teams should consult the full PSUSA documentation for any detail beyond this summary, since the entry itself gives no assessment findings.

Official source: EMA ↗

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

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