PharmacovigilanceOfficial

EMA publishes PSUSA outcome for aprotinin: marketing authorisations to be maintained

🇪🇺 EMA · Fri 30 Oct 2026

The agency's single assessment of periodic safety update reports for aprotinin ends with a 'maintenance' outcome, and a list of nationally authorised products has been published.

The European Medicines Agency (EMA) has published the outcome of a periodic safety update report single assessment (PSUSA) for aprotinin, under procedure number PSUSA/00000230/202602. The outcome was first published on 30 October 2026.

The regulatory outcome is recorded as 'maintenance'. The source page does not describe any findings, safety concerns or changes to product information arising from the assessment, so none can be reported here.

The accompanying document is a list of nationally authorised medicinal products covered by the procedure. It is available in English as a PDF of about 191 KB, with the reference number EMADOC-1700519818-3538195.

As general 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 of nationally authorised aprotinin products should check the published product list to confirm their products are covered by this procedure.
  • A 'maintenance' outcome is stated; the source gives no details of any variation to the terms of the marketing authorisations, so teams should review the full documents for any follow-up.
  • Pharmacovigilance teams can file the procedure number PSUSA/00000230/202602 and document reference EMADOC-1700519818-3538195 for their records.

Official source: EMA ↗

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

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