PharmacovigilanceOfficial

EMA publishes PSUSA outcome for rabies vaccine, with marketing authorisations maintained

🇪🇺 EMA · Fri 30 Oct 2026

The European Medicines Agency has released the result of a periodic safety update report single assessment for rabies vaccine, recording a regulatory outcome of 'maintenance'.

The European Medicines Agency (EMA) published the outcome of procedure PSUSA/00009277/202603 on 30 October 2026. The procedure is a periodic safety update report single assessment (PSUSA) covering the active substance rabies vaccine.

The regulatory outcome is listed as 'maintenance'. The source page gives no further detail on the assessment, such as safety findings or changes to product information, so none can be reported here.

The accompanying document is a list of nationally authorised medicinal products in scope of the procedure. It is an English-language PDF of about 392 KB, with the reference number EMADOC-1700519818-3509174.

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 points after a medicine is authorised.

What it means for your team

  • Marketing-authorisation holders of rabies vaccines in the EU should check the published product list to confirm whether their nationally authorised products fall within this procedure.
  • The 'maintenance' outcome is the only regulatory result stated; teams should consult the full EMA documentation before concluding that no further action applies.
  • Pharmacovigilance teams can use the listing to keep PSUR and PSUSA tracking records up to date for rabies vaccine.

Official source: EMA ↗

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

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