PharmacovigilanceOfficial

EMA publishes PSUSA outcome for furazidine, with marketing authorisations maintained

🇪🇺 EMA · Fri 30 Oct 2026

The EMA has published the single assessment outcome for furazidine (PSUSA/00011098/202602), with the regulatory outcome listed as maintenance of existing authorisations.

The European Medicines Agency published the outcome of a periodic safety update report single assessment (PSUSA) for furazidine on 30 October 2026. The procedure number is PSUSA/00011098/202602.

The regulatory outcome is recorded as "maintenance". The source gives no further detail on the assessment, and it does not describe any safety findings or changes to product information.

The EMA's accompanying document is a list of nationally authorised medicinal products covered by the procedure. It is an English-language PDF of 260.22 KB, reference number EMADOC-1700519818-3537110.

As background, 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 authorisation.

What it means for your team

  • Marketing-authorisation holders of nationally authorised furazidine products should check the EMA's published product list to confirm their products are covered.
  • The "maintenance" outcome indicates no change to the authorisations is recorded in the published item; teams should consult the full documents for any detail.
  • Pharmacovigilance teams can note the PSUSA procedure number, PSUSA/00011098/202602, 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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