PharmacovigilanceOfficial

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

🇪🇺 EMA · Fri 30 Oct 2026

The European Medicines Agency has released the result of a periodic safety update report single assessment for tenoxicam, with the regulatory outcome listed as maintenance.

The European Medicines Agency (EMA) published the outcome of a periodic safety update report single assessment (PSUSA) for tenoxicam on 30 October 2026. The procedure is numbered PSUSA/00002893/202602.

The regulatory outcome is recorded as "maintenance". The source page gives no further detail on the assessment, such as safety findings, changes to product information or follow-up measures.

The EMA page links to one document: a list of nationally authorised medicinal products covered by the procedure, in English, as a PDF of about 180 KB. The listing indicates that the products in scope are authorised at national level rather than centrally.

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 at defined time points after authorisation.

What it means for your team

  • Holders of nationally authorised tenoxicam products should check the published product list to confirm whether their products are included in the procedure.
  • A maintenance outcome, as recorded, indicates no change to the status of the authorisations is flagged on the EMA page; teams should check the full documents for any other requirements.
  • Pharmacovigilance teams should keep PSUR submission schedules and internal records aligned with PSUSA/00002893/202602.

Official source: EMA ↗

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

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