PharmacovigilanceOfficial

EMA publishes diacerein PSUSA outcome recommending variation to nationally authorised products

🇪🇺 EMA · Fri 23 Oct 2026

The outcome of PSUSA/00001026/202512 for diacerein is a regulatory variation, with CMDh conclusions and product information amendments published on 23 October 2026.

The European Medicines Agency has published the outcome of a periodic safety update report single assessment (PSUSA) for diacerein, procedure number PSUSA/00001026/202512. The regulatory outcome is listed as a variation.

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 PSURs at defined time points after a medicine is authorised.

Two English-language documents were first published on 23 October 2026. One is a list of nationally authorised medicinal products covered by the procedure. The other sets out the CMDh scientific conclusions and grounds for variation, amendments to the Product Information and the timetable for implementation.

The CMDh document is also available in 23 other EU languages, all published on the same date. The source page as provided does not reproduce the content of the scientific conclusions or the specific product information changes, so those details are not covered here.

What it means for your team

  • Marketing-authorisation holders of nationally authorised diacerein products should review the CMDh conclusions and the implementation timetable, as the outcome is a variation.
  • Regulatory affairs teams should check the published list of nationally authorised products to confirm whether their products are in scope.
  • Pharmacovigilance and labelling teams should consult the amended Product Information text in the CMDh document, since the details are not summarised in the source page.
  • Translations in all EU languages are available, which may help with national implementation.

Official source: EMA ↗

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

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