PharmacovigilanceOfficial

EMA publishes PSUSA outcome for alendronate, concluding with a variation to product information

🇪🇺 EMA · Wed 21 Oct 2026

The outcome of the periodic safety update report single assessment for alendronate, procedure PSUSA/00000078/202601, was published on 21 October 2026 and leads to a variation.

The European Medicines Agency has published the outcome of a periodic safety update report single assessment (PSUSA) covering the active substance alendronate. The procedure is numbered PSUSA/00000078/202601, and the regulatory outcome is listed as a variation.

The documents went online on 21 October 2026. They include a CMDh document setting out the scientific conclusions and grounds for variation, amendments to the product information and the timetable for implementation. A separate list covers the nationally authorised medicinal products in scope of the procedure.

The source page does not describe the content of the scientific conclusions or the wording of the product information amendments in its text; these are contained in the linked PDFs. The page also does not give the implementation dates.

The conclusions document is available in English and in 23 other languages, with the Estonian version carrying a last-updated date of 27 October 2026. All versions were first published on 21 October 2026.

As context, a PSUSA is a single assessment of related periodic safety update reports 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

  • Marketing-authorisation holders of nationally authorised alendronate products should review the CMDh conclusions and the list of products to confirm that their products are in scope.
  • Regulatory affairs teams should check the published timetable for implementation and plan the resulting variations to the product information accordingly.
  • Pharmacovigilance teams should read the full English document, as the web page itself does not summarise the specific safety conclusions.

Official source: EMA ↗

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

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