PharmacovigilanceOfficial

EMA publishes PSUSA outcome for ethinylestradiol/gestodene: maintenance of authorisations

🇪🇺 EMA · Thu 05 Nov 2026

The EMA has published the single assessment outcome for the ethinylestradiol/gestodene combination, with a regulatory outcome of maintenance and a list of nationally authorised products.

The European Medicines Agency published the outcome of a periodic safety update report single assessment (PSUSA) for ethinylestradiol / gestodene on 5 November 2026. The procedure is numbered PSUSA/00001308/202603.

The regulatory outcome is listed as "maintenance". The source page does not give further detail on the assessment, any findings reviewed, or any changes to product information.

The published document is a list of nationally authorised medicinal products in scope of the procedure, available in English as a 316.62 KB PDF (reference EMADOC-1700519818-3547975).

As general 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 a medicine's authorisation.

What it means for your team

  • Marketing-authorisation holders of nationally authorised ethinylestradiol / gestodene products should check the published product list to confirm their products are covered.
  • The outcome is recorded as maintenance, and the source does not describe any additional regulatory action.
  • Pharmacovigilance teams should consult the full EMA procedure page and document for the detail behind the outcome.

Official source: EMA ↗

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

More Pharmacovigilance All →