PharmacovigilanceOfficial

EMA publishes PSUSA outcome for cyproterone acetate/estradiol valerate, with marketing authorisations maintained

🇪🇺 EMA · Fri 30 Oct 2026

The EMA has published the single-assessment outcome for cyproterone acetate/estradiol valerate under procedure PSUSA/00000907/202603, with a regulatory outcome of 'maintenance'.

The European Medicines Agency published the outcome of a periodic safety update report single assessment (PSUSA) for the combination of cyproterone acetate and estradiol valerate on 30 October 2026. The procedure number is PSUSA/00000907/202603.

The regulatory outcome is listed as 'maintenance'. The page published by the agency does not give any further detail on the assessment, such as the safety data reviewed or the reasoning behind the outcome.

The documents attached to the entry consist of a list of nationally authorised medicinal products covered by the procedure, in English, as a PDF of 159.11 KB. It carries the reference number EMADOC-1700519818-3537362.

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 regularly at defined points after a medicine's authorisation.

What it means for your team

  • Marketing-authorisation holders of products containing cyproterone acetate/estradiol valerate should check the published list of nationally authorised products against their own portfolios.
  • The 'maintenance' outcome is recorded on the EMA page; the source gives no indication of any change to product information in this entry.
  • Pharmacovigilance teams should file the PSUSA reference (PSUSA/00000907/202603) in their records and track any follow-up from national competent authorities.

Official source: EMA ↗

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

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