PharmacovigilanceOfficial

EMA publishes PSUSA outcome for diethylamine-salicylate/escin: marketing authorisations maintained

🇪🇺 EMA · Thu 05 Nov 2026

The European Medicines Agency has released the outcome of a periodic safety update report single assessment for diethylamine-salicylate/escin, with the regulatory outcome listed as maintenance.

The European Medicines Agency (EMA) published on 5 November 2026 the outcome of a periodic safety update report single assessment (PSUSA) for the combination of diethylamine-salicylate and escin. The procedure is numbered PSUSA/00009144/202603.

The regulatory outcome is recorded as 'maintenance'. The published information does not set out the detail of the assessment or any specific safety findings.

The only document listed with the entry is a list of nationally authorised medicinal products covered by the procedure. It is an English-language PDF of about 195 KB, with the reference number EMADOC-1700519818-3549605.

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 regularly at defined time points after a medicine is authorised.

What it means for your team

  • Marketing-authorisation holders of diethylamine-salicylate/escin products should check the published list of nationally authorised products against their own portfolios.
  • The 'maintenance' outcome is the only regulatory conclusion given in the entry; no further details on the assessment are provided there.
  • Pharmacovigilance teams should consult the EMA procedure page for any follow-up documents or obligations relating to PSUSA/00009144/202603.

Official source: EMA ↗

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

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