PharmacovigilanceOfficial

EMA publishes PSUSA outcome for pooled, virus-inactivated human plasma: maintenance of authorisations

🇪🇺 EMA · Fri 30 Oct 2026

The EMA has published a PSUSA outcome for pooled, virus-inactivated human plasma, with the regulatory result recorded as 'maintenance'.

The European Medicines Agency published the outcome of periodic safety update report single assessment PSUSA/00001635/202602 on 30 October 2026. The procedure covers the active substance human plasma (pooled and treated for virus inactivation).

The regulatory outcome is listed as 'maintenance'. The page does not set out any further detail on the assessment, and no safety findings or product information changes are described in the text available.

Published alongside the entry is a document titled as a list of nationally authorised medicinal products for the substance under this procedure. It is an English-language PDF of 343.86 KB, with the reference number EMADOC-1700519818-3537311.

By way of 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 regularly at defined time points after a medicine's authorisation.

What it means for your team

  • Marketing-authorisation holders of nationally authorised plasma-derived products in scope should check the published product list to confirm whether their medicines are covered.
  • The 'maintenance' outcome is the only regulatory result stated; the source gives no indication of required changes, though teams should review the full documentation on the EMA site.
  • Pharmacovigilance teams should record the procedure number PSUSA/00001635/202602 and the 30 October 2026 publication date in their tracking systems.

Official source: EMA ↗

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

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