PharmacovigilanceOfficial

EMA publishes PSUSA outcome for intravenous amino acid combinations: marketing authorisations maintained

🇪🇺 EMA · Tue 20 Oct 2026

A periodic safety update report single assessment of intravenous amino acid combinations has ended with a 'maintenance' outcome, according to EMA's publication of 20 October 2026.

The European Medicines Agency has published the outcome of a periodic safety update report single assessment (PSUSA) covering intravenous amino acid combinations. The procedure is numbered PSUSA/00010187/202601, and the regulatory outcome is listed as 'maintenance'.

The scope covers combinations of pure amino acids, and combinations of amino acids with mineral compounds or electrolytes, when given intravenously. EMA first published the entry on 20 October 2026.

The only document listed is a list of nationally authorised medicinal products affected by the procedure, issued as an English-language PDF of about 434 KB under reference EMADOC-1700519818-3513633. The source text gives no details of the safety data reviewed, and does not describe any new warnings or changes to product information.

As background, a PSUSA is a single assessment of related periodic safety update reports (PSURs) for an active substance found in medicines authorised in the EU. A PSUR is a pharmacovigilance report that marketing-authorisation holders submit regularly at defined time points after authorisation.

What it means for your team

  • A 'maintenance' outcome means the source text records no change to the authorisations. Teams should still check the published product list for their products.
  • Marketing-authorisation holders of nationally authorised intravenous amino acid products should check whether their products appear in the published list.
  • The source text gives no assessment findings, so teams needing the scientific rationale should look for further documentation beyond this entry.

Official source: EMA ↗

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

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