PharmacovigilanceOfficial

EMA publishes PSUSA outcome for cystine and pyridoxine hydrochloride: marketing authorisations maintained

🇪🇺 EMA · Fri 30 Oct 2026

The EU regulator has posted the single assessment outcome for cystine / pyridoxine hydrochloride, recording a 'maintenance' result for the nationally authorised products concerned.

The European Medicines Agency (EMA) published the outcome of a periodic safety update report single assessment (PSUSA) for the combination of cystine and pyridoxine hydrochloride on 30 October 2026. The procedure is numbered PSUSA/00000910/202603.

The regulatory outcome is listed as 'maintenance'. The source page gives no further detail on the assessment's findings, and it does not describe any change to the product information.

The only document attached is a list of nationally authorised medicinal products covered by the procedure (reference EMADOC-1700519818-3537490, English PDF, 151.35 KB). The wording suggests that the products in scope are authorised at national level rather than through the centralised procedure.

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 at defined time points after authorisation.

What it means for your team

  • Holders of nationally authorised cystine / pyridoxine hydrochloride products should check the published product list against their own portfolio.
  • The 'maintenance' outcome is recorded on the page, but the source gives no detail of any safety conclusions, so teams should consult the full procedure documents for any follow-up obligations.
  • Pharmacovigilance teams can log the procedure number PSUSA/00000910/202603 and the 30 October 2026 publication date in their PSUR tracking.

Official source: EMA ↗

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

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