PharmacovigilanceOfficial

EMA publishes PSUSA outcome for nitrofurantoin medicines, with regulatory outcome of 'maintenance'

🇪🇺 EMA · Fri 30 Oct 2026

The EMA has posted the single assessment of periodic safety update reports for nitrofurantoin and nitrofurantoin/pyridoxine hydrochloride, with a maintenance outcome and a list of nationally authorised products.

The European Medicines Agency has published the outcome of periodic safety update report single assessment PSUSA/00002174/202602, covering nitrofurantoin and the combination of nitrofurantoin with pyridoxine hydrochloride. The page was first published on 30 October 2026.

The regulatory outcome is listed as "maintenance". The source page does not give further detail on the assessment, such as the safety data reviewed, any changes to product information, or the reasoning behind the outcome.

The only document attached to the entry is a list of nationally authorised medicinal products in scope of the procedure, a 259.83 KB PDF in English (reference EMADOC-1700519818-3537557).

For context, a PSUSA is a single assessment of related periodic safety update reports for active substances 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 nitrofurantoin and nitrofurantoin/pyridoxine products should check the published list of nationally authorised products against their own portfolios.
  • The listed outcome is "maintenance"; the source page does not describe any specific new safety measures or labelling changes.
  • PV and regulatory teams should consult the full documents on the EMA site for any follow-up obligations, as the summary page gives no further detail.

Official source: EMA ↗

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

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