PharmacovigilanceOfficial

EMA publishes PSUSA outcome for diclofenac sodium/orphenadrine citrate: maintenance of authorisations

🇪🇺 EMA · Fri 30 Oct 2026

The EMA has published the outcome of a periodic safety update report single assessment for diclofenac sodium and orphenadrine citrate, with a regulatory outcome of maintenance.

The European Medicines Agency has published the outcome of PSUSA/00001045/202603, a periodic safety update report single assessment covering the combination of diclofenac sodium and orphenadrine citrate. The page was first published on 30 October 2026.

The listed regulatory outcome is "maintenance". The source does not provide further detail on the assessment, such as the data reviewed, the reporting period or any discussion of safety findings.

The EMA has attached a PDF listing the nationally authorised medicinal products in scope of the procedure (reference EMADOC-1700519818-3537556, 176.21 KB, English). The source does not say how many products or countries the list covers.

As general 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 authorisation.

What it means for your team

  • Marketing-authorisation holders of diclofenac sodium/orphenadrine citrate products should check the published list of nationally authorised products against their own portfolios.
  • The outcome is recorded as maintenance, and the source text gives no indication of changes to product information in this entry.
  • Pharmacovigilance teams should consult the full EMA procedure documents for any follow-up obligations, as none are described in the source text.

Official source: EMA ↗

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

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