PharmacovigilanceOfficial

EMA publishes PSUSA outcome for dimeticone/guaiazulene: marketing authorisations to be maintained

🇪🇺 EMA · Fri 30 Oct 2026

The EU regulator's single assessment of periodic safety update reports for the dimeticone and guaiazulene combination ends with a 'maintenance' outcome, and a list of nationally authorised products has been published.

The European Medicines Agency (EMA) published on 30 October 2026 the outcome of a periodic safety update report single assessment (PSUSA) for the fixed combination of dimeticone and guaiazulene. The procedure number is PSUSA/00001099/202603.

The regulatory outcome is listed as 'maintenance'. The published information does not describe any change to the marketing authorisations in the summary of the procedure.

Alongside the outcome, EMA has posted a PDF document listing the nationally authorised medicinal products covered by the procedure (reference EMADOC-1700519818-3535738, English, 187.79 KB). The source does not provide further detail on the assessment, such as safety findings or the products concerned beyond that list.

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 authorisation.

What it means for your team

  • Marketing-authorisation holders of dimeticone/guaiazulene products authorised nationally should check the published product list to confirm their products are included.
  • A 'maintenance' outcome indicates no change to the authorisations is flagged in the published summary; teams should still review the full documents for any follow-up.
  • Pharmacovigilance teams should keep PSUR submission schedules aligned with the PSUSA procedure for this substance combination.

Official source: EMA ↗

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

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