Quality & complianceOfficial

Denmark flags November supply disruption for Epistatus buccal midazolam due to manufacturer delays

🇩🇰 DKMA · Tue 27 Oct 2026

The Danish Medicines Agency expects Epistatus 10 mg oromucosal solution from SERB S.A. to be affected from early to late November 2026, citing manufacturer delays.

The Danish Medicines Agency (DKMA) has published a notice of upcoming supply problems with Epistatus 10 mg oromucosal solution, marketed by SERB S.A. The notice is dated 27 October 2026.

The product contains midazolam, as midazolam maleate, and carries the ATC code N05CD08. The agency gives the expected period of disruption as the start of November to the end of November 2026.

DKMA states the cause as delays at the manufacturer. It provides no further detail on the nature of those delays, the scale of the shortfall, or whether supply is expected to recover immediately after November.

The agency directs questions about the current status to SERB S.A. The notice sits within DKMA's section on supply notifications for medicines.

What it means for your team

  • Hospital and community pharmacy teams in Denmark should plan for limited Epistatus availability during November 2026 and review available alternatives.
  • Supply-chain and quality teams should seek current stock and delivery information directly from SERB S.A., as DKMA refers status queries to the company.
  • The notice gives no information on alternatives or on the extent of the shortage, so teams should not assume the disruption will end when November does.

Official source: DKMA ↗

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

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