Quality & complianceOfficial

DKMA flags Trisenox supply gap from Teva Denmark running into late 2027

🇩🇰 DKMA · Tue 27 Oct 2026

Denmark's medicines agency expects supply problems with Trisenox 2 mg/ml arsenic trioxide concentrate from end April to end September 2027, citing production problems at the company.

The Danish Medicines Agency (DKMA) published a supply notice on 27 October 2026 warning of upcoming problems with Trisenox 2 mg/ml concentrate for solution for infusion. The product is marketed in Denmark by Teva Denmark A/S.

The notice names arsenic trioxide as the active substance and gives the ATC code as L01XX27. It puts the expected period of disruption at the end of April 2027 to the end of September 2027, and attributes the problem to production issues.

The notice is brief. It does not say how severe the shortage will be, whether all pack sizes are affected, or whether foreign alternatives or other supply measures are planned. DKMA directs questions about the current status to the company.

The notice appears in DKMA's section on medicine supply announcements. The disruption is flagged about six months before the expected start, which leaves time for planning.

What it means for your team

  • Supply and QA teams handling Trisenox in Denmark should confirm the current status directly with Teva Denmark A/S, as DKMA advises.
  • The notice names no alternatives. Teams should not assume substitutes or imports are available until DKMA or the company says so.
  • The expected window, end April to end September 2027, gives an early basis for continuity-of-care planning for this oncology product.
  • The period and cause are the company's current expectations as reported by DKMA, so the notice should be re-checked for updates.

Official source: DKMA ↗

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

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