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Flolan 500 microgram to be permanently withdrawn from Danish market from end of December 2027

🇩🇰 DKMA · Fri 30 Oct 2026

GlaxoSmithKline Pharma A/S will end marketing of the epoprostenol infusion product in Denmark for commercial reasons, the Danish Medicines Agency has announced.

The Danish Medicines Agency (DKMA) has published a supply notice stating that marketing of Flolan 500 microgram powder and solvent for solution for infusion will cease. The product is supplied by GlaxoSmithKline Pharma A/S. The notice is dated 30 October 2026.

The active substance is epoprostenol (ATC code B01AC09). DKMA gives the expected period as starting from the end of December 2027, and the stated reason is commercial. The agency describes the measure as a permanent market discontinuation, not a temporary shortage.

The notice does not name alternative products or set out any continuity arrangements. DKMA says questions about the current status should be directed to the company. The item appears in the agency's section on supply notices for medicines.

The notice is dated well ahead of the expected cessation, which leaves more than a year between the announcement and the stated start of the withdrawal.

What it means for your team

  • Supply-chain and market-access teams should note the permanent withdrawal and the expected start at the end of December 2027, and check the DKMA notice and the company for current status.
  • Because the notice names no alternatives, teams should check separately whether other epoprostenol products or therapeutic options are available in Denmark.
  • Regulatory and quality teams should update product and supply-risk records to reflect a permanent discontinuation for commercial reasons, not a temporary shortage.

Official source: DKMA ↗

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

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