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GSK to permanently withdraw Flolan 1.5 mg from Danish market from end-2027

🇩🇰 DKMA · Fri 30 Oct 2026

DKMA's supply notice says GlaxoSmithKline Pharma A/S will end marketing of Flolan 1.5 mg epoprostenol infusion powder for commercial reasons, with the withdrawal expected from late December 2027.

The Danish Medicines Agency (DKMA) has published a supply notice stating that GlaxoSmithKline Pharma A/S will stop marketing Flolan 1.5 mg powder and solvent for solution for infusion. The notice is dated 30 October 2026.

The product contains epoprostenol (as epoprostenol sodium) and carries ATC code B01AC09. DKMA lists the expected period as starting at the end of December 2027 and describes the move as a permanent market discontinuation.

The stated reason is commercial. The notice does not give details of stock levels, interim supply arrangements or therapeutic alternatives, and it does not mention other strengths or presentations of Flolan.

DKMA directs questions about the current status to the company. The notice appears in the agency's section on supply notifications for human medicines.

What it means for your team

  • Supply and regulatory teams in Denmark should note the expected end-December 2027 start date and the permanent nature of the discontinuation.
  • Check with GlaxoSmithKline Pharma A/S for current status, as DKMA's notice refers such questions to the company.
  • The notice gives no information on alternatives or continuity measures, so any contingency planning will need to draw on other sources.

Official source: DKMA ↗

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

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