RegulatoryOfficial

Denmark flags Froidir 100 mg clozapine supply problems from Orion Pharma until early December

🇩🇰 DKMA · Fri 23 Oct 2026

The Danish Medicines Agency reports production problems affecting Froidir 100 mg clozapine tablets, with disruption expected from mid-October to the start of December 2026.

The Danish Medicines Agency (DKMA) has published a supply notice on current problems with Froidir 100 mg tablets from Orion Pharma A/S. The notice is dated 23 October 2026.

Froidir contains the active substance clozapine, an antipsychotic with ATC code N05AH02. DKMA gives production problems as the cause of the disruption.

The agency expects the supply difficulty to run from mid-October to the start of December 2026. It does not specify which pack sizes or batches are affected, and it names no alternative products.

DKMA directs questions about the current status to the company, Orion Pharma A/S. The notice appears in the agency's section on supply of medicines, which sits under its pages on medicine shortages.

What it means for your team

  • Pharmacies and prescribers in Denmark should check current availability of Froidir 100 mg with Orion Pharma A/S, as DKMA refers status queries to the company.
  • Supply teams should plan around the expected window of mid-October to early December 2026, bearing in mind that the dates are an expectation rather than a firm commitment.
  • The notice offers no detail on alternatives or the scale of the shortfall, so continuity-of-treatment planning will need further information from the company.

Official source: DKMA ↗

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

More Regulatory All →