Quality & complianceOfficial

Denmark flags Leponex 100 mg supply problems from Viatris until April 2027

🇩🇰 DKMA · Fri 23 Oct 2026

The Danish Medicines Agency reports supply difficulties with Viatris' clozapine 100 mg tablets, expected from late October 2026 to early April 2027 and attributed to increased demand.

The Danish Medicines Agency (DKMA) has published a supply notice for Leponex 100 mg tablets, saying there are current problems with supply of the product from Viatris ApS. The notice is dated 23 October 2026.

The product contains clozapine (ATC code N05AH02). DKMA gives the expected period of difficulty as the end of October 2026 to the start of April 2027, a span of roughly five months.

The stated cause is increased sales or demand. The notice does not describe any quality, manufacturing or regulatory problem, and it gives no volumes or details on how severely availability will be affected.

DKMA's notice does not name alternative products or recommend steps for prescribers or pharmacies. It says questions about the current status should be directed to the company. Clozapine is used in treatment-resistant schizophrenia, so supply interruptions may affect continuity of treatment.

What it means for your team

  • Teams with Danish exposure should check Viatris' current stock position directly, as DKMA refers status questions to the company.
  • Because the notice names no alternatives, contingency planning, such as foreign-supply options or other strengths, will need to draw on separate sources.
  • The expected shortage window runs to early April 2027, so supply-continuity and communication plans should cover several months.
  • The cause is given as demand rather than a quality issue, so the notice does not point to a product-quality or safety concern.

Official source: DKMA ↗

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

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