Quality & complianceOfficial

DKMA flags Clozapin "Hexal" 100 mg supply problems from Sandoz through January 2027

🇩🇰 DKMA · Tue 03 Nov 2026

Denmark's medicines agency reports delivery difficulties for Sandoz's clozapine 100 mg tablets, expected to last from October 2026 to the end of January 2027.

The Danish Medicines Agency (DKMA) has published a supply notice about Clozapin "Hexal" 100 mg tablets, marketed in Denmark by Sandoz A/S. The notice, dated 3 November 2026, states that there are current problems with the supply of the product.

DKMA gives the expected period of disruption as starting in October 2026 and ending in January 2027. The stated cause is delivery difficulties. The active substance is clozapine, ATC code N05AH02.

The notice offers no further detail on the nature of the delivery problems, on how many packs or patients may be affected, or on recommended alternatives. DKMA directs anyone with questions about the current status to the company, Sandoz A/S.

The item appears in the agency's section for supply notices on medicines, which sits within its wider work on shortages of medicines.

What it means for your team

  • Supply and QA teams with clozapine products in Denmark should check stock positions and contact Sandoz A/S for current status, as DKMA refers such queries to the company.
  • The notice gives an expected window of October 2026 to January 2027, but no cause beyond delivery difficulties, so planning should allow for the timeline changing.
  • Pharmacovigilance and medical teams may want to consider continuity-of-treatment issues if patients are moved to other products, although DKMA names no alternatives in this notice.

Official source: DKMA ↗

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

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