Quality & complianceOfficial

Denmark flags supply problems with Accord's clozapine 100 mg tablets due to production issues

🇩🇰 DKMA · Fri 23 Oct 2026

The Danish Medicines Agency reports a supply disruption of Clozapin 'Accord' 100 mg tablets, ongoing since August 2026 with no end date given, attributed to production problems.

The Danish Medicines Agency (Lægemiddelstyrelsen, DKMA) has published a supply notice on Clozapin "Accord" 100 mg tablets, marketed by Accord Healthcare B.V. It states that there are current problems with the supply of the product.

According to the notice, dated 23 October 2026, the disruption is expected to have started in August 2026. The end of the period is listed as unknown. The cause given is production problems. The agency does not elaborate on the nature of those problems.

The product's active substance is clozapine (ATC code N05AH02), an antipsychotic used in treatment-resistant schizophrenia. The notice does not mention alternative products, affected pack sizes, or any steps for prescribers and pharmacies.

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

What it means for your team

  • Supply and market-access teams in Denmark should check the status of Clozapin "Accord" 100 mg with Accord Healthcare B.V., as DKMA refers status questions to the company.
  • The open-ended duration of the shortage means contingency planning should not assume a near-term return of supply.
  • The notice gives no guidance on alternatives, so any substitution decisions rest with prescribers and pharmacies using other available sources.

Official source: DKMA ↗

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

More Quality & compliance All →