Quality & complianceOfficial

Denmark flags prasugrel 10 mg supply problems from Viatris until March 2027

🇩🇰 DKMA · Fri 13 Nov 2026

The Danish Medicines Agency says Viatris ApS's Prasugrel Viatris 10 mg tablets face supply difficulties, blamed on manufacturer delays, with disruption expected to run from April 2025 to March 2027.

The Danish Medicines Agency (DKMA) has updated its supply notice for Prasugrel Viatris 10 mg film-coated tablets, reporting current supply problems with the product from Viatris ApS. The notice was first published on 21 May 2025 and was updated on 13 November 2026.

According to the agency, the expected period of disruption runs from the start of April 2025 to the end of March 2027. The stated cause is delays at the manufacturer. The product's active substance is prasugrel, ATC code B01AC22.

DKMA notes that the product was previously marketed as Prasugrel "Mylan". The agency says questions about the current supply status should be directed to the company rather than to the authority.

The notice does not say which pack sizes are affected or how severe the shortage is. It also gives no recommended alternatives or substitution advice. As general context, prasugrel is an antiplatelet agent, so continuity of supply can matter for prescribers and pharmacies.

What it means for your team

  • Supply teams should note the stated disruption window of April 2025 to March 2027 when planning Danish availability of this product.
  • Questions on current status should go to Viatris ApS, as DKMA directs, since the notice contains no stock or recovery details.
  • Quality and pharmacovigilance staff may wish to monitor for switching to other antiplatelet products, although the notice itself offers no guidance on alternatives.
  • Manufacturer delays are the cited cause, so teams may want to track further updates to the DKMA notice.

Official source: DKMA ↗

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

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