Quality & complianceOfficial

Denmark flags Prasugrel Viatris 5 mg supply problem, expected to last until March 2027

🇩🇰 DKMA · Fri 13 Nov 2026

DKMA's updated notice attributes the shortage of Viatris ApS's 5 mg prasugrel tablets to manufacturer delays, with the disruption running from June 2025 to end-March 2027.

The Danish Medicines Agency (DKMA) has updated its supply notice for Prasugrel Viatris 5 mg film-coated tablets, marketed in Denmark by Viatris ApS. The notice was first published on 2 June 2025 and was revised on 13 November 2026. It reports current problems with supply of the product.

DKMA gives the cause as delays at the manufacturer. The expected period of disruption runs from the start of June 2025 to the end of March 2027, which would make it a long-running shortage if that timeline holds.

The notice lists the active substance as prasugrel (ATC code B01AC22) and says the product was previously marketed as Prasugrel "Mylan". It does not name alternative products or give a timetable for partial resupply. DKMA directs questions about the current status to the company.

Prasugrel is an antiplatelet medicine used after acute coronary syndrome. The notice itself does not discuss clinical impact or recommended substitutions.

What it means for your team

  • Supply and quality teams with Danish exposure should check the current status of Prasugrel Viatris 5 mg directly with Viatris ApS, as DKMA advises.
  • The stated disruption window of June 2025 to end-March 2027 should feed into continuity planning for this product in Denmark.
  • Pharmacovigilance teams may wish to watch for any treatment switches linked to the shortage, since the notice names no alternatives.

Official source: DKMA ↗

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

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