Quality & complianceOfficial

Denmark flags November supply problems with Novartis' SomaKit TOC gallium-68 kit

🇩🇰 DKMA · Wed 11 Nov 2026

The Danish Medicines Agency reports production problems affecting SomaKit TOC 40 microgram, with disruption expected from the start to the end of November 2026.

The Danish Medicines Agency (Lægemiddelstyrelsen, DKMA) has published a supply notice on SomaKit TOC 40 microgram radiopharmaceutical preparation kit, citing current problems with availability. The marketing company is Novartis Healthcare A/S.

The notice, dated 11 November 2026, gives production problems as the cause. It lists the active substance as gallium [68-Ga] edotreotide and the ATC code as V09IX09. The expected period of disruption runs from the start to the end of November 2026.

The agency does not say how many batches or patients are affected, whether a restart date has been agreed, or whether any alternative product or import route is being arranged. It directs questions about the current status to the company.

The notice appears in DKMA's section for supply announcements on human medicines. For context, such notices are intended to inform healthcare professionals and the supply chain of shortages and interruptions.

What it means for your team

  • Nuclear medicine departments and radiopharmacies in Denmark should check directly with Novartis Healthcare A/S for the current status, as DKMA says it will not answer status questions.
  • The stated window is November 2026; the notice gives no information on whether supply will resume at the end of that period.
  • Supply-chain and market-access teams should note that production problems are the stated cause and that DKMA lists no alternatives in this notice.
  • Teams should monitor DKMA's supply notices page for any update to the expected duration.

Official source: DKMA ↗

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

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