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DKMA updates Vivelle Dot 37.5 supply notice: shortage expected to last until end of December

🇩🇰 DKMA · Fri 13 Nov 2026

Denmark's medicines agency says production problems at Sandoz A/S are disrupting Vivelle Dot 37.5 micrograms/24 hours patches, with foreign packs allowed as a stopgap.

The Danish Medicines Agency (DKMA) updated its supply notice for Vivelle Dot 37.5 micrograms/24 hours transdermal patches on 13 November 2026. The notice was first published on 24 April 2026. It describes current supply problems with the product from Sandoz A/S.

The patches contain estradiol, as estradiol hemihydrate, and carry ATC code G03CA03. DKMA gives production problems as the cause. The expected period of disruption runs from the start of April to the end of December 2026.

DKMA says questions about the current status should go to the company. The notice itself gives no stock levels or recovery date beyond the stated period.

As an interim measure, the agency notes that foreign packs may be prescribed and dispensed under section 29(2) of the Danish Medicines Act when marketed packs cannot be obtained. Prescriptions must state the full product name. DKMA links to a list of permits with details of the foreign medicines concerned.

What it means for your team

  • Supply, quality and market-access teams should note that DKMA expects the disruption to last until the end of December 2026 and attributes it to production problems.
  • Pharmacy and prescriber-facing teams should be aware that section 29(2) permits allow foreign packs when marketed packs are unavailable, and that the full product name must appear on the prescription.
  • Questions about current availability should go to Sandoz A/S, as DKMA directs; the full DKMA notice and permit list should be checked for the foreign products that can be dispensed.

Official source: DKMA ↗

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

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