Quality & complianceOfficial

Denmark flags Vivelle Dot 25 microgram patch shortage linked to Sandoz production problems

🇩🇰 DKMA · Fri 13 Nov 2026

The Danish Medicines Agency expects supply of Sandoz's estradiol patches to be disrupted from October to the end of December 2026 because of manufacturing issues.

The Danish Medicines Agency (DKMA) has reported current supply problems with Vivelle Dot 25 micrograms/24 hours transdermal patches marketed by Sandoz A/S. The notice was first published on 8 October 2026 and updated on 13 November 2026.

The product contains estradiol, as estradiol hemihydrate, and carries ATC code G03CA03. DKMA gives production problems as the cause and expects the disruption to run from the start of October to the end of December 2026.

DKMA says questions about the current status of supply should be directed to Sandoz. The agency does not give further detail on the nature of the manufacturing difficulties.

As a mitigation measure, DKMA 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 show the full product name. The agency points to a list of authorised foreign medicines that can be supplied under this route.

What it means for your team

  • Market-access and supply teams should note the expected October to December 2026 window and confirm stock positions directly with Sandoz.
  • Pharmacies and prescribers in Denmark can use the section 29(2) route for foreign packs, provided the full product name appears on the prescription.
  • Regulatory affairs teams handling alternatives should check DKMA's list of foreign medicines permitted under section 29(2).

Official source: DKMA ↗

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

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