Quality & complianceOfficial

Denmark flags supply problems with Sandoz's Vivelle Dot 75 microgram estradiol patches until December

🇩🇰 DKMA · Fri 13 Nov 2026

The Danish Medicines Agency attributes the shortage of Sandoz's 75 micrograms/24 hours HRT patch to production problems, with foreign packs permitted as an alternative.

The Danish Medicines Agency (Lægemiddelstyrelsen, DKMA) has reported current supply problems with Vivelle Dot 75 micrograms/24 hours transdermal patches from 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 the cause as production problems and the expected period of disruption as the start of October to the start of December 2026.

The agency says questions about the current status should be directed to the company. It does not provide details of the manufacturing issue or any information on when normal supply will resume beyond the stated period.

As a mitigation, 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. Prescribers are reminded that the full product name must appear on the prescription. The agency points to a list of foreign medicines that may be dispensed under that provision, with the relevant authorisation details.

What it means for your team

  • Supply teams should track the Sandoz Vivelle Dot 75 microgram shortage in Denmark, which DKMA expects to run until the start of December 2026.
  • Section 29(2) permits foreign packs only where marketed packs are unavailable, so prescriptions must carry the full product name.
  • Market-access and quality contacts should ask Sandoz directly for current status, as DKMA refers such queries to the company.

Official source: DKMA ↗

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

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