RegulatoryOfficial

DKMA updates foreign-supply window for estradiol 75 microgram patches in Danish supply failure

🇩🇰 DKMA · Fri 13 Nov 2026

The Danish Medicines Agency has revised the expected period during which foreign packs of estradiol 75 micrograms/24 hours depot patches are needed under section 29(2) of the Medicines Act.

The Danish Medicines Agency (DKMA) has updated the time period for an estradiol medicine on its list of products in supply failure. For these products, the agency wants the Danish market supplied with an equivalent foreign medicine under section 29(2) of the Danish Medicines Act. The page was first published on 18 May 2026 and updated on 13 November 2026.

The entry covers estradiol depot patches at 75 micrograms/24 hours, ATC code G03CA03, for human use. DKMA gives the expected period of need as mid-May to early December 2026. In its remarks, it notes a larger delivery expected in mid-September 2026.

DKMA states that the expected period for supplying foreign packs may change on an ongoing basis. Updates will draw on information the agency receives from marketing authorisation holders. The full list, together with further information on selling foreign packs under section 29(2), is available on its page for pharmaceutical companies on foreign alternatives in supply failure.

The source does not say what caused the supply failure, nor does it name specific products, suppliers or the exact nature of the change to the period.

What it means for your team

  • Companies planning imports of foreign estradiol 75 microgram/24 hour patches for Denmark should check the current period on DKMA's list: mid-May to early December 2026.
  • Marketing authorisation holders should note that DKMA bases updates on information they provide, so timely supply-status reporting affects the published window.
  • Supply and market-access teams should keep monitoring the page, as DKMA says the expected period can change on an ongoing basis.

Official source: DKMA ↗

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

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