RegulatoryOfficial

Denmark updates supply-failure period for estradiol 37.5 microgram patches, foreign alternative allowed

🇩🇰 DKMA · Fri 13 Nov 2026

The Danish Medicines Agency has revised the expected period during which foreign-pack estradiol 37.5 micrograms/24 hours depot patches may supply the Danish market under section 29(2) of the Medicines Act.

The Danish Medicines Agency (DKMA) has updated the time period for an estradiol 37.5 micrograms/24 hours depot patch on its list of medicines in supply failure. For these products, Denmark wants the market supplied with an equivalent foreign medicine under section 29(2) of the Danish Medicines Act.

The entry covers estradiol, ATC code G03CA03, for human use, in the form of depot patches. The expected period for the supply need is given as the end of April to the end of December 2026. The notice was first published on 24 April 2026 and updated on 13 November 2026.

DKMA states that the expected period for supplying foreign packs may change on an ongoing basis. It is revised on the basis of information the agency receives from the marketing authorisation holder or holders.

The notice directs companies to DKMA's full list of foreign alternatives in supply failure, which also carries further information on selling foreign packs under section 29(2). The source text does not say what changed in the period or explain the reason for the supply failure.

What it means for your team

  • Marketing authorisation holders and suppliers planning imports of foreign estradiol 37.5 microgram/24 h patches should check the updated period on DKMA's list.
  • The stated window runs from the end of April to the end of December 2026, but DKMA says it may change as holders report new information.
  • Holders' supply updates to DKMA feed directly into these periods, so keeping the agency informed matters for import planning.

Official source: DKMA ↗

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

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