RegulatoryOfficial

Denmark adds bendroflumethiazide/potassium chloride tablets to foreign-supply list amid shortage

🇩🇰 DKMA · Fri 06 Nov 2026

The Danish Medicines Agency has listed bendroflumethiazide/potassium chloride 2.5+573 mg tablets as in supply failure, opening the way for equivalent foreign-labelled products under section 29(2) of the Medicines Act.

The Danish Medicines Agency (DKMA) has added bendroflumethiazide and potassium chloride 2.5+573 mg tablets to its list of medicines in supply failure. For these products, Denmark wants its market supplied with an equivalent foreign medicine under section 29(2) of the Danish Medicines Act.

The notice, dated 6 November 2026, is addressed to pharmaceutical companies. It identifies the product as a human medicine with the ATC code C03AB01.

DKMA gives the expected period of need for foreign packs as the start of November 2026 to the start of January 2027. It stresses that this timeframe may change and will be updated according to information the agency receives from marketing authorisation holders.

The agency refers companies to its full list of foreign alternatives in supply failure, which also contains further information on selling foreign packs under section 29(2). The source text does not give the cause of the shortage or name any suppliers.

What it means for your team

  • Marketing authorisation holders and importers should note the expected November 2026 to January 2027 window for foreign packs, which DKMA says may be revised.
  • Companies considering supplying foreign-labelled packs should consult DKMA's full list and its guidance on sales under section 29(2).
  • Supply-chain and market-access teams should keep in touch with DKMA, since the timeline depends on information from marketing authorisation holders.

Official source: DKMA ↗

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

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