Quality & complianceOfficial

DKMA flags Pinex 1000 mg suppository supply problems from Teva Denmark

🇩🇰 DKMA · Mon 09 Nov 2026

The Danish Medicines Agency lists delivery difficulties for paracetamol suppositories and points prescribers to foreign packs under section 29(2) of the Medicines Act.

The Danish Medicines Agency (DKMA) has published a supply notice for Pinex 1000 mg suppositories, a paracetamol product (ATC code N02BE01) from Teva Denmark A/S. The notice refers to upcoming supply problems and gives the cause as delivery difficulties.

The expected period of disruption runs from the start of May to the start of November 2026. The page was first published on 21 April 2026 and last updated on 9 November 2026. The text does not say what the latest update changed or whether supply has been restored.

Where marketed packs cannot be obtained, DKMA says foreign packs may be prescribed and dispensed under section 29(2) of the Danish Medicines Act. The full product name of the foreign medicine must appear on the prescription. The agency links to a list of foreign medicines that may be dispensed under that provision.

DKMA directs questions about the current status to the company rather than to the agency.

What it means for your team

  • Supply and QA teams handling Pinex 1000 mg in Denmark should check the DKMA notice for the latest update and contact Teva Denmark A/S for current status.
  • Foreign alternatives can only be dispensed under section 29(2) when marketed packs are unavailable, and the prescription must carry the full foreign product name.
  • Market-access and pharmacovigilance teams may want to confirm that any foreign substitute packs are traceable and that their labelling and safety information are accessible.

Official source: DKMA ↗

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

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