Quality & complianceOfficial

Denmark flags Pinex 500 mg paracetamol suppository supply problems from Teva

🇩🇰 DKMA · Mon 09 Nov 2026

The Danish Medicines Agency says Teva Denmark is facing delivery difficulties with Pinex 500 mg suppositories, with foreign packs permitted as a substitute under section 29(2) of the Medicines Act.

The Danish Medicines Agency (DKMA) has published a supply notice for Pinex 500 mg suppositories, a paracetamol product (ATC code N02BE01) marketed by Teva Denmark A/S. The agency says there are current problems with supply of the product.

DKMA gives delivery difficulties as the cause. The notice was first posted on 5 August 2026 and updated on 9 November 2026. The expected disruption period is listed as the start of August to the end of October 2026.

Where marketed packs cannot be obtained, DKMA says foreign packs may be prescribed and dispensed under section 29(2) of the Danish Medicines Act (lægemiddelloven). Prescribers are reminded that the full product name of the foreign medicine must appear on the prescription.

The agency points readers to its list of foreign medicines that may be dispensed under that provision, which includes the relevant authorisation details. Questions about the current status of supply should go to the company, according to the notice.

What it means for your team

  • Pharmacy and prescribing teams in Denmark should check the DKMA list of foreign medicines allowed under section 29(2) when Pinex 500 mg suppositories are unavailable.
  • Prescriptions for foreign substitutes must state the full product name of the foreign product.
  • The notice was updated on 9 November 2026, after the listed disruption window of August to October, so the current position should be confirmed with Teva Denmark.
  • Supply and quality teams should note that DKMA directs status enquiries to the marketing company rather than the agency.

Official source: DKMA ↗

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

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