Quality & complianceOfficial

Salazopyrin Entabs 500 mg faces Danish supply difficulties as demand rises, DKMA says

🇩🇰 DKMA · Mon 02 Nov 2026

The Danish Medicines Agency has flagged upcoming supply problems for Pfizer's sulfasalazine gastro-resistant tablets, attributing them to increased sales and demand.

The Danish Medicines Agency (Lægemiddelstyrelsen, DKMA) has published a notice about upcoming supply problems for Salazopyrin Entabs 500 mg gastro-resistant tablets, marketed in Denmark by Pfizer ApS. The active substance is sulfasalazine (ATC code A07EC01).

According to the notice, the cause is increased sales and demand. The agency lists the expected period as end of October to end of October 2026, so the entry does not give a clear window for how long the difficulties may last. The notice was first published on 1 September 2026 and updated on 2 November 2026.

The notice does not describe the scale of the shortfall, name alternative products or set out any mitigation measures. DKMA says questions about the current status should be put to the company, Pfizer ApS.

The entry appears in the agency's section on supply notifications for medicines, which sits within its wider work on medicine shortages.

What it means for your team

  • Supply and QA teams in Denmark should check current availability of Salazopyrin Entabs 500 mg directly with Pfizer ApS, as DKMA points status queries to the company.
  • The stated cause is demand-driven rather than quality-related, and the notice mentions no recall or product defect.
  • The expected period is given only as end of October 2026, so teams should not assume a firm resolution date and should watch for further updates to the notice.
  • No alternatives are named in the notice, so any continuity-of-treatment planning will need information from other sources.

Official source: DKMA ↗

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

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