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Denmark updates Voltabak eye drop supply notice, with shortage expected to run to mid-May 2027

🇩🇰 DKMA · Fri 13 Nov 2026

The Danish Medicines Agency says quality problems are disrupting supply of Laboratoires Thea's diclofenac eye drops, with foreign packs allowed under section 29(2) of the Medicines Act.

The Danish Medicines Agency (DKMA) has updated its notice on supply difficulties with Voltabak 1 mg/ml eye drops, solution, made by Laboratoires Thea S.A.S. The notice was first published on 10 October 2025 and revised on 13 November 2026.

The active substance is diclofenac, as diclofenac sodium, and the product carries ATC code S01BC03. DKMA gives the cause of the problem as quality issues. The expected period of disruption runs from the start of September 2025 to mid-May 2027. The company is listed as Laboratoires Thea S.A.S. / Thea Nordic AB.

The agency does not describe the nature of the quality problems. It says questions about the current status should be directed to the company.

As a workaround, DKMA says foreign packs may be prescribed and dispensed under section 29(2) of the Danish Medicines Act when marketed packs cannot be obtained. The full product name of the foreign medicine must appear on the prescription. The agency points to a separate list of foreign medicines that can be dispensed under that provision, with the relevant details.

What it means for your team

  • Supply-chain teams should plan around a disruption that DKMA expects to last until mid-May 2027, and confirm the current position with Thea Nordic AB.
  • Prescribers and pharmacies using foreign packs under section 29(2) must ensure the full foreign product name is on the prescription.
  • Quality teams should note that DKMA cites quality problems as the cause but publishes no further detail; any specifics would have to come from the company.

Official source: DKMA ↗

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

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