Quality & complianceOfficial

DKMA flags Gilenya 0.25 mg capsule supply problems linked to production issues

🇩🇰 DKMA · Tue 10 Nov 2026

Denmark's medicines agency lists Novartis Healthcare's fingolimod 0.25 mg hard capsules as affected by manufacturing difficulties, with the notice last updated on 10 November 2026.

The Danish Medicines Agency (DKMA) has published a supply notice for Gilenya 0.25 mg hard capsules from Novartis Healthcare A/S. The notice says there are current problems with supply of the product. The active substance is fingolimod (as fingolimod hydrochloride), ATC code L04AE01.

DKMA gives the cause as production problems. It lists the expected period of supply difficulty as the end of July to the start of September 2026. The notice was first posted on 10 August 2026 and updated on 10 November 2026.

The notice does not say what the update changed. It also gives no information on whether supply has been restored, nor on alternative products or substitution arrangements for this strength. DKMA tells readers to put questions about the current status to the company.

The entry appears in the agency's section for notifications about medicine supply. Fingolimod is an oral immunomodulator, and in Europe it is generally associated with the treatment of multiple sclerosis.

What it means for your team

  • Marketing authorisation holders and local affiliates should check the current status of Gilenya 0.25 mg directly with Novartis Healthcare A/S, as DKMA directs, because the notice does not state it.
  • Supply and regulatory teams should note that the stated expected period (end July to start September 2026) predates the 10 November update, so the current timeline is unclear from the notice alone.
  • Teams tracking Danish continuity of care should look for any separate DKMA guidance on foreign alternatives or substitution, as none is given in this notice.

Official source: DKMA ↗

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

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