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AIFA ends RAXONE registry monitoring for Leber's hereditary optic neuropathy from 22 October

🇮🇹 AIFA · Thu 22 Oct 2026

Italy's medicines agency says monitoring of Raxone in LHON stops on 22 October 2026, following publication of Determina DTS 54/2026 in the Official Gazette.

The Italian Medicines Agency (AIFA) has announced that monitoring in the RAXONE registry ends on 22 October 2026 for the product's sole indication listed in the notice. The indication is the treatment of visual impairment in adult and adolescent patients with Leber's hereditary optic neuropathy (LHON).

AIFA links the change to Determina DTS n. 54/2026, which appeared in Gazzetta Ufficiale no. 245 on 21 October 2026. The notice, issued by the agency's Monitoring Registries Office, is addressed to users of the Medicines Monitoring Registries. The determination is attached as a PDF, but the notice itself gives no reason for the closure.

For clinicians, AIFA reminds users that the end-of-treatment form can be completed by choosing 'Chiusura Monitoraggio' (monitoring closure) from the list of reasons for ending treatment. The date entered, picked from the calendar tool, must be the same as or later than the monitoring end date.

AIFA's registries are used to track the prescribing of certain medicines reimbursed by the Italian national health service. The notice does not say whether any further steps are planned for patients already enrolled.

What it means for your team

  • Teams supporting Italian prescribers should check that registry users know the new closure option and the date rule for end-of-treatment forms.
  • Market-access staff should read Determina DTS 54/2026 for the formal basis and any wider conditions, as the notice does not explain the decision.
  • Nothing in the notice points to a safety reason for the closure.

Official source: AIFA ↗

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

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