PharmacovigilanceOfficial

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

🇮🇹 AIFA · Thu 22 Oct 2026

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

The Italian Medicines Agency (AIFA) has announced that monitoring under the Raxone registry will end on 22 October 2026 for the product's stated therapeutic indication. The closure follows publication of Determination DTS n. 54/2026 in Gazzetta Ufficiale no. 245 of 21 October 2026.

The indication concerned is the treatment of visual impairment in adult and adolescent patients with Leber's hereditary optic neuropathy (LHON). AIFA's notice, issued by its Registries Office, is addressed to users of the registries for medicines subject to monitoring.

The agency also set out how clinicians should handle open records. When completing the end-of-treatment form, prescribers can choose "Chiusura Monitoraggio" (monitoring closure) from the list of reasons for ending treatment. To use this option, they must select a date that is the same as or later than the monitoring end date, using the calendar tool in the system.

The notice links to the text of the determination as a PDF. It does not give the reasons for the closure or any further details of the decision.

What it means for your team

  • Market-access and pricing teams holding Raxone in Italy should check Determination DTS n. 54/2026 for the full terms of the change to the monitoring requirement.
  • Prescribing centres and any medical affairs staff supporting them should be aware of the "Chiusura Monitoraggio" option and the date rule for closing out treatment records.
  • Teams tracking Italian registry-linked access conditions should update their records to reflect that monitoring for the LHON indication ended on 22 October 2026.

Official source: AIFA ↗

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

More Pharmacovigilance All →