PharmacovigilanceOfficial

AIFA ends monitoring registry for Farydak in relapsed or refractory multiple myeloma

🇮🇹 AIFA · Thu 22 Oct 2026

Italy's medicines agency says monitoring of the Farydak registry stops from 22 October 2026 for its sole listed indication, following a determination published in the Official Gazette.

The Italian Medicines Agency (AIFA) has announced that monitoring of the Farydak (panobinostat) registry ends on 22 October 2026. The notice, issued by AIFA's Registries Monitoring Office, is addressed to users of the registries for medicines under monitoring.

The closure follows Determination DTS No. 53/2026, which was published in Gazzetta Ufficiale No. 245 on 21 October 2026. AIFA has posted the determination as a PDF alongside the notice.

The registry closure applies to Farydak used in combination with bortezomib and dexamethasone in adults with relapsed and/or refractory multiple myeloma. These patients must have received at least two prior regimens that included bortezomib and an immunomodulatory agent.

AIFA also reminded clinicians how to wrap up existing records. On the end-of-treatment form, they can choose 'Chiusura Monitoraggio' (monitoring closure) from the list of reasons for stopping treatment. They must then use the calendar tool to select a date on or after the monitoring end date.

What it means for your team

  • Hospital pharmacy and clinical teams in Italy should plan to complete end-of-treatment forms for any open Farydak registry cases, using the monitoring closure reason.
  • The closure date entered on the form must be 22 October 2026 or later, as the system requires.
  • Market-access and regulatory teams holding Farydak-related registry obligations can consult Determination DTS/53/2026 for the formal basis of 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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