HSE - PCRS

Application Details

HSE Application ID

HSE100076

HTA Number

25062

HTA Link

https://www.ncpe.ie/risdiplam-evrysdi-hta-id-25062/

Drug

risdiplam

Brand

Evrysdi®

Applicant

Roche

Indication Applied For

Indicated for the treatment of 5q spinal muscular atrophy (SMA) in adult patients with a clinical diagnosis of SMA Type 2 or Type 3 or with one to four SMN2 copies.

Application Date

22/10/2025

Marketing Authorisation Date

26/03/2021

Application Status

HSE Drugs Group Review Pending

24/02/2026

Proposal from Applicant Under Review

06/02/2026

Awaiting Proposal from Applicant

22/01/2026

Applicant Meeting Held with CPU

22/01/2026

Rapid Review Completed

20/11/2025

Pricing and Reimbursement Application Complete

22/10/2025

Rapid Review Commissioned

17/10/2025

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