HSE - PCRS

Application Details

HSE Application ID

HSE100060

HTA Number

25048

HTA Link

https://www.ncpe.ie/givinostat-duvyzat-hta-id-25048/

Drug

givinostat

Brand

Duvyzat®

Applicant

Italfarmaco Pharma

Approved Indication

For the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.

Application Date

06/08/2025

Marketing Authorisation Date

06/06/2025

Application Status

HSE Approval Letter Issued to Applicant

01/07/2026

Reviewed by HSE Senior Leadership Team

16/06/2026

Managed Access Protocol (MAP) Commissioned

12/06/2026

Reviewed by HSE Drugs Group

09/06/2026

HSE Drugs Group Review Pending

26/05/2026

Proposal from Applicant Under Review

08/05/2026

Awaiting Proposal from Applicant

27/03/2026

Applicant Meeting Held with CPU

27/03/2026

NCPE Assessment Completed

03/03/2026

Full Health Technology Assessment Commissioned by HSE

26/08/2025

Rapid Review Completed

14/08/2025

Pricing and Reimbursement Application Complete

06/08/2025

Rapid Review Commissioned

05/08/2025