HSE - PCRS

Application Details

HSE Application ID

HSE100081

HTA Number

25065

HTA Link

https://www.ncpe.ie/obinutuzumab-gazyvaro-hta-id-25065/

Drug

obinutuzumab

Brand

Gazyvaro®

Applicant

Roche

Indication Applied For

Gazyvaro in combination with mycophenolate mofetil (MMF) indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN).

Application Date

15/12/2025

Marketing Authorisation Date

04/12/2025

Application Status

Proposal from Applicant Under Review

18/02/2026

Awaiting Proposal from Applicant

29/01/2026

Applicant Meeting Held with CPU

29/01/2026

Pricing and Reimbursement Application Complete

15/12/2025

Rapid Review Completed

08/12/2025

Rapid Review Commissioned

04/11/2025

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