HSE - PCRS

Application Details

HSE Application ID

HSE100040

HTA Number

25022

HTA Link

https://www.ncpe.ie/infliximab-remsima-for-crohns-disease-dose-escalation-hta-id-25022/

Drug

Infliximab

Brand

Remsima®

Applicant

Celltrion Healthcare

Approved Indication

Dose escalation (240mg) in maintenance treatment of Crohn’s disease in adult patients who initially responded to induction regimen with infliximab but who lost response on standard (120mg) subcutaneous (SC) maintenance dose as per European Commission variation approval on the 28th June 2024.

Application Date

13/03/2025

Marketing Authorisation Date

28/06/2024

Application Status

HSE Approval Letter Issued to Applicant

01/11/2025

Proposal from Applicant Under Review

04/07/2025

Awaiting Proposal from Applicant

12/06/2025

Applicant Meeting Held with CPU

12/06/2025

Rapid Review Completed

11/04/2025

Rapid Review Commissioned

18/03/2025

Pricing and Reimbursement Application Complete

13/03/2025

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