HSE - PCRS

Application Details

HSE Application ID

HSE100104

HTA Number

26017

HTA Link

https://www.ncpe.ie/infliximab-remsima-sc-induction-phase-of-treatment-in-patients-with-rheumatoid-arthritis-hta-id-26017/

Drug

infliximab

Brand

Remsima®

Applicant

Celltrion Healthcare

Indication Applied For

Subcutaneous infliximab induction phase of treatment in patients with rheumatoid arthritis. 
In combination with methotrexate for the reduction of signs and symptoms as well as the improvement in physical function in: 
• Adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate. 
• Adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.

Application Date

08/04/2026

Marketing Authorisation Date

30/04/2021

Application Status

Proposal from Applicant Under Review

19/06/2026

Awaiting Proposal from Applicant

04/06/2026

Applicant Meeting Held with CPU

04/06/2026

Rapid Review Completed

24/04/2026

Rapid Review Commissioned

08/04/2026

Pricing and Reimbursement Application Complete

08/04/2026

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