HSE - PCRS

Application Details

HSE Application ID

HSE100046

HTA Number

25036

HTA Link

https://www.ncpe.ie/nivolumab-opdivo-subcutaneous-hta-id-25036/

Drug

nivolumab

Brand

Opdivo®

Applicant

Bristol-Myers Squibb Pharma EEIG

Indication Applied For

For subcutaneous use co-formulated with recombinant human hyaluronidase (rHuPH20), indicated across multiple previously approved adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

Application Date

30/05/2025

Marketing Authorisation Date

26/05/2025

Application Status

HSE Drugs Group Review Pending

30/09/2025

Proposal from Applicant Under Review

26/08/2025

Awaiting Proposal from Applicant

31/07/2025

Applicant Meeting Held with CPU

31/07/2025

Rapid Review Completed

18/06/2025

Pricing and Reimbursement Application Complete

30/05/2025

Rapid Review Commissioned

19/05/2025

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