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decitabine, cedzuridine (Inaqovi®)
Application Details
HSE Application ID
HSE100092
HTA Number
26007
HTA Link
https://www.ncpe.ie/decitabine-cedazuridine-inaqovi-hta-id-26007/
Drug
decitabine, cedzuridine
Brand
Inaqovi®
Applicant
Otsuka Pharmaceuticals
Indication Applied For
Indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.
Application Date
18/02/2026
Marketing Authorisation Date
15/09/2023
Application Status
Rapid Review Completed
08/04/2026
Rapid Review Commissioned
19/02/2026
Pricing and Reimbursement Application Complete
18/02/2026
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Status
Pricing and Reimbursement Application Complete
Rapid Review Commissioned
Rapid Review Completed
Applicant Meeting Held with CPU
Awaiting Proposal from Applicant
Proposal from Applicant Under Review
Full Health Technology Assessment Commissioned by HSE
NCPE Assessment Completed
HSE Drugs Group Review Pending
Reviewed by HSE Drugs Group
HSE Rare Disease Technology Review Committee - Review Requested
HSE Rare Disease Technology Review Committee - Review Received
Further Information Requested by HSE Drugs Group
Reviewed by HSE Senior Leadership Team
Managed Access Protocol (MAP) Commissioned
Proposed HSE Decision Issued to Applicant
Applicant Representations Received
HSE Decision Issued to Applicant
Application On Hold at the Request of Applicant
Application Withdrawn at the Request of Applicant
Application on Hold as Agreed by HSE and Applicant
HSE Approval Letter Issued to Applicant
Full Health Technology Assessment Submitted to NCPE
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