Pricing and Reimbursement Application Tracker
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alpha1-proteinase inhibitor (Prolastin®)
Application Details
HSE Application ID
HSE100088
HTA Number
25071
HTA Link
https://www.ncpe.ie/alpha-1-proteinase-inhibitor-prolastin-hta-id-25071/
Drug
alpha1-proteinase inhibitor
Brand
Prolastin®
Applicant
Grifols
Indication Applied For
Indicated for long-term augmentation therapy in subjects with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi (null,null) and PiSZ).
Application Date
23/01/2026
Marketing Authorisation Date
05/01/2007
Application Status
Application Withdrawn at the Request of Applicant
03/06/2026
Applicant Meeting Held with CPU
21/05/2026
Pricing and Reimbursement Application Complete
23/01/2026
Rapid Review Completed
13/01/2026
Rapid Review Commissioned
19/12/2025
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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Application Withdrawn at the Request of Applicant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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