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semaglutide (Wegovy®)
Application Details
HSE Application ID
HSE100034
HTA Number
25025
HTA Link
https://www.ncpe.ie/semaglutide-2-4-mg-wegovy-in-adolescent-patients-hta-id-25025/
Drug
semaglutide
Brand
Wegovy®
Applicant
Novo Nordisk
Indication Applied For
Indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with • obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts and • body weight above 60 kg.
Application Date
19/03/2025
Marketing Authorisation Date
28/04/2023
Application Status
Rapid Review Completed
01/05/2025
Rapid Review Commissioned
21/03/2025
Pricing and Reimbursement Application Complete
19/03/2025
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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Application Withdrawn at the Request of Applicant
HSE Approval Letter Issued to Applicant
Full Health Technology Assessment Submitted to NCPE
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