HSE - PCRS

Application Details

HSE Application ID

HSE100074

HTA Number

25060

HTA Link

https://www.ncpe.ie/semaglutide-ozempic-2mg-hta-id-25060/

Drug

semaglutide

Brand

Ozempic®

Applicant

NovoNordisk

Indication Applied For

Semaglutide (Ozempic®) 2mg solution for injection in pre-filled pen: 
Indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise 
• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
• in addition to other medicinal products for the treatment of diabetes.

Application Date

06/10/1225

Marketing Authorisation Date

11/01/2022

Application Status

Proposal from Applicant Under Review

16/12/2025

Awaiting Proposal from Applicant

11/12/2025

Applicant Meeting Held with CPU

11/12/2025

Rapid Review Completed

23/10/2025

Rapid Review Commissioned

06/10/2025

Pricing and Reimbursement Application Complete

06/10/1225

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