HSE - PCRS

Application Details

HSE Application ID

HSE100085

HTA Number

25072

HTA Link

https://www.ncpe.ie/cabotegravir-apretude-hta-id-25072/

Drug

cabotegravir

Brand

Apretude®

Applicant

GlaxoSmithKline Limited

Indication Applied For

Apretude indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg.

Application Date

30/12/2025

Marketing Authorisation Date

15/09/2023

Application Status

Awaiting Proposal from Applicant

26/03/2026

Applicant Meeting Held with CPU

26/03/2026

Rapid Review Completed

28/01/2026

Pricing and Reimbursement Application Complete

30/12/2025

Rapid Review Commissioned

22/12/2025

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