HSE - PCRS

Application Details

HSE Application ID

HSE100015

HTA Number

25007

HTA Link

https://www.ncpe.ie/progesterone-lubion-hta-id-25007/

Drug

progesterone

Brand

Lubion®

Applicant

IBSA Farmaceutici Italia S.r.l

Indication Applied For

Indicated in adults for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women who are unable to use or tolerate vaginal preparations.

Application Date

24/01/2025

Marketing Authorisation Date

22/11/2024

Application Status

HSE Approval Letter Issued to Applicant

01/08/2025

Proposal from Applicant Under Review

11/06/2025

Awaiting Proposal from Applicant

29/05/2025

Applicant Meeting Held with CPU

29/05/2025

Rapid Review Completed

07/03/2025

Rapid Review Commissioned

29/01/2025

Pricing and Reimbursement Application Complete

24/01/2025

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