HSE - PCRS

Application Details

HSE Application ID

HSE100057

HTA Number

25044

HTA Link

https://www.ncpe.ie/levodopa-inbrija-hta-id-25044/

Drug

levodopa

Brand

Inbrija®

Applicant

Merz Therapeutics

Indication Applied For

Indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease treated with a levodopa/dopa-decarboxylase inhibitor.

Application Date

07/07/2025

Marketing Authorisation Date

19/09/2019

Application Status

HSE Decision Issued to Applicant

07/08/2026

Reviewed by HSE Senior Leadership Team

28/07/2026

Reviewed by HSE Drugs Group

14/07/2026

Applicant Representations Received

06/07/2026

Applicant Representations Received

01/07/2026

HSE Drugs Group Review Pending

30/06/2026

Applicant Representations Received

17/06/2026

Proposed HSE Decision Issued to Applicant

05/05/2026

Reviewed by HSE Senior Leadership Team

03/03/2026

Reviewed by HSE Drugs Group

10/02/2026

HSE Drugs Group Review Pending

25/11/2025

Proposal from Applicant Under Review

21/10/2025

Awaiting Proposal from Applicant

09/10/2025

Applicant Meeting Held with CPU

09/10/2025

Rapid Review Completed

07/08/2025

Pricing and Reimbursement Application Complete

07/07/2025

Rapid Review Commissioned

04/07/2025

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