HSE - PCRS

Application Details

HSE Application ID

HSE100098

HTA Number

26013

HTA Link

Drug

budesonide

Brand

Budenofalk®

Applicant

Dr Falk Pharma

Indication Applied For

Indicated for the short-term treatment of mild to moderate acute ulcerative colitis limited to the rectum (ulcerative proctitis) in adult patients.

Application Date

17/03/2026

Marketing Authorisation Date

10/02/2023

Application Status

Proposal from Applicant Under Review

26/06/2026

Awaiting Proposal from Applicant

18/06/2026

Applicant Meeting Held with CPU

18/06/2026

Rapid Review Completed

13/04/2026

Rapid Review Commissioned

20/03/2026

Pricing and Reimbursement Application Complete

17/03/2026