Norucholzuur Medicine 04 December 2025 Extended indication Treatment of primary sclerosing cholangitis (PSC) in adults. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Norucholzuur Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Liver diseases Extended indication Treatment of primary sclerosing cholangitis (PSC) in adults. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Dr. Falk Portfolio holder Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2025 Expected Registration December 2026 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Er is nog geen geregistreerde medicatie op de markt voor de behandeling van Primaire Scleroserende Cholangitis (EASL richtlijn). Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 1.500mg References NCT03872921; NCT01755507; EASL richtlijn Primaire Scleroserende Cholangitis EASL, J Hepatol. 2022; 77(3): 761-806 Additional remarks Behandelduur en dosering in afwachting van registratie. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References leverpatientenvereniging.nl (1). Additional remarks De inschatting voor het aantal patiënten met de diagnose PSC in Nederland is 1.020 (1). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks