Coördinatiecomplex van ijzercitraat Medicine 03 June 2025 Extended indication Treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD). Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Coördinatiecomplex van ijzercitraat Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Metabolic diseases Extended indication Treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD). Current proprietary name Already available biosimilars / generics Proprietary name Xoanacyl Manufacturer Averoa Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date April 2024 Expected Registration June 2025 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in maart 2025. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 3 times a day Dosage per administration References Additional remarks Begindosis is 2 tabletten oraal 3 keer per dag bij de maaltijd. Pas de dosis zo nodig aan met 1 tot 2 tabletten om de serumfosfor op het gewenste niveau te houden, tot een maximum van 12 tabletten per dag. De dosis kan met tussenpozen van 1 week of langer worden getitreerd. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks