Ferrimaltol Medicine 04 December 2025 Extended indication Feraccru is indicated for the treatment of iron deficiency in adults and adolescents aged 12 years and older. Therapeutic value No estimate possible yet Total cost € 15,000.00 Registration phase Positive CHMP opinion Product Active substance Ferrimaltol Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Other non-oncological hematological medications Extended indication Feraccru is indicated for the treatment of iron deficiency in adults and adolescents aged 12 years and older. Current proprietary name Already available biosimilars / generics Proprietary name Feraccru Manufacturer Norgine Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Oral suspension Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2025 Expected Registration June 2026 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in maart 2026. Therapeutic value Current treatment options Orale ferripreparaten Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen studie resultaten bekend. Duration of treatment Frequency of administration Dosage per administration References NCT05126901 (FORTIS); Schmidt et al. J Clin Med. 2021; Expertopinie Additional remarks Expected patient volume per year Patient volume < 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratiedata Additional remarks In 2024 waren er 27 gebruikers van orale ferri-preparaten in Nederland. Met deze indicatieuitbreiding zal dit getal iets toenemen. Expected cost per patient per year Cost € 1,000.00 - 2,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References gebaseerd op orale ijzertherapie Additional remarks Potential total cost per year Total cost € 15,000.00 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