Ferrimaltol Medicine 04 December 2025 Extended indication Extension of indication to include treatment of iron deficiency anaemia in paediatric population (adolescents aged 12 years and above). Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Ferrimaltol Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Other non-oncological hematological medications Extended indication Extension of indication to include treatment of iron deficiency anaemia in paediatric population (adolescents aged 12 years and above). Current proprietary name Already available biosimilars / generics Proprietary name Feraccru Manufacturer Norgine Portfolio holder Mechanism of action Unknown 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 Unknown ATMP No Submission date June 2025 Expected Registration April 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 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 ferripreparaten in Nederland. Met deze indicatieuitbreiding zal dit getal iets toenemen. 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