Amisulpride Medicine 04 December 2025 Extended indication Amisulpride in combination with dexamethasone for preventive treatment of post-operative nausea and vomiting in infants and toddlers over 2 months of age, children and adolescents. Therapeutic value Total cost Registration phase Clinical trials Product Active substance Amisulpride Domain Oncology Reason of inclusion New medicine (specialité) Main indication Extended indication Amisulpride in combination with dexamethasone for preventive treatment of post-operative nausea and vomiting in infants and toddlers over 2 months of age, children and adolescents. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Eagle Portfolio holder Eagle Mechanism of action Route of administration Intravenous Therapeutical formulation Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date March 2026 Expected Registration April 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration 0,035mg per kg intraveneus, maximaal 5mg References NCT05546359 Additional remarks Expected patient volume per year Patient volume 0 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks