Zonisamide Medicine 03 June 2025 Extended indication Zonisamide monotherapy for add-on treatment of partial-onset Seizure in infants over 1 month of age, toddlers, children and adolescents. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Zonisamide Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Epilepsy Extended indication Zonisamide monotherapy for add-on treatment of partial-onset Seizure in infants over 1 month of age, toddlers, children and adolescents. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Azurity 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 Unknown Particularity New therapeutical formulation ATMP No Submission date September 2025 Expected Registration April 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 Dosage per administration References NCT06534502 Additional remarks Titratieperiode: 1mg/kg/dag toegediend als verdeelde dosis van 0,5mg/kg tweemaal daags gedurende 2 weken, vervolgens verhoogd met 1mg/kg/dag (als verdeelde doses) met wekelijkse tussenpozen in week 3 tot en met 8. Onderhoudsperiode: Tot 8mg/kg/dag toegediend als een verdeelde dosis tweemaal daags gedurende 4 weken (dat wil zeggen week 9 tot en met 12). Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Er wordt geschat dat dit ingezet zal worden bij een van de tien patiënten. 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