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 Clinical trials 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 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 Particularity New therapeutical formulation ATMP No Submission date June 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials 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 € 800.00 - 900.00 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 GIPdatabank Additional remarks In 2024 werd er €845,10 per gebruiker zonisamide gedeclareerd. 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