Budesonide Medicine 04 June 2026 Extended indication Jorveza 0.2 mg/mL oral suspension is indicated for the treatment of eosinophilic esophagitis (EoE) in paediatric patients 2 to 17 years of age. Therapeutic value Total cost Registration phase Registered Product Active substance Budesonide Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Jorveza 0.2 mg/mL oral suspension is indicated for the treatment of eosinophilic esophagitis (EoE) in paediatric patients 2 to 17 years of age. Current proprietary name Already available biosimilars / generics Proprietary name Jorveza Manufacturer Dr. Falk Portfolio holder Dr. Falk 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 New therapeutical formulation ATMP No Submission date March 2025 Expected Registration April 2026 Orphan drug Yes Registration phase Registered Reimbursement Reimbursed from the basic package Medicine sluice Additional remarks Positieve CHMP-opinie in februari 2026, EC geregistreerd in april 2026. Therapeutic value Current treatment options Andere lokale corticosteroïden Therapeutic value Substantiation Mogelijk zal dit dit product een plaats kunnen krijgen. Lokale corticosteroïden nemen een belangrijke plaats in in de behandeling van deze aandoening. Budesonide is een goede optie door de zeer biologische beschikbaarheid. Een vloeibare orale vorm lijkt praktisch/gewenst bij lokale therapie van de slokdarm. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Children 2 to 11 years of age - The recommended daily dose is 1 mg budesonide to be administered as two separate doses per day: one dose of 2.5 mL suspension (corresponding to 0.5 mg budesonide) in the morning and one dose of 2.5 mL suspension (corresponding to 0.5 mg budesonide) in the evening. Adolescents 12 to 17 years of age - The recommended daily dose is 2 mg budesonide to be administered as two separate doses per day: one dose of 5 mL suspension (corresponding to 1 mg budesonide) in the morning and one dose of 5 mL suspension (corresponding to 1 mg budesonide) in the evening. Expected patient volume per year Patient volume 100 - 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratiedata Additional remarks In 2024 waren er tussen de 100 en 200 gebruikers van Jorveza smelttablet onder de 18 jaar oud. 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