Mycofenolaatmofetil Medicine 04 June 2024 Extended indication Extension of indication to include paediatric patients (3 months to 18 years of age) for hepatic and cardiac transplants and to extend the indication for renal transplants for paediatric patients starting from 3 months Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Mycofenolaatmofetil Domain Oncology Reason of inclusion Indication extension IND Main indication Unknown Extended indication Extension of indication to include paediatric patients (3 months to 18 years of age) for hepatic and cardiac transplants and to extend the indication for renal transplants for paediatric patients starting from 3 months Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Roche Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2023 Expected Registration September 2024 Orphan drug Unknown 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 Additional remarks Expected patient volume per year Patient volume 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks