Fampridine Medicine 10 December 2019 Extended indication Therapeutische indicaties Fampridine Accord is geïndiceerd voor de verbetering van het lopen bij volwassen patiënten met multiple sclerosis met beperkt loopvermogen. Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Fampridine Domain Neurological disorders Reason of inclusion Generic G Main indication Multiple sclerosis Extended indication Therapeutische indicaties Fampridine Accord is geïndiceerd voor de verbetering van het lopen bij volwassen patiënten met multiple sclerosis met beperkt loopvermogen. Current proprietary name Fampyra (Biogen) Already available biosimilars / generics Proprietary name Fampridine Accord Manufacturer Accord Healthcare Portfolio holder Mechanism of action Ion channel blocker Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date September 2019 Expected Registration September 2020 Orphan drug Unknown Registration phase Registered Reimbursement Medicine sluice Additional remarks SPC Fampridine (Biogen) verloopt op 24 juli 2026. Therapeutic value Current treatment options Therapeutic value Possible equal value 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