Teriflunomide Medicine 07 December 2021 Extended indication Volwassenen met 'relapsing remitting' multipele sclerose (RRMS). Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Teriflunomide Domain Neurological disorders Reason of inclusion Generic G Main indication Multiple sclerosis Extended indication Volwassenen met 'relapsing remitting' multipele sclerose (RRMS). Current proprietary name Aubagio (Genzyme) Already available biosimilars / generics geen Proprietary name Teriflunomide Accord Manufacturer Accord Healthcare Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Dihydroorotate dehydrogenase inhibitors Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2021 Expected Registration November 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Per september 2022 positieve opinie. SPC verleend en van kracht per 4 april 2022 en verloopt per 03 april 2027. 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