Ibiglustat Medicine 09 January 2018 Extended indication Ziekte van Fabry Therapeutic value No judgement Total cost Registration phase Unknown Product Active substance Ibiglustat Domain Metabolism and Endocrinology Reason of inclusion Main indication Metabolic diseases Extended indication Ziekte van Fabry Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Sanofi Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug Yes Registration phase Unknown Reimbursement Medicine sluice Additional remarks Formeel nog geen weesgeneesmiddelstatus verkregen van de EMA. Therapeutic value Current treatment options Therapeutic value No judgement 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