Pravastatine/fenofibraat Medicine 04 June 2024 Extended indication Extension of indication to include treatment of mixed hyperlipidaemia in adult patients while on a treatment with pravastatin 40 mg monotherapy or on another moderate-intensity statin regimen Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Pravastatine/fenofibraat Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Lipid-lowering medications Extended indication Extension of indication to include treatment of mixed hyperlipidaemia in adult patients while on a treatment with pravastatin 40 mg monotherapy or on another moderate-intensity statin regimen Current proprietary name Already available biosimilars / generics Proprietary name Pravafenix Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Galephar Netherlands Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date December 2023 Expected Registration October 2024 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks NCT03214211 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