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Pravastatine/​fenofibraat

Pravafenix

Extended indication Extension of indication to include treatment of mixed hyperlipidaemia in adult patients while on a t
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Pravastatine/​fenofibraat
Domain Cardiovascular diseases
Reason of inclusion Indication extension
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
Proprietary name Pravafenix
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Galephar Netherlands

Registration

Registration route Centralised (EMA)
Submission date December 2023
Expected Registration October 2024
Orphan drug No
Registration phase Registration application pending
Additional remarks NCT03214211

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.