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sofosbuvir / velpatasvir

Epclusa

Extended indication

Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged

Therapeutic value

No estimate possible yet
Registration phase

Positive CHMP opinion

Product

Active substance

sofosbuvir / velpatasvir
Domain

Infectious diseases
Reason of inclusion

Indication extension
Main indication

Viral infections other
Extended indication

Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 3 years of age and older.
Proprietary name

Epclusa
Manufacturer

Gilead
Route of administration

Oral
Therapeutical formulation

Tablet
Budgetting framework

Extramural (GVS)
Additional comments 
Werkingsmechanisme: sofosbuvir (NS5B-remmer), velpastasvir (NS5A-remmer)

Registration

Registration route

Centralised (EMA)
Submission date

2021
Expected Registration

January 2022
Registration phase

Positive CHMP opinion
Additional comments 
Positieve CHMP-opinie in november 2021.

Therapeutic value

Therapeutic value

No estimate possible yet
Substantiation

Betreft een uitbreiding voor kinderen.
Dosage per administration

400/100MG

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

References 
medicijnkosten.nl
Additional comments 
Gemiddelde prijs betreft €321,16 inclusief btw en exclusief afleverkosten.

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.