Expand all sections

Elbasvir / grazoprevir

Zepatier

Extended indication

Extension of indication to include treatment of chronic hepatitis C (CHC) in paediatric patients 12

Therapeutic value

No estimate possible yet
Registration phase

Registration application pending

Product

Active substance

Elbasvir / grazoprevir
Domain

Infectious diseases
Reason of inclusion

Indication extension
Main indication

Viral infections other
Extended indication

Extension of indication to include treatment of chronic hepatitis C (CHC) in paediatric patients 12 years of age and older who weigh at least 30kg for Zepatier.
Proprietary name

Zepatier
Manufacturer

MSD
Mechanism of action

Virus inhibitor
Route of administration

Oral
Therapeutical formulation

Tablet
Budgetting framework

Extramural (GVS)

Registration

Registration route

Centralised (EMA)
ATMP

No
Submission date

March 2021
Expected Registration

January 2022
Orphan drug

No
Registration phase

Registration application pending

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.