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 Other viral infections
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.