Extended indication Extension of indication to include treatment of chronic hepatitis B-infected children from 6 years
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Tenofovir alafenamide
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Viral infections other
Extended indication Extension of indication to include treatment of chronic hepatitis B-infected children from 6 years and older and weighing at least 25 kilograms for Vemlidy, based on the interim results from Week 24 clinical study report (CSR).
Proprietary name Vemlidy
Manufacturer Gilead
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date June 2022
Expected Registration July 2023
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

Additional comments De kosten voor tenofovir alafenamide oraal tablet 300 mg is rond de $106 voor een voorraad van 20 tabletten in de VS. De prijs in Nederland is nog niet bekend.

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.