Extended indication Treatment of paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen an
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Remdesivir
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Viral infections other
Extended indication Treatment of paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19
Proprietary name Veklury
Manufacturer Gilead
Mechanism of action Virus inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments RNA-replicaseremmers.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2022
Expected Registration January 2023
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

Cost 1,840.00 - 5,515.00
References www.medicijnkosten.nl (Lijstprijs inclusief BTW) SmPC Veklury
Additional comments Een kuur duurt tussen de 5 en 10 dagen. Op de eerste dag wordt een dubbele dosering toegediend. For patients at high risk of progressing to severe COVID-19, including hospitalisation and not requiring supplemental oxygen, the total duration of treatment should be 3 days.

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.