Remdesivir

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
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 remarks	RNA-replicaseremmers.

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	No estimate possible yet

There is currently nothing known about the expected patient volume.

Cost	1,840.00 - 5,515.00
References	www.medicijnkosten.nl (Lijstprijs inclusief BTW) SmPC Veklury
Additional remarks	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.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.