Extended indication Extension of indication to include adults who do not require invasive mechanical ventilation at star
Therapeutic value Possibly no place in the treatment regimen
Registration phase Registered

Product

Active substance Remdesivir
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication COVID-19
Extended indication Extension of indication to include adults who do not require invasive mechanical ventilation at start of treatment. • In adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).
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)
ATMP No
Submission date February 2021
Expected Registration February 2022
Orphan drug No
Registration phase Registered

Therapeutic value

Therapeutic value Possibly no place in the treatment regimen
Substantiation De resultaten vallen tegen. Er zullen waarschijnlijk andere geneesmiddelen ingezet worden voor deze indicatie.

Expected patient volume per year

Additional comments Zie opmerkingen bij therapeutische waarde, verwachting: geen plaats in de behandeling en daarom geen patiënten verwacht die hiervoor in aanmerking zullen komen.

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.