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Remdesivir

Veklury

Extended indication Extension of indication to include treatment of COVID-19 for paediatric patients weighing at least 1
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 COVID-19
Extended indication Extension of indication to include treatment of COVID-19 for paediatric patients weighing at least 1.5 kg
Proprietary name Veklury
Manufacturer Gilead
Mechanism of action Virus inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date January 2024
Expected Registration February 2025
Orphan drug No
Registration phase Registration application pending
Additional remarks Verwachte registratie op basis van IHSI-inschatting.

Therapeutic value

Therapeutic value No estimate possible yet
References NCT04431453 (GS-US-540-5823)

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.