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Bulevirtide

Hepcludex

Extended indication Extension of indication to include treatment of chronic hepatitis delta virus (HDV) infection in pae
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Bulevirtide
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Extended indication Extension of indication to include treatment of chronic hepatitis delta virus (HDV) infection in paediatric patients 3 years of age and older weighing at least 10 kg with compensated liver disease for Hepcludex.
Proprietary name Hepcludex
Manufacturer Gilead
Portfolio holder Gilead
Mechanism of action Virus inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Submission date November 2023
Expected Registration September 2024
Orphan drug Yes
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

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.