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Vonicog alfa

Veyvondi

Extended indication Extension of indication to include prophylactic treatment to prevent or reduce the frequency of bl
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Vonicog alfa
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Hemostasis promoting medication
Extended indication Extension of indication to include prophylactic treatment to prevent or reduce the frequency of bleeding episodes in Pediatric and Adult Patients.
Proprietary name Veyvondi
Manufacturer Baxalta
Mechanism of action Coagulant
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Recombinant Von Willebrand factor

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2023
Expected Registration January 2024
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
References NCT03879135

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.