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Turoctocog alfa pegol

Esperoct

Extended indication Extension of indication to include children below 12 years of age for treatment and prophylaxis of b
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Turoctocog alfa pegol
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Hemostasis promoting medication
Extended indication Extension of indication to include children below 12 years of age for treatment and prophylaxis of bleeding with haemophilia A for Esperoct, including previously untreated patients (PUPs).
Proprietary name Esperoct
Manufacturer Novo Nordisk
Portfolio holder Novo Nordisk
Mechanism of action Coagulant
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Centre of expertise Hemofilie Behandel Centra
Additional remarks A long acting recombinant factor VIII derivative.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2024
Expected Registration January 2025
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.