Extended indication Extension of indication to include long-term prophylaxis (deletion of wording ‘short-term’ and curre
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Proteïne C
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Antithrombotic medications
Extended indication Extension of indication to include long-term prophylaxis (deletion of wording ‘short-term’ and currently listed conditions) of purpura fulminans and coumarin induced skin necrosis in patients with severe congenital protein C deficiency.
Proprietary name Ceprotin
Manufacturer Takeda
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 April 2022
Expected Registration February 2023
Orphan drug No
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

References medicijnkosten
Additional comments De gemiddelde prijs per verpakking ex. btw is € 1.024. De behandelduur is nog niet bekend.

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.