Proteïne C

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.
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 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	No estimate possible yet

There is currently nothing known about the expected patient volume.

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

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.