Extended indication Treatment of children aged 1 month to 18 years for the following indications: - during an operation,
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Fibrinogen / Thrombin
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Other medication for cardiovascular diseases
Extended indication Treatment of children aged 1 month to 18 years for the following indications: - during an operation, to stop bleeding and to seal the surfaces of internal organs; - as support to stitching during surgery on the blood vessels; - during neurological surgery to prevent leakage of the fluid surrounding the brain (called cerebrospinal fluid or CSF).
Proprietary name TachoSil
Manufacturer Cslbehring
Route of administration Local
Therapeutical formulation Tissue adhesive matrix
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date June 2022
Expected Registration April 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.nl
Additional comments De prijs per stuk bedraagt €392,28

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.