Extended indication Supportive treatment in adults where standard surgical techniques are insufficient for improvement o
Therapeutic value Possible equal value

Product

Active substance Human fibrinogen / Human thrombin
Domain Cardiovascular diseases
Main indication Hemostasis
Extended indication Supportive treatment in adults where standard surgical techniques are insufficient for improvement of haemostasis and as suture support in vascular surgery.
Proprietary name VeraSeal
Manufacturer grifols
Route of administration Local
Therapeutical formulation Liquid
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2017
Expected Registration December 2017
Orphan drug No
Additional remarks Positieve CHMP opinie september 2017

Therapeutic value

Current treatment options Chirurgische hemostase, spongostan
Therapeutic value Possible equal value
Duration of treatment Average 1 day / days
Dosage per administration 80 mg/ml fibrinogen, 500 IU/ml thrombin
References EMA
Additional remarks Eenmalige toediening tijdens chirurgische ingreep.

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Additional remarks Meerkosten. Behandeling komt bovenop huidige maatregelen.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use Yes

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.