Human fibrinogen / Human thrombin Medicine 09 January 2018 Extended indication Supportive treatment in adults where standard surgical techniques are insufficient for improvement of haemostasis and as suture support in vascular surgery. Therapeutic value Possible equal value Total cost Registration phase Unknown Product Active substance Human fibrinogen / Human thrombin Domain Cardiovascular diseases Reason of inclusion 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. Current proprietary name Already available biosimilars / generics Proprietary name VeraSeal Manufacturer Grifols Portfolio holder Mechanism of action Unknown Route of administration Local Therapeutical formulation Liquid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date January 2017 Expected Registration December 2017 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie september 2017 Therapeutic value Current treatment options Chirurgische hemostase, spongostan Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 1 day / days Frequency of administration 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 Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Meerkosten. Behandeling komt bovenop huidige maatregelen. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks