Fibrinogen / Thrombin Medicine 07 June 2022 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). Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Fibrinogen / Thrombin Domain Cardiovascular diseases Reason of inclusion Indication extension IND 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). Current proprietary name Already available biosimilars / generics Proprietary name TachoSil Manufacturer Cslbehring Portfolio holder Mechanism of action Unknown Route of administration Local Therapeutical formulation Tissue adhesive matrix Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date June 2022 Expected Registration April 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks 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 Medicijnkosten.nl Additional remarks De prijs per stuk bedraagt €392,28 Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks