Thrombin, conc.
Thrombin (Human) (For Further Manufacturing Use)
Status: used for manufacture of other products
Organizations involved:
Baxter Hyland Immuno – Manuf.; R&D; Tech.
Baxter Healthcare Corp. – Parent
Cross ref: See the entries for Fibrin Sealant Products and FloSeal Matrix Hemostatic Sealant.
Description: Thrombin (Human) (For Further Manufacturing Use) is a human plasma-derived thrombin preparation used for manufacture of FloSeal Matrix Hemostatic Sealant. This component replaced bovine-derived thrombin used in this product.
Nomenclature: Thrombin, conc. [BIO]: ThThrombin (Human) (For Further Manufacturing Use) [FDA]
Companies.: Baxter Hyland Immuno, Baxter Healthcare Corp., CBER/FDA est. no. 0140, manufactures this intermediate/precursor for further manufacturing of FloSeal Matrix Hemostatic Sealant.
FDA class: Biologic BLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 20050218; BLA, original approval
Indications: [From FDA Web site]: For further manufacturing with FloSeal Matrix Hemostatic Sealant
Status: The BLA was approved on Feb. 18, 2005.
Companies involvement:
Full monograph
807 Thrombin, conc.
Nomenclature:
Thrombin, conc. [BIO]
Thrombin (Human) (For Further Manufacturing Use) [FDA]
FDA Class: Biologic BLA
Year of approval (FDA) = 2005
Date of 1st FDA approval = 20050218
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
blood products
human materials used<!-- humansource -->
intermediate/precursor products
mammalian cell culture
nonoxynol 101 (Triton N101)
Plasma (Human)
thrombin, human
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
North American coral snake
EU200 Currently Approved in EU
UM999 Not Available/Not Marketed in US
US200 Currently Approved in US
EM999 Not Available/Not Marketed in EU
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