Product Approval Information
Proper Name: Thrombin, Topical (Human)
Tradename: EVITHROM
Manufacturer: OMRIX Biopharmaceuticals, Ltd, License #1603
Package Insert (PDF - 104 KB) - August, 2007
Danger Giving Topical Thrombin Intravascularly - 8/2008
Date: August 27, 2007
Indication: An aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical
October 15, 2007 Corrected Approval Letter
August 27, 2007 Approval Letter
FDA Approves Human Thrombin for Topical Use in Surgery
Summary Basis for Approval (PDF - 76 KB)