Product Approval Information
Proper Name: Protein C Concentrate (Human)
Tradename: CEPROTIN
Manufacturer: Baxter Healthcare Corp, License #0140
Package Insert (PDF - 492 KB) - Approved: March 30, 2007
Patient Information (PDF - 119 KB) - Approved: March 30, 2007
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Date: March 30, 2007
Indication: For patients with Severe Congenital Protein C Deficiency for the prevention and treatment of venous thrombosis and purpura fulminans
March 30, 2007 Approval Letter
Press Release: FDA Approves First Biologic to Treat Rare Clotting Disorder - March 30, 2007
Summary Basis for Approval (PDF - 232 KB)