Product Approval Information
Proper Name: Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method
Tradename: Advate
Manufacturer: Baxter Healthcare Corp, License #0140
Package Insert (PDF - 68 KB) - July, 2003
Date: July 25, 2003
Indication: Indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes, and in the perioperative management of patients with hemophilia A
July 25, 2003 Approval Letter
Summary Basis for Approval
New Recombinant Antihemophilic Factor Licensed