Vaccines, Blood & Biologics
Profilnine SD - Factor IX Complex
Proper Name: Factor IX Complex
Trade Name: Profilnine® SD
Manufacture: Grifols Biologicals Inc.
Indication: for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B.
August 26, 2010 Approval Letter, STN: BL 102476/5218 - Profilnine® SD
To include the change to a new Medimop Mix2Vial Reconstitution System and the revised Package Insert.