Product Approval Information
Proper Name: Hepatitis B Immune Globulin (Human)
Tradename: Nabi-HB
Manufacturer: Nabi Biopharmaceuticals, License #1687
Date: October 23, 2001
Indication: Treatment of acute exposure to HBsAg following acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons, and household exposure of infants to persons with acute hepatitis B virus infection
October 23, 2001 Approval Letter
SBA (PDF - 286 KB)
Date: March 24, 1999
Indication: For the treatment of acute exposure to HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure of infants to persons with acute HBV infection
March 24, 1999 Approval Letter
SBA (PDF - 850 KB)