Product Approval Information

Proper Name: Hepatitis B Immune Globulin Intravenous (Human)
Tradename: HepaGam B
Manufacturer: Cangene Corp, License #1201

Package Insert (PDF - 155 KB) - April, 2007

Date: April 6, 2007
Indication: For the prevention of Hepatitis B recurrence following liver transplantation in HBsAg-positive liver transplant patients. Also indicated for the treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection.
April 6, 2007 Approval Letter
Press Release

Date: January 27, 2006
Indication: Treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection
January 27, 2006 Approval Letter
Summary Basis for Approval (PDF - 92KB) - January, 2006