Vaccines, Blood & Biologics

Resources for You

Proper Name: Hepatitis B Immune Globulin (Human)
Tradename: Nabi-HB
Manufacturer: Nabi Biopharmaceuticals, License #1687
Indications:

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.
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.

October 23, 2001 Approval Letter - Nabi-HB
Acute exposure to HBsAg following exposure to blood containing HBsAg, perinatal exposure of infants of HBsAg-positive mothers, sexual exposure to HBsAg-positive persons, and household exposure of infants to persons with acute hepatitis B virus infection
Summary of Basis for Approval (10/23/01) - Nabi-HB (PDF - 285KB)
March 24, 1999 Approval Letter - Nabi-HB
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
Summary of Basis for Approval - Nabi-HB (PDF - 850KB)

(800) 835-4709

(301) 827-1800

Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448