Vaccines, Blood & Biologics
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Nabi-HB
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.
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Supporting Documents
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 infectionSummary 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 infectionSummary of Basis for Approval - Nabi-HB (PDF - 850KB)
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Contact FDA
(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
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