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Vaccines, Blood & Biologics
Engerix-B
Proper Name: Hepatitis B Vaccine (Recombinant)
Tradename: Engerix-B
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Indications:
- Thimerosal-free formulation
- In individuals (adults) with chronic Hepatitis C infection.
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Supporting Documents
- October 15, 2009 Approval Letter - Engerix-B
Introduction of a 10 pack carton of Engerix-B 10 mcg Pre-Filled Syringes for Pediatric/Adolescent use, and accompanying Package Insert. - January 30, 2007 Approval Letter - Engerix-B
Thimerosal-free formulation. - Clinical Review - Engerix-B (PDF - 277KB)
- March 28, 2000 Approval Letter - Engerix-B
Preservative-free pediatric monodose presentation. - July 7, 1998 Approval Letter - Engerix-B
In individuals (adults) with chronic Hepatitis C infection. - Summary for Basis of Approval - Engerix-B (PDF - 649KB)
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Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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