Product Approval Information
Proper Name: Hepatitis B Vaccine (Recombinant)
Tradename: Engerix-B
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Package Insert (PDF - 105 KB) - Approved: January 30, 2007
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Date: January 30, 2007
Indication: Thimerosal-free formulation
January 30, 2007 Approval Letter
Review (PDF - 278 KB)
Date: March, 28, 2000
Manufacturing Change: Preservative-free pediatric monodose presentation
March, 28, 2000 Approval Letter
Date: July 7, 1998
Indication: In individuals (adults) with chronic Hepatitis C infection
July 7, 1998 Approval Letter