Product Approval Information
Proper Name: Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine
Tradename: Twinrix
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Package Insert (PDF - 115 KB) - March, 2007
Date: May 11, 2001
Indication: Active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus
May 11, 2001 Approval Letter
FDA Talk Paper: New Combination Vaccine Approved for Protection Against Two Hepatitis Viruses
Date: March 28, 2007
Revised Package Insert: For an accelerated dosing schedule of 0, 7, 21-30 days and a month 12 booster dose
March 28, 2007 Approval Letter