Product Approval Information
Proper Name: Hepatitis B Vaccine (Recombinant)
Tradename: RECOMBIVAX HB
Manufacturer: Merck & Co, Inc, License #0002
Package Insert (PDF - 126 KB) - Approved: May 15, 2007
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Date: September 23, 1999
Labeling Supplement: Addition of two doses of the 10 mcg formulation (1.0 mL) administered at 0 and 4 to 6 months as an alternate regimen for the routine vaccination of healthy adolescents 11 to 15 years of age
September 23, 1999 Approval Letter
Date: August 27, 1999
Manufacturing Change: Preservative-free pediatric/adolescent product
August 27, 1999 Approval Letter