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STN: BL 101066
Proper Name: Hepatitis B Vaccine (Recombinant)
Tradename: RECOMBIVAX HB
Manufacturer: Merck & Co, Inc, License #0002
Indication: RECOMBIVAX HB is indicated for vaccination against infection caused by all known subtypes of hepatitis B virus.
December 8, 2011 Approval Letter - Recombivax
to change the package insert to update the labeling text on yeast DNA in the Description Section and the labeling text on Geriatric Use in the Precaution section.
October 5, 2011 Approval Letter - Recombivax
To revise the package insert to include the residual formaldehyde content of the vaccine in the Description section, and the term “uveitis” in the Adverse Reactions section.
May 4, 2011 Approval Letter - Recombivax HB
To revise labeling to address latex hypersensitivity in the Precautions section of the package insert.
September 23, 1999 Approval Letter - Recombivax HB
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.
August 27, 1999 Approval Letter - Recombivax HB
Preservative-free pediatric/adolescent product.
Summary Basis for Regulatory Action - Recombivax HB(PDF - 2.1MB)