STN: BL 101066
Proper Name: Hepatitis B Vaccine (Recombinant)
Tradename: RECOMBIVAX HB
Manufacturer: Merck & Co, Inc, License #0002
- RECOMBIVAX HB is indicated for vaccination against infection caused by all known subtypes of hepatitis B virus.
May 20, 2014 Approval Letter - Recombivax HB
To include changes to the package insert to update the format to conform with Physician's Labeling Rule (PLR).
December 8, 2011 Approval Letter - Recombivax[ARCHIVED]
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[ARCHIVED]
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[ARCHIVED]
To revise labeling to address latex hypersensitivity in the Precautions section of the package insert.
September 23, 1999 Approval Letter - Recombivax HB[ARCHIVED]
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[ARCHIVED]
Preservative-free pediatric/adolescent product.
Summary Basis for Regulatory Action - Recombivax HB(PDF - 2.1MB)