STN: BL 103623
Proper Name: Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine
Manufacturer: Merck & Co., Inc, License #0002
Indication: COMVAX is indicated for vaccination against invasive disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants 6 weeks to 15 months of age born of HBsAg negative mothers.
April 20, 2011 Approval Letter - COMVAX
To revise labeling to address latex hypersensitivity in the Precautions section of the package insert.
October 2, 1996 Approval Letter - COMVAX Summary Basis for Regulatory Action - Comvax(PDF - 6MB)