Hepacare - Hepagene; hepatitis B virus vaccine, rDNA, triple antigen (hepatitis B surface antigen, pre-S1, pre-S2) -- Product Record

Hepatitis B Vaccine, rDNA/Medeva

    Nomenclature:
      Hepatitis B Vaccine, rDNA/Medeva [BIO]
      Hepacare [TR]
      Hepagene [TR former]
      HBsAg, rDNA [SY]
      hepatitis B virus vaccine, rDNA, triple antigen [SY]

    FDA Class:  Biologic

Index Terms:

  • Product Class Index:
      biopharmaceutical products
      exempt from CBER lot release requirements
      recombinant DNA
      vaccines, subunit
      vaccines, viral
  • Biological Index:
      exempt from CBER lot release requirements
      hepatitis B virus (HBV)
      hepatitis B virus (HBV)
      mammalian cell culture
      mumps virus Jeryl Lynn strain
      murine monoclonal antibody, RFT5
      virus culture
  • Chemical Index:
      aluminum hydroxide
      hepatitis B virus (HBV)
  • Source/Host/Expression System: Murine myeloma mammurmyel
  • Regulatory/Status Index:
      approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
      FD&C Yellow 5
      North American coral snake
      North American coral snake
      EU011 Approved Formerly in EU/withdrawn
      UM999 Not Available/Not Marketed in US
      US01 FDA application withdrawn or rejected
      EM999 Not Available/Not Marketed in EU