Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted - Hexavac -- Product Record

DTaP-HBV, rDNA-Hib-IPV/Sanofi

    Nomenclature:
      DTaP-HBV, rDNA-Hib-IPV/Sanofi [BIO]
      HEXAVAC [SY]
      Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted [EU common name]

    FDA Class:  Biologic BLA

Index Terms:

  • Product Class Index:
      biopharmaceutical products
      conjugates
      recombinant DNA
      vaccines, bacterial
      vaccines, combination
      vaccines, toxoids (inactivated toxins)
  • Biological Index:
      adw, hepatitis B virus subtype
      bacterial culture <!-- bacterialculture -->
      Clostridium tetani
      Clostridium tetani
      Corynebacterium diphtheriae
      filamentous hemagglutinin (FHA), Bordetella pertussis
      Haemophilus influenzae b prophylaxis
      hepatitis B virus (HBV)
      media, serum-free
      monkey diploid cells, fetal rhesus<!-- monkeycells -->
      monkey diploid cells, fetal rhesus<!-- monkeycells -->
      polio prophylaxis
      poliovirus type 1
      poliovirus type 2
      Saccharomyces cerevisiae (yeast)
      vegetable oil extraction
  • Chemical Index:
      aluminum hydroxide
      Diphtheria Toxoid
      disodium phosphate
      formaldehyde
      Haemophilus influenzae type b
      media, serum-free
      monomethoxy polyethylene glycol (PEG)
      pertactin (69 kDa protein)
      Pertussis Vaccine Adsorbed, Acellular
      polio prophylaxis
      polymyxin
      sodium bicarbonate
      sodium bromide
      Sterile Water for Injection
      sucrose
      Tetanus Toxoid
      trisodium citrate
  • Source/Host/Expression System: NA
  • Regulatory/Status Index:
      approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
      North American coral snake
      North American coral snake
      EU011 Approved Formerly in EU/withdrawn
      UM999 Not Available/Not Marketed in US
      US000 never filed/no plans
      EM999 Not Available/Not Marketed in EU