Aafact; Antihemophilic Factor (Human) - Factor VIII -- Product Record

Factor VIII/Sanquin

    Nomenclature:
      Factor VIII/Sanquin [BIO]
      Aafact [TR]
      Antihemophilic Factor [SY]
      Antihemophilic Factor (Human) [SY]
      Factor VIII [SY]

    FDA Class:  Biologic BLA

Index Terms:

  • Product Class Index:
      antihemophilic factors
      biopharmaceutical products
      blood products
      human materials used<!-- humansource -->
      nonoxynol 101 (Triton N101)
  • Biological Index:
      ATCC HB 10494
      gentamicin (gentamycin)
  • Chemical Index:
      Albumin (Human)
      calcium chloride
      histidine
      immunoaffinity chromatography
      lyophilized (freeze-dried)
      methanol
      monoclonal antibody, murine
      murine monoclonal antibody, CD3
      octoxynol (Triton X-100)
      Plasma (Human)
      polyethylene glycol (PEG)
      polysiloxane
      sodium chloride
      tri-n-butyl phosphate (TNBP)
      viral inactivation, solvent detergent
  • Source/Host/Expression System: human blood/plasma mamprimehumblood
  • Regulatory/Status Index:
      North American coral snake
      EU200 Currently Approved in EU
      UM999 Not Available/Not Marketed in US
      US000 never filed/no plans
      EM001 Marketed Product in EU