Filgrastim - Nivestim; Granulocyte Colony Stimulating Factor, recombinant -- Product Record

G-CSF, rDNA/Hospira

    Nomenclature:
      G-CSF, rDNA/Hospira [BIO]
      Nivestim [TR]
      colony-stimulating factor (human clone 1034) , N-L-methionyl- [CAS]
      Filgrastim [USAN INN BAN MESH]
      135968-09-1 [CAS RN]
      granulocyte colony stimulating factor, recombinant [SY]

    FDA Class:  Biologic BLA

Index Terms:

  • Product Class Index:
      biopharmaceutical products
      Biorex-70 resin
      exempt from CBER lot release requirements
      growth factors, hematopoietic
  • Biological Index:
      bacterial culture <!-- bacterialculture -->
      Escherichia coli (E. coli)
  • Chemical Index:
      polysorbate 80 (Tween 80)
      sodium hydroxide
      somatropin, recombinant
      Water for Injection
  • Source/Host/Expression System: E. coli micbacecoli
  • Regulatory/Status Index:
      BHK-21 (C-13)
      EU200 Currently Approved in EU EU777
      UM999 Not Available/Not Marketed in US
      US002 FDA application pending
      EM001 Marketed Product in EU