Vepacel - bird flu vaccine; avian influenza vaccine -- Product Record

influenza vaccine, H5N1/Baxter

    Nomenclature:
      influenza vaccine, H5N1/Baxter [BIO]
      Vepacel [TR]
      A/H5N1 pre-pandemic influenza vaccine (whole virion, vero cell derived, inactivated) [INN]
      Prepandemic influenza vaccine (A/H5N1) (whole virion, Vero cell derived, inactivated) [EU name]
      avian influenza vaccine [SY]
      bird flu vaccine [SY]
      influenza virus H5N1, inactivated [SY]

    FDA Class:  Biologic BLA

Index Terms:

  • Product Class Index:
      biopharmaceutical products
      vaccines, inactivated
      vaccines, viral
  • Biological Index:
      influenza virus
      vegetable oil extraction
      virus culture
  • Chemical Index:
      polysorbate 80 (Tween 80)
      sodium chloride
      trisodium citrate
      Water for Injection
  • Source/Host/Expression System: monkey kidney mamprimemonkkidney
  • Regulatory/Status Index:
      BHK-21 (C-13)
      conjugates
      EU200 Currently Approved in EU
      UM999 Not Available/Not Marketed in US
      US000 never filed/no plans
      EM001 Marketed Product in EU