Product Information

• Package Insert (Military) (PDF - 224KB)
• Package Insert (Commercial) and Patient Information Sheet (PDF - 224KB)

Supporting Documents

• Summary Basis for Regulatory Action - Ixiaro
  September 23, 2010
• October 14, 2010 Approval Letter - Ixiaro
  Efficacy Supplement for Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed, Pediatric Requirement
• October 23, 2009 Approval Letter - Ixiaro
  Revisions to the military version of the package insert.
• March 30, 2009 Approval Letter
  Indication: For the prevention of disease caused by Japanese encephalitis virus in persons 17 years of age and older.
• FDA Approves New Vaccine to Prevent Japanese Encephalitis
  Press Release: March 30, 2009
• Ixiaro - Summary Basis for Regulatory Action
• Approval History, Letters, Reviews, and Related Documents - Ixiaro Intercell Biomedical

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