Product Approval Information
Proper Name: Japanese Encephalitis Vaccine, Inactivated, Adsorbed
Tradename: IXIARO
Manufacturer: Intercell Biomedical, License #
1790
STN: 125280/0
Approval Date: March 30, 2009
Package Insert (Military) (PDF - 191 KB) - Approved, March 2009
Package Insert (Commercial) (PDF - 200 KB) - Approved, January 2009
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Date: March 30, 2009
Indication: For the prevention of disease caused by Japanese encephalitis virus in persons 17 years of age and older.
March 30, 2009 Approval Letter
Press Release: FDA Approves New Vaccine to Prevent Japanese Encephalitis - March 30, 2009
Summary Basis for Regulatory Action
Approval History, Letters, Reviews, and Related Documents