IXIARO
STN: BL 125280
Proper Name: Japanese Encephalitis Vaccine, Inactivated, Adsorbed
Tradename: IXIARO
Manufacturer: Valneva Austria GmbH
Indication:
- For the prevention of disease caused by Japanese encephalitis virus in persons 2 months of age and older.
Product Information
Supporting Documents
February 24, 2016 Approval Letter - IXIARO (PDF - 15KB)
To indicate a change in the distributor, as the vaccine would now be distributed through Valneva’s U.S. subsidiary, Intercell USA, Inc.Clinical Review - IXIARO (PDF - 743KB) [ARCHIVED]May 2, 2013 Statistical Review and Evaluation - IXIARO (PDF - 777KB) [ARCHIVED]- May 16, 2013 Summary Basis for Regulatory Action - IXIARO (PDF - 141KB)
May 17, 2013 Approval Letter - IXIARO
To extend the age range to include infants, children, and adolescents 2 months to <17 years of age for active immunization for the prevention of disease caused by Japanese encephalitis virus.Summary Basis for Regulatory Action - Ixiaro
September 23, 2010October 14, 2010 Approval Letter - Ixiaro [ARCHIVED]
Efficacy Supplement for Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed, Pediatric RequirementOctober 23, 2009 Approval Letter - Ixiaro [ARCHIVED]
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.Ixiaro - Summary Basis for Regulatory Action Approval History, Letters, Reviews, and Related Documents - Ixiaro [ARCHIVED]Intercell Biomedical