STN: BL 125280
Proper Name: Japanese Encephalitis Vaccine, Inactivated, Adsorbed
Manufacturer: Valneva Austria GmbH
- For the prevention of disease caused by Japanese encephalitis virus in persons 2 months of age and older.
- October 4, 2018 Approval Letter - IXIARO
To include data to support the concomitant use of IXIARO primary immunization series, to 0.5 mL doses administered 28 days apart with U.S. licensed rabies vaccines (RabAvert) administered for pre-exposure prophylaxis.
October 2, 2018 Summary Basis of Regulatory Action - IXIARO
- Statistical Review - IXIARO
- Clinical Review -IXIARO
- Toxicology Review - IXIARO
- April 13, 2018 Approval Letter - IXIARO
To include the data from study IC51-322, and long-term pediatric studies IC51-325 and IC51-324 to update the package insert.
- April 12, 2018 Summary Basis of Regulatory Action - IXIARO
- February 24, 2016 Approval Letter - IXIARO
To indicate a change in the distributor, as the vaccine would now be distributed through Valneva’s U.S. subsidiary, Intercell USA, Inc.
- Approval History, Letters, Reviews, and Related Documents - Ixiaro
- Supporting Documents older than three years - IXIARO