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
October 4, 2018 Approval Letter - IXIARO (PDF - 35KB)
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 (PDF - 117KB)Statistical Review - IXIARIO (PDF - 234KB)Clinical Review -IXIARO (PDF - 380KB)Toxicology Review - IXIARO (PDF - 14KB)April 13, 2018 Approval Letter - IXIARO (PDF - 62KB)
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 (PDF - 166KB)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.Approval History, Letters, Reviews, and Related Documents - Ixiaro (ZIP - 2.1MB)Supporting Documents older than three years - IXIARO 