Reason for request

Extension of indication

-


Clinical Benefit

Substantial

Substantial for active immunisation against Japanese encephalitis in children from 2 months to 18 years of age only in populations recommended by the High Council for Public Health.

 


Clinical Added Value

important

Taking into account :

- the severity of infections due to the Japanese encephalitis virus,

- the absence of an alternative with Marketing Authorisation,

and despite the very limited immunogenicity data in non-endemic areas, IXIARO provides a substantial improvement in actual benefit (level II) in the prevention of Japanese encephalitis in children (from 2 months to 18 years of age) in the populations recommended by the High Council for Public Health (HCPH).