Reason for request
Extension of indication
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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.
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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). |