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IXIARO

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Opinions on drugs - Posted on Sep 09 2014

Reason for request

Extension of indication

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Actual benefit

Important

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.

 


Improvement in actual benefit

II (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).