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NIMENRIX

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Opinions on drugs - Posted on May 21 2013

Reason for request

Inclusion for hospital use.

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Actual benefit

Important

Substantial in subjects aged 12 months and older, and only in those populations recommended by the Haut Conseil de santé publique ( HCSP, or the French High Council for Public Health), i.e., people with risk factors for invasive meningococcal infections and people visiting an endemic area.


Improvement in actual benefit

I (majeur)

In light of the available information and given the lack of alternative treatments with a Marketing Authorisation for serogroups A, W135 and Y in the 12-to-23-month age range, the Committee considers that NIMENRIX offers a substantial improvement in actual benefit (IAB I) in the prevention of invasive meningococcal infection caused by serogroups A, W135 and Y in children 12 to 23 months of age

in the populations recommended by the HCSP.

V (absence)

NIMENRIX does not offer an improvement in actual benefit (non-existent IAB) in the prevention of invasive meningococcal infection caused by serogroups A, C, W135 and Y in children aged 2 years and older, adolescents and adults.