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CERVARIX

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Opinions on drugs - Posted on Feb 01 2012

Reason for request

Following the submission of new data (immunogenicity, preventative efficacy, safety) and the new vaccination recommendations from the Haut Conseil de la Sante Publique (High Council of Public Health, HCSP), reassessment of the improvement in actual benefit in accordance with article R163-12 of the Social Security Code.

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Actual benefit

Important

The actual benefit of this vaccine remains substantial in the only Marketing Authorisation indications recommended by the HCSP in the current vaccination schedule in force.


Improvement in actual benefit

III (modéré)

the Committee considers that CERVARIX, equivalent to the GARDASIL vaccine, provides a moderate improvement in actual benefit (level III) in the prevention strategy for premalignant genital lesions of the cervix caused by certain types of oncogenic Human Papillomavirus.


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