INDICATIONS AND USAGE
CERVARIX® is indicated for the prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18 [see Clinical Studies (14)]:
Cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and
Cervical intraepithelial neoplasia (CIN) grade 1.
CERVARIX is approved for use in females 10 through 25 years of age.
Limitations of Use and Effectiveness
CERVARIX does not provide protection against disease due to all HPV types
CERVARIX has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity.
Females should continue to adhere to recommended cervical cancer screening procedures
Vaccination with CERVARIX may not result in protection in all vaccine recipients.