EPARs - Gardasil//human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed) II

FICHA FARMACOLÓGICA de human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed). Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. Marzo 16, 2009. [Se publican las dos marcas comerciales a efectos que no queden dudas sobre los contenidos monográficos e investigacionales].

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EPARs for authorised medicinal products for human use - Gardasil

Active Substance
human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
International Nonproprietary Name or Common Name
human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Pharmaco-therapeutic Group
Viral vaccines
ATC Code
J07BM01

Therapeutic Indication:
Gardasil is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal ), cervical cancer and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18 (see section 5.1).

The indication is based on the demonstration of efficacy of Gardasil in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents. Protective efficacy has not been evaluated in males (see section 5.1).

The use of Gardasil should be in accordance with official recommendations.

Date of issue of Marketing Authorisation valid throughout the European Union
20 September 2006