Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) - EPARs for authorised medicinal products for human use - Cervarix

FICHA FARMACOLÓGICA de Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) Contiene la Monografía en distintos idiomas (de la Unión 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. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. DICIEMBRE 02, 2009.

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EPARs for authorised medicinal products for human use - Cervarix

Active Substance
Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
International Nonproprietary Name or Common Name
Human Papillomavirus vaccine [Types 16, 18]
Pharmaco-therapeutic Group
Papillomavirus vaccines
ATC Code
J07BM02

Therapeutic Indication:
Cervarix is a vaccine for the prevention of premalignant cervical lesions and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18 (see section 5.1).

The indication is based on the demonstration of efficacy in women aged 15-25 years following vaccination with Cervarix and on the immunogenicity of the vaccine in girls and women aged 10-25 years.

See section 5.1 for information on the evidence that supports the efficacy of Cervarix in prevention of premalignant cervical lesions associated with HPV-16 and/or HPV-18.

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

Date of issue of Marketing Authorisation valid throughout the European Union
20 September 2007

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use