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🇪🇺EU · EMAAuthorisedATC: J07BM01

Gardasil(human papillomavirus type 6 L1 protein;human papillomavirus type 11 L1 protein;human papillomavirus type 16 L1 protein;human papillomavirus type 18 L1 protein)

Papillomavirus Infections;Uterine Cervical Dysplasia;Condylomata Acuminata;Immunization

Marketing Authorisation Holder: Merck Sharp & Dohme B.V.

EMA Authorisation: 20/09/2006

INN: human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)

Indication

Gardasil is a vaccine for use from the age of 9 years for the prevention of: premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types; genital warts (condyloma acuminata) causally related to specific HPV types. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Gardasil should be in accordance with official recommendations.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.