European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - human papillomavirus1 type 16 l1 protein, human papillomavirus type 18 l1 protein - papillomavirus infections; uterine cervical dysplasia; immunization - vaccines - cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain oncogenic human papillomavirus (hpv) types. see sections 4.4 and 5.1 for important information on the data that support this indication.the use of cervarix should be in accordance with official recommendations.

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: glaxosmithkline philippines, inc.; distributor: glaxosmithkline philippines, inc. - human papillomavirus vaccine [types 16 and 18] (recombinant, adjuvanted, adsorbed) - suspension for injection (im) - formulation: 1 dose (0.5 ml) contains: human papillomavirus type 16 ll protein*...............20 mcg human papillomavirus type 18 l1 protein*... ..........20 mcg *adjuvanted by as04 containing 3-o-desacyl-4-monophosphoryl lipid a (mpl) and aluminum hydroxide, hydrated [al(oh)3]

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: glaxosmithkline philippines, inc.; distributor: glaxosmithkline philippines, inc. - human papillomavirus vaccine [types 16 and 18] (recombinant, adjuvanted, adsorbed) - suspension for injection (im) - formulation: 1 dose (0.5 ml) contains: human papillomavirus type 16 ll protein*..............20 mcg human papillomavirus type 18 l1 protein*... ...........20 mcg *adjuvanted by as04 containing 3-o-desacyl-4-monophosphoryl lipid a (mpl) and aluminum hydroxide, hydrated [al(oh)3]

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - human papillomavirus type 18 l1 protein; human papillomavirus type 16 l1 protein - suspension for injection

Philippines - English - FDA (Food And Drug Administration)

glaxosmithkline philippines, inc. - human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed) - suspension for injection (i.m.) - 0.5 ml

European Union - English - EMA (European Medicines Agency)

merck sharp dohme ltd - 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 - vaccines - silgard 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 silgard should be in accordance with official recommendations.

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - 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 - vaccines - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hpv type 16 l1 protein, quantity: 20 microgram; hpv type 18 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: monobasic sodium phosphate; aluminium hydroxide hydrate; water for injections; 3-o-desacyl-4'-monophosphoryl lipid a; sodium chloride - cervarix is indicated in females from 10 to 45 years of age for the prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by human papillomavirus types 16 and 18. lmmunogenicity studies have been conducted in females aged 10 to 14 years and 26 to 45 years to link efficacy in females aged 15 to 25 years to other populations (see precautions and clinical trials).

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed) - condylomata acuminata; papillomavirus infections; immunization; uterine cervical dysplasia - papillomavirus vaccines - gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following hpv diseases:premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine hpv typesgenital warts (condyloma acuminata) caused by specific hpv types.see sections 4.4 and 5.1 for important information on the data that support these indications.the use of gardasil 9 should be in accordance with official recommendations.

United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - human papillomavirus type 6 l1 capsid protein antigen (unii: 61746o90dy) (human papillomavirus type 6 l1 capsid protein antigen - unii:61746o90dy), human papillomavirus type 11 l1 capsid protein antigen (unii: z845vhq61p) (human papillomavirus type 11 l1 capsid protein antigen - unii:z845vhq61p), human papillomavirus type 16 l1 capsid protein antigen (unii: 6lte2dnx63) (human papillomavirus type 16 l1 capsid protein antigen - unii:6lte2dnx63), human papillomavirus type 18 l1 capsid protein antigen (unii: - human papillomavirus type 6 l1 capsid protein antigen 20 ug in 0.5 ml - gardasil® is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by human papillomavirus (hpv) types included in the vaccine: - cervical, vulvar, vaginal, and anal cancer caused by hpv types 16 and 18 - genital warts (condyloma acuminata) caused by hpv types 6 and 11 and the following precancerous or dysplastic lesions caused by hpv types 6, 11, 16, and 18: - cervical intraepithelial neoplasia (cin) grade 2/3 and cervical adenocarcinoma in situ (ais) - cervical intraepithelial neoplasia (cin) grade 1 - vulvar intraepithelial neoplasia (vin) grade 2 and grade 3 - vaginal intraepithelial neoplasia (vain) grade 2 and grade 3 - anal intraepithelial neoplasia (ain) grades 1, 2, and 3 gardasil is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by hpv types included in the vaccine: - anal cancer caused by hpv types 16 and 18 - genital warts (condyloma acuminata) caused by hpv types 6 and