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.

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

Philippines - English - FDA (Food And Drug Administration)

merck sharp & dohme (i.a.) llc - human papillomavirus vaccine (types 6, 11, 16 and 18) (recombinant adsorbed - suspension for injection im - each 0.5 ml contains: type 6 ll protein 20 ug type 11 l1 protein 40 ug type 16 l1 protein 40 ug type 18 l1 protein 20 ug

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

merck sharp & dohme ltd - human papillomavirus type 6 l1 protein; human papillomavirus type 18 l1 protein; human papillomavirus type 16 l1 protein; human papillomavirus type 11 l1 protein - suspension for injection

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.

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

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 30 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 60 microgram; hpv type 18 l1 protein, quantity: 40 microgram; hpv type 31 l1 protein, quantity: 20 microgram; hpv type 33 l1 protein, quantity: 20 microgram; hpv type 45 l1 protein, quantity: 20 microgram; hpv type 52 l1 protein, quantity: 20 microgram; hpv type 58 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: polysorbate 80; aluminium; histidine; sodium chloride; borax; water for injections - gardasil 9 is indicated in females aged 9 to 45 years* for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,gardasil 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,* evidence of vaccine efficacy is based on the core efficacy population of females aged 16 to 26 years. immunogenicity studies have been conducted to link efficacy to younger populations (females and males aged 9 to 15 years). immunogenicity studies of gardasil 9 have been conducted relating to females over 26 years of age (see section 5.1 clinical trials for gardasil 9).

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

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 30 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 60 microgram; hpv type 18 l1 protein, quantity: 40 microgram; hpv type 31 l1 protein, quantity: 20 microgram; hpv type 33 l1 protein, quantity: 20 microgram; hpv type 45 l1 protein, quantity: 20 microgram; hpv type 52 l1 protein, quantity: 20 microgram; hpv type 58 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: sodium chloride; histidine; borax; aluminium; water for injections; polysorbate 80 - gardasil 9 is indicated in females aged 9 to 45 years* for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,gardasil 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,* evidence of vaccine efficacy is based on the core efficacy population of females aged 16 to 26 years. immunogenicity studies have been conducted to link efficacy to younger populations (females and males aged 9 to 15 years). immunogenicity studies of gardasil 9 have been conducted relating to females over 26 years of age (see section 5.1 clinical trials for gardasil 9).

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

a-s medication solutions - 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: - 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