Philippines - English - FDA (Food And Drug Administration)

n/a; importer: merck sharp & dohme (i.a.) llc; distributor: n/a - human papillomavirus 9-valent vaccine (recombinant, adsorbed) - suspension for injection (im) - formulation: each dose (0.5 ml) contains: human papillomavirus type 6 l1 protein-30mcg human papillomavirus type 11 l1 protein-40mcg human papillomavirus type 16 ll protein-60mcg human papillomavirus type 18 li protein-40mcg human papillomavirus type 31 ll protein-20 mcg human papillomavirus type 33 l1 protein-20mcg human papillomavirus type 45 ll protein-20mcg human papillomavirus type 52 l1 protein-20mcg human papillomavirus type 58 li protein-20mcg adsorbed on amorphous aluminum hydroxide sulphate adjuvant -500 mcg al

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.

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: merck sharp & dohme (1.a.) llc; distributor: n/a - human papillomavirus 9-valent vaccine (recombinant, adsorbed) - suspension for injection (im) - formulation: each dose (0.5 ml) contains: human papillomavirus type 6 1.1-30 mcg protein human papillomavirus type 11 1.1 protein-40 mcg human papillomavirus type 16 1.1 protein-60 mcg human papillomavirus type 18 1.1 protein-40 mcg human papillomavirus type 31 1.1 protein-20 mcg human papillomavirus type 33 1.1 protein -20 mcg human papillomavirus type 45 1.1 protein -20 mcg human papillomavirus type 52 1.1 protein-20 mcg human papillomavirus type 58 1.1 protein-20 mcg adsorbed on amorphous aluminum hydroxyphosphate sulphate adjuvant (500 mcg al)

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - human papillomavirus (hpv) 11 l1 protein 40ug;  ; human papillomavirus (hpv) 16 l1 protein 60ug;  ; human papillomavirus (hpv) 18 l1 protein 40ug;  ; human papillomavirus (hpv) 31 l1 protein 20ug;  ; human papillomavirus (hpv) 33 l1 protein 20ug;  ; human papillomavirus (hpv) 45 l1 protein 20ug;  ; human papillomavirus (hpv) 52 l1 protein 20ug;  ; human papillomavirus (hpv) 58 l1 protein 20ug;  ; human papillomavirus (hpv) 6 l1 protein 30ug;   - suspension for injection - 0.5 ml - active: human papillomavirus (hpv) 11 l1 protein 40ug   human papillomavirus (hpv) 16 l1 protein 60ug   human papillomavirus (hpv) 18 l1 protein 40ug   human papillomavirus (hpv) 31 l1 protein 20ug   human papillomavirus (hpv) 33 l1 protein 20ug   human papillomavirus (hpv) 45 l1 protein 20ug   human papillomavirus (hpv) 52 l1 protein 20ug   human papillomavirus (hpv) 58 l1 protein 20ug   human papillomavirus (hpv) 6 l1 protein 30ug   excipient: aluminium as amorphous aluminium hydroxyphosphate sulfate adjuvant histidine polysorbate 80 sodium borate sodium chloride water for injection - gardasil 9 is indicated in females aged 9 through 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 9 through 45 years of age for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions and infection caused by hpv types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).

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

merck sharp & dohme ltd - human papillomavirus type 6 l1 protein; human papillomavirus type 31 l1 protein; human papillomavirus type 58 l1 protein; human papillomavirus type 52 l1 protein; human papillomavirus type 11 l1 protein; human papillomavirus type 16 l1 protein; human papillomavirus type 18 l1 protein; human papillomavirus type 33 l1 protein; human papillomavirus type 45 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.

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.

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.

Canada - English - Health Canada

merck canada inc - recombinant human papillomavirus type 6 l1 protein; recombinant human papillomavirus type 11 l1 protein; recombinant human papillomavirus type 16 l1 protein; recombinant human papillomavirus type 18 l1 protein - suspension - 20mcg; 40mcg; 40mcg; 20mcg - recombinant human papillomavirus type 6 l1 protein 20mcg; recombinant human papillomavirus type 11 l1 protein 40mcg; recombinant human papillomavirus type 16 l1 protein 40mcg; recombinant human papillomavirus type 18 l1 protein 20mcg - vaccines

Canada - English - Health Canada

merck canada inc - recombinant human papillomavirus type 6 l1 protein; recombinant human papillomavirus type 11 l1 protein; recombinant human papillomavirus type 16 l1 protein; recombinant human papillomavirus type 18 l1 protein; recombinant human papillomavirus type 31 l1 protein; recombinant human papillomavirus type 33 l1 protein; recombinant human papillomavirus type 45 l1 protein; recombinant human papillomavirus type 52 l1 protein; recombinant human papillomavirus type 58 l1 protein - suspension - 30mcg; 40mcg; 60mcg; 40mcg; 20mcg; 20mcg; 20mcg; 20mcg; 20mcg - recombinant human papillomavirus type 6 l1 protein 30mcg; recombinant human papillomavirus type 11 l1 protein 40mcg; recombinant human papillomavirus type 16 l1 protein 60mcg; recombinant human papillomavirus type 18 l1 protein 40mcg; recombinant human papillomavirus type 31 l1 protein 20mcg; recombinant human papillomavirus type 33 l1 protein 20mcg; recombinant human papillomavirus type 45 l1 protein 20mcg; recombinant human papillomavirus type 52 l1 protein 20mcg; recombinant human papillomavirus type 58 l1 protein 20mcg - vaccines