GARDASIL 9
STN: 125508
Proper Name: Human Papillomavirus 9-valent Vaccine, Recombinant
Tradename: GARDASIL 9
Manufacturer: Merck Sharp & Dohme LLC
Indications:
- Indicated in girls and women 9 through 45 years of age for the prevention of the following diseases:
- Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58.
- 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, 18, 31, 33, 45, 52, and 58:
- 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.
- Indicated in boys and men 9 through 45 years of age for the prevention of the following diseases:
- Anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
- 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, 18, 31, 33, 45, 52, and 58:
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
Product Information
Supporting Documents
- March 14, 2024 Approval Letter - GARDASIL 9
- April 28, 2023 Approval Letter - GARDASIL 9
- August 20, 2020 Approval Letter - GARDASIL 9
- June 12, 2020 Approval Letter - GARDASIL 9
- June 9, 2020 Clinical Review - GARDASIL 9
- February 20, 2020 Approval Letter - GARDASIL 9
- October 5, 2018 Approval Letter - GARDASIL 9
- October 5, 2018 Summary Basis of Regulatory Action - GARDASIL 9
- February 9, 2018 Approval Letter - GARDASIL 9
- Statistical Review - GARDASIL 9
- Clinical Review - GARDASIL 9
- Clinical Review (STN 125508/0) - GARDASIL 9
- Statistical Review (STN 125508/0) - GARDASIL 9
- Approval History, Letters, Reviews, and Related Documents - GARDASIL 9
- Supporting Documents older than three years - GARDASIL 9