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                Vaccines

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          GARDASIL 9Vaccines GARDASIL 9
  
  	
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    Print**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

Package Insert - GARDASIL 9
	Patient Information - GARDASIL 9Supporting Documents

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

                                                                                  Content current as of:
      04/28/2023
              
              
Regulated Product(s)
		 BiologicsVaccines

          
                        Emergency Use Authorization for Vaccines Explained
          Approved Vaccine Products
          Questions about Vaccines
 
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