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                Vaccines

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          GardasilVaccines Gardasil
  
  	
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    Print**STN:**125126**Proper Name:** Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant**Tradename:** Gardasil**Manufacturer:** Merck & Co., Inc

**Indications:**

Prevention of vulvar and vaginal cancer
	Vaccination in females 9 through 26 years of age for prevention of the following diseases caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18:
	Cervical cancer
		Genital warts (condyloma acuminata) and the following precancerous or dysplastic lesions:
		Cervical adenocarcinoma in situ (AIS)
			Cervical intraepithelial neoplasia (CIN) grade 2 and grade 3
			Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
			Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3
			Cervical intraepithelial neoplasia (CIN) grade 1
	Vaccination in boys and men 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11
	Vaccination in people ages 9 through 26 years for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18Product Information

Package Insert - Gardasil
	Patient Information about GardasilSupporting Documents

Approval History, Letters, Reviews, and Related Documents - Gardasil
	Supporting Documents older than three years - GardasilRelated Information

FDA Information on Gardasil - Presence of DNA Fragments Expected, No Safety Risk (Archived)
	Gardasil Vaccine Safety (Archived)
	FDA Sentinel study finds no association between venous thromboembolism and Gardasil vaccination
	Two FDA CBER Mini-Sentinel Studies Completed on the Safety of Gardasil and Rotavirus Vaccines (Archived)

                                                                                  Content current as of:
      03/06/2023
              
              
Regulated Product(s)
		 Biologics
			  			     			  						              
			
			 
			  VaccinesVaccines

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