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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  12/10/2014
 
Trade Name:  Gardasil 9
 
Generic Name or Proper Name (*):  Human Papillomavirus 9-valent Vaccine, Recombinant*
 
Indications Studied:  Indicated in girls and women 9 through 26 years of age for prevention of the following diseases: Cervical, vulvar, vaginal, and anal cancer 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. Human Papillomavirus 9-valent Vaccine, Recombinant is indicated in boys 9 through 15 years of age for the prevention of the following diseases: •Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58. Genital warts (condyloma acuminata) caused by HPV types 6 and 11. nd the following Aprecancerous 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
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Merck Sharp & Dohme Corp.
 
Therapeutic Category:  Preventative Vaccine
 
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