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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:  12/22/2010
 
Trade Name:  GARDASIL
 
Generic Name or Proper Name (*):  Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant*
 
Indications Studied:  Prevention of anal cancer caused by HPV types 16 and 18, and prevention of anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types included in the vaccine
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Merck
 
NNPS:  FALSE
 
Therapeutic Category:  Preventive Vaccine
 
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