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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:  10/07/2016
 
Trade Name:  Gardasil 9
 
Generic Name or Proper Name (*):  Human Papillomavirus 9-valent Vaccine, Recombinant*
 
Indications Studied:  To include a 2-dose regimen for individuals 9 through 14 years of age.
 
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.
 
NNPS:  FALSE
 
Therapeutic Category:  Preventive Vaccine
 
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