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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:  05/01/2019
 
Trade Name:  DENGVAXIA
 
Generic Name or Proper Name (*):  DENGUE Tetravalent Vaccine, Live*
 
Indications Studied:  Indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.
 
Label Changes Summary:  See Package Insert for new information on biologics
 
PREA(P):  P
 
Sponsor:  Sanofi Pasteur
 
NNPS:  FALSE
 
Therapeutic Category:  Preventive Vaccine
 
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