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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:  01/14/2016
 
Trade Name:  HIBERIX
 
Generic Name or Proper Name (*):  Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) *
 
Indications Studied:  Active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b in children 6 weeks through 4 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:  GlaxoSmithKline Biologicals
 
NNPS:  FALSE
 
Therapeutic Category:  Vaccine
 
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