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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:  04/03/2008
 
Trade Name:  ROTARIX
 
Generic Name or Proper Name (*):  Rotavirus Vaccine, Live, Oral*
 
Indications Studied:  Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9)
 
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:  Preventive Vaccine
 
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