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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:  12/17/2015
 
Trade Name:  Emend
 
Generic Name or Proper Name (*):  aprepitant**
 
Indications Studied:  Prevention of chemotherapy induced nausea and vomiting in patients ages 6 months of age and older
 
Label Changes Summary:  *Safety and effectiveness of Emend oral suspension have been established in pediatric patients 6 months and older. *Safety and effectiveness have not been established in patients less than 6 months. *New dosage form.
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Merck Sharp & Dohme Corp.
 
NNPS:  FALSE
 
Therapeutic Category:  Antiemetic
 
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