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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:  02/27/2013
 
Trade Name:  Intelence
 
Generic Name or Proper Name (*):  etravirine
 
Indications Studied:  Postmarketing study
 
Label Changes Summary:  *Information on 48 week safety*The safety profile for patients who completed 48 weeks of treatment was similar to the safety profile for patients who completed 24 weeks of treatment*Postmarketing study
 
Product Labeling:    Opens a new window
 
PREA(P):  P
 
Sponsor:  Janssen
 
NNPS:  TRUE
 
Therapeutic Category:  Antiviral
 
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