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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 safetyThe safety profile for patients who completed 48 weeks of treatment was similar to the safety profile for patients who completed 24 weeks of treatmentPostmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Janssen
 
NNPS:  TRUE'
 
Therapeutic Category:  Antiviral
 
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