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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  06/24/2008
 
Trade Name:  Viramune Tablets 200 mg Viramune Oral Suspension 10 mg/mL
 
Generic or Proper Name (*):  nevirapine
 
Indications Studied:  Use in combination with other antiretroviral agents for the treatment of HIV-1 infection
 
Therapeutic Category:  Antiviral
 
Ages Studied:  15 days - <16 years
 
Study #:  1
 
Study Type:  Safety/Pharmacokinetic/Tolerability
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  123
 
No Centers:  4
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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