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Pediatric Studies Characteristics - Detail
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Pediatrics
Pediatric Studies Characteristics
Detail
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Approval Date:
12/16/2011
Trade Name:
Prezista
Generic or Proper Name (*):
darunavir
Indications Studied:
Treatment of HIV-1 infection in adults and pediatric patients 3 years of age and older and weighing at least 10 kg
Therapeutic Category:
Antiviral
Ages Studied:
3 - <6 years
Study #:
1
Study Type:
Safety/Pharmacokinetic/Pharmacodynamic/Tolerability
Study Design:
Open Label/Traditional Pharmacokinetic
No Patients:
27
No Centers:
11
No Countries:
5
BPCA(B), PREA(P):
B, P
Unknown:
0
Countries:
Argentina, Brazil, Kenya, South Africa, India
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