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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
09/24/2015
Trade Name:
Reyataz Oral Powder
Generic Name or Proper Name (*):
atazanavir
Indications Studied:
HIV-1
Label Changes Summary:
*Expanded indication to patients 3 months and older weighing 5 to < 10 kg and to those weighing > 25 kg; previously approved in patients 3 months of age and older weighing at least 10 kg. *Not recommended for patients weighing less than 5 kg. *Information on PK, dosing and clinical trial. *Postmarketing study
BPCA(B) and PREA(P):
B, P
NNPS:
FALSE
Therapeutic Category:
Antiviral
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