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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:
12/02/2003
Trade Name:
Malarone
Generic Name or Proper Name (*):
atovaquone/ proguanil
Indications Studied:
Prophylaxis and treatment of malaria
Label Changes Summary:
Safety and effectiveness established down to e 11kg Information on dose, efficacy, PK parameters and AE profile Elimination half-life is shorter in pediatric patients (1 to 2 days) than in adults (2 to 3 days) Attributable AEs occurring in ³ 5% of the pediatric patients were vomiting (10%) and pruritus (6%)
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
GlaxoSmithKline
Pediatric Exclusivity Granted Date:
08/06/2003
NNPS:
FALSE'
Therapeutic Category:
Antimalarial
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