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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:  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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  GlaxoSmithKline
 
Pediatric Exclusivity Granted Date:  08/06/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Antimalarial
 
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