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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
Sponsor:  GlaxoSmithKline
Pediatric Exclusivity Granted Date:  08/06/2003
Therapeutic Category:  Antimalarial