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An Entity of Type : prov:Entity, within Data Space : webisadb.webdatacommons.org associated with source dataset(s)

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  • The ???Pediatric use??? subsection of the labeling must also cite any limitations on the pediatric use statement, need for specific monitoring, specific hazards associated with use of the drug in any subsets of the pediatric population (e.g., neonates), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.
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