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Fact Sheet for Health Care Providers: Emergency Use Authorization (EUA) of VEKLURY® (remdesivir) for Hospitalized Pediatric Patients weighing 3.5 kg to less than 40 kg OR Hospitalized Pediatric Patients less than 12 years of age weighing at least 3.5 kg.

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Title

Fact Sheet for Health Care Providers: Emergency Use Authorization (EUA) of VEKLURY® (remdesivir) for Hospitalized Pediatric Patients weighing 3.5 kg to less than 40 kg OR Hospitalized Pediatric Patients less than 12 years of age weighing at least 3.5 kg.

Description

EUA: For emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.

On October 22, 2020, FDA approved Veklury (remdesivir) for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.  This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the EUA for Veklury continues to authorize Veklury for emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.

For additional information, also see: FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—The Science of Safety and Effectiveness

Date

2020-05-01

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