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Xofluza (baloxavir marboxil)
药品名称
Xofluza (baloxavir marboxil)
承诺描述
Submit the clinical study reports including the pharmacokinetic/ pharmacodynamic modeling data and the supporting PK, safety and efficacy data from all the relevant studies in adult and pediatric patients to extrapolate efficacy of baloxavir marboxil in pediatric subjects from birth to less than 12 months of age for the prevention of influenza as postexposure prophylaxis in household contacts of an index case. Include characterization of baloxavir-resistant substitutions including supporting datasets
承诺状态描述
The study has not been initiated, but it does not meet the criterion for delayed.