补充批准 · 说明书变更
批准信：Prior Approval；This Prior Approval sNDA provides for the definition of systemic inflammatory response syndrome (SIRS) used in the analysis of a secondary endpoint of the pivotal CONFIRM study, for which data are presented in Table 2…
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批准信原文要点
This Prior Approval sNDA provides for the definition of systemic inflammatory response syndrome (SIRS) used in the analysis of a secondary endpoint of the pivotal CONFIRM study, for which data are presented in Table 2 of the Prescribing Information.
Labeling-Package Insert（PI）
申报事项：说明书/标签变更（Prior Approval）
变更信息：This Prior Approval sNDA provides for the definition of systemic inflammatory response syndrome (SIRS) used in the analysis of a secondary endpoint of the pivotal CONFIRM study, for which data are presented in Table 2…
来源：官方文件