LABELINGLABELING · 标签/说明书变更 · 标准审评 · SUPPL:2
补充批准 · 说明书变更
批准信：Prior Approval；更新 Velsipity 处方信息第 13.1 节致癌/致突变/生育力损害：将小鼠口服致癌性研究中肿瘤发生率升高的最低剂量表述替换为该研究中未见肿瘤发生率升高的剂量水平。
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批准信原文要点
This Prior Approval sNDA provides for updates to the Prescribing Information Section 13.1 Carinogenesis, Mutagenesis, Impariment of Fertility to replace the lowest level at which increased turmor incidence was observed in an oral carcinogencitity study in mice with the level at which no increase in tumor incidence was observed in that study.
Labeling-Package Insert（PI）
摘录（本节点）letter_ok
申报事项：说明书/标签变更（Prior Approval）
变更信息：更新 Velsipity 处方信息第 13.1 节致癌/致突变/生育力损害：将小鼠口服致癌性研究中肿瘤发生率升高的最低剂量表述替换为该研究中未见肿瘤发生率升高的剂量水平。
来源：官方文件