LABELINGLABELING · 标签/说明书变更 · 标准审评 · SUPPL:12
补充批准 · 说明书变更
批准信：Prior Approval；Oxbryta (voxelotor) 标签更新，新增 DRESS 综合征至超敏反应及上市后经验章节，并修订因不良反应进行剂量调整的相关说明
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批准信原文要点
These Prior Approval sNDAs provide for the following updates for the labeling: • Addition of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), to Section 5.1 Hypersensitivity Reactions • Addition of the adverse drug reactions (ADRs) of DRESS, pruritis, and angioedema to Section 6.2 Postmarketing Experience • Revised lanauage regarding dosage modifications (dose reduction or dosing interruption) due to adverse reactions in Section 6.1 Clinical Trials Experience
Labeling-Package Insert；Labeling-Patient Package Insert（PI；PPI）
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申报事项：说明书/标签变更（Prior Approval）
变更信息：Oxbryta (voxelotor) 标签更新，新增 DRESS 综合征至超敏反应及上市后经验章节，并修订因不良反应进行剂量调整的相关说明
来源：官方文件