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化学药品、生物制品说明书指导原则(pdf33)

发布时间11-08   方案资源网

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目 录 一.概述························4 二.药品说明书形式与内容的一般要求···········4 三.说明书形式与内容的具体要求·············8 (一)标题························································································8(二)警示语····················································································8(三)药品名称·················································································8 (四)成份························································································9 (五)性状························································································9 (六)处方组成·················································································9 (七)药理毒理·················································································9 (八)药代动力学···········································································10 (九)临床研究···············································································11 (十)适应证··················································································11 (十一)用法用量···········································································12 (十二)不良反应···········································································13
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