化学药品及中药的药品说明书撰写原则.pdfVIP

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2015-12-06 发布于云南
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化学药品及中药的药品说明书撰写原则.pdf

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【 H 】 G C L 5 - 1 指导原则编号：化学药品、生物制品说明书指导原则（第二稿）二 00 四年三月一日 1 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