化学药品生物制品说明书指导原则.PDF
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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·········································································
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