【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 ···················...
