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化学药品、生物制品说明书指导原则--第1页
指导原则编号:【H】GCL5-1
化学药品、治疗用生物制品说明书
指导原则
化学药品、生物制品说明书指导原则--第1页
化学药品、生物制品说明书指导原则--第2页
二○○四年十一月
目录
一、概述1
二、药品说明书格式与内容的一般要求1
三、说明书格式与内容的具体要求4
（一）标题··································································4
（二）警示语·······························································4
（三）药品名称····························································5
（四）成份··································································5
（五）性状··································································6
（六）处方组成····························································6
（七）适应症·······························································6
（八）规格··································································7
（九）用法用量····························································7
（十）不良反应····························································8
（十一）禁忌·······························································9
（十二）警告····························································10·
（十三）注意事项······················································10·
（十四）妊娠期及哺乳期妇女用药·································11·
（十五）儿童用药······················································13·
化学药品、生物制品说明书指导原则--第2页
化学药品、生物制品说明书指导原则--第3页
（十六）老年用药······················································14·
（十七）药物相互作用··
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