化学药品、治疗用生物制品说明书指导原则

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1、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二○○五年三月目录一、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

2、求···········································································4(一)标题·························································································································4(二)警示语···································································

3、···············································4(三)药品名称·············································································································5(四)成份···········································································································

4、············5(五)性状························································································································6(六)处方组成·············································································································6(七)适应症···············

5、···································································································6(八)规格·······················································································································6(九)用法用量·············································

6、·······························································7(十)不良反应···········································································································8(十一)禁忌····························································································

7、·····················8(十二)警告·················································································································9(十三)注意事项······································································································9(十四)妊娠期及哺乳期妇女用药·········

8、·······················································11(十五)