psur报告模板

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psur报告模板
篇一：psuR报告大纲
********定期安全性更新报告
第1次报告
报告期：报告提交时间：
国内首次获得药品批准证明文件时间：国际诞生日（ibd）以及国家：
药品生产企业：地址：邮编：传真：负责药品安全的部门：负责人：手机：固定电话：电子邮箱：
目录
一、药品基本信息................................................. ................................................... .. (3)
1、药品通用名称：...............................................
....................................32、药品商品名称：............................................... ................................................... ....................................33、剂型：............................................... ................................................... ................................................... .34、规格：............................................... ................................................... ................................................... .35、批准文号：............................................... ................................................... ............................................36、处方组成：............................................... ................................................... ............................................37、功能主治：...............................................
............................................38、用法用量：............................................... ................................................... ............................................3二、国内外上市情况................................................. ................................................... . (3)
1、获得上市许可的国家：............................................... ................................................... ........................3
2、获得上市许可的时间：............................................... ................................................... ........................3
3、首次上市销售商品名：............................................... ................................................... ........................3
4、首次上市销售的时间：............................................... ...................................................
........................35、批准上市时提出的要求：............................................... ................................................... ....................36、批准的适应症和特殊人群：............................................... ................................................... ................3三、因药品安全原因而采取措施的情况................................................. ................................................... .. (3)
1、暂停生产、销售、使用，撤销药品批准证明文件：............................................... ............................3
2、再注册申请未获批准：............................................... ................................................... ........................3
3、限制销售：............................................... ................................................... ............................................3
4、暂停临床研究：............................................... ...................................................
....................................35、剂量调整：............................................... ................................................... ............................................36、改变用药人群或适应症（功能主治）：.............................................. .................................................37、改变剂型或处方：............................................... ................................................... ................................38、改变或限制给药途径：............................................... ................................................... ........................3四、药品安全性信息的变更：............................................... ................................................... ..........................3五、估算用药人数：............................................... ................................................... ..........................................3六、药品
不良反应报告信息：...............................................。