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wqssfj1

铁杆木虫 (著名写手)

[求助] 求助翻译

The  CDS displays the company’s current position on important characteristics of the product, including the Core Safety Information according to ICH E2C.
The  CDS contains all relevant information relating to indications, dosing, pharmacovigilance and Core Safety Information which Novartis requires to be listed for the product in all countries where the product is registered.
谢谢!
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yuanbing0000

至尊木虫 (小有名气)

【答案】应助回帖

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爱与雨下(金币+1): 2012-02-29 21:12:44
sltmac(金币+7, 翻译EPI+1): 2012-03-10 09:37:47
我理解的意思如下:
      根据人用药品注册技术规定国际协调会议中上市药品定期安全性更新报告的核心安全信息,编码序列显示了公司目前在产品重要性方面所处的地位。
      编码序列涵盖所有与适应症、剂量、药物警戒以及基础安全信息相关的资料。诺华要求在注册了该产品的所有国家列出产品的这些信息。
2楼2012-02-29 20:37:10
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