| EMA对药用辅料右旋糖酐新的安全性评价 |
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| 引用本文： | 萧惠来. EMA对药用辅料右旋糖酐新的安全性评价[J]. 现代药物与临床, 2019, 42(6): 1069-1074 |
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| 作者姓名： | 萧惠来 |
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| 作者单位： | 国家药品监督管理局 药品审评中心, 北京 100022 |
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| 摘 要： | 欧洲药品局（EMA）于2018年11月发布了"人用药品辅料右旋糖酐的包装说明书资料",该文件引用大量文献全面评价了右旋糖酐的安全性,特别指出含有右旋糖酐辅料的注射和吸入制剂的疫苗与药品,应在说明书中描述有关其过敏反应信息的新要求。介绍该文件的主要内容,期望对我国这类药品说明书的撰写和监管有所帮助。
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| 关 键 词： | 欧洲药品局 右旋糖酐 药用辅料 过敏反应 药品说明书 |
| 收稿时间： | 2019-01-06 |
New safety evaluation of dextrans as pharmaceutical excipients by EMA |
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| XIAO Huilai. New safety evaluation of dextrans as pharmaceutical excipients by EMA[J]. Drugs & Clinic, 2019, 42(6): 1069-1074 |
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| Authors: | XIAO Huilai |
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| Affiliation: | Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China |
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| Abstract: | EMA issued Information for the package leaflet regarding dextrans used as excipients in medicinal products for human use (Draft) in November 2018. Citing a large number of references, the document comprehensively evaluated the safety of dextran, and pointed out in particular that vaccines and drugs containing dextran excipients for injection and inhalation should be described in the package leaflets for new requirements for information on their allergic reactions. This document is described in detail in the article and is expected to be helpful for the writing and supervision of such drug labeling in our country. |
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| Keywords: | EMA dextran pharmaceutical excipient allergic reaction drug labeling |
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