| 丙氧氨酚复方片英国撤市原因分析及对我国的启示 |
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| 引用本文： | 王丹,杨悦.丙氧氨酚复方片英国撤市原因分析及对我国的启示[J].中国药房,2007,18(28):2207-2209. |
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| 作者姓名： | 王丹 杨悦 |
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| 作者单位： | 1. 沈阳药科大学工商管理学院,沈阳市,110016;国家食品药品监督管理局药品评价中心,北京市,100045
2. 沈阳药科大学工商管理学院,沈阳市,110016 |
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| 摘 要： | 目的:探讨我国药品安全监管工作中存在的问题及发展方向。方法:通过查阅国内、外文献资料和全国药品不良反应数据库,分析丙氧氨酚复方片在英国撤市的原因及国内类似产品的安全性问题,进一步探讨其撤市事件给我国药品安全监管工作带来的启示。结果:药品过量引起的毒性反应是该产品撤市的主要原因;我国也存在类似的安全隐患,但不良事件的报告数量较少。结论:探索开展药物警戒工作和灵活多样的药品风险管理手段,是我国目前药品监管工作面临的新任务。
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| 关 键 词： | 丙氧氨酚复方片 撤市 启示 |
| 文章编号： | 1001-0408（2007）28-2207-03 |
| 收稿时间： | 2007-07-12 |
| 修稿时间： | 2007-08-28 |
Causes of Withdrawal of Co-proxamol in UK and its Implication for China |
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| WANG Dan,YANG Yue.Causes of Withdrawal of Co-proxamol in UK and its Implication for China[J].China Pharmacy,2007,18(28):2207-2209. |
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| Authors: | WANG Dan YANG Yue |
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| Institution: | 1.School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China;2.Center for Drug Reevaluation, SFDA, Beijing 100045, China |
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| Abstract: | OBJECTIVE:To explore the problems and development directions of drug safety regulation in China.METHODS:Through referring to domestic and overseas literature and national ADR database,we analyzed the causes of the withdrawal of Co-proxamol in the UK and the potential safety problems of domestic Co-proxamol analog,and further discussed the implication of the withdrawal for our drug regulation system.RESULTS:The toxic reaction related to Co-proxamolin overdose is the main cause of its withdrawal in UK.Though few adverse events have been reported,there are also the similar potential risks in China.CONCLUSION:Currently it is urgently needed for us to conduct pharmacovigilance work and seek diversified and flexible approaches in risk management. |
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| Keywords: | Co-proxamol tablet Withdrawal Implication |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ |
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