| 欧洲药品局药物警戒风险评估委员会的氟吡汀撤市评估报告介绍 |
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| 引用本文： | 萧惠来.欧洲药品局药物警戒风险评估委员会的氟吡汀撤市评估报告介绍[J].现代药物与临床,2019,42(4):597-605,611. |
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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： | 欧洲药物警戒风险评估委员会（PRAC）于2018年2月8日发布了有关氟吡汀撤市评估报告。人用药品相互承认和分散程序协调小组（CMDh）于2018年3月21日批准了这项报告。EMA于2018年3月23日宣布撤销含有氟吡汀药品的上市许可决定。详细介绍PRAC的该报告，期待对认识氟吡汀的肝脏毒性和受益-风险以及决定我国是否也将其撤市有帮助。
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| 关 键 词： | 药物警戒风险评估委员会 氟吡汀 肝脏毒性 撤市 |
| 收稿时间： | 2019/2/26 0:00:00 |
Introduction to assessment report on withdrawal of flupirtine from pharmacovigilance risk assessment committee of European Medicines Agency |
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| XIAO Huilai.Introduction to assessment report on withdrawal of flupirtine from pharmacovigilance risk assessment committee of European Medicines Agency[J].Drugs & Clinic,2019,42(4):597-605,611. |
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| Authors: | XIAO Huilai |
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| Institution: | Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China |
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| Abstract: | The Pharmacovigilance Risk Assessment Committee (PRAC) of European Medicines Agency (EMA) issued an assessment report on the withdrawal of flupirtine on February 8,2018.CMDh approved the report on March 21,2018.EMA announced its decision to revoke the marketing license of the drug containing flupirtine on March 23,2018.A detailed introduction to the PRAC report is expected to help identify hepatic toxicity and benefit-risk associated with flupirtine as well as determine whether China will remove it from the market. |
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| Keywords: | Pharmacovigilance Risk Assessment Committee (PRAC) flupirtine hepatic toxicity withdrawal |
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