[關(guān)鍵詞]
[摘要]
歐洲藥物警戒風(fēng)險(xiǎn)評(píng)估委員會(huì)(PRAC)于2018年2月8日發(fā)布了有關(guān)氟吡汀撤市評(píng)估報(bào)告。人用藥品相互承認(rèn)和分散程序協(xié)調(diào)小組(CMDh)于2018年3月21日批準(zhǔn)了這項(xiàng)報(bào)告。EMA于2018年3月23日宣布撤銷(xiāo)含有氟吡汀藥品的上市許可決定。詳細(xì)介紹PRAC的該報(bào)告,期待對(duì)認(rèn)識(shí)氟吡汀的肝臟毒性和受益-風(fēng)險(xiǎn)以及決定我國(guó)是否也將其撤市有幫助。
[Key word]
[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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