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欧洲药品评估局(EMEA)的医药产品专利委员会(CPMP)在2001年3月的一次会议上,建议中止左醋美沙朵(levacetylmethadol,Orlaam)的上市权。委员会的此项决定是依据在电生理和临床研究中,发现该药有潜在的心律失常倾向及QTc间隙呈持续显著增加的报告。一项左醋美沙朵的风险-效益再评估未能确认它比现有的代用品有任何特殊优点,也未发现该药的治疗益处超过其引起的
At a meeting in March 2001, the Medicines Patent Commission of the European Medicines Agency (EMEA) proposed suspending the listing of levacetylmethadol (Orlaam). The committee’s decision is based on reports of potential arrhythmia and sustained and significant increases in QTc gap in electrophysiological and clinical studies. The risk-benefit reassessment of a left vinegar sand alone failed to confirm that it has any particular advantage over existing surrogates and does not find the drug’s therapeutic benefits outweighed its