國家藥監局批准輝瑞(PFE.US)新冠治療藥物Paxlovid進口註冊
國家藥監局於上周五(11日)根據《藥品管理法》相關規定,按照藥品特別審批程序,進行應急審評審批,附條件批准輝瑞(PFE.US)新冠病毒治療藥物奈瑪特韋片/利托那韋片組合包裝(即Paxlovid)進口註冊。
Paxlovid為口服小分子新冠病毒治療藥物,用於治療成人伴有進展為重症高風險因素的輕至中度新冠肺炎患者,例如伴有高齡、慢性腎臟疾病、糖尿病、心血管疾病、慢性肺病等重症高風險因素的患者。
國家藥監局要求上市許可持有人繼續開展相關研究工作,限期完成附條件的要求,及時提交後續研究結果。
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