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國藥監局:兩款新冠藥附條件獲批上市
阿思達克 01-30 07:24
國家藥監局根據《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,附條件批准兩款新冠感染治療藥物上市,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。 兩款新藥分別為海南先聲藥業有限公司申報的1類創新藥先諾特韋片/利托那韋片組合包裝,商品名稱為先諾欣,以及君實生物(01877.HK)控股子公司上海旺實生物醫藥科技有限公司申報的1類創新藥氫溴酸氘瑞米德韋片,商品名稱為民得維。 兩款藥物均為口服小分子新冠病毒感染治療藥物,用於治療輕中度新型冠狀病毒感染的成年患者。
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