紅日藥業(300026.SZ):血必淨注射液新增適應症獲申請批件
格隆匯4月14日丨紅日藥業(300026.SZ)公佈,公司於近日收到國家藥品監督管理局下發的關於公司產品血必淨注射液新增適應症的《藥品補充申請批件》。
根據《中華人民共和國藥品管理法》有關規定,以及國家衞健委辦公廳國家中醫藥管理局辦公室2020年3月3日發佈的《新型冠狀病毒肺炎診療方案(試行第七版)》和疫情救治臨牀實踐,批准血必淨注射液説明書【功能主治】項增加“可用於新型冠狀病毒肺炎重型、危重型的全身炎症反應綜合徵或/和多臟器功能衰竭。”,【用法與用量】項增加“用於新型冠狀病毒肺炎:100ml加0.9%氯化鈉注射液250ml稀釋,一天2次。”。質量標準【功能主治】【用法與用量】項內容以及標籤內容與説明書相應內容保持一致。
血必淨注射液是目前國內唯一經國家藥品監督管理局批准的治療膿毒症和多臟器功能失常綜合徵的國家二類新藥,具有專利保護。2019年,國際危重症醫學領域頂級期刊《重症醫學》(CCM)雜誌發表血必淨注射液能降低重症肺炎病死率8.8%的重磅成果,標誌着該研究成果通過了國際同行專家嚴格審核並獲得一致認可。同年血必淨注射液通過國家醫保談判進入《2019版國家醫保藥品目錄》。
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