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國藥現代(600420.SH):控股子公司獲得藥品補充申請批准通知書
格隆匯 07-30 16:20

格隆匯7月30日丨國藥現代(600420.SH)公佈,本公司控股子公司國藥一心製藥有限公司(簡稱國藥一心)收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,批准醋酸奧曲肽注射液在已有品規1ml:0.1mg(國藥準字H20041557,2021年11月通過一致性評價)的基礎上新增規格1ml:0.3mg並視同通過仿製藥質量與療效的一致性評價(簡稱一致性評價),核發藥品批准文號。

醋酸奧曲肽最初由諾華公司研發並於1988年首次上市,臨牀主要用於控制手術治療或放射治療不能充分控制病情的肢端肥大症患者的症狀、緩解與功能性胃腸胰腺(GEP)內分泌腫瘤有關的症狀、預防胰腺手術後併發症、肝硬化患者胃-食管靜脈曲張所致出血的緊急治療等。

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