珍寶島(603567.SH):獲得靈芪加口服液的藥品補充申請批准通知書
格隆匯11月3日丨珍寶島(603567.SH)公佈,近日,黑龍江珍寶島藥業股份有限公司獲得國家藥品監督管理局下發的《藥品補充申請批准通知書》。靈芪加口服液獲批准如下補充申請事項:
1.變更藥品規格。2.變更製劑處方中的輔料。3.變更藥品註冊標準。【規格】由“每支裝10ml”修訂為“每1ml相當於飲片0.65g”。“每支裝10ml”列入【包裝】項下。【有效期】18個月。藥品註冊標準執行國家食品藥品監督管理總局國家藥品標準(編號:WS-11254(ZD-1254)-2002-2015Z)有關規定,其中修訂以下內容:【製法】中將“加入蔗糖100g”修訂為“加入三氯蔗糖0.9g”。【檢查】中相對密度由“應不低於1.05”修訂為“應不低於1.01”。【規格】修訂為“每1ml相當於飲片0.65g”。説明書、標籤應符合有關規定。其中,【成份】中輔料將“蔗糖”修訂為“三氯蔗糖”。【規格】修訂為“每1毫升相當於飲片0.65克”。【有效期】18個月。
靈芪加口服液是珍寶島的獨家產品。該產品為中藥口服制劑,由靈芝、黃芪、刺五加三味中藥組成,具有扶正固本,滋補強壯,安神鎮靜的功效。用於心脾兩虛所致的心悸失眠,倦怠乏力,食少便溏。此次補充申請研發總投入約54萬元。
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