海思科(002653.SZ):獲得脂肪乳氨基酸(17)葡萄糖(11%)注射液補充申請批准通知書
格隆匯7月21日丨海思科(002653.SZ)公佈,公司全資子公司遼寧海思科製藥有限公司於近日收到國家藥品監督管理局下發的《藥品註冊證書》,藥品名稱為脂肪乳氨基酸(17)葡萄糖(11%)注射液。
審評結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准本品增加900ml[脂肪乳注射液(20%) 159ml;複方氨基酸注射液(17) 188ml;葡萄糖注射液(11%) 553ml]規格,核發藥品批准文號。
此次增加的900ml規格是對本品現有規格1440ml的有效補充,可以滿足臨牀上對於小規格三腔袋腸外營養產品的需求。與原規格相比,900ml規格可避免臨牀使用中可能出現的能量過剩,而且更適合作為補充性腸外營養(SPN)支持,便於臨牀上靈活地進行個性化營養支持並減少浪費和降低醫療成本。
據米內網數據顯示,脂肪乳氨基酸(17)葡萄糖(11%)注射液2020年在中國城市公立及縣級公立醫院銷售額超過24億元人民幣。
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