科倫藥業(002422.SZ):複方氨基酸(15AA-Ⅱ)/葡萄糖(10%)電解質注射液獲得藥品註冊證書
格隆匯1月29日丨科倫藥業(002422.SZ)宣佈,公司獲悉國家藥品監督管理局於今日發佈信息,公司的“複方氨基酸(15AA-Ⅱ)/葡萄糖(10%)電解質注射液”獲得《藥品註冊證書》。
複方氨基酸(15AA-Ⅱ)/葡萄糖(10%)電解質注射液為百特開發的氨基酸葡萄糖即用型腸外營養雙室袋,1997年在美國獲批,適用於腸內營養不可行、不足或禁忌時,為需要腸外營養的患者提供能量、蛋白質和電解質。目前該產品原研尚未進口,公司為國內首家批准上市。
腸外營養在危重、嚴重創傷等患者的救治中具有重要作用,可快速提供機體所需營養物質、促進患者康復、改善疾病預後。之前公司已獲批上市9個腸外營養新產品,覆蓋單袋(瓶)、雙室袋、三腔袋包裝形式,差異化的產品配方可滿足不同類型(肝功能受損、圍手術期、危重症等)和不同能量需求患者的營養治療。
複方氨基酸(15AA-Ⅱ)/葡萄糖(10%)電解質注射液的獲批使公司腸外營養產品的上市數量已達到10個,其配方科學合理,適用人羣廣(可用於兒童和成人),且給藥方式靈活(可外周或中心靜脈給藥),可滿足多種疾病狀態患者的用藥需求。該產品獲批,將進一步擴大公司腸外營養產品的使用人羣,且隨着本品及後續系列品種的續貫獲批,公司將成為品類齊全、國內領先的腸外營養專業供應商。
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