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萊美藥業(300006.SZ):取得注射用艾司奧美拉唑鈉的藥品註冊證書
格隆匯 12-08 17:27

格隆匯 12 月 8日丨萊美藥業(300006.SZ)公佈,近日,公司收到國家藥品監督管理局核准簽發的注射用艾司奧美拉唑鈉《藥品註冊證書》。

審批結論: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,批准註冊,發給藥品註冊證書。生產工藝、質量標準、説明書及標籤按所附執行。同時批准重慶萊美隆宇藥業有限公司生產的艾司奧美拉唑鈉在該製劑中使用,質量標準、包裝標籤及生產工藝信息表照所附執行。

艾司奧美拉唑是奧美拉唑的單一左旋異構體,具有快速、持久穩定抑酸特點,該藥最先由瑞典AstraZeneca AB公司研製,2000年口服劑型在瑞典上市,2003年注射劑型上市。目前國內已上市主要劑型有腸溶片、腸溶膠囊及注射劑。注射用艾司奧美拉唑鈉主要用於:1作為當口服療法不適用時,胃食管反流病的替代療法2用於口服療法不適用的急性胃或十二指腸潰瘍出血的低危患者(胃鏡下Forrest分級IIc-III);3用於降低成人胃和十二指腸潰瘍出血內鏡治療後再出血風險;4預防重症患者應激性潰瘍出血。

根據米內網數據顯示注射用艾司奧美拉唑鈉2017年、2018年、2019年在中國城市公立醫院終端市場銷售額分別為21.86億、23.67億、26.83億,近三年銷售額均穩步增長。

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