石藥集團(01093.HK)旗下"注射用艾司奧美拉唑鈉"獲藥品註冊批件
格隆匯4月22日丨石藥集團(01093.HK)宣佈,集團附屬公司石藥集團歐意藥業有限公司開發的"注射用艾司奧美拉唑鈉(40mg)"("該產品")已獲得中華人民共和國國家藥品監督管理局頒發的藥品註冊批件,並視同通過仿製藥質量和療效一致性評價。
艾司奧美拉唑為胃壁細胞中質子泵的特異性抑制劑,通過特異性的質子泵抑制作用減少胃酸分泌,對基礎胃酸分泌和受刺激後的胃酸分泌均產生抑制。該產品的適應症為:(i)作為當口服療法不適用時,胃食管反流病的替代療法;(ii)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(Forrest分級IIc-III);(iii)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;及(iv)預防重症患者應激性潰瘍出血。
該產品的獲批將進一步豐富集團於消化系統疾病領域的產品線。
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