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健友股份(603707.SH):子公司的格隆溴銨注射液獲批在美上市
格隆匯 07-07 18:41

格隆匯7月7日丨健友股份(603707.SH)公吿,公司子公司香港健友實業有限公司於近日收到美國食品藥品監督管理局簽發的格隆溴銨注射液,0.2 mg/mL、0.4 mg/ 2mL、1 mg/ 5mL和4 mg/ 20mL(ANDA號:212802)批准信。

格隆溴銨是一種抗膽鹼能藥物,其注射液是由A.H.RobinsCompany公司最初研究,1975年02月在美國批准上市,商品名為Robinul®,臨牀上用於預防新斯的明和吡啶斯的明這類能逆轉非去極化肌松劑神經肌肉阻滯的膽鹼酯酶抑制劑的外周毒蕈鹼樣作用(如心動過緩和腺體過度分泌);作為手術前抗毒蕈鹼類藥以減少唾液、咽及支氣管腺體分泌,降低胃內容物酸度;作為術前或術中的抗毒蕈鹼劑減弱或預防琥珀膽鹼使用或心臟迷走神經反射相關的術中心動過緩;當需要迅速發揮抗膽鹼作用或口服藥物不能耐受時,用於成人消化性潰瘍的輔助治療。

新批准產品近期將安排在美國上市銷售,有望對公司經營業績產生積極影響。

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