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四環醫藥(00460.HK):鹽酸莫西沙星氯化鈉注射液獲得藥品註冊證書
格隆匯 07-09 06:33

格隆匯7月9日丨四環醫藥(00460.HK)發佈公吿,集團開發的鹽酸莫西沙星氯化鈉注射液獲得中國國家藥品監督管理局頒發的《藥品註冊證書》。該產品規格為250ml:鹽酸莫西沙星(按C21H24FN3O4計)0.4g與氯化鈉2.0g。

該產品適用於治療成人敏感細菌所引起的下列感染:(1)急性細菌性鼻竇炎:由肺炎鏈球菌、流感嗜血桿菌或卡他莫拉菌引起;(2)慢性支氣管炎急性發作:由肺炎鏈球菌、流感嗜血桿菌、副流感嗜血桿菌、肺炎克雷伯菌、甲氧西林敏感的金黃色葡萄球菌或卡他莫拉菌引起;(3)社區獲得性肺炎:由肺炎鏈球菌(包括多藥耐藥株)、流感嗜血桿菌、卡他莫拉菌、甲氧西林敏感的金黃色葡萄球菌、肺炎克雷伯菌、肺炎支原體或肺炎衣原體引起;(4)非複雜性皮膚和皮膚組織感染:由甲氧西林敏感的金黃色葡萄球菌或化膿性鏈球菌引起;(5)複雜性皮膚和皮膚組織感染:由甲氧西林敏感的金黃色葡萄球菌、大腸埃希氏菌、肺炎克雷伯氏菌或陰溝腸桿菌引起;(6)複雜性腹腔內感染:由大腸桿菌、脆弱類桿菌、咽峽炎鏈球菌、星座鏈球菌、糞腸球菌、變形桿菌、產氣莢膜梭菌、多形類桿菌或消化鏈球菌屬等引起,包括腹腔膿腫;及(7)鼠疫,包括成人因鼠疫耶爾森氏桿菌(Y.pestis)引起的肺鼠疫和敗血性鼠疫。

抗感染領域為集團重點佈局領域,本次該產品獲頒《藥品註冊證書》,將進一步惠及廣大患者,同時為集團的抗感染藥物管線再添一重磅品種,利於該藥品未來的市場銷售和市場競爭,對集團的經營業績產生積極影響。

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