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李氏大藥廠(00950.HK):Cetraxal® Plus已成功向香港藥劑業及毒藥管理局註冊
格隆匯 10-04 21:55

格隆匯10月4日丨李氏大藥廠(00950.HK)公吿,於2021年10月4日,公司全資附屬公司李氏大藥廠(香港)有限公司已於香港市場推出Laboratorios Salvat,S.A.("Salvat")特許授權的滴耳液產品Cetraxal® PlusCetraxal® Plus於2020年12月已成功向香港藥劑業及毒藥管理局註冊。

Cetraxal® Plus治療急性外耳道炎及伴有鼓膜置管的急性中耳炎。第III期臨牀試驗已於2021年1月在中國開展,計劃招募合共600名對象。迄今已為計劃招募575名對象。

Cetraxal® Plus由Laboratorios Salvat,S.A.開發,自2002年首次於西班牙獲批以來,環丙沙星0.3%加醋酸氟輕鬆0.025%(CIPRO+FLUO)耳液已在超過50個國家獲得審批,以10毫升瓶裝盛載的多次使用配方形式面市。此審批申請的單次使用小瓶及主體形式的CIPRO+FLUO耳液,亦在2016年4月於美國獲批,在2016年12月於加拿大獲批,並自2018年1月以來在多個歐洲國家獲批,用於治療因金黃葡萄球菌及銅綠假單胞菌所引起急性外耳道炎特定微生物易感菌株產生的發炎,以及年齡為6個月及以上的患者因金黃葡萄球菌、肺炎鏈球菌、流感嗜血桿菌、卡他莫拉菌及銅綠假單胞菌所引起伴有鼓膜置管的急性中耳炎特定微生物易感菌株產生的發炎。CIPRO+FLUO耳液單次使用配方的設計是不含防腐劑的便利滴耳液。

每個單次使用小瓶(0.25毫升)載有0.75毫克環丙沙星及0.0625毫克醋酸氟輕鬆。此複方乃中國首個含有喹諾酮抗生素及皮質類固醇的外用滴耳液。根據中國國家藥品監督管理局發佈的化學藥品註冊分類及申報資料要求,CetraxalPlus歸類為第5.1類藥品。

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