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興齊眼藥(300573.SZ)收到鹽酸莫西沙星滴眼液藥品註冊受理通知書
格隆匯 11-18 16:35

格隆匯11月18日丨興齊眼藥(300573.SZ)公佈,公司於近日收到國家藥品監督管理局下發的藥品註冊受理通知書。

產品名稱:鹽酸莫西沙星滴眼液;根據《中華人民共和國行政許可法》第三十二條的規定,經審查,決定予以受理。受理號:CYHS1900780國。

鹽酸莫西沙星滴眼液公司的研發代碼為SQ-735,申報的臨牀適應症為:用於治療下列敏感微生物(革蘭氏陽性菌:棒狀桿菌屬、藤黃微球菌、金黃色葡萄球菌、表皮葡萄球菌、溶血性葡萄球菌、人葡萄球菌、瓦氏葡萄球菌、肺炎鏈球菌、草綠色鏈球菌羣;革蘭氏陰性菌:魯氏不動桿菌、流感嗜血桿菌、副流感嗜血桿菌、鮑氏不動桿菌、瓊氏不動桿菌、嗜麥芽窄食單胞菌、金黃桿菌屬;其它微生物:沙眼衣原體)引起的細菌性結膜炎。

根據國家相關注冊法規規定,上述藥品已獲得註冊申請受理,報送國家藥品監督管理局藥品審評中心進行審評審批。

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