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興齊眼藥(300573.SZ):收到藥品註冊受理通知書 涉及左氧氟沙星滴眼液
格隆匯 03-22 20:19

格隆匯 3 月 22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

申請事項境內生產藥品補充申請;產品名稱:左氧氟沙星滴眼液;根據《中華人民共和國行政許可法》三十二條的規定,審查,決定予以受理。受理號CYHB2101037

左氧氟沙星滴眼液公司研發代碼為SQ-716,申報的臨牀適應症為:用於治療眼瞼炎、瞼腺炎、淚囊炎、結膜炎、瞼板腺炎、角膜炎以及用於眼科圍手術期的無菌化療法。此次申請是在公司左氧氟沙星滴眼液(國藥準字H20203593)基礎上進行的補充申請。

目前,國內已有二十多家左氧氟沙星滴眼液上市。原研藥品由日本參天製藥株式會社生產,為多劑量眼用製劑,現已進入中國。左氧氟沙星滴眼液為國家醫保目錄甲類產品。

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