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西點藥業(301130.SZ):玻璃酸鈉滴眼液獲得藥品補充申請批准通知書
格隆匯 02-24 17:29

格隆匯2月24日丨西點藥業(301130.SZ)公佈,公司於近日收到國家藥品監督管理局簽發的玻璃酸鈉滴眼液《藥品補充申請批准通知書》。經審查,本品此次申請事項符合藥品註冊的有關要求,同意按照《藥品上市後變更管理辦法(試行)》相關規定,批准本品上市許可持有人由“龍吉川(寧夏)醫藥科技發展有限公司(地址:寧夏回族自治區銀川市興慶區蘇銀產業園橫城花園二期56號)”變更為“吉林省西點藥業科技發展股份有限公司(地址:吉林省磐石經濟開發區西點大街777號)”,藥品批准文號不變。轉讓藥品的生產場地、處方、生產工藝、質量標準等與原藥品一致,不發生變更。轉讓的藥品在通過藥品生產質量管理規範符合性檢查後,符合產品放行要求的,可以上市銷售。

玻璃酸鈉滴眼液是一種人工淚液,主要成分玻璃酸鈉是一種線性多糖,它能與纖維連結蛋白結合,加速上皮細胞的黏附和延展,對眼睛具有多方面的保護和改善作用,用於治療伴隨下述疾患的角結膜上皮損傷:乾燥綜合徵(Sjogren's syndrome)、斯·約二氏綜合徵(Stevens-Johnson syndrome)、乾眼綜合徵(dryeye syndrome)等內因性疾患;手術後、藥物性、外傷、配戴隱形眼鏡等外因性疾患。

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