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福安藥業(300194.SZ)子公司收到注射用氨曲南一致性評價受理通知書
格隆匯 01-03 16:09

格隆匯1月3日丨福安藥業(300194.SZ)公佈,公司子公司福安藥業集團慶餘堂製藥有限公司於近日收到國家藥品監督管理局下發的注射用氨曲南一致性評價受理通知書。藥品名稱為注射用氨曲南;規格為0.5g/1.0g/2.0g;申請事項:報國家藥品監督管理局審批的補充申請事項:修改藥品註冊標準;進口藥品、國內生產的注射劑、眼用製劑、氣霧劑、粉霧劑、噴霧劑變更直接接觸藥品的包裝材料或者容器;使用新型直接接觸藥品的包裝材料或者容器;其他;結論:經審查,決定予以受理。

注射用氨曲南主要適用治療敏感需氧革蘭陰性菌所致的各種感染。

注射用氨曲南申報一致性評價獲受理,標誌着該品種一致性評價工作進入了審評階段,公司將積極推進後續相關工作,如通過一致性評價將增加該產品市場競爭力。

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