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白雲山(00874.HK)收到普盧利沙星藥品再註冊批件
格隆匯 10-14 17:06

格隆匯10月14日丨白雲山(00874.HK)公佈,公司分公司廣州白雲山醫藥集團股份有限公司白雲山化學制藥廠近日收到廣東省藥品監督管理局核准簽發的《藥品再註冊批件》。

經審查,同意普盧利沙星再註冊。由於本品長期未生產,恢復生產時,須向省藥監局提出現場檢查申請,經省藥監局現場檢查並抽驗一批產品合格後,方可上市銷售。

據悉,普盧利沙星為化學制藥廠原料藥品種,2008年3月18日由化學制藥廠獲得新藥證書,並取得批准文號,屬化學藥品3.1類新藥。普盧利沙星主要適用於對普盧利沙星敏感的淺表性皮膚感染,深層皮膚感染症;外傷和燙傷以及手術創傷等淺表性繼發性感染;急性上呼吸道感染、慢性呼吸系統疾病的繼發性感染和肺炎等。目前化學制藥廠未生產和銷售該原料藥。根據藥智網數據,除化學制藥廠外,國內共有9家企業生產該原料藥,公司亦無法從公開數據查詢到市場上其他企業該原料藥的生產和銷售情況。

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