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仟源醫藥(300254.SZ):磷黴素氨丁三醇散通過一致性評價
格隆匯 07-27 16:55

格隆匯 7 月 27日丨仟源醫藥(300254.SZ)公佈,公司近日收到了國家藥品監督管理局核准簽發的“磷黴素氨丁三醇散”的《藥品補充申請批准通知書》,該藥品通過仿製藥質量與療效一致性評價(“一致性評價”)。

藥品通用名稱:磷黴素氨丁三醇散;劑型:散劑;規格:3g(300萬單位)(按C3H7O4P計);審查結論主要內容:根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發[2015]44號)和《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)的規定,經審查,本品視同通過仿製藥質量和療效一致性評價。

“磷黴素氨丁三醇散”適用於急性單純性尿路感染、無症狀菌尿症以及預防外科手術或下尿路診斷過程引起的感染。該品種現已列入國家醫保目錄和國家基本藥物目錄。

根據國家相關政策,通過一致性評價的藥品品種,在藥品招標、醫保支付層面等方面獲得一定支持。因此公司“磷黴素氨丁三醇散”通過一致性評價,有利於提高產品市場競爭力,並對公司的經營產生積極的影響。

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