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*ST龍津(002750.SZ):獲得非布司他片的藥品補充申請批準通知書
格隆匯 03-05 17:47

格隆匯3月5日丨*ST龍津(002750.SZ)公佈,公司近日收到國家藥品監督管理局覈準簽發的《藥品補充申請批準通知書》(通知書編號:2025B00871、2025B00868)。獲批準非布司他片上市許可持有人由“蕪湖楊燕製藥有限公司”變更爲“昆明龍津藥業股份有限公司”,藥品批準文號不變。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。

非布司他片適用於痛風患者高尿酸血癥的長期治療,不推薦用於無臨牀症狀的高尿酸血癥,該產品最早由日本帝人制藥株式會社研製開發,其活性成份非布司他是一種黃嘌呤氧化酶抑制劑,通過抑制尿酸合成降低血清尿酸濃度,具有高度選擇性,作用強於別嘌醇。

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