中國生物製藥(01177.HK)X射線造影劑“碘帕醇注射液”獲藥品註冊批件
格隆匯 7 月 14日丨中國生物製藥(01177.HK)發佈公告,集團開發的X射線造影劑“碘帕醇注射液”(商品名稱:晴立達)已獲得國家藥品監督管理局頒發藥品註冊批件,且視同通過仿製藥質量和療效一致性評價。該產品獲批上市,將與集團現有的碘克沙醇注射液(商品名稱:晴立明)形成差異化產品組合,加強集團在造影劑領域的實力。
碘帕醇注射液為X射線非離子型碘造影劑,在患者接受X射線檢查中,能增強人體組織或器官顯影,提供臨牀可靠的診斷依據。碘帕醇注射液具有滲透壓低,局部以及全身耐受性好,對血管以及神經毒性低的特點。碘帕醇為醫保甲類品種,被多個臨牀指南推薦為一線使用的X射線造影劑。晴立達的上市,將為患者提供更多優質和安全的造影劑產品選擇。
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