白雲山(00874.HK):子公司藥品通過仿製藥一致性評價
格隆匯6月18日丨白雲山(00874.HK公佈,2024年6月17日,公司全資子公司廣州白雲山明興製藥有限公司(以下簡稱"明興藥業")收到國家藥品監督管理局簽發的《藥品補充申請批准通知書》,鹽酸多巴胺注射液(規格:5ml:100mg)已通過仿製藥質量和療效一致性評價。
明興藥業的鹽酸多巴胺注射液現有2m:20mg和5ml:100mg兩個規格,其中2ml:20mg於1982年獲批生產,5ml:100mg為新增加的規格,明興藥業於2023年4月20日向國家藥品監督管理局遞交一致性評價申請,於2023年4月28日獲得受理。
鹽酸多巴胺注射液適用於心肌梗死、創傷、內毒素敗血症、心臟手術、腎功能衰竭、充血性心力衰竭等引起的休克綜合徵;補充血容量後休克仍不能糾正者,尤其有少尿及周圍血管阻力正常或較低的休克。由於本品可增加心排血量,也用於洋地黃和利尿劑無效的心功能不全。
目前中國境內上市的鹽酸多巴胺注射液的生產廠家還包括上海禾豐製藥有限公司、遠大醫藥(中國)有限公司等。根據米內網數據顯示,2023年鹽酸多巴胺注射液在中國公立醫院的銷售額為人民幣33,838萬元。
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