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中關村(000931.SZ):下屬公司山東華素琥珀酸美託洛爾原料藥獲批上市
格隆匯 08-22 16:00

格隆匯8月22日丨中關村(000931.SZ)公佈,近日,公司下屬公司山東華素製藥有限公司(簡稱:山東華素)“琥珀酸美託洛爾原料藥”於近日通過國家藥品監督管理局藥品審評中心(簡稱:CDE)技術審評,並獲得國家藥品監督管理局核准簽發的《化學原料藥上市申請批准通知書》。

美託洛爾最早於1969年在瑞典的Hassle實驗室研發成功,是一種選擇性β1腎上腺素受體阻滯劑,通過藥物與β1受體結合,拮抗神經遞質和兒茶酚胺對β受體的激動作用,提高血管平滑肌對血管介質的敏感性,抑制腎素的分泌。臨牀上用於治療高血壓、心絞痛、心力衰竭。目前CDE原輔包登記信息平台顯示,琥珀酸美託洛爾原料藥共16家,12家狀態為“A”,4家狀態為“I”。國家藥監局藥品信息檢索顯示琥珀酸美託洛爾有30個製劑批文。

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