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中關村(000931.SZ):北京華素的氨酚羥考酮片上市許可申請獲受理
格隆匯 12-18 16:23

格隆匯12月18日丨中關村(000931.SZ)公佈,公司下屬公司北京華素製藥股份有限公司(以下簡稱:北京華素)於近日收到國家藥品監督管理局簽發的《受理通知書》,氨酚羥考酮片(規格:每片含鹽酸羥考酮5mg和對乙酰氨基酚325mg)上市許可申請獲得受理。

氨酚羥考酮片適用於嚴重程度足以需要使用阿片類鎮痛劑且缺乏其他替代治療的中、重度疼痛的治療。羥考酮是一種對阿片受體具有相對選擇性的全阿片激動劑,通過作用於整個大腦和脊髓中的內源性具有類阿片活性的化合物中樞神經系統特異性阿片受體而發揮鎮痛作用;對乙酰氨基酚鎮痛特性被認為與中樞作用有關。本品原研未在中國境內上市,目前境內已有3家仿製藥獲批上市,北京華素是第4家提交本品上市許可申請的境內企業。

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