中关村(000931.SZ):氨酚羟考酮片上市许可申请获得受理

智通财经
Dec 18, 2024

智通财经APP讯,中关村(000931.SZ)发布公告,公司下属公司北京华素制药股份有限公司(以下简称:北京华素)于近日收到国家药品监督管理局签发的《受理通知书》,氨酚羟考酮片(规格:每片含盐酸羟考酮5mg和对乙酰氨基酚325mg)上市许可申请获得受理。

据悉,氨酚羟考酮片适用于严重程度足以需要使用阿片类镇痛剂且缺乏其他替代治疗的中、重度疼痛的治疗。羟考酮是一种对阿片受体具有相对选择性的全阿片激动剂,通过作用于整个大脑和脊髓中的内源性具有类阿片活性的化合物中枢神经系统特异性阿片受体而发挥镇痛作用;对乙酰氨基酚镇痛特性被认为与中枢作用有关。本品原研未在中国境内上市,目前境内已有3家仿制药获批上市,北京华素是第4家提交本品上市许可申请的境内企业。

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