美諾華(603538.SH):控股子公司米氮平原料藥通過CDE技術審評
格隆匯3月15日丨美諾華(603538.SH)公佈,近日,公司控股子公司浙江燎原米氮平原料藥通過國家藥品監督管理局藥品審評中心(簡稱“CDE”)技術審評,在CDE原料藥、藥用輔料和藥包材登記信息公示平台上顯示登記號轉為“A”狀態。
藥品適應症:適用於抑鬱症治療。可改善抑鬱症狀以及患者睡眠結構,提高睡眠質量;較少引起性功能障礙,提高患者依從性;使用方便、較少的藥物相互作用、耐受性好。
藥理作用:米氮平具有四環結構,屬於哌嗪-氮卓類化合物,是H1受體的強效拮抗劑,這種屬性可產生鎮靜作用。
截至2020年12月31日,米氮平原料藥全球銷售量為68.27噸,其中:歐洲市場銷售量41.87噸,北美洲市場銷售量11.03噸,拉丁美洲市場銷售量4.00噸。
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