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國藥現代(600420.SH):咪達唑侖注射液獲得藥品註冊證書
格隆匯 04-11 18:16

格隆匯4月11日丨國藥現代(600420.SH)公佈古,近日,公司全資子公司國工有限收到國家藥品監督管理局核准簽發的咪達唑侖注射液(1ml:5mg)藥品註冊證書。經審查,本品符合藥品註冊的有關要求,批准註冊。根據國家相關政策,國工有限咪達唑侖注射液按新4類批准生產可視同通過一致性評價。

國工有限的咪達唑侖原料藥同時通過關聯審評。咪達唑侖注射液主要用於診斷、治療、內窺鏡手術之前或操作過程中的鎮靜/抗焦慮/記憶缺失。咪達唑侖注射液原研企業為Roche(美國),最早於1985年在美國批准上市。根據CDE網站顯示,目前該藥品通過/視同通過一致性評價的企業還有江蘇恩華藥業股份有限公司及宜昌人福藥業有限責任公司。根據米內網數據庫顯示,咪達唑侖注射液2020年城市公立醫院銷售額為4.91億元,2021年上半年銷售額為2.78億元。

截至目前國工有限在該項目累計投入研發費用約人民幣348.86萬元(未經審計)。

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