康哲藥業(00867.HK):地西泮鼻噴霧劑中國註冊上市許可申請已獲受理
格隆匯7月5日丨康哲藥業(00867.HK)公佈,地西泮鼻噴霧劑註冊上市許可申請已於2021年7月5日獲得中國國家藥品監督管理局受理。作為一種急性治療藥物,產品用於治療六歲及以上癲癇患者的間歇性、刻板性癲癇頻繁發作活動(即癲癇叢集性發作、急性反覆性癲癇發作),這種發作不同於患者通常的癲癇發作模式。產品已獲得美國食品藥品監督管理局上市批准。
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