人福醫藥(600079.SH):咪達唑侖注射液獲得法國國家藥品和健康產品安全局上市許可
格隆匯6月30日丨人福醫藥(600079.SH)公佈,控股子公司宜昌人福藥業有限責任公司(簡稱“宜昌人福”,公司持有其80%的股權)收到法國國家藥品和健康產品安全局(ANSM)覈準簽發的咪達唑侖注射液的上市許可批準信。咪達唑侖注射液獲得法國國家藥品和健康產品安全局(ANSM)的上市許可,被批準的適應症包括:1)在診斷或治療性操作前後及過程中進行清醒鎮靜(無論是否聯合局部麻醉);2)成人麻醉誘導前的術前用藥、麻醉誘導、以及與其他麻醉劑作爲鎮靜藥物聯合使用;兒童麻醉誘導前的術前用藥;3)重症監護病房(ICU)中的鎮靜。宜昌人福於2023年12月以DCP(DecentralizedProcedure)程序提交咪達唑侖注射液上市許可申請並獲得受理,現獲得法國國家藥品和健康產品安全局(ANSM)上市批準,有效期五年,本項目累計研發投入約爲800萬元人民幣。根據IQVIA數據統計,2024年咪達唑侖注射液在法國市場的年銷售額約爲3,300萬美元,主要生產廠商包括NEURAXPHARM、NORDICGROUP等。
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