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健民集團(600976.SH):抗癲癇藥左乙拉西坦口服溶液獲藥品註冊批件
格隆匯 04-21 17:32

格隆匯4月21日丨健民集團(600976.SH)公佈,近日,公司全資子公司健民集團葉開泰國藥(隨州)有限公司(以下簡稱“葉開泰國藥”)收到國家藥品監督管理局核准簽發的左乙拉西坦口服溶液《藥品註冊批件》。

左乙拉西坦口服溶液適用於成人、兒童及一個月以上嬰幼兒癲癇患者部分性發作的加用治療。抗癲癇的藥物種類較多,常用藥有丙戊酸鈉、左乙拉西坦、奧卡西平等。據國家藥品監督管理局數據顯示,已上市的左乙拉西坦有片劑、緩釋片、口服溶液、注射用濃溶液等4個劑型,各種劑型包括原研在內的生產廠家13個(不含葉開泰國藥及原料藥生產廠家)。據米內網數據顯示,2018年全國城市公立醫院抗癲癇藥銷售總額為49.14億元,其中左乙拉西坦以10.39億元的銷售額位列第二。截至目前,該藥品累計研發投入共計1982.09萬元。本藥品目前的審批階段為批准生產。

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