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信立泰(002294.SZ):左乙拉西坦片(0.25g)通過一致性評價
格隆匯 11-01 20:38

格隆匯11月1日丨信立泰(002294.SZ)公佈,近日,公司收到國家藥品監督管理局核准簽發的左乙拉西坦片(0.25g)的《藥品補充申請批件》,該藥品通過仿製藥質量和療效一致性評價。

藥品通用名稱:左乙拉西坦片;劑型:片劑;規格:0.25g;註冊分類:化學藥品;原藥品批准文號:國藥準字H20143163;審批結論:根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發〔2015〕44號)和《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)的規定,經審查,本品通過仿製藥質量和療效一致性評價。

左乙拉西坦片(信同安®)用於成人及4歲以上兒童癲癇患者部分性發作(伴或不伴繼發性全面性發作)的治療,成人及16歲以上青少年癲癇患者全面性強直陣攣發作的加用治療。左乙拉西坦片屬於國家醫保乙類產品,國家組織藥品集中採購品種之一。

左乙拉西坦是一種具有全新抗癲癇作用機制的新型抗癲癇藥物,其最早由比利時UCB公司研製。根據公開信息,國內已通過或視同通過一致性評價的左乙拉西坦片劑生產企業包括浙江京新藥業股份有限公司、浙江普洛康裕製藥有限公司、華潤賽科藥業有限責任公司。公司擁有左乙拉西坦片、左乙拉西坦緩釋片兩種劑型並均通過一致性評價,為患者提供更多的選擇方案,提高患者長期用藥的依從性,提升產品的綜合競爭力,對公司的業績提升產生積極的影響。

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