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普利製藥(300630.SZ):左乙拉西坦注射液獲得加拿大批准通知
格隆匯 05-18 19:41

格隆匯5月18日丨普利製藥(300630.SZ)公佈,公司於近日收到加拿大衞生部簽發的左乙拉西坦注射液的批准通知。

左乙拉西坦注射液是抗癲癇藥物,主要用於患者以下症狀發作時的輔助治療:4歲及以上兒童和成人癲癇患者的部分性癲癇發作的加用治療;12歲及以上青少年和成人癲癇患者的肌陣攣性癲癇發作的加用治療;12歲及以上兒童和成人患有特發性全身性癲癇發作的原發性強直陣攣發作的加用治療。

普利製藥的左乙拉西坦注射液成功研發後進行了多國註冊申報,已分別於2016年11月獲得德國上市許可,2016年12月獲得荷蘭上市許可,2017年3月獲得美國上市許可,2019年9月獲得英國上市許可,2020年8月獲得中國國家藥品監督管理局的藥品註冊批件,2020年11月獲得西班牙藥品醫療器械管理局上市許可,2021年6月獲得泰國食品藥品管理局上市許可,2021年10月獲得馬來西亞藥品管理局的批准通知。

近日,公司收到的加拿大衞生部的批准通知,標誌着普利製藥具備了在加拿大銷售左乙拉西坦注射液的資格,將對公司拓展加拿大市場帶來積極影響。

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