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京新藥業(002020.SZ)獲得左乙拉西坦口服溶液的藥品註冊批件
格隆匯 12-02 18:16

格隆匯12月2日丨京新藥業(002020.SZ)公佈,2019年12月2日,公司收到國家藥品監督管理局批准簽發的左乙拉西坦口服溶液【規格150ml:15g(10%)】藥品註冊批件,批准文號為國藥準字H20193334,批准文號有效期至2024年11月17日。

左乙拉西坦口服溶液用於成人、兒童及1個月以上嬰幼兒癲癇患者部分性發作的加用治療。

左乙拉西坦是比利時UCB公司開發研製的一種新型抗癲癇藥物,2006年11月獲得SFDA批准進口中國。公司現有左乙拉西坦片(0.25g)已於2018年5月國內首家通過仿製藥質量和療效一致性評價。公司此次獲得左乙拉西坦口服溶液的藥品註冊批件,將進一步豐富公司精神神經系列產品和劑型,有利於提升公司精神神經系列產品的市場競爭力,對公司未來經營業績產生積極的影響。

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