普利製藥(300630.SZ):左乙拉西坦注射用濃溶液獲得藥品註冊批件
格隆匯 8 月 17日丨普利製藥(300630.SZ)公佈,近日獲得國家藥品監督管理局簽發的左乙拉西坦注射用濃溶液生產批件,現將相關情況公告如下:
一、藥品基本情況
(一)藥品名稱:左乙拉西坦注射用濃溶液
(二)劑型:注射劑
(三)規格:5ml:500mg
(四)註冊分類:化學藥品4類
(五)批准文號:國藥準字H20203415
(六)申請人及上市許可持有人:海南普利製藥股份有限公司
二、藥品的其他相關情況
左乙拉西坦注射用濃溶液是抗癲癇藥物,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)的加用治療。本品可在患者暫時無法應用口服制劑時替代給藥。
公司左乙拉西坦注射用濃溶液繼美國、荷蘭、德國、英國批准上市後,又於近日取得國家藥品監督管理局上市許可。公司左乙拉西坦注射用濃溶液其他市場的註冊工作仍在持續推進中。
公司會盡快啟動國內上市銷售工作,該品種的國內獲批將對公司拓展市場帶來積極影響。
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