北大醫藥(000788.SZ):鹽酸莫西沙星注射液獲藥品註冊批件
格隆匯1月14日丨北大醫藥(000788.SZ)公佈,近日,公司收到國家藥品監督管理局核准簽發的《藥品註冊批件》。
藥品名稱:鹽酸莫西沙星注射液;英文名/拉丁名:Moxifloxacin Hydrochloride Injection;主要成份:鹽酸莫西沙星;劑型:注射劑;規格:20ml:0.4g(按C21H24FN3O4計);申請事項:國產藥品註冊;註冊分類:原化學藥品第5類;藥品有效期:12個月;藥品批准文號:國藥準字H20193431;藥品準文號有效期:至2024年12月29日。
鹽酸莫西沙星屬於第四代廣譜氟喹諾酮類抗感染藥物,與前三代抗感染藥物相比,對革蘭氏陽性菌、革蘭氏陰性菌、厭氧菌等常見病原菌的抗菌活性更強,同時具有安全性高、耐藥率低的優勢。鹽酸莫西沙星注射液主要用於治療成人(≥18歲)敏感細菌所引起的感染,包括社區獲得性肺炎、急性細菌性鼻竇炎、慢性支氣管炎急性發作、複雜性腹腔內感染、皮膚和皮膚組織感染等。
公司鹽酸莫西沙星注射液為《國家基本醫療保險、工傷保險和生育保險目錄(2019年版)》乙類藥品。
鹽酸莫西沙星因其較高的臨牀價值,未來市場前景良好,公司的鹽酸莫西沙星注射液獲批上市,進一步完善了公司在抗感染領域的產品結構,有利於提升公司在抗感染治療領域產品市場的競爭力,對公司未來業績的提升有積極作用。
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