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魯抗醫藥(600789.SH):阿莫西林膠囊通過仿製藥一致性評價
格隆匯 11-07 19:35

格隆匯11月7日丨魯抗醫藥(600789.SH)公佈,近日,公司收到國家藥品監督管理局頒發的關於阿莫西林膠囊的《藥品補充申請批件》(批件號:2019B04059、2019B04060),該藥品通過仿製藥質量和療效一致性評價。

阿莫西林屬於青黴素類廣譜β-內酰胺類抗生素,對大多數致病的革蘭氏陽性菌及革蘭氏陰性菌均有強大的抑菌和殺菌作用,臨牀廣泛用於治療敏感菌所致上呼吸道感染、泌尿生殖道感染、皮膚軟組織感染、下呼吸道感染以及與其他藥物聯用根除幽門螺桿菌,且輕中度腎病患者無需調整劑量。被《中國成人社區獲得性肺炎診斷和治療(2016年版)》、《抗菌藥物臨牀應用指導原則(2015年版)》等權威指南和共識廣泛推薦。阿莫西林膠囊已進入甲類醫保和2018年國家基藥目錄。2018年,阿莫西林膠囊國內銷售額約為24億元人民幣,公司該產品的銷售收入為1.46億元。

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