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科倫藥業(002422.SZ):阿莫西林顆粒通過一致性評價
格隆匯 11-26 15:44

格隆匯11月26日丨科倫藥業(002422.SZ)公佈,公司子公司湖南科倫製藥有限公司於近日獲得國家藥品監督管理局核准簽發的化學藥品“阿莫西林顆粒”的《藥品補充申請批件》。

藥品名稱:阿莫西林顆粒;劑型:顆粒劑;規格:0.125g(按C16H19N3O5S計);申請事項:國產藥品註冊一致性評價;註冊分類:化學藥品;申請人:湖南科倫製藥有限公司;審批結論:經審查,本品通過仿製藥質量和療效一致性評價。

近日公司的阿莫西林顆粒已通過一致性評價並獲得藥品註冊批件,該品種主要用於敏感菌(不產β內酰胺酶菌株)所致的成人與兒童的感染性疾病。

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、下呼吸道感染、泌尿生殖道感染、皮膚軟組織感染以及與其他藥物聯用根除幽門螺桿菌,且輕中度腎功能不全患者無需調整劑量。《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使用。目前阿莫西林國內已有膠囊、片劑、顆粒劑、分散片等劑型,其中阿莫西林顆粒更適用於兒童與吞嚥困難的患者,並已進入甲類醫保和2018年國家基藥目錄。

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