科倫藥業(002422.SZ):奧硝唑片通過仿製藥一致性評價
格隆匯1月14日丨科倫藥業(002422.SZ)公佈,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“奧硝唑片”的《藥品補充申請批件》。
藥品名稱:奧硝唑片;劑型:片劑;規格:0.25g;申請事項:國產藥品註冊一致性評價註冊分類:化學藥品;審批結論:經審查,本品視同通過仿製藥質量和療效一致性評價。
近日公司奧硝唑片國內首家通過一致性評價並獲得藥品註冊批件,主要用於治療和預防已證明或高度懷疑由敏感細菌引起的感染。
奧硝唑是繼甲硝唑、替硝唑之後的第三代硝基咪唑類藥物,臨牀廣泛用於治療由厭氧菌、阿米巴原蟲、賈滴蟲、毛滴蟲等感染引起的多種疾病。奧硝唑具有療效確切、適用人羣廣、依從性好、不良反應小等臨牀優勢,目前已被《抗菌藥物臨牀應用指導原則(2015年版)》和《膽道外科抗菌藥物規範化應用專家共識(2019版)》等國內權威指南或專家共識廣泛推薦使用。奧硝唑片為國家醫保乙類藥物,2018年中國銷售額2.69億元。
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