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科倫藥業(002422.SZ):泊沙康唑口服混懸液國內首仿獲批
格隆匯 03-03 16:54

格隆匯3月3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的化學藥品“泊沙康唑口服混懸液”於近日獲得國家藥品監督管理局的藥品註冊批准。

泊沙康唑為默克研發的三唑類抗真菌藥,2003年美國首獲批口服混懸液,後相繼獲批腸溶片和注射劑。泊沙康唑口服混懸液2013年國內獲批進口,用於預防侵襲性麴黴菌和念珠菌感染,以及治療口咽念珠菌病。

目前公司已有系列抗感染產品獲批或通過一致性評價,且劑型和包裝形式多樣,已在感染性疾病領域形成優勢產品集羣,可為臨牀提供針對各種細菌、真菌、病毒感染的系統解決方案。此次公司泊沙康唑口服混懸液為國內首仿獲批,將進一步豐富公司在感染性疾病領域的產品管線。

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