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悦康藥業(688658.SH):注射用頭孢曲松鈉通過仿製藥一致性評價
格隆匯 12-10 17:40

格隆匯12月10日丨悦康藥業(688658.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的關於注射用頭孢曲松鈉(0.5g、1.0g)的《藥品補充申請批准通知書》(通知書編號:2021B04498、2021B04497),該藥品通過仿製藥質量和療效一致性評價。

注射用頭孢曲松鈉最早由瑞士Roche公司研發,於1982年首次在瑞士上市,1984年獲得美國FDA批准上市。注射用頭孢曲松鈉為長效、廣譜的第三代頭孢菌素類抗生素,較第一、二代頭孢菌素對革蘭氏陰性菌活性與β-內酰胺酶穩定性增強;與其他第三代頭孢菌素相比,具有半衰期長、組織穿透力強、毒副作用小等優勢,目前已在臨牀廣泛應用於呼吸科、外科、婦產科等科室,已被《抗菌藥物臨牀應用指導原則(2015)》、《中國腹腔感染診治指南(2019)》、《兒童社區獲得性肺炎診療規範(2019)》、《成人社區獲得性肺炎基層合理用藥指南(2020)》等國內權威指南推薦。

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