金城醫藥(300233.SZ):注射用頭孢唑林鈉通過一致性評價
格隆匯6月23日丨金城醫藥(300233.SZ)公佈,公司於2021年6月23日收到控股子公司廣東金城金素製藥有限公司(“金城金素”)的通知,金城金素於2021年6月23日收到國家藥品監督管理局核准簽發的注射用頭孢唑林鈉《藥品補充申請批準通知書》,批准該藥品通過仿製藥質量和療效一致性評價。
申請內容:1、仿製藥注射劑一致性評價;2、延長藥品有效期至24個月。
審批結論主要內容:經審查,本品通過仿製藥質量和療效一致性評價。藥品有效期為24個月。
頭孢唑林鈉(Cefazolin Sodium)是第一代頭孢菌素,抗菌譜廣,適用於治療敏感細菌所致的支氣管炎及肺炎等呼吸道感染、尿路感染、皮膚軟組織感染、骨和關節感染、敗血症、感染性心內膜炎、肝膽系統感染及眼、耳、鼻、喉科等感染,也可作為外科手術前的預防用藥。
注射用頭孢唑林鈉於1973年以BRAND-NAME:ANCEF安斯夫®、KEFZOL®(ACS DOBFAR SPA)在美國註冊上市。注射用頭孢唑林鈉對葡萄球菌包括產β內酰胺黴菌株、鏈球菌、大腸桿菌和奇異變形桿菌引起的感染有效,臨牀上廣泛用於預防手術感染,尤其是預防膽道手術、整形外科、心臟和婦科外科手術感染。
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