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金城醫藥(300233.SZ):頭孢羥氨苄幹混懸劑增加規格取得藥品補充申請批准通知書
格隆匯 05-16 18:21

格隆匯5月16日丨金城醫藥(300233.SZ)公佈,山東金城醫藥集團股份有限公司之全資子公司上海金城素智藥業有限公司(以下簡稱“金城素智”)收到國家藥品監督管理局下發的頭孢羥氨苄幹混懸劑《藥品補充申請批准通知書》(證書編號:2024B012112、2024B012111、2024B012110)。審批同意本品增加5g(250mg/5ml)(按C16H17N3O5S計)、7.5g(500mg/5ml)(按C16H17N3O5S計)、10g(500mg/5ml)(按C16H17N3O5S計)規格,核發藥品批准文號。

頭孢羥氨苄幹混懸劑可用於治療以下疾病中由敏感菌引起的感染,如:尿路感染,由大腸埃希菌、奇異變形桿菌和克雷伯桿菌引起;皮膚和皮膚組織感染,由葡萄球菌和/或鏈球菌引起;咽炎和/或扁桃體炎,由化膿性鏈球菌(A組B溶血性鏈球菌)引起。米內網數據顯示,頭孢羥氨苄相關製劑城市公立醫院2021~2023年全國銷售額分別約為人民幣8,841萬元、9,768萬元和11,206萬元,其中片劑、膠囊劑、散劑及顆粒劑分別佔通用名銷售額的92.05%、7.64%、0.31%。經查詢藥智網數據庫,截至公吿披露日,金城素智為國內首家按新註冊分類3類獲批頭孢羥氨苄幹混懸劑產品的企業。

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