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華潤雙鶴(600062.SH):鹽酸氨溴索氯化鈉注射液獲藥品註冊批件
格隆匯 02-24 18:22

格隆匯2月24日丨華潤雙鶴(600062.SH)公佈,近期,公司下屬三家全資子公司三個藥品分別取得國家藥品監督管理局一致性評價補充申請通過、申報生產註冊申請通過、藥品註冊批件。現將相關情況公告如下:

一、從國家藥監局網站獲悉,全資子公司北京萬輝雙鶴藥業有限責任公司提交的“蒙脱石散”仿製藥質量和療效一致性評價補充申請已獲得批准。

二、從國家藥監局網站獲悉,全資子公司華潤雙鶴利民藥業(濟南)有限公司提交的“枸櫞酸咖啡因注射液”申報生產註冊申請已獲得批准。

三、全資子公司安徽雙鶴藥業有限責任公司收到了國家藥監局核准簽發的鹽酸氨溴索氯化鈉注射液《藥品註冊批件》,批准該藥品生產。該藥品適用於下述患者嚴重病例(中度)以上伴有痰液分泌不正常及排痰功能不良的急性、慢性呼吸道疾病,例如慢性支氣管炎急性加重、喘息型支氣管炎、支氣管擴張及支氣管哮喘的祛痰治療。術後肺部併發症的預防性治療。截至本公告日,該藥品研發投入研發費用累計約為人民幣144萬元(未經審計)。

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