華潤醫藥(03320.HK):華潤雙鶴旗下鹽酸氨溴索氯化鈉注射液獲藥品註冊批件
格隆匯2月25日丨華潤醫藥(03320.HK)A股上市附屬華潤雙鶴(600062.SH)宣佈,華潤雙鶴下屬三家全資子公司三個藥品分別取得國家藥監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,且該生產批件獲取視同通過一致性評價。這是國內首家該藥品通過一致性評價的廠家。枸櫞酸咖啡因注射液已成為歐美地區臨牀上治療早產兒呼吸暫停的首選藥物,被當前世界衞生組織核心基本藥物標準目錄以及兒童基本藥物標準目錄明確收載,併成為國外新生兒重症監護室(NICU)的常用藥物之一。
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(Ambroxol Hydrochloride and Sodium Chloride Injection)《藥品註冊批件》,批准該藥品生產(國藥準字H20193429)。
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。
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