中生製藥(01177.HK)「天依寧」獲藥監局藥品頒發註冊證書
中生製藥(01177.HK)公布,開發的心血管複方新產品「氨氯地平阿托伐他汀鈣片」(天依寧)已獲中國國家藥品監督管理局頒發藥品註冊證書。
該產品按化學藥品4類申報,視同通過仿製藥質量和療效一致性評價,是同品種國內仿製藥第二家獲批及第二家通過一致性評價。
公司表示,氨氯地平阿托伐他汀鈣片可同時降低血壓和低密度脂蛋白膽固醇兩大致病因素,具有多重心血管保護效果,有利於最大程度降低心血管事件和死亡風險,將成為心血管產品線的重要產品。
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