華潤醫藥(03320.HK)旗下兩款藥品分別獲批上市申請及藥品補充申請
華潤醫藥(03320.HK)公布,旗下商丘雙鶴溴夫定原料藥獲得國家藥監局頒發的《化學原料藥上市申請批准通知書》,待通過GMP符合性檢查後可生產銷售至國內市場;以及集團旗下雙鶴利民硫酸阿米卡星注射液獲得國家藥監局《藥品補充申請批准通知書》,並通過仿製藥質量和療效一致性評價。
溴夫定屬於抗病毒藥,用於免疫功能正常的成年急性帶狀皰疹的早期治療。目前在國家藥品監督管理局藥品審評中心原料藥、藥用輔料和藥包材登記信息公示平台上登記溴夫定原料藥的企業共有3家。
硫酸阿米卡星是一種氨基糖(甘)類抗生素,臨床適用於銅綠假單胞菌及其他假單胞菌、大腸埃希菌等敏感革蘭陰性桿菌與葡萄球菌屬所致嚴重感染,如菌血症或敗血症、細菌性心內膜炎等。
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