石四藥集團(02005.HK):氨茶礆注射液(10ml:0.25g及20ml:0.5g)獲藥品生產註冊批件
格隆匯10月31日丨石四藥集團(02005.HK)發佈公吿,集團已取得中國國家藥品監督管理局有關氨茶礆注射液(10ml:0.25g 及 20ml:0.5g)的藥品生產註冊批件,屬於化學藥品第3類新藥,視同通過一致性評價。氨茶礆注射液主要用於治療哮喘和其他慢性肺部疾病(如肺氣腫和慢性支氣管炎)相關的症狀急性惡化和可逆性氣流阻塞。
自今年十月起至本公吿日期為止,集團已從國家藥監局取得有關製劑產品共8個品種10個規格的批件、1個原料藥產品的批件,及有關藥物臨牀試驗共2個品種4個規格的批件。
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