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山東新華製藥(00719.HK)治療哮喘及支氣管炎仿製藥通過內地一致性評價
阿思達克 11-18 16:51
山東新華製藥股份(00719.HK)公佈,近日公司收到國家藥品監督管理局覈準簽發的氨茶礆注射液(10ml:0.25g)《藥品補充申請批準通知書》,該產品通過仿製藥質量和療效一致性評價。 氨茶礆注射液適用於支氣管哮喘、慢性喘息性支氣管炎、慢性阻塞性肺病等,可緩解喘息症狀;也可用於心功能不全和心源性哮喘。目前,公司針對氨茶礆注射液的一致性評價已投入研發費用約1,000.26萬元人民幣。
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