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仙琚製藥(002332.SZ):噻託溴銨吸入噴霧劑藥品註冊申請獲得受理

格隆匯7月11日丨仙琚製藥(002332.SZ)公佈,公司於近日收到國家藥品監督管理局下發的噻託溴銨吸入噴霧劑境內生產藥品註冊受理通知書。

噻託溴銨吸入噴霧劑,規格爲每瓶60噴,每噴遞送劑量爲噻託溴銨2.5μg(按C??H??NO?S?計),藥液濃度含噻託溴銨0.2262mg/ml(按C₁₉H₂₂NO₄S₂計),參比製劑爲原研藥噻託溴銨吸入噴霧劑,持證商是Boehringer Ingelheim International GmbH,商品名爲Spiriva® Respimat®。適應症爲用於慢性阻塞性肺疾病(COPD,簡稱慢阻肺,包括慢性支氣管炎和肺氣腫)及其相關呼吸困難的維持治療,改善COPD患者的生活質量,能夠減少COPD急性加重。

本次公司申報的噻託溴銨吸入噴霧劑規格與參比製劑上市的規格一致,按化學藥品4類進行申報。

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