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天宇股份(300702.SZ):子公司取得孟魯司特鈉咀嚼片、阿哌沙班片的藥品註冊證書
格隆匯 07-15 20:46

格隆匯7月15日丨天宇股份(300702.SZ)公佈,公司全資子公司浙江諾得藥業有限公司(“諾得藥業”)於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的關於孟魯司特鈉咀嚼片、阿哌沙班片的《藥品註冊證書》。

孟魯司特鈉咀嚼片適應症為本品適用於2歲至14歲兒童哮喘的預防和長期治療,包括預防白天和夜間的哮喘症狀,治療對阿斯匹林敏感的哮喘患者以及預防運動誘發的支氣管收縮。本品適用於減輕過敏性鼻炎引起的症狀(2歲至14歲兒童的季節性過敏性鼻炎和常年性過敏性鼻炎)。根據國家藥監局網站數據查詢,截至公吿日,該規格製劑除諾得藥業外,國內生產商另有海南日中天製藥有限公司、北京福元醫藥股份有限公司等7家企業。

阿哌沙班片適應症為用於髖關節或膝關節擇期置換術的成年患者,預防靜脈血栓栓塞事件。根據國家藥監局網站數據查詢,截至公吿日,該規格國內製劑生產商除諾得藥業外,另有正大天晴藥業集團股份有限公司、江蘇萬邦生化醫藥集團有限公司等25家企業。

公司產品孟魯司特鈉咀嚼片、阿哌沙班片獲得國家藥監局批件後即可在境內生產、銷售,進一步豐富了公司的製劑品種,有望增加公司製劑業務收入,有助於提升公司產品的市場競爭力,對公司的經營業績產生積極的影響。

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