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珍寶島(603567.SH):注射用帕瑞昔布鈉的註冊上市許可獲受理
格隆匯 12-06 15:52

格隆匯12月6日丨珍寶島(603567.SH)公佈,近日,公司獲得國家藥品監督管理局下發的《受理通知書》。公司收到的《受理通知書》為仿製藥注射用帕瑞昔布鈉的註冊上市許可,待取得國家藥品監督管理局註冊批件或上市許可批件後方可進行銷售。

帕瑞昔布鈉屬於非甾體抗炎藥(NSAIDs),能選擇性抑制炎症和疼痛刺激誘導產生的環氧化酶-2(COX-2)而發揮鎮痛抗炎作用,而對維持人體正常生理需要的環氧化酶-1(COX-1)無明顯抑制作用,臨牀用於手術疼痛的控制,先後被國內外權威臨牀指南推薦,廣泛用於骨科、普外科、肝膽外科、泌尿外科、胸外科、婦產科等多個科室手術後疼痛的短期治療。

注射用帕瑞昔布鈉的原研公司為瑞典法瑪西亞公司(已被輝瑞收購),商品名:Dynastat/特耐,適應症為手術後疼痛的短期治療,2002年全球首次上市,2008年進口我國,目前已經在英國、德國等十幾個國家上市。

公司注射用帕瑞昔布鈉項目已完成註冊申報並獲得受理通知書,後續還需完成註冊檢驗、根據國家藥監局審評意見完成相關研究後方可獲得生產批件。截止目前累計研發投入約669.52萬元。

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