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中國生物製藥(01177.HK)注射用帕瑞昔布鈉獲通過一致性評價
格隆匯 01-11 16:37

格隆匯1月11日丨中國生物製藥(01177.HK)宣佈,集團的鎮痛藥注射用帕瑞昔布鈉(商品名:予安)(規格:20mg和40mg)已獲中國國家藥品監督管理局頒發藥品補充申請批准通知書,通過了仿製藥質量和療效一致性評價。

注射用帕瑞昔布鈉為國內外唯一一個注射型的選擇性環氧化酶-2(COX-2)抑制劑,主要用於術後疼痛的治療,是臨牀多模式鎮痛的基礎用藥之一。帕瑞昔布鈉是一種高選擇性COX-2抑制劑,具有鎮痛效果好、起效迅速、作用持久、胃腸安全性高、不影響血小板功能、不會額外增加心血管風險等特點;與阿片類藥物聯用,能顯著減少阿片類藥物用量及相關不良反應。

注射用帕瑞昔布鈉已被國內外權威指南推薦廣泛用於普通外科、婦科、骨科、口腔科等多個科室術後疼痛的治療。予安雙規格通過一致性評價,將有利於進一步推動進口替代,讓高質量的國產藥品惠及更多患者。

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