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普利製藥(300630.SZ):地氯雷他定片(5mg)通過一致性評價
格隆匯 11-24 18:20

格隆匯11月24日丨普利製藥(300630.SZ)公佈,公司於近日收到國家藥品監督管理局簽發的地氯雷他定片《藥品補充申請批件》(一致性評價)

地氯雷他定為非鎮靜性的長效三環類抗組膠藥,為氯雷他定的活性代謝物,可通過選擇性地阻斷外周H1受體,抑制各種過敏性致炎的化學介質的釋放,緩解過敏性鼻炎或慢性特發性蕁麻疹的相關症狀。地氯雷他定Sepracor公司研制,Schering-Plough公司開發並在全球53個國家上市。地氯雷他定片2001年首次在歐洲上市;2002年在美國上市在國內,目前地氯雷他定片獲批進口,商品名:恩理思,規格:5mg

公司的地氯雷他定片2002228首次獲國家藥品監督管理局批准上市,批准文號國藥準字H20020088。後積極響應國務院和國家藥品監督管理部門號召的產業升級、提升產品質量和走出去的戰略該產品啟動一致性評價工作同時申報中國一致性評價補充申請和歐DCP(非集中審評)流程歐盟DCP已於20191120日審評結束,結論批准,現處於荷蘭和德國國家階段的產品特性概要説明書和標籤的審核和批件發放階段近日,公司收到國家藥品監督管理局籤地氯雷他定片5mg的補充申請批准件(一致性評價)。

地氯雷他定片(5mg)通過一致性評價,將對公司持續開發此產品的銷售市場有積極的意義

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