普利製藥(300630.SZ):地氯雷他定片(5mg)通過一致性評價
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。地氯雷他定由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,目前地氯雷他定片已獲批進口,商品名:恩理思,規格:5mg。
公司的地氯雷他定片於2002年2月28日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後,同時申報了中國一致性評價補充申請和歐盟DCP(非集中審評)流程。歐盟DCP已於2019年11月20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。於近日,公司收到了國家藥品監督管理局籤發的地氯雷他定片5mg的補充申請批准件(一致性評價)。
地氯雷他定片(5mg)的通過一致性評價,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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