博瑞醫藥(688166.SH):恩替卡韋原料藥獲歐洲CEP證書
格隆匯 6 月 22日丨博瑞醫藥(688166.SH)公佈,近日,公司的恩替卡韋原料藥收到了歐洲藥品質量管理局(“EDQM”)簽發的CEP(歐洲藥典適用性認證)證書。
恩替卡韋主要適用於病毒複製活躍,血清丙氨酸氨基轉移酶(ALT)持續升高或肝臟組織學顯示有活動性病變的慢性成人乙型肝炎的治療。恩替卡韋也是歐洲肝臟研究學會(EASL)制訂的乙型肝炎治療指南所推薦的抗病毒治療藥物。
此次公司恩替卡韋原料藥獲得CEP證書,代表該原料藥產品符合歐洲藥典的質量要求,標誌着該原料藥產品可以在歐洲市場及承認CEP證書的加拿大、澳大利亞等其他市場進行銷售。
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