德展健康(000813.SZ):氨氯地平阿託伐他汀鈣片獲批上市
格隆匯6月28日丨德展健康(000813.SZ)公佈,公司全資子公司北京嘉林藥業股份有限公司(“嘉林藥業”)於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《藥品註冊證書》,藥品名稱為氨氯地平阿託伐他汀鈣片。
審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。質量標準、説明書、標籤及生產工藝照所附執行。藥品生產企業應當符合藥品生產質量管理規範要求方可生產銷售。
氨氯地平阿託伐他汀鈣片適用於需氨氯地平和阿託伐他汀聯合治療的患者,是降血壓降血脂複方製劑。其中氨氯地平是二氫吡啶類鈣離子拮抗劑,它直接作用於血管平滑肌,從而降低外周血管阻力和血壓,而阿託伐他汀是3-羥基-3-甲基戊二酰輔酶A(HMG-CoA)還原酶抑制劑,通過抑制肝臟內HMG-CoA還原酶及膽固醇的合成而降低血漿膽固醇和脂蛋白水平。氨氯地平阿託伐他汀鈣片屬於《國家基本醫療保險、工傷保險和生育保險藥品目錄(2020年版)》乙類藥品。
氨氯地平阿託伐他汀鈣片原研由輝瑞製藥有限公司(Pfizer)研發,於2004年在美國上市,於2008年在中國批准上市。全球主要生產廠商有Pfizer、Mylan、Dr Reddy's Lab、Apotex等,國內目前僅有Pfizer生產,瀚暉製藥有限公司進口分包裝產品。
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