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新華製藥(000756.SZ):獲批成為瑞舒伐他汀鈣片(20mg;10mg)的上市許可持有人
格隆匯 01-21 17:01

格隆匯1月21日丨新華製藥(000756.SZ)公佈,近日,山東新華製藥股份有限公司收到國家藥品監督管理局核准簽發的瑞舒伐他汀鈣片(20mg;10mg)(以下簡稱“本品”)《藥品補充申請批准通知書》,批准本品上市許可持有人轉讓補充申請。

本品適用於經飲食控制和其它非藥物治療(如:運動治療,減輕體重)仍不能適當控制血脂異常的原發性高膽固醇血癥(IIa型,包括雜合子家族性高膽固醇血癥)或混合型血脂異常症(IIb型)。本品在降脂治療的同時,可延緩成人患者的動脈粥樣硬化進展。也適用於純合子家族性高膽固醇血癥的患者,作為飲食控制和其它降脂措施(如LDL去除療法)的輔助治療,或在這些方法不適用時使用。根據有關統計數據顯示,2023年中國城市公立醫療機構瑞舒伐他汀鈣片的年度銷售額為人民幣11.59億元;2024年上半年銷售額為人民幣6.13億元,其中10mg規格銷售額佔比94.79%。

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