新華製藥(000756.SZ):乳果糖口服溶液(100ml:66.7g)上市許可持有人轉讓申請獲得批准
格隆匯12月2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乳果糖口服溶液(100ml:66.7g)(以下簡稱“本品”)《藥品補充申請批准通知書》,該產品上市許可持有人轉讓申請獲得批准。
2024年9月,新華製藥向國家藥品監督管理局遞交上市許可持有人變更的補充申請資料並獲得受理,2024年11月獲得藥品補充申請批准通知書,審評結論為:經審查,本品持有人轉讓申請符合藥品上市後變更管理的有關要求,批准本品上市許可持有人變更。
乳果糖口服液主要用於慢性或習慣性便祕:調節結腸的生理節律;用於肝性腦病:治療和預防肝昏迷或昏迷前狀態。根據有關數據顯示,2023年中國公立醫療機構乳果糖口服溶液的銷售額約為人民幣17.69億元。
乳果糖口服溶液(100ml:66.7g)於2024年11月通過國家藥品監督管理局審批,新華製藥成為本品的上市許可持有人。該產品的上市,有利於豐富公司消化系統藥物產品線,提升公司綜合競爭優勢。
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