山东新华制药股份(00719):新达制药获得布洛芬颗粒药品注册证书

智通财经
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智通财经APP讯,山东新华制药股份(00719)发布公告,近日,山东新华制药股份有限公司(以下简称“公司”)之全资子公司山东淄博新达制药有限公司(以下简称“新达制药”)收到国家药品监督管理局核准签发的布洛芬颗粒(以下简称“本品”)《药品注册证书》。

2023年12月,新达制药向国家药品监督管理局药品审评中心(CDE)递交布洛芬颗粒上市许可注册申报资料并获受理,2026年3月获得《药品注册证书》,审评结论为批准注册。

本品用于缓解轻至中度疼痛,如头痛、关节痛、偏头痛、牙痛、肌肉痛、神经痛、痛经,也可用于普通感冒或流行性感冒引起的发热。

布洛芬颗粒是《国家基本医疗保险、工伤保险和生育保险药品目录》(2025年版)乙类品种。根据有关统计数据,2024年中国公立医疗机构布洛芬相关剂型销售额约为人民币44亿元。

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