山东新华制药股份(00719)盐酸艾司洛尔注射液(10ml:0.1g)获得《药品补充申请批准通知书》

智通财经
02 Dec 2024

智通财经APP讯,山东新华制药股份(00719)公布,近日,公司收到国家药品监督管理局核准签发的盐酸艾司洛尔注射液(10ml:0.1g)《药品补充申请批准通知书》,该产品上市许可持有人转让申请获得批准。

根据《中华人民共和国药品管理法》及相关规定,经审查,本品此次申请事项符合药品注册的有关要求,同意按照《药品上市后变更管理办法(试行)》相关规定,批准本品上市许可持有人变更申请,发给《药品补充申请批准通知书》。

新华制药盐酸艾司洛尔注射液(10ml:0.1g)的上市,有利于丰富公司心脑血管产品线,有助于提升公司产品的市场竞争力。

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