海辰药业(300584.SZ):公司注射用盐酸兰地洛尔获得药品注册批件
格隆汇 12 月 20日丨海辰药业(300584.SZ)公布,公司于近日收到国家药品监督管理局(以下简称"国家药监局")核准签发的化学药品"注射用盐酸兰地洛尔"《药品注册证书》。
肾上腺素β受体阻滞药是一类作用广泛、重要的心血管治疗药物。超短效β受体阻滞药由于起效快、代谢快、停药后β受体阻滞作用消失快,在新发生的快速性心律失常的治疗中发挥重要且不可替代的作用。兰地洛尔是一个新型的超短效肾上腺素β受体阻滞药,具有选择性高(其对β1受体的阻滞作用约为β2受体的255倍,对β1受体的选择性为另一个超短效β受体阻滞药艾司洛尔的8倍)、起效迅速(给药后1至6分钟起效)、半衰期短(约为4分钟)、停药后失效快、对心脏血流动力学影响小、无明显负性肌力作用等优点。
注射用盐酸兰地洛尔2002年在日本上市,2016年相继在欧洲多个国家上市,临床适用于(1)手术过程中发生的下列快速性心律失常的紧急治疗:心房纤颤、心房扑动、窦性心动过速;(2)手术后循环系统动态监护时发生的快速性心律失常的紧急治疗:心房纤颤、心房扑动、窦性心动过速;(3)心功能不全患者发生下列快速性心律失常的治疗:心房纤颤、心房扑动。
目前该产品原研尚未进口,公司为国内首家批准上市。该产品的上市为国内术中和术后快速性心律失常以及心功能不全患者提供了有效的治疗手段。
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