恒瑞医药(600276.SH):“缬沙坦氨氯地平片(I)”获得药品注册证书
格隆汇9月22日丨恒瑞医药(600276.SH)公布,近日收到国家药品监督管理局核准签发的《药品注册证书》。现将相关情况公告如下:
1、药品名称:缬沙坦氨氯地平片(I)
剂型:片剂
规格:每片含缬沙坦80mg,氨氯地平5mg
注册分类:化学药品4类
受理号:CYHS1800064国
证书编号:2020S00618
药品批准文号:国药准字H20203486
审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药品注册的有关要求,批准注册,发给药品注册证书。
2、药品的其他相关情况
2018年3月12日,恒瑞医药向江苏省食品药品监督管理局递交的药品注册申请获得受理。缬沙坦氨氯地平片(I)包括缬沙坦和氨氯地平两种降压活性成份,两种成份合用的降压效果优于其中任一成份单药治疗。本品拟用于治疗原发性高血压,用于单药治疗不能充分控制血压的患者。
缬沙坦氨氯地平片(AmlodipineandValsartanTablets,商品名Exforge)是瑞士诺华公司研制的降血压复方片,2007年1月在欧盟获得EMEA的批准,同年2月在瑞士获批上市;2007年6月又经过美国FDA批准上市,并在2008年7月被美国FDA批准用于高血压的一线治疗。本品于2009年9月批准进口,规格为氨氯地平/缬沙坦(5/80mg),商品名为倍博特。目前,除公司外,国内已有百奥药业、花园药业同产品获批上市;另有华海药业、成都倍特等在内的6家企业申报生产。经查询EvaluatePharma数据库,瑞士诺华公司的缬沙坦氨氯地平片2019年全球销售额约为10.25亿美元。
截至目前,该产品累计已投入研发费用约为1535万元人民币。
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