| 药品名称 | NEURACEQ | | 申请号 | 204677 | 产品号 | 001 | | 活性成分 | FLORBETABEN F-18 | 市场状态 | 处方药 | | 剂型或给药途径 | SOLUTION;INTRAVENOUS | 规格 | 30ML (1.4-135mCi/ML) | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2014/03/19 | 申请机构 | PIRAMAL IMAGING SA
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard review drug |
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| 与本品相关的市场独占权保护信息 | | 独占权代码 | 失效日期 | | NCE | 2019/03/21 | | 历史市场独占权保护信息 | | 无 |
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| 与药品注册相关的信息 | | 申请号 | 修订号 | 审批结论 | 公开文档类型 | 文档创建时间 | 获取文档 | | 204677 | 012 | AP | Letter | 2016/08/29 | 下载 | | 204677 | 012 | AP | Label | 2016/08/29 | 下载 | | 204677 | 011 | AP | Letter | 2016/10/04 | 下载 | | 204677 | 011 | AP | Label | 2016/10/06 | 下载 | | 204677 | 001 | AP | Letter | 2014/04/04 | 下载 | | 204677 | 001 | AP | Label | 2014/04/08 | 下载 | | 204677 | 000 | AP | Review | 2014/04/14 | 下载 | | 204677 | 000 | AP | Summary Review | 2014/04/14 | 下载 | | 204677 | 000 | AP | Label | 2014/03/20 | 下载 | | 204677 | 000 | AP | Letter | 2014/03/21 | 下载 |
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| 药品注册审批历史信息 | | 申请号 | 修订号 | 审批结论 | 审批日期 | 审批内容 | | 204677 | 013 | AP | 2016/03/08 | Manufacturing Change or Addition | | 204677 | 012 | AP | 2016/08/25 | Labeling Revision | | 204677 | 011 | AP | 2016/09/29 | Labeling Revision | | 204677 | 009 | AP | 2016/01/25 | Manufacturing Change or Addition | | 204677 | 007 | AP | 2015/05/18 | Manufacturing Change or Addition | | 204677 | 006 | AP | 2015/05/19 | Manufacturing Change or Addition | | 204677 | 005 | AP | 2015/05/04 | Manufacturing Change or Addition | | 204677 | 004 | AP | 2014/08/13 | Manufacturing Change or Addition | | 204677 | 003 | AP | 2014/10/15 | Manufacturing Change or Addition | | 204677 | 002 | AP | 2014/10/15 | Manufacturing Change or Addition | | 204677 | 001 | AP | 2014/04/03 | Labeling Revision | | 204677 | 000 | AP | 2014/03/19 | Approval |
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