| 药品名称 | GATTEX KIT | | 申请号 | 203441 | 产品号 | 001 | | 活性成分 | TEDUGLUTIDE RECOMBINANT | 市场状态 | 处方药 | | 剂型或给药途径 | POWDER;SUBCUTANEOUS | 规格 | 5MG/VIAL | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2012/12/21 | 申请机构 | NPS PHARMACEUTICALS INC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard review drug | | 罕用药/孤儿药 | 是 | | |
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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 | 2017/12/21 | | ODE | 2019/12/21 | | 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 | | 203441 | 008 | AP | Letter | 2016/05/31 | 下载 | | 203441 | 002 | AP | Letter | 2014/06/27 | 下载 | | 203441 | 002 | AP | Label | 2014/06/30 | 下载 | | 203441 | 002 | AP | Review | 2016/02/03 | 下载 | | 203441 | 000 | AP | Letter | 2012/12/27 | 下载 | | 203441 | 000 | AP | Label | 2012/12/27 | 下载 | | 203441 | 000 | AP | Other | 2012/12/27 | 下载 | | 203441 | 000 | AP | Medication Guide | 2013/01/03 | 下载 | | 203441 | 000 | AP | Review | 2013/01/25 | 下载 | | 203441 | 000 | AP | Summary Review | 2013/01/25 | 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 | | 203441 | 008 | AP | 2016/05/27 | Supplement | | 203441 | 007 | AP | 2016/03/30 | Manufacturing Change or Addition | | 203441 | 006 | AP | 2015/10/05 | Manufacturing Change or Addition | | 203441 | 005 | AP | 2015/05/18 | Manufacturing Change or Addition | | 203441 | 004 | AP | 2015/01/05 | Manufacturing Change or Addition | | 203441 | 002 | AP | 2014/06/26 | Efficacy Supplement with Clinical Data to Support | | 203441 | 000 | AP | 2012/12/21 | Approval |
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