| 药品名称 | VISUDYNE | | 申请号 | 021119 | 产品号 | 001 | | 活性成分 | VERTEPORFIN | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 15MG/VIAL | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2000/04/12 | 申请机构 | VALEANT PHARMACEUTICALS LUXEMBOURG SARL
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority 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 | | 无 | | 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 | | 021119 | 027 | AP | Letter | 2016/05/12 | 下载 | | 021119 | 027 | AP | Label | 2016/05/17 | 下载 | | 021119 | 022 | AP | Label | 2012/06/29 | 下载 | | 021119 | 022 | AP | Letter | 2012/06/29 | 下载 | | 021119 | 021 | AP | Label | 2007/03/31 | 下载 | | 021119 | 021 | AP | Letter | 2007/04/09 | 下载 | | 021119 | 013 | AP | Label | 2008/06/30 | 下载 | | 021119 | 013 | AP | Letter | 2008/07/01 | 下载 | | 021119 | 012 | AP | Letter | 2005/03/30 | 下载 | | 021119 | 012 | AP | Label | 2005/03/30 | 下载 | | 021119 | 010 | AP | Letter | 2004/03/02 | 下载 | | 021119 | 006 | AP | Letter | 2004/03/02 | 下载 | | 021119 | 005 | AP | Letter | 2002/12/09 | 下载 | | 021119 | 005 | AP | Label | 2002/11/25 | 下载 | | 021119 | 004 | AP | Letter | 2002/05/29 | 下载 | | 021119 | 004 | AP | Label | 2002/05/29 | 下载 | | 021119 | 004 | AP | Review | 2005/03/08 | 下载 | | 021119 | 003 | AP | Review | 2005/03/08 | 下载 | | 021119 | 003 | AP | Letter | 2002/04/30 | 下载 | | 021119 | 003 | AP | Label | 2002/04/30 | 下载 | | 021119 | 001 | AP | Letter | 2001/08/22 | 下载 | | 021119 | 001 | AP | Label | 2001/08/22 | 下载 | | 021119 | 001 | AP | Review | 2001/08/22 | 下载 | | 021119 | 000 | AP | Review | 2000/04/12 | 下载 | | 021119 | 000 | AP | Letter | 2000/04/12 | 下载 | | 021119 | 000 | AP | Label | 2000/04/12 | 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 | | 021119 | 027 | AP | 2016/05/11 | Labeling Revision | | 021119 | 026 | AP | 2014/05/06 | Manufacturing Change or Addition | | 021119 | 025 | AP | 2013/10/08 | Manufacturing Change or Addition | | 021119 | 022 | AP | 2012/06/28 | Labeling Revision | | 021119 | 021 | AP | 2007/03/28 | Labeling Revision | | 021119 | 013 | AP | 2008/06/30 | Efficacy Supplement with Clinical Data to Support | | 021119 | 012 | AP | 2005/03/25 | Labeling Revision | | 021119 | 010 | AP | 2004/02/12 | Package Change | | 021119 | 006 | AP | 2004/02/12 | Labeling Revision | | 021119 | 005 | AP | 2002/11/25 | Labeling Revision | | 021119 | 004 | AP | 2002/05/29 | Manufacturing Change or Addition | | 021119 | 003 | AP | 2002/04/30 | Labeling Revision | | 021119 | 002 | AP | 2002/02/15 | Manufacturing Change or Addition | | 021119 | 001 | AP | 2001/08/22 | New or Modified Indication | | 021119 | 000 | AP | 2000/04/12 | Approval |
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