产品信息
| 产品号 | 商品名 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 参比药物(RLD) | 生物等效参考标准(RS) | 治疗等效代码 | 该申请号批准日期 | 该产品号批准日期 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|
| 001 | ENBREL | ETANERCEPT | VIAL; SUBCUTANEOUS | 25MG/VIAL | No | No | None | 1998/11/02 | -- | Prescription |
| 002 | ENBREL | ETANERCEPT | SYRINGE | 50MG/ML | No | No | None | -- | Prescription |
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|---|---|---|---|---|---|
| 2023/10/18 | SUPPL-5595（补充） | Approval | Efficacy | STANDARD | ||
| 2023/06/09 | SUPPL-5594（补充） | Approval | Labeling | STANDARD | ||
| 2022/08/16 | SUPPL-5591（补充） | Approval | Labeling | STANDARD | ||
| 2022/06/17 | SUPPL-5590（补充） | Approval | Labeling | STANDARD | ||
| 2021/02/26 | SUPPL-5582（补充） | Approval | Labeling | STANDARD | ||
| 2020/03/05 | SUPPL-5577（补充） | Approval | Manufacturing (CMC) | UNKNOWN | ||
| 2020/03/05 | SUPPL-5574（补充） | Approval | Labeling | STANDARD | ||
| 2019/02/14 | SUPPL-5571（补充） | Approval | Labeling | STANDARD | ||
| 2018/10/03 | SUPPL-5569（补充） | Approval | Labeling | STANDARD | ||
| 2018/05/25 | SUPPL-5564（补充） | Approval | Labeling | STANDARD | ||
| 2018/05/25 | SUPPL-5563（补充） | Approval | STANDARD | |||
| 2018/05/11 | SUPPL-5565（补充） | Approval | Labeling | STANDARD | ||
| 2017/11/22 | SUPPL-5559（补充） | Approval | Efficacy | STANDARD | ||
| 2017/10/06 | SUPPL-5561（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2017/09/14 | SUPPL-5556（补充） | Approval | Efficacy | STANDARD | ||
| 2017/07/11 | SUPPL-5551（补充） | Approval | Labeling | STANDARD | ||
| 2016/11/04 | SUPPL-5552（补充） | Approval | Efficacy | STANDARD | ||
| 2015/03/25 | SUPPL-5548（补充） | Approval | Labeling | STANDARD | ||
| 2015/03/20 | SUPPL-5532（补充） | Approval | Supplement | |||
| 2013/11/15 | SUPPL-5531（补充） | Approval | Labeling | STANDARD | ||
| 2012/12/10 | SUPPL-5507（补充） | Approval | Labeling | STANDARD | ||
| 2012/12/04 | SUPPL-5503（补充） | Approval | Labeling | STANDARD | ||
| 2011/12/22 | SUPPL-5484（补充） | Approval | Labeling | STANDARD | ||
| 2011/11/29 | SUPPL-5462（补充） | Approval | Labeling | STANDARD | ||
| 2011/09/07 | SUPPL-5475（补充） | Approval | Labeling | STANDARD | ||
| 2011/08/10 | SUPPL-5474（补充） | Approval | Labeling | STANDARD | ||
| 2011/01/25 | SUPPL-5431（补充） | Approval | Labeling | STANDARD | ||
| 2010/11/18 | SUPPL-5415（补充） | Approval | Labeling | STANDARD | ||
| 2010/10/13 | SUPPL-5445（补充） | Approval | Labeling | STANDARD | ||
| 2010/09/29 | SUPPL-5443（补充） | Approval | Labeling | STANDARD | ||
| 2010/07/29 | SUPPL-5437（补充） | Approval | Labeling | STANDARD | ||
| 2010/07/20 | SUPPL-5391（补充） | Approval | Labeling | STANDARD | ||
| 2010/06/03 | SUPPL-5400（补充） | Approval | Labeling | STANDARD | ||
| 2010/06/03 | SUPPL-5397（补充） | Approval | Labeling | STANDARD | ||
| 2008/06/23 | SUPPL-5359（补充） | Approval | Supplement | |||
| 2008/03/21 | SUPPL-5356（补充） | Approval | Supplement | |||
| 2007/10/31 | SUPPL-5338（补充） | Approval | Supplement | |||
| 2007/08/02 | SUPPL-5336（补充） | Approval | Supplement | |||
| 2007/06/29 | SUPPL-5333（补充） | Approval | Supplement | |||
| 2007/06/21 | SUPPL-5328（补充） | Approval | Supplement | |||
| 2007/02/01 | SUPPL-5322（补充） | Approval | Supplement | |||
| 2007/01/12 | SUPPL-5301（补充） | Approval | Supplement | |||
| 2006/12/08 | SUPPL-5317（补充） | Approval | Supplement | |||
| 2006/12/01 | SUPPL-5304（补充） | Approval | Labeling | STANDARD | ||
| 2006/12/01 | SUPPL-5302（补充） | Approval | Labeling | STANDARD | ||
| 2006/11/09 | SUPPL-5313（补充） | Approval | Supplement | |||
| 2006/11/02 | SUPPL-5310（补充） | Approval | Supplement | |||
| 2006/11/02 | SUPPL-5296（补充） | Approval | Supplement | |||
| 2006/09/25 | SUPPL-5294（补充） | Approval | Labeling | STANDARD | ||
| 2006/06/16 | SUPPL-5285（补充） | Approval | Supplement | |||
| 2006/06/14 | SUPPL-5286（补充） | Approval | Labeling | STANDARD | ||
| 2006/05/17 | SUPPL-5256（补充） | Approval | Efficacy | STANDARD ;Orphan | ||
| 2006/04/26 | SUPPL-5289（补充） | Approval | Supplement | |||
| 2006/04/13 | SUPPL-5283（补充） | Approval | Supplement | |||
| 2006/04/04 | SUPPL-5278（补充） | Approval | Supplement | |||
| 2006/04/04 | SUPPL-5274（补充） | Approval | Supplement | |||
| 2006/03/23 | SUPPL-5271（补充） | Approval | Supplement | |||
| 2006/03/21 | SUPPL-5277（补充） | Approval | Supplement | |||
| 2006/03/02 | SUPPL-5273（补充） | Approval | Supplement | |||
| 2006/03/02 | SUPPL-5266（补充） | Approval | Labeling | STANDARD | ||
| 2006/02/16 | SUPPL-5262（补充） | Approval | Supplement | |||
| 2006/02/07 | SUPPL-5260（补充） | Approval | Supplement | |||
| 2006/01/24 | SUPPL-5259（补充） | Approval | Supplement | |||
| 2005/07/28 | SUPPL-5229（补充） | Approval | Labeling | STANDARD | ||
| 2005/06/28 | SUPPL-5225（补充） | Approval | Labeling | STANDARD | ||
| 2005/05/27 | SUPPL-5191（补充） | Approval | Efficacy | STANDARD | ||
| 2004/09/27 | SUPPL-5184（补充） | Approval | Efficacy | STANDARD | ||
| 2004/09/24 | SUPPL-5162（补充） | Approval | Efficacy | STANDARD | ||
| 2004/04/30 | SUPPL-5149（补充） | Approval | Efficacy | STANDARD | ||
| 2003/11/25 | SUPPL-5125（补充） | Approval | Efficacy | STANDARD | ||
| 2003/10/17 | SUPPL-5110（补充） | Approval | Efficacy | STANDARD | ||
| 2003/10/09 | SUPPL-5099（补充） | Approval | Labeling | STANDARD | ||
| 2003/08/21 | SUPPL-5102（补充） | Approval | Efficacy | STANDARD | ||
| 2003/07/24 | SUPPL-5123（补充） | Approval | Efficacy | PRIORITY | ||
| 2003/07/24 | SUPPL-5097（补充） | Approval | Efficacy | STANDARD | ||
| 2003/07/24 | SUPPL-5055（补充） | Approval | Supplement | |||
| 2003/06/05 | SUPPL-5109（补充） | Approval | Supplement | |||
| 2002/09/12 | SUPPL-5070（补充） | Approval | Labeling | STANDARD | ||
| 2002/09/12 | SUPPL-5051（补充） | Approval | Efficacy | STANDARD | ||
| 2002/08/30 | SUPPL-5071（补充） | Approval | Labeling | STANDARD | ||
| 2002/01/15 | SUPPL-5034（补充） | Approval | Efficacy | PRIORITY | ||
| 2002/01/15 | SUPPL-5016（补充） | Approval | Efficacy | STANDARD | ||
| 2002/01/15 | SUPPL-5014（补充） | Approval | Efficacy | STANDARD | ||
| 2001/06/15 | SUPPL-5015（补充） | Approval | Labeling | STANDARD | ||
| 2000/06/06 | SUPPL-1004（补充） | Approval | Efficacy | STANDARD | ||
| 1999/05/27 | SUPPL-1001（补充） | Approval | Efficacy | PRIORITY ;Orphan | ||
| 1998/11/02 | ORIG-1（原始申请） | Approval | Type 1 - New Molecular Entity | PRIORITY |
