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 | OPDIVO | NIVOLUMAB | INJECTABLE;INJECTION | 40MG/4ML | TBD | No | None | 2014/12/22 | -- | 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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|---|---|---|---|---|---|
| 2014/12/22 | ORIG-1（原始申请） | Approval | Type 1 - New Molecular Entity | PRIORITY ;Orphan |
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|---|---|---|---|---|---|
| 2025/07/01 | SUPPL-131（补充） | Approval | Labeling-Package Insert,Labeling-Package Insert | STANDARD ;Orphan | ||
| 2025/05/23 | SUPPL-133（补充） | Approval | Efficacy-New Indication | PRIORITY ;Orphan | ||
| 2025/04/11 | SUPPL-129（补充） | Approval | Efficacy-Accelerated Approval | STANDARD ;Orphan | ||
| 2025/04/08 | SUPPL-132（补充） | Approval | Efficacy-Accelerated Approval | PRIORITY ;Orphan | ||
| 2024/10/03 | SUPPL-127（补充） | Approval | Efficacy-New Indication | STANDARD ;Orphan | ||
| 2024/03/06 | SUPPL-128（补充） | Approval | Labeling-Package Insert | STANDARD ;Orphan | ||
| 2024/03/06 | SUPPL-125（补充） | Approval | Efficacy-Labeling Change With Clinical Data | PRIORITY ;Orphan | ||
| 2024/01/26 | SUPPL-122（补充） | Approval | Efficacy-Manufacturing Change With Clinical Data | STANDARD ;Orphan | ||
| 2023/10/13 | SUPPL-121（补充） | Approval | Efficacy-New Indication | STANDARD ;Orphan | ||
| 2023/02/15 | SUPPL-119（补充） | Approval | Efficacy-New Patient Population | PRIORITY ;Orphan | ||
| 2023/02/15 | SUPPL-118（补充） | Approval | Efficacy-New Patient Population | PRIORITY ;Orphan | ||
| 2023/02/15 | SUPPL-117（补充） | Approval | Efficacy-New Patient Population | PRIORITY ;Orphan | ||
| 2022/07/14 | SUPPL-114（补充） | Approval | Efficacy-Labeling Change With Clinical Data | STANDARD | ||
| 2022/05/27 | SUPPL-106（补充） | Approval | Efficacy-New Indication | STANDARD ;Orphan | ||
| 2022/05/27 | SUPPL-105（补充） | Approval | Efficacy-New Indication | STANDARD ;Orphan | ||
| 2022/05/11 | SUPPL-108（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 2022/03/04 | SUPPL-112（补充） | Approval | Efficacy-New Indication | PRIORITY | ||
| 2022/02/25 | SUPPL-109（补充） | Approval | Labeling-Package Insert | STANDARD ;Orphan | ||
| 2021/08/19 | SUPPL-97（补充） | Approval | Efficacy-New Indication | PRIORITY | ||
| 2021/07/23 | SUPPL-107（补充） | Approval | Labeling-Package Insert | STANDARD ;Orphan | ||
| 2021/07/15 | SUPPL-99（补充） | Approval | Efficacy-Labeling Change With Clinical Data,Labeling-Package Insert | STANDARD ;Orphan | ||
| 2021/05/20 | SUPPL-92（补充） | Approval | Efficacy-New Indication | PRIORITY | ||
| 2021/04/16 | SUPPL-91（补充） | Approval | Efficacy-New Indication | PRIORITY ;Orphan | ||
| 2021/03/30 | SUPPL-98（补充） | Approval | Labeling-Package Insert | STANDARD ;Orphan | ||
| 2021/01/22 | SUPPL-90（补充） | Approval | Efficacy-New Dosing Regimen | PRIORITY | ||
| 2020/12/29 | SUPPL-95（补充） | Approval | Labeling-Package Insert | STANDARD ;Orphan | ||
| 2020/11/10 | SUPPL-71（补充） | Approval | Labeling-Medication Guide,Labeling-Package Insert | STANDARD ;Orphan | ||
| 2020/10/02 | SUPPL-89（补充） | Approval | Efficacy-New Indication | PRIORITY ;Orphan | ||
| 2020/09/25 | SUPPL-86（补充） | Approval | Labeling-Package Insert | STANDARD ;Orphan | ||
| 2020/09/18 | SUPPL-85（补充） | Approval | Efficacy-Labeling Change With Clinical Data | STANDARD | ||
| 2020/09/18 | SUPPL-84（补充） | Approval | Efficacy-Labeling Change With Clinical Data | STANDARD | ||
| 2020/06/23 | SUPPL-83（补充） | Approval | Labeling-Package Insert | STANDARD ;Orphan | ||
| 2020/06/10 | SUPPL-81（补充） | Approval | Efficacy-New Indication | PRIORITY ;Orphan | ||
| 2020/05/26 | SUPPL-82（补充） | Approval | Efficacy-New Indication | PRIORITY ;Orphan | ||
| 2020/05/15 | SUPPL-80（补充） | Approval | Efficacy-New Indication | PRIORITY | ||
| 2020/03/10 | SUPPL-78（补充） | Approval | Efficacy-New Indication | PRIORITY ;Orphan | ||
| 2019/09/18 | SUPPL-75（补充） | Approval | Labeling-Package Insert | STANDARD ;Orphan | ||
| 2019/05/02 | SUPPL-73（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2019/04/18 | SUPPL-70（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 2019/03/07 | SUPPL-42（补充） | Approval | Efficacy-Accelerated Approval | PRIORITY ;Orphan | ||
| 2019/02/01 | SUPPL-72（补充） | Approval | Labeling-Package Insert | STANDARD ;Orphan | ||
| 2018/11/15 | SUPPL-69（补充） | Approval | Labeling-Package Insert | STANDARD ;Orphan | ||
| 2018/08/16 | SUPPL-67（补充） | Approval | Efficacy-New Patient Population | PRIORITY ;Orphan | ||
| 2018/07/10 | SUPPL-63（补充） | Approval | Efficacy-New Indication | PRIORITY | ||
| 2018/04/16 | SUPPL-58（补充） | Approval | Efficacy-New Indication | PRIORITY | ||
| 2018/03/05 | SUPPL-66（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD ;Orphan | ||
| 2018/03/05 | SUPPL-65（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 2018/03/05 | SUPPL-64（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD ;Orphan | ||
| 2018/03/05 | SUPPL-62（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD ;Orphan | ||
| 2018/03/05 | SUPPL-61（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD ;Orphan | ||
| 2018/03/05 | SUPPL-52（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 2018/03/05 | SUPPL-51（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 2018/03/05 | SUPPL-50（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD ;Orphan | ||
| 2018/03/05 | SUPPL-49（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 2018/03/05 | SUPPL-48（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 2018/02/15 | SUPPL-45（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 2018/02/15 | SUPPL-44（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD ;Orphan | ||
| 2018/02/13 | SUPPL-56（补充） | Approval | Labeling-Package Insert | STANDARD ;Orphan | ||
| 2018/01/09 | SUPPL-39（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 2018/01/09 | SUPPL-38（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 2018/01/09 | SUPPL-37（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD ;Orphan | ||
| 2018/01/09 | SUPPL-36（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 2018/01/09 | SUPPL-35（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 2017/12/20 | SUPPL-55（补充） | Approval | Efficacy-New Patient Population | PRIORITY ;Orphan | ||
| 2017/09/22 | SUPPL-41（补充） | Approval | Efficacy-New Indication | PRIORITY ;Orphan | ||
| 2017/09/06 | SUPPL-40（补充） | Approval | Labeling-Package Insert | STANDARD ;Orphan | ||
| 2017/07/31 | SUPPL-34（补充） | Approval | Efficacy-New Indication | PRIORITY | ||
| 2017/04/25 | SUPPL-31（补充） | Approval | Efficacy-New Indication | PRIORITY ;Orphan | ||
| 2017/02/02 | SUPPL-24（补充） | Approval | Efficacy-New Indication | PRIORITY | ||
| 2016/11/10 | SUPPL-22（补充） | Approval | Efficacy-New Indication | PRIORITY | ||
| 2016/10/04 | SUPPL-16（补充） | Approval | Efficacy-Labeling Change With Clinical Data | STANDARD | ||
| 2016/09/13 | SUPPL-18（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 2016/09/13 | SUPPL-17（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD ;Orphan | ||
| 2016/05/17 | SUPPL-19（补充） | Approval | Efficacy-New Indication | PRIORITY ;Orphan | ||
| 2016/01/23 | SUPPL-7（补充） | Approval | Efficacy-New Indication | PRIORITY ;Orphan | ||
| 2015/11/23 | SUPPL-12（补充） | Approval | Efficacy-New Indication | PRIORITY | ||
| 2015/11/23 | SUPPL-1（补充） | Approval | Efficacy-Accelerated Approval | PRIORITY ;Orphan | ||
| 2015/10/09 | SUPPL-5（补充） | Approval | Efficacy-New Indication | PRIORITY | ||
| 2015/09/30 | SUPPL-2（补充） | Approval | Efficacy-New Indication | PRIORITY ;Orphan | ||
| 2015/04/14 | SUPPL-4（补充） | Approval | STANDARD | |||
| 2015/04/14 | SUPPL-3（补充） | Approval | STANDARD |