法规知识库 · EMA 集中审评
Yervoy
Ipilimumab · EMEA/H/C/002213 · 已授权
获批上市许可
2011-07-13
欧委会决定日
2026-05-07
持有人 / 申请人
Bristol-Myers Squibb Pharma EEIG
终止日期字段
无
从产品到官方文件
文件记录
31
官方索引 31
EPAR / 审评
29
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01FX04
治疗领域：Melanoma;Carcinoma, Renal Cell;Carcinoma, Non-Small-Cell Lung;Mesothelioma, Malignant;Colorectal Neoplasms
药理分类：Antineoplastic agents
修订号：60 · 最新影响 PI 的程序：VR/0000319172
适应症（原文）：Melanoma Yervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4). Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Renal cell carcinoma (RCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Non-small cell lung cancer (NSCLC) Yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Malignant pleural mesothelioma (MPM) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) Yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability high colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer; treatment of metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5.1). Oesophageal squamous cell carcinoma (OSCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.Hepatocellular carcinoma (HCC) Yervoy in combination with nivolumab is indicated for the first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2026-05-07 · 欧委会决定
2011-07-13 · 获批上市许可
2011-05-19 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
- 打开官方文件 ↗
Yervoy : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-06-24
- 打开官方文件 ↗
Yervoy : EPAR - Risk management plan
rmp · 2026-06-24
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Yervoy-H-C-WS-2717 : EPAR - Assessment Report - Variation
variation-report · 2025-03-17 · EMA/CHMP/59173/2025
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Yervoy : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-03-17
- 打开官方文件 ↗
Yervoy : EPAR - Medicine overview
overview · 2025-03-17 · EMA/85145/2025
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Yervoy-H-C-WS2672 : EPAR - Assessment Report - Variation
variation-report · 2025-01-13 · EMA/CHMP/554847/2024
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Yervoy-H-C-002213-II-0100 : EPAR - Assessment report - Variation
variation-report · 2023-06-15 · EMA/221125/2023
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Yervoy-H-C-WS2113 : EPAR - Assessment Report - Variation
variation-report · 2022-04-20 · EMA/155438/2022
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Yervoy-H-C-PSUSA-00009200-202103 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-01-24 · EMA/760060/2021
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Yervoy-H-C-002213-P46-043 : EPAR - Assessment Report
variation-report · 2021-07-21 · EMA/400368/2021
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Yervoy-H-C-002213-WS-1840 : EPAR Assessment Report - Variation
variation-report · 2021-06-29 · EMA/314215/2021
- 打开官方文件 ↗
Yervoy-H-C-002213-P46-042 : EPAR - Assessment Report
variation-report · 2021-06-18 · EMA/CHMP/125573/2021
- 打开官方文件 ↗
Yervoy-H-C-WS-1881 : EPAR Assessment Report - Variation
variation-report · 2021-06-16 · EMA/CHMP/260350/2021
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Yervoy-H-C-PSUSA-00009200-202003 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-01-18 · EMA/584901/2020
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Yervoy-H-C-WS-1783 : EPAR - Assessment Report - Variation
variation-report · 2020-11-20 · EMA/CHMP/603938/2020
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Yervoy-H-C-PSUSA-00009200-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-12-20 · EMA/CHMP/679440/2019
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Yervoy-H-C-002213-WS-1278 : EPAR - Assessment Report - Variation
variation-report · 2019-01-22 · EMA/902855/2019
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Yervoy-H-C-2213-II-0055 : EPAR - Assessment Report - Variation
variation-report · 2018-06-05 · EMA/291536/2018
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Yervoy : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2018-01-29 · EMA/192236/2017
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Yervoy-H-C-002213-II-0044 : EPAR - Assessment Report - Variation
variation-report · 2018-01-29 · EMA/6592/2018
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Yervoy-H-C-PSUSA-00009200-201703 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-01-12 · EMA/23883/2018
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Yervoy-H-C-2213-P46-034.1 : EPAR - Assessment Report
variation-report · 2017-09-28 · EMA/CHMP/513045/2017
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Yervoy-H-C-PSUSA-00009200-201503: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-02-01 · EMA/765899/2015
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Yervoy-H-C-PSUSA-00009200-201409 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-08-26 · EMA/CHMP/332517/2015
- 打开官方文件 ↗
Yervoy-H-C-2213-P46-0032 : EPAR - Assessment Report
variation-report · 2015-03-24 · EMA/CHMP/195973/2015
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Yervoy-H-C-2213-PSUV-0020 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-03-11 · EMA/110752/2014
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Yervoy-H-C-2213-II-0008 : EPAR - Assessment Report - Variation
variation-report · 2013-12-05 · EMA/603930/2013
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Yervoy : EPAR - Public assessment report
assessment-report · 2011-07-25
- 打开官方文件 ↗
Yervoy : EPAR - Conditions imposed on member states for safe and effective use
conditions-member-states · 2011-07-25
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。