法规知识库 · EMA 集中审评
Adcetris
Brentuximab vedotin · EMEA/H/C/002455 · 已授权
获批上市许可
2012-10-25
欧委会决定日
2026-02-18
持有人 / 申请人
Takeda Pharma A/S
终止日期字段
无
从产品到官方文件
文件记录
23
官方索引 23
EPAR / 审评
21
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01FX05
治疗领域：Lymphoma, Non-Hodgkin;Hodgkin Disease
药理分类：Antineoplastic agents
修订号：38 · 最新影响 PI 的程序：VR/0000323310
适应症（原文）：Hodgkin lymphomaAdcetris is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).Adcetris is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD).Adcetris is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT).Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):- following ASCT, or- following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.Systemic anaplastic large cell lymphomaAdcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). Adcetris is indicated for the treatment of adult patients with relapsed or refractory sALCL.Cutaneous T-cell lymphomaAdcetris is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy.
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。
2026-02-18 · 欧委会决定
2012-10-25 · 获批上市许可
2012-07-19 · 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 ↗
Adcetris : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-03-20
- 打开官方文件 ↗
Adcetris : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-03-20
- 打开官方文件 ↗
Adcetris-H-C-002455-II-0111 : EPAR - Assessment report - Variation
variation-report · 2025-12-04 · EMA/324858/2025
- 打开官方文件 ↗
Adcetris : EPAR - Risk management plan
rmp · 2025-10-01
- 打开官方文件 ↗
Adcetris : EPAR - Medicine overview
overview · 2025-10-01 · EMA/146881/2025
- 打开官方文件 ↗
Adcetris : Orphan Maintenance Assessment Report (II-107)
orphan-maintenance-report-post · 2024-06-27 · EMA/OD/0000136638
- 打开官方文件 ↗
Adcetris : Orphan maintenance assessment report (II-70)
orphan-maintenance-report-post · 2024-06-27 · EMADOC-360526170-469340
- 打开官方文件 ↗
Adcetris : Orphan maintenance assessment report (II-55)
orphan-maintenance-report-post · 2024-06-27 · EMA/115413/2019
- 打开官方文件 ↗
Adcetris : Orphan maintenance assessment report (II-48)
orphan-maintenance-report-post · 2024-06-27 · EMA/977/2018
- 打开官方文件 ↗
Adcetris-H-C-002455-II-0107 : EPAR - Assessment report - Variation
variation-report · 2023-12-01 · EMA/CHMP/440104/2023
- 打开官方文件 ↗
Adcetris-H-C-002455-II-0099 : EPAR - Assessment Report - Variation
variation-report · 2022-06-21 · EMA/205567/2022
- 打开官方文件 ↗
Adcetris-H-C-PSUSA-00010039-202102 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-01-04 · EMA/570590/2021
- 打开官方文件 ↗
Adcetris-H-C-002455-II-0093 : EPAR - Assessment Report - Variation
variation-report · 2022-01-04 · EMA/754188/2021
- 打开官方文件 ↗
Adcetris : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2022-01-04 · EMA/629749/2021
- 打开官方文件 ↗
Adcetris-H-C-PSUSA-00010039-202002 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-12-18 · EMA/535271/2020
- 打开官方文件 ↗
Adcetris-H-C-002455-PSR-S-0022 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2020-08-07 · EMA/417615/2020
- 打开官方文件 ↗
Adcetris-H-C-002455-II-0070 : EPAR - Assessment Report - Variation
variation-report · 2020-06-08 · EMA/CHMP/213609/2020
- 打开官方文件 ↗
Adcetris-H-C-002455-II-0055 : EPAR - Assessment Report - Variation
variation-report · 2019-03-13 · EMA/6661/2019
- 打开官方文件 ↗
Adcetris-H-C-002455-II-0048 : EPAR - Assessment Report - Variation
variation-report · 2018-02-01 · EMA/753623/2017
- 打开官方文件 ↗
Adcetris-H-C-2455-II/0025- Assessment Report - Variation
variation-report · 2016-08-26 · EMA/CHMP/655943/2016
- 打开官方文件 ↗
Adcetris : EPAR - Public assessment report
assessment-report · 2012-11-22 · EMA/702390/2012
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。