法规知识库 · EMA 集中审评
Thalidomide BMS (previously Thalidomide Celgene)
thalidomide · EMEA/H/C/000823 · 已授权
获批上市许可
2008-04-16
欧委会决定日
2025-01-21
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
12
官方索引 12
EPAR / 审评
10
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AX02
治疗领域：Multiple Myeloma
药理分类：Immunosuppressants
修订号：33 · 最新影响 PI 的程序：N/0080
适应症（原文）：Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. Thalidomide BMS is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).
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。
2025-01-21 · 欧委会决定
2008-04-16 · 获批上市许可
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 ↗
Thalidomide BMS (previously Thalidomide Celgene) : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-01-22
- 打开官方文件 ↗
Thalidomide Celgene : EPAR - Risk management plan
rmp-summary · 2024-03-19
- 打开官方文件 ↗
Thalidomide BMS (previously Thalidomide Celgene) : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2023-11-30
- 打开官方文件 ↗
Thalidomide BMS (previously Thalidomide Celgene) : EPAR - Medicine overview
overview · 2022-06-30 · EMA/58328/2022
- 打开官方文件 ↗
Thalidomide Celgene-H-C-PSUSA-00002919-202010 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-07-29 · EMA/422464/2021
- 打开官方文件 ↗
Thalidomide Celgene-H-C-PSUSA-00002919-201910: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-10-09 · EMA/492111/2020
- 打开官方文件 ↗
Thalidomide Celgene-H-C-PSUSA-00002919-201810: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-08-19 · EMA/461960/2019
- 打开官方文件 ↗
Thalidomide Celgene-H-C-PSUSA-00002919-201710: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-08-17 · EMA/558621/2018
- 打开官方文件 ↗
Thalidomide Celgene (previously Thalidomide Pharmion)-H-C-PSUSA-00002919-201510: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-10-25 · EMA/342411/2016
- 打开官方文件 ↗
Thalidomide Celgene : EPAR - Public assessment report
assessment-report · 2008-05-19
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。