法规知识库 · EMA 集中审评
Itovebi
inavolisib · EMEA/H/C/006353 · 已授权
获批上市许可
2025-07-18
欧委会决定日
2026-04-30
持有人 / 申请人
Roche Registration GmbH
终止日期字段
无
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:—
治疗领域:Breast Neoplasms
药理分类:Antineoplastic agents;Protein kinase inhibitors
修订号:3 · 最新影响 PI 的程序:VR/0000309145
适应症(原文):Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment (see section 5.1). Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence. In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist.
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。
2026-04-30 · 欧委会决定
2025-07-18 · 获批上市许可
2025-05-22 · 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 ↗
Itovebi : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-05-08
- 打开官方文件 ↗
Itovebi : EPAR - Medicine overview
overview · 2025-08-27 · EMA/186272/2025
- 打开官方文件 ↗
Itovebi : EPAR - Risk management plan
rmp · 2025-08-27
- 打开官方文件 ↗
Itovebi : EPAR - Public assessment report
assessment-report · 2025-08-27 · EMA/CHMP/122122/2025
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。