跳到正文

法规知识库 · EMA 集中审评

Tizveni

tislelizumab · EMEA/H/C/005542 · 已撤市

额外监测

获批上市许可

2024-04-19

欧委会决定日

未记录

持有人 / 申请人

BeiGene Ireland Ltd

终止日期字段

无

从产品到官方文件

文件记录

5

官方索引 5

EPAR / 审评

3

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:L01FF09

治疗领域:Carcinoma, Non-Small-Cell Lung

药理分类:Antineoplastic agents

修订号:— · 最新影响 PI 的程序:—

适应症(原文):Non-small cell lung cancer (NSCLC)Tizveni in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous non-small cell lung cancer whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have:• locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or• metastatic NSCLC.Tizveni in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous non-small cell lung cancer who have:• locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or• metastatic NSCLC.Tizveni as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.

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。

  1. 2024-04-19 · 获批上市许可

  2. 2024-02-22 · 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 3产品信息 2其他 0

EPAR / 审评资料

产品信息

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。