法规知识库 · EMA 集中审评
Tizveni
tislelizumab · EMEA/H/C/005542 · 已撤市
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。
2024-04-19 · 获批上市许可
2024-02-22 · CHMP 意见通过
说明书、EPAR 与其他文件
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EPAR / 审评资料
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