法规知识库 · EMA 集中审评
Pemetrexed Baxter
pemetrexed disodium heptahydrate · EMEA/H/C/005848 · 已撤市
获批上市许可
2022-12-09
欧委会决定日
2022-12-09
持有人 / 申请人
Baxter Holding B.V.
终止日期字段
2025-05-02
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:L01BA04
治疗领域:Carcinoma, Non-Small-Cell Lung;Mesothelioma
药理分类:Antineoplastic agents
修订号:— · 最新影响 PI 的程序:—
适应症(原文):Malignant pleural mesotheliomaPemetrexed Baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancerPemetrexed Baxter in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1). Pemetrexed Baxter is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5.1). Pemetrexed Baxter is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
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。
2025-05-02 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
2022-12-09 · 欧委会决定
2022-12-09 · 获批上市许可
2022-10-13 · 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
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。