法规知识库 · EMA 集中审评
Pemetrexed Pfizer (previously Pemetrexed Hospira)
pemetrexed disodium;pemetrexed disodium hemipentahydrate · EMEA/H/C/003970 · 已授权
获批上市许可
2015-11-19
欧委会决定日
2026-01-15
持有人 / 申请人
Pfizer Europe MA EEIG
终止日期字段
无
从产品到官方文件
文件记录
10
官方索引 10
EPAR / 审评
6
assessment / overview 等
产品信息
4
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：19 · 最新影响 PI 的程序：N/0000323208
适应症（原文）：Malignant pleural mesothelioma Pemetrexed Pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Pfizer 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. Pemetrexed Pfizer 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. Pemetrexed Pfizer 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.
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。
2026-01-15 · 欧委会决定
2015-11-19 · 获批上市许可
2015-09-23 · 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
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Pemetrexed Pfizer (previously Pemetrexed Hospira) : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-15
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Pemetrexed Hospira : EPAR - Summary for the public
overview · 2025-07-02
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Pemetrexed Pfizer (previously Pemetrexed Hospira) : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-04-25
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Pemetrexed Pfizer : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2021-07-28
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Pemetrexed Hospira : EPAR - Public assessment report
assessment-report · 2015-12-01 · EMA/700366/2015
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Pemetrexed Hospira : EPAR - Risk-management-plan summary
rmp-summary · 2015-12-01 · EMA/790392/2015
产品信息
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Pemetrexed Pfizer : EPAR - Product Information
product-information · 2026-01-15
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Pemetrexed Pfizer (previously Pemetrexed Hospira) : EPAR - Product information - tracked changes
product-information-tracked-changes · 2025-09-17
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Pemetrexed Pfizer (previously Pemetrexed Hospira) : EPAR - All Authorised presentations
all-authorised-presentations · 2022-09-21
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Pemetrexed Pfizer : EPAR - All Authorised presentations
all-authorised-presentations · 2021-07-28
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。