法规知识库 · EMA 集中审评
Tarceva
erlotinib · EMEA/H/C/000618 · 已授权
获批上市许可
2005-09-19
欧委会决定日
2025-03-04
持有人 / 申请人
Cheplapharm Registration GmbH
终止日期字段
无
从产品到官方文件
文件记录
15
官方索引 15
EPAR / 审评
13
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01EB02
治疗领域：Carcinoma, Non-Small-Cell Lung;Pancreatic Neoplasms
药理分类：Antineoplastic agents
修订号：34 · 最新影响 PI 的程序：VR/0000256063
适应症（原文）：Non-small cell lung cancer (NSCLC) Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy. Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours. Pancreatic cancer Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer. When prescribing Tarceva, factors associated with prolonged survival should be taken into account.
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。
2025-03-04 · 欧委会决定
2005-09-19 · 获批上市许可
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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Tarceva : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-03-05
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Tarceva : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-03-05
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Tarceva-H-C-PSUSA-1255-202111 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2023-04-17 · EMA/173328/2023
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Tarceva : EPAR - Risk-management plan
rmp · 2019-04-24
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Tarceva : EPAR - Medicine overview
overview · 2019-04-24 · EMA/841615/2018
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Tarceva-H-C-618-II-0051 : EPAR - Assessment Report - Variation
variation-report · 2018-03-26 · EMA/184796/2018
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Tarceva-H-C-618-II-0043 : EPAR - Assessment Report - Variation
variation-report · 2016-03-09 · EMA/CHMP/816728/2015
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Tarceva-H-C-618-PSU-0020 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2013-10-09 · EMA/CHMP/349608/2013
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Tarceva-H-C-618-II-0020 : EPAR - Assessment Report - Variation
variation-report · 2011-11-14 · EMA/657134/2011
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Tarceva-H-C-618-II-0017 : EPAR - Assessment Report - Variation
variation-report · 2010-05-19 · EMA/CHMP/298837/2010
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Tarceva-H-C-618-II-0002 : EPAR - Assessment Report - Variation
variation-report · 2007-03-29
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Tarceva : EPAR - Scientific Discussion
scientific-discussion · 2005-11-03
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Tarceva : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-11-03
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。