法规知识库 · EMA 集中审评
Tafinlar
dabrafenib mesilate · EMEA/H/C/002604 · 已授权
获批上市许可
2013-08-26
欧委会决定日
2026-04-30
持有人 / 申请人
Novartis Europharm Limited
终止日期字段
无
从产品到官方文件
文件记录
19
官方索引 19
EPAR / 审评
16
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01EC02
治疗领域：Melanoma
药理分类：Antineoplastic agents
修订号：40 · 最新影响 PI 的程序：VR/0000278305
适应症（原文）：Melanoma Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection. Non-small cell lung cancer (NSCLC) Dabrafenib in combination with trametinib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation. Differentiated thyroid cancer (DTC) Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).
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。
2026-04-30 · 欧委会决定
2013-08-26 · 获批上市许可
2013-06-27 · 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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Tafinlar : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2026-05-19 · EMADOC-1700519818-3039069
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Tafinlar-VR-0000271728 : EPAR - Assessment report - Variation
variation-report · 2026-05-19 · EMADOC-1700519818-2637645
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Tafinlar-VR-0000278305 : EPAR - Assessment report - Variation
variation-report · 2026-05-19 · EMADOC-1700519818-2934719
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Tafinlar : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-05-19
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Tafinlar : EPAR - Risk management plan
rmp · 2026-05-19
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Tafinlar : EPAR - Medicine overview
overview · 2026-05-19 · EMADOC-1829012207-48585
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Tafinlar-H-C-PSUSA-00010084-202505 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-04-09
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Tafinlar : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-07-23
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Tafinlar-H-C-PSUSA-00010084-202405 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-06-17 · EMA/154380/2025
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Tafinlar-PSUSA-00010084-201808: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-06-04 · EMA/271621/2019
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Tafinlar -H-C-WS-1274: EPAR - Assessment Report - Variation
variation-report · 2018-09-11 · EMA/550929/2019
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Tafinlar-H-C-PSUSA-00010084-201608 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2017-06-21 · EMA/395587/2017
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Tafinlar-H-C-WS-0996 : EPAR - Assessment Report - Variation
variation-report · 2017-05-22 · EMA/240244/2017
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Tafinlar-H-C-2604-WS-0736 : EPAR - Assessment Report - Variation
variation-report · 2015-11-03 · EMA/589140/2015
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Tafinlar-H-C-2604-PSUV-0005: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-01-22 · EMA/CHMP/750482/2014
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Tafinlar : EPAR - Public assessment report
assessment-report · 2013-09-18 · EMA/CHMP/242419/2013
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。