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法规知识库 · EMA 集中审评

Imfinzi

durvalumab · EMEA/H/C/004771 · 已授权

获批上市许可

2018-09-21

欧委会决定日

2026-03-12

持有人 / 申请人

AstraZeneca AB

终止日期字段

无

从产品到官方文件

文件记录

23

官方索引 23

EPAR / 审评

20

assessment / overview 等

产品信息

3

PI / presentations

其他

0

RMP / PIP 等

ATC:L01XC28

治疗领域:Carcinoma, Non-Small-Cell Lung

药理分类:Antineoplastic agents

修订号:28 · 最新影响 PI 的程序:VR/0000282058

适应症(原文):Non-Small Cell Lung Cancer (NSCLC)Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Imfinzi as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1). Imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5.1).Imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations. Small Cell Lung Cancer (SCLC)Imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). Biliary Tract Cancer (BTC)Imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (BTC). Hepatocellular Carcinoma (HCC)Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Endometrial Cancer Imfinzi in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with: - Imfinzi as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR) - Imfinzi in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). Muscle Invasive Bladder Cancer (MIBC) Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC). Gastric or Gastro-oesophageal Junction Adenocarcinoma (GC/GEJC) Imfinzi in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, is indicated for the treatment of adults with resectable gastric or gastro‑oesophageal junction adenocarcinoma.

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。

  1. 2026-03-12 · 欧委会决定

  2. 2018-09-21 · 获批上市许可

  3. 2018-07-26 · 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 20产品信息 3其他 0

EPAR / 审评资料

  • Imfinzi-H-C-004771-II-0046 : EPAR - Assessment report - Variation

    variation-report · 2026-10-13 · EMA/29546/2023

    打开官方文件 ↗
  • Imfinzi : EPAR - Risk management plan

    rmp · 2026-05-18

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  • Imfinzi-VR-0000282058 : EPAR - Assessment report - Variation

    variation-report · 2026-05-18 · EMADOC-1700519818-2830778

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  • Imfinzi : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2026-05-18

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  • Imfinzi : EPAR - Medicine overview

    overview · 2026-05-18 · EMADOC-1829012207-42312

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  • Imfinzi-H-C-1049-WS-2463 : EPAR - Assessment Report - Variation

    variation-report · 2026-03-19 · EMA/346655/2024

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  • Imfinzi-H-C-WS2543 : EPAR - Assessment report - Variation

    variation-report · 2026-02-10 · EMA/20881/2026

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  • Imfinzi-H-C-004771-II-0073 : EPAR - Assessment report - Variation

    variation-report · 2025-07-11 · EMA/196723/2025

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  • Imfinzi : EPAR - Procedural steps taken and scientific information after authorisation (archived)

    procedural-steps-after · 2025-07-11

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  • Imfinzi-H-C-004771-II-0064 : EPAR - Assessment report - Variation

    variation-report · 2025-06-18 · EMA/100461/2025

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  • Imfinzi-H-C-004771-II-0069 : EPAR - Assessment report - Variation

    variation-report · 2025-05-16 · EMA/57978/2025

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  • Imfinzi-H-C-PSUSA-00010723-202404 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2025-02-20

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  • Imfinzi-H-C-004771-II-0057 : EPAR - Assessment report - Variation

    variation-report · 2024-06-12 · EMA/146357/2024

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  • Imfinzi-EMEA-H-C-PSUSA-00010723-202304 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2024-04-05

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  • Imfinzi-H-C-4771-II-0041 : EPAR - Assessment report - Variation

    variation-report · 2023-04-14 · EMA/42901/2023

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  • Imfinzi-H-C-4771-II-0045 : EPAR - Assessment report - Variation

    variation-report · 2023-04-14 · EMA/42902/2023

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  • Imfinzi-H-C-PSUSA-00010723-202104 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2022-04-04 · EMA/759829/2021

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  • Imfinzi-H-C-4771-II-0014-G : EPAR - Assessment Report - Variation

    variation-report · 2020-09-30 · EMA/CHMP/210563/2020

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  • Imfinzi-H-C-PSUSA-00010723-201910 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2020-08-17 · EMA/345734/2020

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  • Imfinzi : EPAR - Public assessment report

    assessment-report · 2020-02-11 · EMA/CHMP/548232/2018

    打开官方文件 ↗

产品信息

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。