法规知识库 · EMA 集中审评
Nucala
Mepolizumab · EMEA/H/C/003860 · 已授权
获批上市许可
2015-12-01
欧委会决定日
2026-07-21
持有人 / 申请人
GlaxoSmithKline Trading Services Limited
终止日期字段
无
从产品到官方文件
文件记录
27
官方索引 27
EPAR / 审评
25
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：R03DX09
治疗领域：Asthma
药理分类：Drugs for obstructive airway diseases
修订号：29 · 最新影响 PI 的程序：VR/0000357265
适应症（原文）：Severe eosinophilic asthma Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older . Chronic rhinosinusitis with nasal polyps (CRSwNP) Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. Eosinophilic granulomatosis with polyangiitis (EGPA) Nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA). Hypereosinophilic syndrome (HES) Nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.
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。
2026-07-21 · 欧委会决定
2015-12-01 · 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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Nucala : EPAR - Medicine overview
overview · 2026-09-18 · EMA/532586/2021
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Nucala-PAM-0000324417 : EPAR - Assessment report
variation-report · 2026-08-19 · EMADOC-1700519818-2857977
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Nucala-PAM-0000336241 : EPAR - Assessment report
variation-report · 2026-08-19 · EMADOC-1700519818-2988231
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Nucala : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-07-22
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Nucala-PAM-0000327347 : EPAR - Assessment report
variation-report · 2026-06-16 · EMADOC-1700519818-2898731
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Nucala-VR-0000257645 : EPAR - Assessment report - Variation
variation-report · 2026-03-09 · EMADOC-1700519818-2683842
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Nucala : EPAR - Risk management plan
rmp · 2026-03-09
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Nucala : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-12-04
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Nucala-H-C-003860-P46-020 : EPAR - Assessment report
variation-report · 2025-07-07 · EMADOC-1700519818-2025831
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Nucala-H-C-003860-P46-019 : EPAR - Assessment report
variation-report · 2024-11-07 · EMA/511946/2024
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Nucala-H-C-003860-P46-018 : EPAR - Assessment report
variation-report · 2024-11-05 · EMA/CHMP/216873/2024
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Nucala-H-C-3860-P046-020 : EPAR - Assessment Report
variation-report · 2024-10-24 · EMA/CHMP/346428/2024
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Nucala-H-C-PSUSA-00010456-202309: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-07-16 · EMA/331057/2024
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Nucala-H-C-003860-II-0036-G : EPAR - Assessment Report - Variation
variation-report · 2022-03-29 · EMA/560927/2021 Corr. 1
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Nucala-H-C-003860-II-0035 : EPAR - Assessment Report - Variation
variation-report · 2021-12-13 · EMA/560926/2021
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Nucala-H-C-003860-II-0037 : EPAR - Assessment Report - Variation
variation-report · 2021-12-13 · EMA/560938/2021
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Nucala-H-C-3860-X-0018 : EPAR - Assessment Report - Variation
variation-report · 2019-09-20 · EMA/341490/2019
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Nucala-H-C-3860-P046-003 : EPAR - Assessment Report
variation-report · 2019-02-27 · EMA/731252/2018
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Nucala-H-C-3860-P46-010 : EPAR - Assessment Report
variation-report · 2018-11-21 · EMA/CHMP/671006/2018
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Nucala-H-C-3860-II-0013-G : EPAR - Assessment Report - Variation
variation-report · 2018-10-22 · EMA/CHMP/547698/2018
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Nucala : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2018-10-08 · EMA/492325/2018
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Nucala-H-C-3860-P46-007 : EPAR - Assessment Report
variation-report · 2018-03-15 · EMA/45109/2018
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Nucala-H-C-3860-P046-006 : EPAR - Assessment Report
variation-report · 2018-01-30 · EMA/58724/2018
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Nucala-H-C-3860-P046-005 : EPAR - Assessment Report
variation-report · 2017-04-18 · EMA/235571/2017
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Nucala : EPAR - Public assessment report
assessment-report · 2016-01-12 · EMA/CHMP/672504/2015 Rev. 1
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。