法规知识库 · EMA 集中审评
Xolair
omalizumab · EMEA/H/C/000606 · 已授权
获批上市许可
2005-10-25
欧委会决定日
2026-06-05
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
37
官方索引 37
EPAR / 审评
34
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：R03DX05
治疗领域：Asthma;Urticaria;Rhinitis
药理分类：Drugs for obstructive airway diseases
修订号：53 · 最新影响 PI 的程序：VR/0000334773
适应症（原文）：Allergic asthma Xolair is indicated in adults, adolescents and children (6 to <12 years of age). Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma. Adults and adolescents (12 years of age and older) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Children (6 to <12 years of age) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Chronic rhinosinusitis with nasal polyps (CRSwNP) Xolair is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control. Chronic spontaneous urticaria (CSU) Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.
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。
2026-06-05 · 欧委会决定
2005-10-25 · 获批上市许可
2005-07-27 · 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
- 打开官方文件 ↗
Xolair : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-06-08
- 打开官方文件 ↗
Xolair : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-28
- 打开官方文件 ↗
Xolair-H-C-000606-P46-075 : EPAR - Assessment report
variation-report · 2024-04-17 · EMA/CHMP/87036/2024
- 打开官方文件 ↗
Xolair-H-C-000606-P46-074 : EPAR - Assessment report
variation-report · 2023-11-29 · EMA/540270/2023
- 打开官方文件 ↗
Xolair-H-C-606-X-0115: EPAR - Assessment report - Extension
variation-report · 2023-11-20 · EMA/CHMP/443507/2023
- 打开官方文件 ↗
Xolair : EPAR - Risk-management-plan summary
rmp-summary · 2023-11-20
- 打开官方文件 ↗
Xolair-H-C-606-P46-073 : EPAR - Assessment Report
variation-report · 2022-05-23 · EMA/214353/2022
- 打开官方文件 ↗
Xolair-H-C-606-II-0101 : EPAR - Assessment Report - Variation
variation-report · 2020-08-24 · EMA/404869/2020
- 打开官方文件 ↗
Xolair : EPAR - Medicine overview
overview · 2020-08-24 · EMA/375834/2020
- 打开官方文件 ↗
Xolair-H-C-606-P46-062 : EPAR - Assessment Report
variation-report · 2019-08-16 · EMA/799896/2018
- 打开官方文件 ↗
Xolair-H-C-606-P46-063 : EPAR - Assessment Report
variation-report · 2019-08-16 · EMA/799955/2018
- 打开官方文件 ↗
Xolair-H-C-606-P46-064 : EPAR - Assessment Report
variation-report · 2019-08-16 · EMA/CHMP/583550/2018
- 打开官方文件 ↗
Xolair-H-C-606-P46-066 : EPAR - Assessment Report
variation-report · 2019-08-12 · EMA/137165/2019
- 打开官方文件 ↗
Xolair-H-C-606-P46-069 : EPAR - Assessment Report
variation-report · 2019-08-12 · EMA/349423/2019
- 打开官方文件 ↗
Xolair-H-C-606-P46-061 : EPAR - Assessment Report
variation-report · 2018-01-08 · EMA/607273/2017
- 打开官方文件 ↗
Xolair-H-C-606-P46-060 : EPAR - Assessment Report
variation-report · 2018-01-05 · EMA/607133/2017
- 打开官方文件 ↗
Xolair-H-C-606-P46-059 : EPAR - Assessment Report
variation-report · 2017-12-01 · EMA/793735/2017
- 打开官方文件 ↗
Xolair-H-C-606-P46-058 : EPAR - Assessment Report
variation-report · 2017-11-30 · EMA/536564/2017
- 打开官方文件 ↗
Xolair-H-C-606-P46-057 : EPAR - Assessment Report
variation-report · 2017-11-29 · EMA/600712/2017
- 打开官方文件 ↗
Xolair-H-C-606-P46-056 : EPAR - Assessment Report
variation-report · 2017-03-13 · EMA/173696/2017
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Xolair-H-C-606-P46-0055 : EPAR - Assessment Report
variation-report · 2016-12-15 · EMA/855820/2016
- 打开官方文件 ↗
Xolair-H-C-PSUSA-00002214-201512 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-10-10 · EMA/662391/2016
- 打开官方文件 ↗
Xolair-H-C-606-P46-054 : EPAR - Assessment Report
variation-report · 2016-10-07
- 打开官方文件 ↗
Xolair-H-C-606-P46-0048 : EPAR - Assessment report
variation-report · 2016-01-05 · EMA/3782/2016
- 打开官方文件 ↗
Xolair-H-C-606-P46-0049 : EPAR - Assessment report
variation-report · 2016-01-05 · EMA/3797/2016
- 打开官方文件 ↗
Xolair-H-C-606-P46-0047 : EPAR - Assessment report
variation-report · 2016-01-05 · EMA/3780/2016
- 打开官方文件 ↗
Xolair-H-C-606-P46-0045 : EPAR - Assessment Report
variation-report · 2015-12-09 · EMA/831199/2015
- 打开官方文件 ↗
Xolair-H-C-606-P46-0044 : EPAR - Assessment Report
variation-report · 2015-12-09 · EMA/831190/2015
- 打开官方文件 ↗
Xolair-H-C-606-P46-0046 : EPAR - Assessment Report
variation-report · 2015-12-09 · EMA/831200/2015
- 打开官方文件 ↗
Xolair-H-C-606-P46-039.2 : EPAR - Assessment Report
variation-report · 2014-11-12 · EMA/521869/2014
- 打开官方文件 ↗
Xolair-H-C-606-II-0048 : EPAR - Assessment Report - Variation
variation-report · 2014-04-03 · EMA/CHMP/137079/2014
- 打开官方文件 ↗
Xolair-H-C-606-II-0018 : EPAR - Assessment Report - Variation
variation-report · 2009-08-13
- 打开官方文件 ↗
Xolair : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-11-25
- 打开官方文件 ↗
Xolair : EPAR - Scientific Discussion
scientific-discussion · 2005-11-25
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。