法规知识库 · EMA 集中审评
Ultomiris
ravulizumab · EMEA/H/C/004954 · 已授权
获批上市许可
2019-07-02
欧委会决定日
2026-06-25
持有人 / 申请人
Alexion Europe SAS
终止日期字段
无
从产品到官方文件
文件记录
16
官方索引 16
EPAR / 审评
13
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AA43
治疗领域：Hemoglobinuria, Paroxysmal
药理分类：Selective immunosuppressants
修订号：21 · 最新影响 PI 的程序：VR/0000341147
适应症（原文）：Paroxysmal nocturnal haemoglobinuria (PNH)Ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with PNH:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity.- in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5.1). Atypical haemolytic uremic syndrome (aHUS)Ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with aHUS who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5.1). Generalized myasthenia gravis (gMG)Ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive. Neuromyelitis Optica Spectrum Disorder (NMOSD)Ultomiris is indicated in the treatment of adult patients with NMOSD who are anti-aquaporin 4 (AQP4) antibody-positive (see section 5.1). Ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity.- in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. Ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.
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。
2026-06-25 · 欧委会决定
2019-07-02 · 获批上市许可
2019-04-26 · 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
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Ultomiris : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-07-21
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Ultomiris-PAM-0000316561 : EPAR - Assessment report
variation-report · 2026-06-09 · EMADOC-1700519818-2802866
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Ultomiris : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-06-19
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Ultomiris : EPAR - Risk management plan
rmp-summary · 2025-06-19
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Ultomiris-H-C-004954-X-0027-G : EPAR - Assessment report - Extension
variation-report · 2023-07-27 · EMA/201701/2023
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Ultomiris : EPAR - Medicine overview
overview · 2023-07-19 · EMA/162681/2023
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Ultomiris-H-C-004954-II-0032 : EPAR - Assessment report - Variation
variation-report · 2023-07-12 · EMA/182657/2023
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Ultomiris-H-C-004954-II-0026 : EPAR - Assessment report - Variation
variation-report · 2022-11-23 · EMA/686052/2022
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Ultomiris-H-C-PSUSA-00010787-202106 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-04-29 · EMA/208358/2022
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Ultomiris-H-C-004954-II-0010 : EPAR - Assessment report - Variation
variation-report · 2021-11-30 · EMA/552844/2021
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Ultomiris-H-C-004954-II-0002 : EPAR - Assessment report - Variation
variation-report · 2020-07-15 · EMA/280465/2020
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Ultomiris : Orphan designation withdrawal assessment report (initial authorisation)
orphan-maintenance-report · 2019-07-11 · EMADOC-2005359794-76678
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Ultomiris : EPAR - Public assessment report
assessment-report · 2019-07-10 · EMA/CHMP/220699/2019
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。