法规知识库 · EMA 集中审评
Tysabri
natalizumab · EMEA/H/C/000603 · 已授权
获批上市许可
2006-06-27
欧委会决定日
2026-06-18
持有人 / 申请人
Biogen Netherlands B.V.
终止日期字段
无
从产品到官方文件
文件记录
21
官方索引 21
EPAR / 审评
18
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AG03
治疗领域：Multiple Sclerosis
药理分类：Monoclonal antibodies
修订号：53 · 最新影响 PI 的程序：VR/0000314828
适应症（原文）：Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: Patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
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。
2026-06-18 · 欧委会决定
2006-06-27 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Tysabri : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-07-06
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Tysabri : EPAR - Risk-management-plan
rmp · 2026-05-26
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Tysabri : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-11-14
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Tysabri : EPAR - Risk-management-plan summary
rmp-summary · 2022-09-13
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Tysabri-H-C-PSUSA-00002127-202108 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-06-08 · EMA/561269/2022
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Tysabri-H-C-PSUSA-00002127-202008 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-06-15 · EMA/158932/2021
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Tysabri-H-C-603-X-0116 : EPAR - Assessment report - Extension
variation-report · 2021-04-06 · EMA/CHMP/102816/2021
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Tysabri-H-C-PSUSA-00002127-201908 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-05-04 · EMA/160227/2020
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Tysabri : EPAR - Medicine overview
overview · 2020-05-04
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Tysabri : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2020-05-04
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Tysabri-H-C-603-II-77 : EPAR - Assessment Report - Variation
variation-report · 2016-09-07 · EMA/579064/2016
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Tysabri : EPAR - Scientific Conclusion
scientific-conclusion · 2016-05-12
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Tysabri-H-C-603-A20-1416 : EPAR - Assessment Report - Article 20
variation-report · 2016-05-12 · EMA/PRAC/171485/2016
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Tysabri-H-C-603-PSUV-0062 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-04-01 · EMA/178698/2014
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Tysabri-H-C-603-II-0059-G : EPAR - Assessment Report - Variation
variation-report · 2013-08-20 · EMA/297726/2013
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Tysabri : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2011-07-08
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Tysabri-H-C-603-A20-0029: EPAR - Assessment Report - Article 20
variation-report · 2010-08-19 · EMA/430923/2010
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Tysabri : EPAR - Scientific Discussion
scientific-discussion · 2007-05-31
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。