法规知识库 · EMA 集中审评
Avonex
interferon beta-1a · EMEA/H/C/000102 · 已授权
获批上市许可
1997-03-13
欧委会决定日
2026-04-16
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
13
官方索引 13
EPAR / 审评
11
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L03AB07
治疗领域：Multiple Sclerosis
药理分类：Immunostimulants
修订号：41 · 最新影响 PI 的程序：VR/0000320809
适应症（原文）：Avonex is indicated for the treatment of: patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; Avonex slows the progression of disability and decreases the frequency of relapses; patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite MS. Avonex should be discontinued in patients who develop progressive MS.
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。
2026-04-16 · 欧委会决定
1997-03-13 · 获批上市许可
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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Avonex-VR-0000320809 : EPAR - Assessment report
variation-report · 2026-05-26 · EMADOC-1700519818-2791881
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Avonex : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-05-26
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Avonex : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-10-16
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Avonex-PAM-0000245472 : EPAR - Assessment Report - Variation
variation-report · 2025-04-10 · EMADOC-1700519818-1850245
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Avonex-H-C-102-II-0193 : EPAR - Assessment Report - Variation
variation-report · 2023-01-18 · EMA/23616/2023
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Avonex-H-C-102-II-0193 : EPAR - Assessment Report - Variation
variation-report · 2023-01-17 · EMA/220860/2022
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Avonex : EPAR - Medicine overview
overview · 2019-12-19 · EMA/685524/2019
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Avonex-H-C-102-II-0108 : EPAR - Assessment Report - Variation
variation-report · 2013-02-07 · EMA/374288/2011
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Avonex : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2006-08-16
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Avonex : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-08-16
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Avonex : EPAR - Scientific Discussion
scientific-discussion · 2006-08-16
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。