法规知识库 · EMA 集中审评
Eylea
aflibercept · EMEA/H/C/002392 · 已授权
获批上市许可
2012-11-21
欧委会决定日
2026-09-18
持有人 / 申请人
Bayer AG
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：S01LA05
治疗领域：Wet Macular Degeneration;Macular Edema;Diabetes Complications;Retinal Vein Occlusion;Choroidal Neovascularization
药理分类：Ophthalmologicals
修订号：41 · 最新影响 PI 的程序：PSUR/0000336116
适应症（原文）：Eylea 114.3 mg/ml solution for injection and Eylea 114.3 mg/ml solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to diabetic macular oedema (DME) visual impairment due to macular oedema secondary to retinal vein occlusion (branch, central and hemiretinal RVO) Eylea 40 mg/mL solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV) Eylea is indicated in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease Eylea 40 mg/mL solution for injection in a vial Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV)
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。
2026-09-18 · 欧委会决定
2012-11-21 · 获批上市许可
2012-09-20 · 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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Eylea-PSUSA-00010020-202511 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-10-19 · EMADOC-1700519818-3486486
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Eylea : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-19
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Eylea-PAM-0000335684 : EPAR - Assessment report
variation-report · 2026-08-21 · EMADOC-1700519818-2998842
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Eylea-VR-0000264981 : EPAR - Assessment Report - Variation
variation-report · 2026-03-04 · EMADOC-1700519818-2706650
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Eylea : EPAR - Risk management plan
rmp-summary · 2026-03-04
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Eylea : EPAR - Medicine overview
overview · 2026-03-04 · EMADOC-1829012207-38698
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Eylea : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-06-27
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Eylea-H-C-2392-X-84-G : EPAR - Assessment Report - Variation
variation-report · 2024-01-09 · EMA/538733/2023
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Eylea-H-C-002392-II-0077-G : EPAR - Assessment report - Variation
variation-report · 2023-02-10 · EMA/44020/2023
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Eylea-H-C-002392-P46-020 : EPAR - Assessment report
variation-report · 2021-11-26 · EMA/605744/2021
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Eylea-H-C-PSUSA-00010020-201911 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-10-12 · EMA/445138/2020
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Eylea-H-C-PSUSA-00010020-201511 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-08-24 · EMA/412133/2016
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Eylea-H-C-2392-II-0021 : EPAR - Assessment Report - Variation
variation-report · 2015-12-09 · EMA/758988/2015
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Eylea-H-C-2392-II-0013 : EPAR - Assessment Report - Variation
variation-report · 2015-04-20 · EMA/CHMP/13670/2015
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Eylea-H-C-2392-II-0001 : EPAR - Assessment Report - Variation
variation-report · 2015-02-13 · EMA/470036/2013
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Eylea-H-C-2392-II-0009 : EPAR - Assessment Report - Variation
variation-report · 2014-09-15
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Eylea-H-C-2392-PSUV-0011 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-08-28 · EMA/521961/2014
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Eylea : EPAR - Public assessment report
assessment-report · 2013-02-21 · EMA/646256/2012 corr
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。