法规知识库 · EMA 集中审评
Edurant
rilpivirine hydrochloride · EMEA/H/C/002264 · 已授权
获批上市许可
2011-11-28
欧委会决定日
2025-04-11
持有人 / 申请人
未知
终止日期字段
无
从产品到官方文件
文件记录
10
官方索引 10
EPAR / 审评
8
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:J05AG05
治疗领域:HIV Infections
药理分类:Antivirals for systemic use
修订号:22 · 最新影响 PI 的程序:N/0000265340
适应症(原文):EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in paediatric patients 2 to less than 18 years of age and weighing at least 14 kg to less than 25 kg without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, and with a viral load ≤ 100,000 HIV 1 RNA copies/ml (see sections 4.4 and 5.1).Genotypic resistance testing should guide the use of EDURANT (see sections 4.4 and 5.1).EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults and paediatric patients weighing at least 25 kg without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, and with a viral load ≤ 100,000 HIV 1 RNA copies/ml (see sections 4.4 and 5.1).Genotypic resistance testing should guide the use of EDURANT (see sections 4.4 and 5.1).
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。
2025-04-11 · 欧委会决定
2011-11-28 · 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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Edurant : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-04-11
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Edurant : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-04-11
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Edurant-H-C-002264-X-0042-G : EPAR - Assessment report
variation-report · 2024-10-23 · EMA/375172/2024
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Edurant-H-C-002264-P46-029 : Assessment report - Variation
variation-report · 2024-10-23 · EMA/319401/2023
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Edurant : EPAR - Risk management plan
rmp · 2024-10-23
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Edurant : EPAR - Medicine overview
overview · 2024-10-23 · EMA/365082/2024
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Edurant-H-C-002264-II-0017-G : EPAR - Assessment Report - Variation
variation-report · 2016-01-22 · EMA/742847/2015
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Edurant : EPAR - Public assessment report
assessment-report · 2011-12-12
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。