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法规知识库 · EMA 集中审评

Viramune

nevirapine · EMEA/H/C/000183 · 已授权

获批上市许可

1998-02-04

欧委会决定日

2026-04-07

持有人 / 申请人

Boehringer Ingelheim International GmbH

终止日期字段

无

从产品到官方文件

文件记录

9

官方索引 9

EPAR / 审评

7

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:J05AG01

治疗领域:HIV Infections

药理分类:Antivirals for systemic use

修订号:46 · 最新影响 PI 的程序:N/0000339673

适应症(原文):Viramune 50 mg/5 mL oral suspension and 200 mg tablets Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age.Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing. Viramune 400 mg prolonged-release tablets Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children three years and above and able to swallow tablets (see section 4.2). Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used (see section 4.2). Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 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。

  1. 2026-04-07 · 欧委会决定

  2. 1998-02-04 · 获批上市许可

  3. 1997-10-22 · CHMP 意见通过

说明书、EPAR 与其他文件

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EPAR / 审评资料 7产品信息 2其他 0

EPAR / 审评资料

  • Viramune : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2026-04-07

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  • Viramune : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2026-04-07

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  • Viramune : EPAR - Medicine overview

    overview · 2025-03-04 · EMA/48208/2025

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  • Viramune-H-C-183-X-95 : EPAR - Assessment Report - Extension

    variation-report · 2011-10-27 · EMA/538380/2011

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  • Viramune : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2005-10-21

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  • Viramune : EPAR - Steps taken after authorisation when a cutoff date has been used

    steps-after-cutoff · 2005-10-21

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  • Viramune : EPAR - Scientific Discussion

    scientific-discussion · 2005-10-21

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产品信息

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。