跳到正文

法规知识库 · EMA 集中审评

Entecavir Viatris (previously Entecavir Mylan)

entecavir monohydrate · EMEA/H/C/004377 · 已授权

仿制药

获批上市许可

2017-09-18

欧委会决定日

2026-09-21

持有人 / 申请人

Viatris Limited

终止日期字段

无

从产品到官方文件

文件记录

7

官方索引 7

EPAR / 审评

5

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:J05AF10

治疗领域:Hepatitis B

药理分类:Antivirals for systemic use

修订号:13 · 最新影响 PI 的程序:VR/0000371212

适应症(原文):Entecavir Viatris is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. decompensated liver disease. For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.Entecavir Viatris is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients.

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. 2026-09-21 · 欧委会决定

  2. 2017-09-18 · 获批上市许可

  3. 2017-05-18 · 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 5产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-09-21

    打开官方文件 ↗
  • Entecavir Viatris : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2025-03-10

    打开官方文件 ↗
  • Entecavir Mylan : EPAR - Risk-management-plan summary

    rmp-summary · 2022-07-29

    打开官方文件 ↗
  • Entecavir Mylan : EPAR - Summary for the public

    overview · 2017-10-26

    打开官方文件 ↗
  • Entecavir Mylan : EPAR - Public assessment report

    assessment-report · 2017-10-10 · EMA/555410/2017

    打开官方文件 ↗

产品信息

  • Entecavir Viatris : EPAR - Product Information

    product-information · 2026-09-21

    打开官方文件 ↗
  • Entecavir Viatris (previously Entecavir Mylan) : EPAR - All Authorised presentations

    all-authorised-presentations · 2024-01-16

    打开官方文件 ↗

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。