法规知识库 · EMA 集中审评
Baraclude
Entecavir · EMEA/H/C/000623 · 已授权
获批上市许可
2006-06-26
欧委会决定日
2025-12-03
持有人 / 申请人
Bristol-Myers Squibb Pharma EEIG
终止日期字段
无
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
9
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：J05AF10
治疗领域：Hepatitis B, Chronic
药理分类：Antivirals for systemic use
修订号：30 · 最新影响 PI 的程序：N/0000313870
适应症（原文）：Baraclude 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.
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。
2025-12-03 · 欧委会决定
2006-06-26 · 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
- 打开官方文件 ↗
Baraclude : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-12-03
- 打开官方文件 ↗
Baraclude : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-12-03
- 打开官方文件 ↗
Baraclude : EPAR - Risk-management-plan
rmp-summary · 2024-08-16
- 打开官方文件 ↗
Baraclude : EPAR - Summary for the public
overview · 2014-09-29
- 打开官方文件 ↗
Baraclude-H-C-623-II-0041 : EPAR - Assessment Report - Variation
variation-report · 2014-09-17
- 打开官方文件 ↗
Baraclude : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2014-09-17
- 打开官方文件 ↗
Baraclude-H-C-623-II-0033 : EPAR - Assessment Report - Variation
variation-report · 2011-04-07 · EMA/CHMP/794988/2010
- 打开官方文件 ↗
Baraclude : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2007-05-21
- 打开官方文件 ↗
Baraclude : EPAR - Scientific Discussion
scientific-discussion · 2007-05-21
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。