法规知识库 · EMA 集中审评
Tasmar
tolcapone · EMEA/H/C/000132 · 已授权
获批上市许可
1997-08-27
欧委会决定日
2025-09-08
持有人 / 申请人
Viatris Healthcare Limited
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：N04BX01
治疗领域：Parkinson Disease
药理分类：Anti-Parkinson drugs;Other dopaminergic agents
修订号：26 · 最新影响 PI 的程序：VR/0000294075
适应症（原文）：Tasmar is indicated in combination with levodopa / benserazide or levodopa / carbidopa for use in patients with levodopa-responsive idiopathic Parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-O-methyltransferase (COMT) inhibitors. Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first-line adjunct therapy to levodopa / benserazide or levodopa / carbidopa. Since Tasmar should be used only in combination with levodopa / benserazide and levodopa / carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar.
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。
2025-09-08 · 欧委会决定
1997-08-27 · 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 ↗
Tasmar : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-09-10
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Tasmar : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-09-10
- 打开官方文件 ↗
Tasmar : EPAR - Summary for the public
overview · 2014-07-28
- 打开官方文件 ↗
Tasmar : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-01-25
- 打开官方文件 ↗
Tasmar : EPAR - Scientific Discussion
scientific-discussion · 2006-01-25
- 打开官方文件 ↗
Tasmar : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2006-01-25
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。