法规知识库 · EMA 集中审评
Tuzulby
methylphenidate hydrochloride · EMEA/H/C/005975 · 已授权
获批上市许可
2025-02-28
欧委会决定日
2026-08-12
持有人 / 申请人
Neuraxpharm Pharmaceuticals S.L.
终止日期字段
无
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:N06BA04
治疗领域:Attention Deficit Disorder with Hyperactivity
药理分类:Psychoanaleptics
修订号:3 · 最新影响 PI 的程序:VR/0000361747
适应症(原文):Tuzulby is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children and adolescents 6-17 years old when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria or the guidelines in International Classification of Diseases, Tenth Revision (ICD-10) and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptoms.
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。
2026-08-12 · 欧委会决定
2025-02-28 · 获批上市许可
2024-12-12 · 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
- 打开官方文件 ↗
Tuzulby : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-08-14
- 打开官方文件 ↗
Tuzulby : EPAR - Medicine overview
overview · 2025-05-08 · EMA/82768/2025
- 打开官方文件 ↗
Tuzulby : EPAR - Risk management plan
rmp · 2025-05-08
- 打开官方文件 ↗
Tuzulby : EPAR - Public assessment report
assessment-report · 2025-05-08 · EMA/19754/2025
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。