法规知识库 · EMA 集中审评
Striascan
ioflupane (123l) · EMEA/H/C/004745 · 已授权
获批上市许可
2019-06-25
欧委会决定日
2026-04-24
持有人 / 申请人
CIS bio international
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：V09AB03
治疗领域：Radionuclide Imaging;Dementia;Movement Disorders
药理分类：Diagnostic radiopharmaceuticals
修订号：5 · 最新影响 PI 的程序：VR/0000341575
适应症（原文）：This medicinal product is for diagnostic use only. Striascan is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum: In adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy. Striascan is unable to discriminate between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy. In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer’s disease. Striascan is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.
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。
2026-04-24 · 欧委会决定
2019-06-25 · CHMP 意见通过
2019-06-25 · 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 ↗
Striascan : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-04-24
- 打开官方文件 ↗
Striascan : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-04-24
- 打开官方文件 ↗
Striascan : EPAR - Risk Management Plan
rmp · 2024-03-12
- 打开官方文件 ↗
Striascan : EPAR - Medicine overview
overview · 2019-08-02 · EMA/410451/2019
- 打开官方文件 ↗
Striascan : EPAR - Public assessment report
assessment-report · 2019-08-02 · EMA/280752/2019
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。