法规知识库 · EMA 集中审评
Locametz
gozetotide · EMEA/H/C/005488 · 已授权
获批上市许可
2022-12-09
欧委会决定日
2026-07-08
持有人 / 申请人
Novartis Europharm 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:V09I
治疗领域:Radionuclide Imaging
药理分类:Diagnostic radiopharmaceuticals
修订号:8 · 最新影响 PI 的程序:N/0000359157
适应症(原文):This medicinal product is for diagnostic use only. Locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high risk PCa prior to primary curative therapy, Suspected PCa recurrence in patients with increasing levels of serum prostate specific antigen (PSA) after primary curative therapy, Identification of patients with PSMA positive progressive metastatic castration resistant prostate cancer (mCRPC) for whom PSMA targeted therapy is indicated (see section 4.4).
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。
2026-07-08 · 欧委会决定
2022-12-09 · 获批上市许可
2022-10-13 · 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 ↗
Locametz: EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-07-09
- 打开官方文件 ↗
Locametz: EPAR - Risk management plan
rmp · 2025-09-15
- 打开官方文件 ↗
Locametz: EPAR - Public assessment report
assessment-report · 2025-05-22 · EMA/871509/2022
- 打开官方文件 ↗
Locametz: EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-02-13
- 打开官方文件 ↗
Locametz: EPAR - Medicine overview
overview · 2022-12-21
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。