欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Locametz
适用类别Human
治疗领域Radionuclide Imaging
通用名/非专利名称gozetotide
活性成分gozetotide
产品号EMEA/H/C/005488
患者安全信息No
许可状态Authorised
ATC编码V09I
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2022/12/09
上市许可开发者/申请人/持有人Novartis Europharm Limited 
人用药物治疗学分组Diagnostic radiopharmaceuticals
兽用药物治疗学分组
审评意见日期2022/10/13
欧盟委员会决定日期2025/03/31
修订号7
治疗适应症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).
适用物种
兽用药物ATC编码
首次发布日期2022/12/21
最后更新日期2025/09/15
产品说明书https://www.ema.europa.eu/en/documents/product-information/locametz-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/locametz
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