欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Tepmetko
适用类别Human
治疗领域Carcinoma, Non-Small-Cell Lung
通用名/非专利名称tepotinib
活性成分Tepotinib hydrochloride monohydrate
产品号EMEA/H/C/005524
患者安全信息no
授权状态Authorised
ATC编码L01EX21
是否额外监管yes
是否仿制药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
批准上市日期2022/02/16
上市许可持有人/公司名称Merck Europe B.V.
人用药物治疗分组Antineoplastic agents
审评意见发布日期2021/12/16
决定日期2023/08/31
修订号2
适应症Tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
首次发布日期2022/05/05
修订日期2023/11/20
产品信息https://www.ema.europa.eu/en/documents/product-information/tepmetko-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/tepmetko
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