欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Tarceva
适用类别Human
治疗领域Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms
通用名/非专利名称erlotinib
活性成分erlotinib
产品号EMEA/H/C/000618
患者安全信息no
授权状态Authorised
ATC编码L01EB02
是否额外监管no
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2005/09/19
上市许可持有人/公司名称Roche Registration GmbH
人用药物治疗分组Antineoplastic agents
决定日期2023/03/16
修订号32
适应症Non-small cell lung cancer (NSCLC)Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy.Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.When prescribing Tarceva, factors associated with prolonged survival should be taken into account.No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours.Pancreatic cancerTarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.When prescribing Tarceva, factors associated with prolonged survival should be taken into account.
首次发布日期2018/08/09
修订日期2023/05/16
产品信息https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/tarceva
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