| 商品名称 | Tagrisso |
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| 适用类别 | Human |
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| 治疗领域 | Carcinoma, Non-Small-Cell Lung |
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| 通用名/非专利名称 | osimertinib |
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| 活性成分 | osimertinib mesilate |
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| 产品号 | EMEA/H/C/004124 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | L01XE |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | No |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | Yes |
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| 是否罕用药 | No |
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| 上市许可日期 | 2016/02/01 |
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| 上市许可开发者/申请人/持有人 | AstraZeneca AB |
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| 人用药物治疗学分组 | Other antineoplastic agents;Protein kinase inhibitors |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2015/12/17 |
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| 欧盟委员会决定日期 | 2025/12/03 |
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| 修订号 | 23 |
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| 治疗适应症 | TAGRISSO as monotherapy is indicated for: the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1). the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum‑based chemoradiation therapy. the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. TAGRISSO is indicated in combination with: pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2018/08/31 |
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| 最后更新日期 | 2025/12/04 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tagrisso |
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