甲磺酸伊马替尼片 | China Drugs ListImatinib tablets | China Drugs List
本页为公开参考信息，不构成医疗建议、处方或药品供应要约。请向持证专业人士确认当前批准情况、可获得性及适用性。
其他
- 商品名
- Gleevec / Glivec
- 企业
- Novartis Europharm Limited (欧盟上市许可持有人)Novartis Europharm Limited (EU authorization holder)
- 药品类型
- 化学药Chemical medicine
- 治疗领域
- 肿瘤科Oncology
- 公开来源记录的适应症
- 欧盟来源摘要：部分用途包括费城染色体阳性慢性髓性白血病；与化疗联合用于新诊断Ph阳性急性淋巴细胞白血病，或单药用于成人复发/难治性疾病；伴PDGFR重排的骨髓增生异常/骨髓增殖性疾病；FIP1L1-PDGFR-α相关高嗜酸性粒细胞综合征或慢性嗜酸性粒细胞白血病；KIT阳性不可切除/转移性胃肠间质瘤，以及复发风险显著时的辅助治疗；和特定不可切除或复发/转移性隆突性皮肤纤维肉瘤。年龄及既往治疗要求因适应症不同。European Union source summary: Selected uses include Philadelphia-chromosome-positive chronic myeloid leukemia; newly diagnosed Ph-positive acute lymphoblastic leukemia with chemotherapy, or relapsed/refractory adult disease as monotherapy; PDGFR-rearranged myelodysplastic/myeloproliferative disease; FIP1L1-PDGFR-alpha-associated hypereosinophilic syndrome or chronic eosinophilic leukemia; KIT-positive unresectable/metastatic gastrointestinal stromal tumors and adjuvant treatment when relapse risk is significant; and specified unresectable or recurrent/metastatic dermatofibrosarcoma protuberans. Age and prior-treatment requirements vary by indication.
- 适应症来源与口径
- 欧盟产品资料 查阅于 2026年11月2日； 未单独提取确切修订日期. 部分境外适应症；不确立中国批准范围。European Union product information accessed 2 November 2026; exact revision date not separately extracted.. Selected overseas indications; does not establish the Chinese approved scope.
- 说明书信息局限
- 已链接境外官方处方资料；尚未核实完整的现行中国说明书。Overseas official prescribing information linked; a complete current Chinese label has not been verified.
- 中国可获得性状态
- 本次英文来源核查未独立核实中国批准、现行批准适应症及持续在售情况。Chinese approval, current approved indications and continuous market availability have not been independently verified in this English-source review.
- 海外状态
- 请参阅所链接的境外监管机构或厂商证据。批准及适应症因司法辖区而异；尚未确认当前供应情况。See the linked overseas regulator / manufacturer evidence. Approval and indications are jurisdiction-specific; current supply is not established.
- 医保分类
- 尚未核实Not yet verified
- 医保版本
- 中国国家医保信息待核实Chinese national insurance review pending
- 医保核查说明
- 本次新增记录尚未确定报销资格；缺少信息不代表未被纳入。No reimbursement determination was made for this addition; missing information is not proof of exclusion.
来源
- https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf
- Gleevec / Glivec——欧盟官方产品资料Gleevec / Glivec — official European Union product information
Official prescribing information · European Union product information accessed 2 November 2026; exact revision date not separately extracted.
已打开完整官方PDF，并核对药品身份及相关适应症文字。此境外来源不确立中国批准范围。Full official PDF opened; medicine identity and relevant indication text checked. This overseas source does not establish the Chinese approved scope.
- Glivec——EMA评估和产品概述Glivec — EMA assessment and product overview
Regulatory product overview · Accessed 2 November 2026
英文监管资料；所列许可持有人对应欧盟产品，并非中国仿制药或生物类似药。English regulatory reference; authorization holder is identified for the EU product, not a Chinese generic or biosimilar.
证据核查日期：