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克唑替尼(Crizotinib)在国内上市了吗
海鸥医学顾问 已帮助: 426人
2025-09-11

克唑替尼(Crizotinib)作为ALK/ROS1抑制剂已在中国上市,但需注意不同适应症的获批情况及用药安全事项,患者应通过正规渠道购买并严格遵循医嘱使用。

1 国内上市状态

(1)批准情况:克唑替尼已获得中国国家药品监督管理局批准上市,适用于ALK阳性非小细胞肺癌治疗。

(2)适应症范围:目前国内获批适应症为ALK阳性晚期NSCLC一线治疗,ROS1阳性适应症尚未正式获批。

2 用药注意事项

(1)处方要求:需凭专科医师处方在正规医疗机构购买,禁止自行调整剂量。

(2)不良反应:常见视觉障碍、胃肠道反应等,用药期间需定期监测肝功能及心电图。

3 购买渠道建议

(1)正规途径:建议通过医院药房或连锁药店购买,保留完整药品包装及发票。

(2)防伪识别:注意核对药品批准文号(国药准字H开头)、生产批号及有效期信息。Crizotinib, as an ALK/ROS1 inhibitor, has been launched in China. However, attention should be paid to the approval status and medication safety issues for different indications. Patients should purchase it through formal channels and strictly follow medical advice.

1. Domestic listing status

(1) Approval status: crizotinib has been approved for marketing by the China National Medical Products Administration and is suitable for the treatment of ALK positive non-small cell lung cancer.

(2) Scope of indications: Currently, the approved indication in China is first-line treatment for ALK positive advanced NSCLC, while the indication for ROS1 positive NSCLC has not been officially approved.

2 Medication precautions

(1) Prescription requirement: Purchase from a regular medical institution with a prescription from a specialist physician, and self adjustment of dosage is prohibited.

(2) Adverse reactions: Common visual impairments, gastrointestinal reactions, etc. Regular monitoring of liver function and electrocardiogram is required during medication.

3 Suggestions for purchasing channels

(1) Regular channels: It is recommended to purchase through hospital pharmacies or chain pharmacies, and keep the complete drug packaging and invoice.

(2) Anti counterfeiting identification: Pay attention to checking the drug approval number (starting with the Chinese medicine standard letter H), production batch number, and expiration date information.

[ 免责声明 ] 以上内容整理于FDA、DRUGS及网络,仅作信息交流使用,如需获得治疗方案指导,请前往正规医院就诊。
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