WHO 发布第 2/2026 号医疗产品警报：三批伪造 JAKAVI（ruxolitinib）
Medical Product Alert N°2/2026: Falsified JAKAVI (ruxolitinib)
WHO 发布第 2/2026 号医疗产品警报，涉及在伊朗、俄罗斯和土耳其发现的三批伪造 JAKAVI（ruxolitinib）。原厂诺华确认批号 AVT50、FNR06、SGL04 并非正品，其中在土耳其检出的 JAKAVI 20 mg（AVT50）样品经检测不含标示的活性成分芦可替尼。这些产品经线上平台非法售予患者，至少有一例由药房提供，相关情况于 2026 年 5 月报告给 WHO。
警报列出三批伪药的批号与已确认的成分缺失，并指出其经线上平台及药房流入患者，可供流通环节核对。
Alert Summary
This WHO Medical Product Alert refers to three batches of falsified JAKAVI (ruxolitinib). These falsified products have been detected in the Islamic Republic of Iran, the Russian Federation and Türkiye and reported to WHO in May 2026. The falsified products have been illicitly sold to patients via online platforms and, in at least one instance, have also been supplied to patients from a pharmacy.
JAKAVI (ruxolitinib) is a medicine used in oncology to treat certain serious blood diseases and complications following stem cell transplantation.
How to identify these falsified products
These products are considered falsified as they deliberately misrepresent their identity, composition, and source.
The genuine manufacturer (NOVARTIS) has confirmed that the batch numbers observed on these falsified products are not valid. Specifically, the batch numbers AVT50, FNR06, and SGL04 are not recognized as genuine. Any JAKAVI (ruxolitinib) product bearing these batch numbers should therefore be considered falsified and should not be used.
Analysis conducted by the genuine manufacturer on a sample of the falsified JAKAVI 20 mg (AVT50) identified in Türkiye confirmed the absence of the stated active ingredient, ruxolitinib.
The genuine manufacturer also reported several visual discrepancies in the packaging. In particular, blister strips from falsified cartons of JAKAVI batches AVT50 and SGL04 do not display a batch number.
Risks
The use of these falsified products may pose significant risks to patient health. These falsified products have not yet undergone laboratory analysis, they may contain no active ingredient, incorrect ingredients, or harmful substances. Their use may lead to treatment failure, resulting in progression of serious disease and an increased risk of death due to lack of therapeutic effect. Patients receiving JAKAVI (ruxolitinib) often have weakened immune systems as a result of their condition. This makes them particularly vulnerable to ineffective or falsified products which may result in rapid deterioration and severe clinical outcomes. Prompt detection and removal of these falsified products from the supply chain is essential to prevent harm to patients.
Advice to health-care professionals, regulatory authorities and the public
Health-care professionals should report any unusual adverse events; unexpected lack of therapeutic effects or observed quality defects associated with JAKAVI (ruxolitinib) to their National Regulatory Authority or National Pharmacovigilance Centre.
WHO advises increased surveillance and monitoring of the supply chain in countries and regions likely to be affected by these falsified products. Increased surveillance of the informal/unregulated market, including online platforms, is especially advised.
National regulatory authorities/health authorities/law enforcement are advised to immediately notify WHO if these falsified products are detected in their country. If you are in possession of these products, WHO recommends that you do not use them. If you, or someone you know, has, or may have used these products, or suffered an adverse event or unexpected side-effect after use, seek immediate medical advice from a health-care professional or contact a poisons control centre. All medical products must be obtained from authorized/licensed suppliers. If you have any information about the manufacture or supply of these products, please contact WHO via [email protected].
Annex: Products subject of WHO Medical Product Alert N°2/2026
来源：WHO 医疗产品质量警报 · who.int