欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Vfend
适用类别Human
治疗领域Candidiasis;Mycoses;Aspergillosis
通用名/非专利名称voriconazole
活性成分voriconazole
产品号EMEA/H/C/000387
患者安全信息No
许可状态Authorised
ATC编码J02AC03
是否额外监管Nei
是否仿制药或hybrid药物Nei
是否生物类似药Nei
是否附条件批准Nei
是否特殊情形Nei
是否加速审评Nei
是否罕用药Nei
上市许可日期2002/03/19
上市许可开发者/申请人/持有人Pfizer Europe MA EEIG
人用药物治疗学分组Antimycotics for systemic use
兽用药物治疗学分组
审评意见日期2001/12/13
欧盟委员会决定日期2025/06/23
修订号57
治疗适应症Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis; treatment of in candidaemianon-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Vfend should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
适用物种
兽用药物ATC编码
首次发布日期2018/06/06
最后更新日期2025/09/18
产品说明书https://www.ema.europa.eu/en/documents/product-information/vfend-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/vfend
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