| 商品名称 | Voriconazole Accord |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Aspergillosis;Candidiasis;Mycoses |
| 通用名/非专利名称 | voriconazole |
| 活性成分 | voriconazole |
| 产品号 | EMEA/H/C/002669 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J02AC03 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 是否生物类似药 | No |
| 是否附条件批准 | No |
| 是否特殊情形 | No |
| 是否加速审评 | No |
| 是否罕用药 | No |
| 上市许可日期 | 2013/05/16 |
| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
| 人用药物治疗学分组 | Antimycotics for systemic use;Triazole derivatives |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/10/17 |
| 修订号 | 22 |
| 治疗适应症 | Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-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. Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/02/08 |
| 最后更新日期 | 2025/10/21 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/voriconazole-accord-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/voriconazole-accord |