| 商品名称 | Voriconazole Hikma (previously Voriconazole Hospira) |
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| 适用类别 | Human |
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| 治疗领域 | Bacterial Infections and Mycoses;Aspergillosis;Candidiasis |
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| 通用名/非专利名称 | voriconazole |
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| 活性成分 | voriconazole |
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| 产品号 | EMEA/H/C/003737 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | J02AC03 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | Yes |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2015/05/27 |
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| 上市许可开发者/申请人/持有人 | Hikma Farmaceutica (Portugal) S.A. |
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| 人用药物治疗学分组 | Antimycotics for systemic use |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2015/03/26 |
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| 欧盟委员会决定日期 | 2025/12/22 |
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| 修订号 | 16 |
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| 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 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 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. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2017/09/20 |
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| 最后更新日期 | 2026/01/06 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/voriconazole-hikma-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/voriconazole-hikma |
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