| 商品名称 | Posaconazole Accord |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Mycoses |
| 通用名/非专利名称 | posaconazole |
| 活性成分 | posaconazole |
| 产品号 | EMEA/H/C/005005 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J02AC04 |
| 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 | 2019/07/25 |
| 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 |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2019/05/29 |
| 欧盟委员会决定日期 | 2025/05/05 |
| 修订号 | 12 |
| 治疗适应症 | Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults: Invasive aspergillosis; Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients: Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2019/08/28 |
| 最后更新日期 | 2025/05/06 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/posaconazole-accord-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/posaconazole-accord |