| 商品名称 | Posaconazole SP |
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| 适用类别 | Human |
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| 治疗领域 | Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis |
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| 通用名/非专利名称 | posaconazole |
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| 活性成分 | posaconazole |
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| 产品号 | EMEA/H/C/000611 |
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| 患者安全信息 | no |
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| 授权状态 | Withdrawn |
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| ATC编码 | J02AC04 |
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| 是否额外监管 | no |
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| 是否仿制药 | no |
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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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| 批准上市日期 | 2005/10/25 |
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| 上市许可持有人/公司名称 | Schering-Plough Europe |
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| 人用药物治疗分组 | Antimycotics for systemic use |
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| 决定日期 | 2008/12/04 |
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| 修订号 | 5 |
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| 适应症 | Posaconazole SP is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- 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;- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.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 SP 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 areat 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. |
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| 首次发布日期 | 2008/12/04 |
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| 修订日期 | 2009/08/04 |
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| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/posaconazole-sp-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/posaconazole-sp |
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