| 商品名称 | Revolade |
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| 适用类别 | Human |
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| 治疗领域 | Purpura, Thrombocytopenic, Idiopathic;Anemia, Aplastic |
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| 通用名/非专利名称 | eltrombopag |
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| 活性成分 | Eltrombopag |
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| 产品号 | EMEA/H/C/001110 |
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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 | B02BX05 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | 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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| 上市许可日期 | 2010/03/11 |
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| 上市许可开发者/申请人/持有人 | Novartis Europharm Limited |
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| 人用药物治疗学分组 | Other systemic hemostatics;Antihemorrhagics |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2009/12/17 |
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| 欧盟委员会决定日期 | 2024/11/25 |
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| 修订号 | 35 |
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| 治疗适应症 | Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.4 and 5.1). Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1). |
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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 | 2018/07/06 |
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| 最后更新日期 | 2024/11/28 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/revolade-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/revolade |
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