| 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 |
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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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| 授权状态 | 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 | 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 | 2010/03/11 |
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| 上市许可持有人/公司名称 | Novartis Europharm Limited |
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| 人用药物治疗分组 | Other systemic hemostatics, Antihemorrhagics |
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| 审评意见发布日期 | 2009/12/17 |
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| 决定日期 | 2023/08/17 |
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| 修订号 | 34 |
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| 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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| 首次发布日期 | 2018/07/06 |
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| 修订日期 | 2023/09/01 |
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| 产品信息 | 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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