| 商品名称 | Intelence |
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| 适用类别 | Human |
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| 治疗领域 | HIV Infections |
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| 通用名/非专利名称 | etravirine |
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| 活性成分 | Etravirine |
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| 产品号 | EMEA/H/C/000900 |
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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 | J05AG04 |
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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 | 2008/08/28 |
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| 上市许可开发者/申请人/持有人 | Janssen-Cilag International NV |
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| 人用药物治疗学分组 | Non-nucleoside reverse transcriptase inhibitors;Antivirals for systemic use |
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| 兽用药物治疗学分组 | |
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| 欧盟委员会决定日期 | 2024/08/08 |
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| 修订号 | 31 |
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| 治疗适应症 | Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age. This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients. |
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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 | 2017/07/13 |
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| 最后更新日期 | 2024/08/13 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/intelence-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/intelence |
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