| 商品名称 | Triumeq |
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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 | abacavir;dolutegravir;lamivudine |
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| 活性成分 | dolutegravir sodium;lamivudine;abacavir (as sulfate) |
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| 产品号 | EMEA/H/C/002754 |
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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 | J05AR13 |
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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 | 2014/08/31 |
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| 上市许可开发者/申请人/持有人 | ViiV Healthcare B.V. |
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| 人用药物治疗学分组 | Antivirals for systemic use |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2014/06/26 |
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| 欧盟委员会决定日期 | 2025/10/16 |
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| 修订号 | 37 |
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| 治疗适应症 | Triumeq is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infected children of at least 3 months of age weighing at least 6 kg to less than 25 kg (see sections 4.4 and 5.1). Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele. Triumeq is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infected adults, adolescents and children weighing at least 25 kg (see sections 4.4 and 5.1). Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele. |
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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 | 2018/07/12 |
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| 最后更新日期 | 2025/11/14 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/triumeq-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/triumeq |
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