| 商品名称 | Delstrigo |
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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 | doravirine;lamivudine;tenofovir disoproxil |
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| 活性成分 | doravirine;lamivudine;tenofovir disoproxil fumarate |
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| 产品号 | EMEA/H/C/004746 |
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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 | J05AR |
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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 | 2018/11/22 |
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| 上市许可开发者/申请人/持有人 | Merck Sharp & Dohme B.V. |
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| 人用药物治疗学分组 | Antivirals for treatment of HIV infections, combinations |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2018/09/20 |
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| 欧盟委员会决定日期 | 2025/10/16 |
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| 修订号 | 14 |
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| 治疗适应症 | Delstrigo is indicated for the treatment of adults infected with HIV 1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir. Delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil. |
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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 | 2018/09/21 |
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| 最后更新日期 | 2025/12/03 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/delstrigo-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/delstrigo |
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