| 商品名称 | Tivicay |
|---|---|
| 适用类别 | Human |
| 治疗领域 | HIV Infections |
| 通用名/非专利名称 | dolutegravir |
| 活性成分 | dolutegravir |
| 产品号 | EMEA/H/C/002753 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J05AX12 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | No |
| 是否生物类似药 | No |
| 是否附条件批准 | No |
| 是否特殊情形 | No |
| 是否加速审评 | No |
| 是否罕用药 | No |
| 上市许可日期 | 2014/01/16 |
| 上市许可开发者/申请人/持有人 | ViiV Healthcare BV |
| 人用药物治疗学分组 | Antivirals for systemic use |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2013/11/21 |
| 欧盟委员会决定日期 | 2025/10/16 |
| 修订号 | 37 |
| 治疗适应症 | Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/03/01 |
| 最后更新日期 | 2025/11/14 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tivicay-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tivicay |