| 商品名称 | Zerit |
|---|---|
| 适用类别 | Human |
| 治疗领域 | HIV Infections |
| 通用名/非专利名称 | stavudine |
| 活性成分 | stavudine |
| 产品号 | EMEA/H/C/000110 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | J05AF04 |
| 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 | 1996/05/08 |
| 上市许可开发者/申请人/持有人 | Bristol-Myers Squibb Pharma EEIG |
| 人用药物治疗学分组 | Antivirals for systemic use |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2019/02/13 |
| 修订号 | 31 |
| 治疗适应症 | Hard capsules Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible. Powder for oral solution Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2006/08/11 |
| 最后更新日期 | 2020/10/13 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/zerit-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/zerit |