| 商品名称 | Dukoral |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Cholera;Immunization |
| 通用名/非专利名称 | cholera vaccine (inactivated, oral) |
| 活性成分 | recombinant cholera toxin B subunit;vibrio cholerae 01 |
| 产品号 | EMEA/H/C/000476 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J07AE01 |
| 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 | 2004/04/28 |
| 上市许可开发者/申请人/持有人 | Valneva Sweden AB |
| 人用药物治疗学分组 | Vaccines |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2021/01/07 |
| 修订号 | 14 |
| 治疗适应症 | Dukoral is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas. The use of Dukoral should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions. Dukoral should not replace standard protective measures. In the event of diarrhoea measures of rehydration should be instituted. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2015/03/16 |
| 最后更新日期 | 2022/04/06 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/dukoral-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/dukoral |