| 商品名称 | Granupas (previously Para-aminosalicylic acid Lucane) |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Tuberculosis |
| 通用名/非专利名称 | para-aminosalicylic acid |
| 活性成分 | para-aminosalicylic acid |
| 产品号 | EMEA/H/C/002709 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J04AA01 |
| 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 | 2014/04/07 |
| 上市许可开发者/申请人/持有人 | Eurocept International B. V. |
| 人用药物治疗学分组 | Antimycobacterials |
| 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 | 2024/08/14 |
| 修订号 | 13 |
| 治疗适应症 | Granupas is indicated for use as part of an appropriate combination regimen for multi-drug resistant tuberculosis in adults and paediatric patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see section 4.4). Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/06/29 |
| 最后更新日期 | 2024/08/16 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/granupas-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/granupas |