| 商品名称 | Ucedane |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hyperammonemia;Amino Acid Metabolism, Inborn Errors |
| 通用名/非专利名称 | carglumic acid |
| 活性成分 | carglumic acid |
| 产品号 | EMEA/H/C/004019 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | A16AA05 |
| 是否额外监管 | Nei |
| 是否仿制药或hybrid药物 | Já |
| 是否生物类似药 | Nei |
| 是否附条件批准 | Nei |
| 是否特殊情形 | Nei |
| 是否加速审评 | Nei |
| 是否罕用药 | Nei |
| 上市许可日期 | 2017/06/23 |
| 上市许可开发者/申请人/持有人 | Eurocept International BV |
| 人用药物治疗学分组 | Other alimentary tract and metabolism products |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2017/04/21 |
| 欧盟委员会决定日期 | 2024/09/24 |
| 修订号 | 13 |
| 治疗适应症 | Ucedane is indicated in treatment of: hyperammonaemia due to N-acetylglutamate synthase primary deficiency; Hyperammonaemia due to isovaleric acidaemia; Hyperammonaemia due to methymalonic acidaemia; Hyperammonaemia due to propionic acidaemia. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/07/19 |
| 最后更新日期 | 2024/09/25 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ucedane-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ucedane |