| 商品名称 | Ammonaps |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Ornithine Carbamoyltransferase Deficiency Disease;Citrullinemia;Carbamoyl-Phosphate Synthase I Deficiency Disease |
| 通用名/非专利名称 | sodium phenylbutyrate |
| 活性成分 | sodium phenylbutyrate |
| 产品号 | EMEA/H/C/000219 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | A16AX03 |
| 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 | 1999/12/07 |
| 上市许可开发者/申请人/持有人 | Immedica Pharma AB |
| 人用药物治疗学分组 | Other alimentary tract and metabolism products |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2022/12/12 |
| 修订号 | 21 |
| 治疗适应症 | Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase. It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/06/28 |
| 最后更新日期 | 2022/12/16 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ammonaps-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ammonaps |