| 商品名称 | Cystadane |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Homocystinuria |
| 通用名/非专利名称 | betaine anhydrous |
| 活性成分 | Betaine anhydrous |
| 产品号 | EMEA/H/C/000678 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | A16AA06 |
| 是否额外监管 | no |
| 是否仿制药 | 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 |
| 批准上市日期 | 2007/02/14 |
| 上市许可持有人/公司名称 | Recordati Rare Diseases |
| 人用药物治疗分组 | Other alimentary tract and metabolism products, |
| 决定日期 | 2021/07/19 |
| 修订号 | 14 |
| 适应症 | Adjunctive treatment of homocystinuria, involving deficiencies or defects in:cystathionine beta-synthase (CBS);5,10-methylene-tetrahydrofolate reductase (MTHFR);cobalamin cofactor metabolism (cbl).Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet. |
| 首次发布日期 | 2018/07/24 |
| 修订日期 | 2021/09/23 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/cystadane-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/cystadane |