| 商品名称 | Orfadin |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Tyrosinemias |
| 通用名/非专利名称 | nitisinone |
| 活性成分 | nitisinone |
| 产品号 | EMEA/H/C/000555 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | A16AX04 |
| 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 | 2005/02/21 |
| 上市许可持有人/公司名称 | Swedish Orphan Biovitrum International AB |
| 人用药物治疗分组 | Other alimentary tract and metabolism products, |
| 审评意见发布日期 | 2004/11/18 |
| 决定日期 | 2023/04/13 |
| 修订号 | 21 |
| 适应症 | Hereditary tyrosinemia type 1 (HT 1)Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.Alkaptonuria (AKU)Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU). |
| 首次发布日期 | 2017/01/26 |
| 修订日期 | 2023/04/14 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/orfadin-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/orfadin |