| 商品名称 | Natalizumab Elan Pharma |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Crohn Disease |
| 通用名/非专利名称 | natalizumab |
| 活性成分 | natalizumab |
| 产品号 | EMEA/H/C/000624 |
| 患者安全信息 | No |
| 许可状态 | Refused |
| ATC编码 | L03AD |
| 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 |
| 拒绝上市许可日期 | 2008/01/11 |
| 上市许可开发者/申请人/持有人 | Elan Pharma International Ltd. |
| 人用药物治疗学分组 | Immunostimulants |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2007/11/15 |
| 欧盟委员会决定日期 | 2008/01/25 |
| 修订号 | |
| 治疗适应症 | Treatment of moderately to severely active Crohn's disease for the reduction of signs and symptoms, and the induction and maintenance of sustained response and remission, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or are intolerant to or have medical contraindications to such therapies. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2008/01/25 |
| 最后更新日期 | 2008/01/25 |
| 产品说明书 | |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/natalizumab-elan-pharma |