| 商品名称 | Raptiva |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Psoriasis |
| 通用名/非专利名称 | efalizumab |
| 活性成分 | efalizumab |
| 产品号 | EMEA/H/C/000542 |
| 患者安全信息 | no |
| 授权状态 | Withdrawn |
| ATC编码 | L04AA21 |
| 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 | 2004/09/20 |
| 上市许可持有人/公司名称 | Serono Europe Limited |
| 人用药物治疗分组 | Immunosuppressants |
| 决定日期 | 2008/11/25 |
| 修订号 | 8 |
| 适应症 | Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (see section 5.1 - Clinical Efficacy). |
| 首次发布日期 | 2008/11/25 |
| 修订日期 | 2009/08/04 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/raptiva-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/raptiva |