| 商品名称 | Inductos |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Tibial Fractures;Fracture Fixation, Internal;Spinal Fusion |
| 通用名/非专利名称 | dibotermin alfa |
| 活性成分 | dibotermin alfa |
| 产品号 | EMEA/H/C/000408 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | M05BC01 |
| 是否额外监管 | Nei |
| 是否仿制药或hybrid药物 | Nei |
| 是否生物类似药 | Nei |
| 是否附条件批准 | Nei |
| 是否特殊情形 | Nei |
| 是否加速审评 | Nei |
| 是否罕用药 | Nei |
| 上市许可日期 | 2002/09/09 |
| 上市许可开发者/申请人/持有人 | Medtronic BioPharma B.V. |
| 人用药物治疗学分组 | Drugs for treatment of bone diseases |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2021/09/02 |
| 修订号 | 23 |
| 治疗适应症 | Inductos is indicated for single level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non operative treatment for this condition. Inductos is indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/08/17 |
| 最后更新日期 | 2021/10/18 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/inductos-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/inductos |