| 商品名称 | NeoRecormon |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Kidney Failure, Chronic;Anemia;Cancer;Blood Transfusion, Autologous |
| 通用名/非专利名称 | epoetin beta |
| 活性成分 | epoetin beta |
| 产品号 | EMEA/H/C/000116 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | B03XA01 |
| 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 |
| 上市许可日期 | 1997/07/16 |
| 上市许可开发者/申请人/持有人 | Roche Registration GmbH |
| 人用药物治疗学分组 | Antianemic preparations |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 1996/10/16 |
| 欧盟委员会决定日期 | 2025/05/01 |
| 修订号 | 35 |
| 治疗适应症 | Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients; treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy; increasing the yield of autologous blood from patients in a pre-donation programme. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/08/09 |
| 最后更新日期 | 2025/05/02 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/neorecormon-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/neorecormon |