| 商品名称 | Retacrit |
|---|
| 适用类别 | Human |
|---|
| 治疗领域 | Anemia;Blood Transfusion, Autologous;Kidney Failure, Chronic;Cancer |
|---|
| 通用名/非专利名称 | epoetin zeta |
|---|
| 活性成分 | epoetin zeta |
|---|
| 产品号 | EMEA/H/C/000872 |
|---|
| 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 | Yes |
|---|
| 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 | 2007/12/18 |
|---|
| 上市许可开发者/申请人/持有人 | Pfizer Europe MA EEIG |
|---|
| 人用药物治疗学分组 | Other antianemic preparations |
|---|
| 兽用药物治疗学分组 | |
|---|
| 审评意见日期 | 2007/10/18 |
|---|
| 欧盟委员会决定日期 | 2025/09/26 |
|---|
| 修订号 | 33 |
|---|
| 治疗适应症 | Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis; treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy). Retacrit can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood-saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (four or more units of blood for females or five or more units for males). Retacrit can be used to reduce exposure to allogeneic blood transfusions in adult non-iron-deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10-13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1800 ml). |
|---|
| 适用物种 | |
|---|
| 兽用药物ATC编码 | |
|---|
| 首次发布日期 | 2018/08/03 |
|---|
| 最后更新日期 | 2025/09/29 |
|---|
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/retacrit-epar-product-information_en.pdf |
|---|
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/retacrit |
|---|