| 商品名称 | Mircera |
|---|
| 适用类别 | Human |
|---|
| 治疗领域 | Anemia; Kidney Failure, Chronic |
|---|
| 通用名/非专利名称 | methoxy polyethylene glycol-epoetin beta |
|---|
| 活性成分 | Methoxy polyethylene glycol-epoetin beta |
|---|
| 产品号 | EMEA/H/C/000739 |
|---|
| 患者安全信息 | no |
|---|
| 授权状态 | Authorised |
|---|
| ATC编码 | B03XA03 |
|---|
| 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 | 2007/07/20 |
|---|
| 上市许可持有人/公司名称 | Roche Registration GmbH |
|---|
| 人用药物治疗分组 | Antianemic preparations |
|---|
| 决定日期 | 2023/07/26 |
|---|
| 修订号 | 29 |
|---|
| 适应症 | Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1).Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (ESA) after their haemoglobin level was stabilised with the previous ESA (see section 5.1). |
|---|
| 首次发布日期 | 2018/08/09 |
|---|
| 修订日期 | 2023/08/11 |
|---|
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/mircera-epar-product-information_en.pdf |
|---|
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/mircera |
|---|