| 商品名称 | Parareg |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism |
| 通用名/非专利名称 | cinacalcet |
| 活性成分 | cinacalcet |
| 产品号 | EMEA/H/C/000575 |
| 患者安全信息 | no |
| 授权状态 | Withdrawn |
| ATC编码 | H05BX01 |
| 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 | 2004/10/22 |
| 上市许可持有人/公司名称 | Dompé Biotec S.p.A. |
| 人用药物治疗分组 | Calcium homeostasis |
| 决定日期 | 2008/10/29 |
| 修订号 | 6 |
| 适应症 | Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).Reduction of hypercalcaemia in patients with:-parathyroid carcinoma.- primary HPT for whom parathyroidectomy would be indicated on the basis of serum calciumlevels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. |
| 首次发布日期 | 2008/10/29 |
| 修订日期 | 2009/05/14 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/parareg-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/parareg |