| 商品名称 | Cinacalcet Accordpharma |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hyperparathyroidism |
| 通用名/非专利名称 | cinacalcet |
| 活性成分 | cinacalcet hydrochloride |
| 产品号 | EMEA/H/C/005236 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | H05BX01 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 | 2020/04/03 |
| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
| 人用药物治疗学分组 | Calcium homeostasis |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2020/01/30 |
| 欧盟委员会决定日期 | 2023/05/15 |
| 修订号 | 4 |
| 治疗适应症 | Secondary hyperparathyroidism AdultsTreatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric populationTreatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4). Cinacalcet Accordpharma may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1). Parathyroid carcinoma and primary hyperparathyroidism in adults Reduction of hypercalcaemia in adult patients with: parathyroid carcinoma. primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2020/04/15 |
| 最后更新日期 | 2024/06/27 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/cinacalcet-accordpharma-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/cinacalcet-accordpharma |