欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Cinacalcet Viatris (previously Cinacalcet Mylan)
适用类别Human
治疗领域Hyperparathyroidism, Secondary;Hypercalcemia
通用名/非专利名称cinacalcet
活性成分cinacalcet hydrochloride
产品号EMEA/H/C/004014
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2015/11/19
上市许可开发者/申请人/持有人Mylan Pharmaceuticals Limited
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2015/09/24
欧盟委员会决定日期2024/10/15
修订号17
治疗适应症Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate. Reduction of hypercalcaemia in 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2017/01/11
最后更新日期2025/01/27
产品说明书https://www.ema.europa.eu/en/documents/product-information/cinacalcet-viatris-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/cinacalcet-viatris
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