欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Cetrotide
适用类别Human
治疗领域Ovulation;Ovulation Induction
通用名/非专利名称cetrorelix
活性成分cetrorelix (as acetate)
产品号EMEA/H/C/000233
患者安全信息No
许可状态Authorised
ATC编码H01CC02
是否额外监管No
是否仿制药或hybrid药物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
上市许可日期1999/04/12
上市许可开发者/申请人/持有人Merck Europe B.V.
人用药物治疗学分组Pituitary and hypothalamic hormones and analogues
兽用药物治疗学分组
欧盟委员会决定日期2025/11/24
修订号30
治疗适应症Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte-pick-up and assisted-reproductive techniques. In clinical trials, Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.
适用物种
兽用药物ATC编码
首次发布日期2018/07/23
最后更新日期2025/11/24
产品说明书https://www.ema.europa.eu/en/documents/product-information/cetrotide-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/cetrotide
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