欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Ganirelix Gedeon Richter
适用类别Human
治疗领域Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
通用名/非专利名称ganirelix
活性成分ganirelix acetate
产品号EMEA/H/C/005641
患者安全信息no
授权状态Authorised
ATC编码H01CC01
是否额外监管no
是否仿制药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
批准上市日期2022/07/15
上市许可持有人/公司名称Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)
人用药物治疗分组Pituitary and hypothalamic hormones and analogues
审评意见发布日期2022/05/19
决定日期2022/07/15
修订号
适应症Prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
首次发布日期2022/05/17
修订日期2022/07/20
产品信息https://www.ema.europa.eu/en/documents/product-information/ganirelix-gedeon-richter-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/ganirelix-gedeon-richter
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