欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Yttriga
适用类别Human
治疗领域Radionuclide Imaging
通用名/非专利名称yttrium [90Y] chloride
活性成分yttrium (90Y) chloride
产品号EMEA/H/C/000596
患者安全信息no
授权状态Authorised
ATC编码V09
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2006/01/19
上市许可持有人/公司名称Eckert Ziegler Radiopharma GmbH
人用药物治疗分组Diagnostic radiopharmaceuticals
审评意见发布日期2005/09/15
决定日期2020/12/18
修订号10
适应症To be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.Radiopharmaceutical precursor - Not intended for direct use in patients.
首次发布日期2014/07/21
修订日期2021/01/29
产品信息https://www.ema.europa.eu/en/documents/product-information/yttriga-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/yttriga
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