欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Aloxi
适用类别Human
治疗领域Vomiting; Cancer
通用名/非专利名称palonosetron
活性成分palonosetron hydrochloride
产品号EMEA/H/C/000563
患者安全信息no
授权状态Authorised
ATC编码A04AA05
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2005/03/22
上市许可持有人/公司名称Helsinn Birex Pharmaceuticals Ltd.
人用药物治疗分组Antiemetics and antinauseants, , Serotonin (5HT3) antagonists
决定日期2018/04/26
修订号22
适应症Aloxi is indicated in adults for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.Aloxi is indicated in paediatric patients 1 month of age and older for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
首次发布日期2018/04/26
修订日期2023/02/24
产品信息https://www.ema.europa.eu/en/documents/product-information/aloxi-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/aloxi
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