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
许可状态Authorised
ATC编码A04AA05
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2005/03/22
上市许可开发者/申请人/持有人Helsinn Birex Pharmaceuticals Ltd.
人用药物治疗学分组Antiemetics and antinauseants;Serotonin (5HT3) antagonists
兽用药物治疗学分组
欧盟委员会决定日期2018/04/26
修订号22
治疗适应症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.
适用物种
兽用药物ATC编码
首次发布日期2018/04/26
最后更新日期2023/02/24
产品说明书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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