商品名称 | Aloxi |
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适用类别 | Human |
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治疗领域 | Vomiting; Cancer |
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通用名/非专利名称 | palonosetron |
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活性成分 | palonosetron hydrochloride |
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产品号 | EMEA/H/C/000563 |
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患者安全信息 | no |
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授权状态 | Authorised |
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ATC编码 | A04AA05 |
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是否额外监管 | no |
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是否仿制药 | no |
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是否生物类似药 | no |
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是否附条件批准 | no |
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是否特殊情形 | no |
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是否加速审评 | no |
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是否罕用药 | no |
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批准上市日期 | 2005/03/22 |
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上市许可持有人/公司名称 | Helsinn Birex Pharmaceuticals Ltd. |
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人用药物治疗分组 | Antiemetics and antinauseants, , Serotonin (5HT3) antagonists |
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决定日期 | 2018/04/26 |
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修订号 | 22 |
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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. |
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首次发布日期 | 2018/04/26 |
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修订日期 | 2023/02/24 |
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产品信息 | https://www.ema.europa.eu/en/documents/product-information/aloxi-epar-product-information_en.pdf |
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公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/aloxi |
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