| 商品名称 | Palonosetron Hospira |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Nausea;Vomiting;Cancer |
| 通用名/非专利名称 | palonosetron |
| 活性成分 | palonosetron hydrochloride |
| 产品号 | EMEA/H/C/004069 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | A04AA05 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | 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 |
| 上市许可日期 | 2016/04/08 |
| 上市许可开发者/申请人/持有人 | Pfizer Europe MA EEIG |
| 人用药物治疗学分组 | Antiemetics and antinauseants |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2018/12/12 |
| 修订号 | 4 |
| 治疗适应症 | Palonosetron Hospira 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. Palonosetron Hospira 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 | 2018/02/01 |
| 最后更新日期 | 2022/04/08 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/palonosetron-hospira-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/palonosetron-hospira |