| 商品名称 | Ebilfumin |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Influenza, Human |
| 通用名/非专利名称 | oseltamivir |
| 活性成分 | oseltamivir |
| 产品号 | EMEA/H/C/003717 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J05AH02 |
| 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 | 2014/05/22 |
| 上市许可开发者/申请人/持有人 | Actavis Group PTC ehf |
| 人用药物治疗学分组 | Antivirals for systemic use;Neuraminidase inhibitors |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2014/03/20 |
| 欧盟委员会决定日期 | 2025/09/01 |
| 修订号 | 16 |
| 治疗适应症 | Treatment of influenzaIn patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community. Ebilfumin is indicated for the treatment of infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). The treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child. Prevention of influenzaPost-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. The appropriate use of Ebilfumin for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older. Ebilfumin is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). Ebilfumin is not a substitute for influenza vaccination. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/05/29 |
| 最后更新日期 | 2025/09/02 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ebilfumin-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ebilfumin |