| 商品名称 | Nyxoid |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Opiate Overdose |
| 通用名/非专利名称 | naloxone |
| 活性成分 | naloxone hydrochloride dihydrate |
| 产品号 | EMEA/H/C/004325 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | V03AB15 |
| 是否额外监管 | Nei |
| 是否仿制药或hybrid药物 | Nei |
| 是否生物类似药 | Nei |
| 是否附条件批准 | Nei |
| 是否特殊情形 | Nei |
| 是否加速审评 | Nei |
| 是否罕用药 | Nei |
| 上市许可日期 | 2017/11/09 |
| 上市许可开发者/申请人/持有人 | Mundipharma Corporation (Ireland) Limited |
| 人用药物治疗学分组 | All other therapeutic products |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/04/25 |
| 修订号 | 10 |
| 治疗适应症 | Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings. Nyxoid is indicated in adults and adolescents aged 14 years and over. Nyxoid is not a substitute for emergency medical care. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/01/10 |
| 最后更新日期 | 2025/06/12 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/nyxoid-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/nyxoid |