| 商品名称 | Sugammadex Adroiq |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Neuromuscular Blockade |
| 通用名/非专利名称 | sugammadex |
| 活性成分 | sugammadex sodium |
| 产品号 | EMEA/H/C/006046 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | V03, V03AB |
| 是否额外监管 | no |
| 是否仿制药 | 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 |
| 批准上市日期 | 2023/05/26 |
| 上市许可持有人/公司名称 | Extrovis EU Ltd. |
| 人用药物治疗分组 | All other therapeutic products |
| 决定日期 | 2023/10/11 |
| 修订号 | 1 |
| 适应症 | Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years. |
| 首次发布日期 | 2023/06/16 |
| 修订日期 | 2023/10/12 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/sugammadex-adroiq-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/sugammadex-adroiq |