| 商品名称 | Buccolam |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Epilepsy |
| 通用名/非专利名称 | midazolam |
| 活性成分 | midazolam |
| 产品号 | EMEA/H/C/002267 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | N05CD08 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | 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 |
| 上市许可日期 | 2011/09/04 |
| 上市许可开发者/申请人/持有人 | Neuraxpharm Pharmaceuticals S.L. |
| 人用药物治疗学分组 | Psycholeptics |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2011/06/23 |
| 欧盟委员会决定日期 | 2024/10/21 |
| 修订号 | 21 |
| 治疗适应症 | Treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults.BUCCOLAM must only be used by parents/carers where the patient has been diagnosed to have epilepsy.For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. See section 4.2. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/07/25 |
| 最后更新日期 | 2024/11/13 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/buccolam-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/buccolam |