| 商品名称 | Circadin |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Sleep Initiation and Maintenance Disorders |
| 通用名/非专利名称 | melatonin |
| 活性成分 | melatonin |
| 产品号 | EMEA/H/C/000695 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | N05CH01 |
| 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 | 2007/06/29 |
| 上市许可持有人/公司名称 | RAD Neurim Pharmaceuticals EEC SARL |
| 人用药物治疗分组 | Psycholeptics |
| 决定日期 | 2023/05/16 |
| 修订号 | 34 |
| 适应症 | Circadin is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over. |
| 首次发布日期 | 2018/07/26 |
| 修订日期 | 2023/05/17 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/circadin-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/circadin |