| 商品名称 | Mysimba |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Obesity;Overweight |
| 通用名/非专利名称 | naltrexone;bupropion |
| 活性成分 | bupropion hydrochloride;naltrexone hydrochloride |
| 产品号 | EMEA/H/C/003687 |
| 患者安全信息 | Yes |
| 许可状态 | Authorised |
| ATC编码 | A08AA |
| 是否额外监管 | Yes |
| 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 | 2015/03/26 |
| 上市许可开发者/申请人/持有人 | Orexigen Therapeutics Ireland Limited |
| 人用药物治疗学分组 | Antiobesity preparations, excl. diet products |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2014/12/18 |
| 欧盟委员会决定日期 | 2025/11/06 |
| 修订号 | 30 |
| 治疗适应症 | Mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension) Treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/07/02 |
| 最后更新日期 | 2025/11/06 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/mysimba-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/mysimba |