| 商品名称 | Xenical |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Obesity |
| 通用名/非专利名称 | orlistat |
| 活性成分 | orlistat |
| 产品号 | EMEA/H/C/000154 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | A08AB01 |
| 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 | 1998/07/29 |
| 上市许可开发者/申请人/持有人 | CHEPLAPHARM Arzneimittel GmbH |
| 人用药物治疗学分组 | Antiobesity preparations, excl. diet products |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2023/05/10 |
| 修订号 | 25 |
| 治疗适应症 | Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m2, or overweight patients (BMI > 28 kg/m2) with associated risk factors. Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5% of the body weight as measured at the start of therapy. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/05/02 |
| 最后更新日期 | 2023/05/10 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/xenical-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/xenical |