| 商品名称 | Zelnorm |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Irritable Bowel Syndrome |
| 通用名/非专利名称 | tegaserod |
| 活性成分 | tegaserod |
| 产品号 | EMEA/H/C/000621 |
| 患者安全信息 | no |
| 授权状态 | Refused |
| ATC编码 | A03AE02 |
| 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 |
| 拒绝批准上市日期 | 2006/05/19 |
| 上市许可持有人/公司名称 | Novartis Europharm Limited |
| 人用药物治疗分组 | Drugs for functional gastrointestinal disorders |
| 审评意见发布日期 | 2006/03/23 |
| 决定日期 | 2009/12/31 |
| 修订号 | 0 |
| 适应症 | Zelnorm is indicated for the repeated symptomatic short-term treatment of women with Irritable Bowel Syndrome (IBS) whose predominant bowel habit is constipation, associated with abdominal pain/discomfort or bloating (see section 4.2). |
| 首次发布日期 | 2009/12/31 |
| 修订日期 | 2009/12/31 |
| 产品信息 | |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/zelnorm |