| 商品名称 | Olanzapine Viatris (previously Olanzapine Mylan) |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Schizophrenia;Bipolar Disorder |
| 通用名/非专利名称 | olanzapine |
| 活性成分 | olanzapine |
| 产品号 | EMEA/H/C/000961 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | N05AH03 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 | 2008/10/06 |
| 上市许可开发者/申请人/持有人 | Viatris Limited |
| 人用药物治疗学分组 | Psycholeptics |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2024/12/19 |
| 修订号 | 22 |
| 治疗适应症 | Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/12/12 |
| 最后更新日期 | 2025/01/27 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/olanzapine-viatris-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/olanzapine-viatris |