| 商品名称 | Duavive |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Postmenopause |
| 通用名/非专利名称 | oestrogens conjugated;bazedoxifene |
| 活性成分 | oestrogens conjugated;bazedoxifene |
| 产品号 | EMEA/H/C/002314 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | G03CC07 |
| 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 | 2014/12/16 |
| 上市许可开发者/申请人/持有人 | Pfizer Europe MA EEIG |
| 人用药物治疗学分组 | conjugated estrogens and bazedoxifene |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2014/10/23 |
| 欧盟委员会决定日期 | 2025/11/06 |
| 修订号 | 18 |
| 治疗适应症 | Duavive is indicated for: Treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate. The experience treating women older than 65 years is limited. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/08/02 |
| 最后更新日期 | 2025/11/06 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/duavive-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/duavive |