| 商品名称 | Ovitrelle |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Anovulation;Reproductive Techniques, Assisted;Infertility, Female |
| 通用名/非专利名称 | choriogonadotropin alfa |
| 活性成分 | choriogonadotropin alfa |
| 产品号 | EMEA/H/C/000320 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | G03GA08 |
| 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 | 2001/02/02 |
| 上市许可开发者/申请人/持有人 | Merck Europe B.V. |
| 人用药物治疗学分组 | Sex hormones and modulators of the genital system |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2000/10/19 |
| 欧盟委员会决定日期 | 2025/05/23 |
| 修订号 | 23 |
| 治疗适应症 | Ovitrelle is indicated in the treatment of: women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth; anovulatory or oligo-ovulatory women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2016/12/04 |
| 最后更新日期 | 2025/05/23 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ovitrelle-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ovitrelle |