| 商品名称 | Fertavid |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Infertility;Hypogonadism |
| 通用名/非专利名称 | follitropin beta |
| 活性成分 | follitropin beta |
| 产品号 | EMEA/H/C/001042 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | G03GA06 |
| 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 | 2009/03/19 |
| 上市许可开发者/申请人/持有人 | Merck Sharp & Dohme 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 | |
| 欧盟委员会决定日期 | 2020/01/20 |
| 修订号 | 12 |
| 治疗适应症 | In the female: Fertavid is indicated for the treatment of female infertility in the following clinical situations: Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomifene citrate Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/07/07 |
| 最后更新日期 | 2020/06/23 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/fertavid-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/fertavid |