| 商品名称 | Bemfola |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Anovulation |
| 通用名/非专利名称 | follitropin alfa |
| 活性成分 | follitropin alfa |
| 产品号 | EMEA/H/C/002615 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | G03GA05 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | No |
| 是否生物类似药 | Yes |
| 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 | 2014/03/26 |
| 上市许可开发者/申请人/持有人 | Gedeon Richter Plc. |
| 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 | 2014/01/22 |
| 欧盟委员会决定日期 | 2024/01/09 |
| 修订号 | 11 |
| 治疗适应症 | In adult women: anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate; stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT); follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l. In adult men: follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/05/15 |
| 最后更新日期 | 2024/01/17 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/bemfola-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/bemfola |