| 商品名称 | Puregon |
|---|---|
| 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/000086 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| 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 | 1996/05/02 |
| 上市许可开发者/申请人/持有人 | N.V. Organon |
| 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 | 1995/12/20 |
| 欧盟委员会决定日期 | 2024/03/27 |
| 修订号 | 35 |
| 治疗适应症 | In the female: Puregon is indicated for the treatment of female infertility in the following clinical situations: anovulation (including polycystic ovarian syndrome, PCOS) 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 intrafallopian 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 | 2018/07/06 |
| 最后更新日期 | 2024/11/28 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/puregon-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/puregon |