| 商品名称 | Firmagon |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Prostatic Neoplasms |
| 通用名/非专利名称 | degarelix |
| 活性成分 | degarelix |
| 产品号 | EMEA/H/C/000986 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L02BX02 |
| 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 | 2009/02/17 |
| 上市许可开发者/申请人/持有人 | Ferring Pharmaceuticals A/S |
| 人用药物治疗学分组 | Endocrine therapy |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2022/03/30 |
| 修订号 | 19 |
| 治疗适应症 | FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated: - for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/07/25 |
| 最后更新日期 | 2022/10/04 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/firmagon-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/firmagon |