| 商品名称 | Thyrogen |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Thyroid Neoplasms |
| 通用名/非专利名称 | thyrotropin alfa |
| 活性成分 | thyrotropin alfa |
| 产品号 | EMEA/H/C/000220 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | H01AB01 |
| 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 | 2000/03/09 |
| 上市许可开发者/申请人/持有人 | Sanofi B.V. |
| 人用药物治疗学分组 | Anterior pituitary lobe hormones and analogues;Pituitary and hypothalamic hormones and analogues |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 1999/12/16 |
| 欧盟委员会决定日期 | 2025/01/13 |
| 修订号 | 32 |
| 治疗适应症 | Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (THST). Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels. Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/01/30 |
| 最后更新日期 | 2025/02/19 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/thyrogen-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/thyrogen |