| Product No | EMEA/H/C/000220 |
|---|---|
| Brand Name | Thyrogen |
| Nonproprietary Name | thyrotropin alfa |
| API | thyrotropin alfa |
| ATC Code | H01AB01 |
| Indications | 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). |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Sanofi B.V. |
| Status | Authorised(授权) |
| Authorization Date | 2000-03-09 |
| Version | 29 |
| Condition Approval | no |
| Exceptions | no |
| Biosimilar | no |
| Details | 查看 (公众评估报告、授权细节、产品规格/剂型、标签、历史评估信息) |
Extended Information