法规知识库 · EMA 集中审评
Thyrogen
thyrotropin alfa · EMEA/H/C/000220 · 已授权
获批上市许可
2000-03-09
欧委会决定日
2025-01-13
持有人 / 申请人
Sanofi Winthrop Industrie
终止日期字段
无
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
10
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：H01AB01
治疗领域：Thyroid Neoplasms
药理分类：Anterior pituitary lobe hormones and analogues;Pituitary and hypothalamic hormones and analogues
修订号：33 · 最新影响 PI 的程序：T/0000236228
适应症（原文）：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).
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2025-01-13 · 欧委会决定
2000-03-09 · 获批上市许可
1999-12-16 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
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Thyrogen : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-02-19
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Thyrogen : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-02-19
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Thyrogen-H-C-PSUSA-00002940-201811 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-10-11 · EMA/556273/2019
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Thyrogen : EPAR - Summary for the public
overview · 2013-01-12
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Thyrogen-H-C-220-II-59 : EPAR - Assessment Report - Variation
variation-report · 2013-01-11 · EMA/CHMP/709596/2012
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Thyrogen-H-C-220-II-38 : EPAR - Assessment Report - Variation
variation-report · 2010-03-12 · EMA/CHMP/22638/2010
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Thyrogen-H-C-220-II-18 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-01-24
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Thyrogen : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2006-01-24
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Thyrogen : EPAR - Scientific Discussion
scientific-discussion · 2006-01-24
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Thyrogen : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-01-24
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。