This is a summary of the European public assessment report (EPAR) for Thyrogen. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Thyrogen.
Thyrogen : EPAR - Summary for the public (PDF/50.64 KB)
First published: 14/02/2008
Last updated: 12/01/2013
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Genzyme Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
10/11/2021 Thyrogen - EMEA/H/C/000220 - N/0110
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Anterior pituitary lobe hormones and analogues
Pituitary and hypothalamic hormones and analogues
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 recombinant human (rh) 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 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.