United States - English - NLM (National Library of Medicine)

genzyme corporation - thyrotropin alfa (unii: avx3d5a4lm) (thyrotropin alfa - unii:avx3d5a4lm) - thyrotropin alfa 0.9 mg in 1 ml - thyrogen® is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin (tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy. limitations of use : - thyrogen-stimulated tg levels are generally lower than, and do not correlate with, tg levels after thyroid hormone withdrawal [see clinical studies (14.1)] . - even when thyrogen-stimulated tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or of underestimating the extent of disease. - anti-tg antibodies may confound the tg assay and render tg levels uninterpretable [see clinical studies (14.1)] . therefore, in such cases, even with a negative or low-stage thyrogen radioiodine scan, consideration should be given to further evaluating patients. thyrogen is indicated for use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients w

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - thyrotropin alfa, quantity: 1.1 mg - injection, powder for - excipient ingredients: nitrogen; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate; sodium chloride; mannitol - thyrogen is indicated for use with serum thyroglobulin (tg) testing, with or without radioactive iodine imaging and undertaken for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy. therapeutic use in post-thyroidectomy patients maintained on hormone suppression therapy in the ablation of thyroid remnant tissue in combination with radioactive iodine.

Israel - English - Ministry of Health

sanofi israel ltd - thyrotropin alfa - powder for solution for injection - thyrotropin alfa 0.9 mg/ml - thyrotropin - thyrotropin - adjunctive diagnostic tool for serum thyroglobulin (tg) testing with or without radioiodine imaging in the follow up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy. adjunctive treatment for radioiodine 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 metastatic thyroid cancer.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sanofi-aventis (malaysia) sdn. bhd. - thyrotropin alfa -

European Union - English - EMA (European Medicines Agency)

sanofi b.v. - thyrotropin alfa - thyroid neoplasms - 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 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).

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - thyrotropin alfa - injection, powder, for solution - 1.1 mg - thyrotropin alfa 1.1 mg

Canada - English - Health Canada

sanofi genzyme, a division of sanofi-aventis canada inc - thyrotropin alfa - powder for solution - 0.9mg - thyrotropin alfa 0.9mg - thyroid function

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

genzyme therapeutics ltd - thyrotropin alfa - powder for solution for injection - 900microgram

Australia - English - Department of Health (Therapeutic Goods Administration)

genzyme australasia pty ltd - thyrotropin alfa -

Philippines - English - FDA (Food And Drug Administration)

sanofi-aventis philippines, inc. - thyrotropin alfa - lyophilized powder for solution for im injection - 900 mcg