Thyrogen

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thyrotropin alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 11/10/2019

Authorisation details

Product details
Name
Thyrogen
Agency product number
EMEA/H/C/000220
Active substance
thyrotropin alfa
International non-proprietary name (INN) or common name
thyrotropin alfa
Therapeutic area (MeSH)
Thyroid Neoplasms
Anatomical therapeutic chemical (ATC) code
H01AB01
Publication details
Marketing-authorisation holder
Genzyme Europe B.V.
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
09/03/2000
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Product information

23/09/2019 Thyrogen - EMEA/H/C/000220 - PSUSA/00002940/201811

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Thyroid function test

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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