The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has been informed by Genzyme Europe B.V., the marketing authorisation holder for Thyrogen (thyrotropin alfa), that the supply shortage for this medicine will continue for longer than anticipated, and supplies will continue to be restricted until 2012.
Thyrogen is authorised for the diagnosis and treatment of thyroid tissue remnants post thyroidectomy in patients with thyroid cancer. To deal with the ongoing shortage, the Committee has agreed with the company that doctors should be informed of revised temporary treatment recommendations:
• No new patients should be prescribed Thyrogen.
• In countries where Thyrogen is still available, supply should be prioritised for patients already scheduled and who are not able to tolerate thyroid hormone withdrawal, or in whom thyroid hormone withdrawal would not be effective.