The Danish Medicines Agency together with the manufacturer of Thyrogen® and the European Medicines Agency (EMA) announce that Thyrogen® will be in limited supply until July 2011.
The manufacturer of Thyrogen® will only be able to meet approx. 45 percent of the demand in the EU until July 2011.
Thyrogen is approved for the treatment of thyroid tissue remnants after thyroidectomy in patients with thyroid cancer (see the summary of product characteristics for further details).
Specialists who are involved in the treatment of thyroid cancer with Thyrogen® should pay attention to the following:
- Until July 2011, the use of Thyrogen® should be limited to patients who will not tolerate thyroid hormone withdrawal or patients for whom thyroid hormone withdrawal will not be efficient.
- To the extent possible, the use of Thyrogen® in other patients should be postponed until the supply situation of Thyrogen® is improved. If such postponement is unacceptable, the treating physician and patient should consider alternative treatment.
The above recommendations do not change the authorised product information of Thyrogen® (see summary of product characteristics and EPAR).