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News
11/07/05 - Proposed licensing of thalidomide in Europe and Australia
In 2003 the pharmaceutical company Pharmion, were in the process of applying for marketing authorisation through the European Union. The European Agency for the Evaluation of Medicinal Products (Pre-authorisation Evaluation of Medicines for Human Use) received the application which was then reviewed by the EMEA's scientific and technical committee - The Committee for Proprietary Medicinal Products - CMPC.
Pharmion was already implementing a compassionate use of thalidomide prior to marketing authorisation including a risk management programme based on the S.T.E.P.S. (System for Thalidomide Education and Prescribing Safety) programme. The S.T.E.P.S. programme is used in the United States and was developed by the Canadian Association for Thalidomide Victims. The Thalidomide Society, together with other patient and supports organisations were part of the monitoring system, set up by the EMEA to ensure that strict protocols were in place for the prescribing of thalidomide.
On May 19th 2004 Pharmion announced that it was going to withdraw its current application and resubmit to the European Medicines Evaluation Agency (EMEA) because they wish to provide additional clinical data for the use of thalidomide for multiple myeloma. Myeloma is the second most common cancer of the blood. As well as affecting the white blood cells (plasma) the cancer also attacks and destroys bones. Pharmion will continue to provide thalidomide on a named patient and compassionate use basis while they pursue approval in Europe. Pharmion will also maintain its application with the EMEA for treating the side effects of leprosy. (Source Pharmion - www.pharmion.com - Investor Relations - News Releases).
For further information on this issue please contact the Thalidomide Society
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