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Published on 5 March 2007

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EMEA accepts thalidomide application

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The European Medicines Agency (EMEA) has accepted for reviewthe Marketing Authorisation Application for thalidomide (ThalidomidePharmion) for untreated multiple myeloma. The application is based ondata from four studies in more than 1,400 patients. The application isfor the following indications: in combination with melphalan andprednisone for treating patients with untreated multiple myeloma aged65 years or older or ineligible for high-dose chemotherapy; and incombination with dexamethasone for induction therapy prior to high-dosechemotherapy and bone marrow transplantation, for treating patientswith untreated multiple myeloma.

National Electronic Library for Medicines 05/03/2007



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