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Protherics plc has officially notified the EMEA of its decision to withdraw the application for a centralised marketing authorisation for Voraxaze® (glucarpidase) powder for solution for injection, which was expected to be used in the adjunctive treatment of patients who are experiencing or at risk of methotrexate toxicity. According to a press release, the company stated in its official letter that the withdrawal was based on the CHMP’s request for additional information, to which the company was unable to respond within the required timeframe.
National Electronic Library for Medicines 30/5/2007