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See Latest ArticlesCell Therapeutics Initiates Process to Obtain Marketing Approval for Pixantrone in Europe
Cell Therapeutics, 07/31/09
Cell Therapeutics, Inc. announced that it was notified by the European Medicines Agency that pixantrone is eligible to be submitted for a Marketing Authorization Application through the EMEA's centralized procedure. The centralized review process provides for a single coordinated review for approval of pharmaceutical products that is conducted by the EMEA on behalf of all European Union member states. The EMEA also designated pixantrone as a New Active Substance; if approved, compounds designated as an NAS receive a 10–year market exclusivity period in EU member states.
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