CTIC announced today 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.
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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.compounds designated as an NAS receive a 10-year market exclusivity period in EU member states. CTI will request a meeting with the EMEA to discuss the submission of the MAA for pixantrone to treat aggressive non-Hodgkin's lymphomain the EU member states.
The SME program is an initiative by the EMEA that is dedicated to addressing the needs of small and medium size companies developing medicinal products in Europe.
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