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CHMP Results – Aplidin

By: Press Release Reporter; Published: March 21, 2018 @ 2:30 am | Comments Disabled

Madrid, Spain (Significant Event Notification) – Pursuant to article 228 of the consolidated text of the Spanish Securities Market Act, we hereby inform you of the fol­low­ing SIGNIFICANT EVENT:

“In rela­tion­ to the Significant Fact n. 260272, Pharma Mar informs that the European Medi­cines Agency (EMA) has ad­vanced to Pharma Mar that in the re­exami­nation pro­cedure requested by Pharma Mar in January 2018 in rela­tion­ to the CHMP Opinion issued in December 2017 recom­mend­ing not to grant the market­ing authori­zation for Aplidin in the multiple myeloma indi­ca­tion, the CHMP has con­firmed its pre­vi­ous negative Opinion”.

Source: PharmaMar.


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