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March 22, 2013
08:40 EDTALXNAlexion gets positive CHMP opinion on extended indication for eculizumab
The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Soliris. The marketing authorization holder for this medicinal product is Alexion Europe SAS. Soliris is currently authorized for the treatment of paroxysmal nocturnal haemoglobinuria in adults only and atypical haemolytic uremic syndrome in adults and children. The CHMPís opinion now recommends that the PNH indication be extended to include children, the EMA announced.
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