definiens: means an EMA Approval that contains a product label for the Indicationwithout a maximum day limitation, provided that ( a ) the Product is the first product to receive marketing authorization fromthe EMA for use in the European Union in the Indication without a maximum day limitation or ( b ) if it is not the first productthe EMA for use in the European Union in the Indication without a maximum day limitation or ( b ) if it is not the first productto receive marketing authorization from the EMA for use in the European Union in the Indication without a maximum daylimitation, EMA Approval does not require either ( i ) the inclusion of a referred to in Article 23 of Regulation(EC ) 726/2004, as amended ), in the Summary of Product Characteristics and the package leaflet of the Product, or ( ii)implementation of a REMS other than a or REMS, as applicable, that does not competitively disadvantagethe Product relative to other products without a maximum day limitation that have received marketing authorization from theEMA for use in the European Union in the Indication