Nordic Group announced today that it has reached an agreement with Bayer HealthCare in which Nordic will acquire Trasylol (aprotinin injection) worldwide excluding the United States. Under this agreement, Nordic will become the Marketing Authorization Holder for aprotinin in the relevant Territories. This follows the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) from February 2012, recommending that the marketing authorisation for aprotinin should be reinstated in the European Union. The recommendation took into account a full review of the benefits and risks of all antifibrinolytic medicines, which found that the results of the study on which the suspension of aprotinin was based were unreliable. This positive opinion is expected to be ratified by the European Commission later in 2012.
Nordic will be managing global supplies of aprotinin in the relevant Territories.
Source: Nordic Group [6]
