CHMP adopts new indication for new strength of rivaroxaban (Xarelto®)

Source: European Medicines Agency Area: News The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a variation to the terms of the marketing authorisation for rivaroxaban (Xarelto®).    The CHMP has adopted a new indication for a new strength 2.5mg as follows: "Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers."   Detailed conditions for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR) after the variation to the marketing authorisation has been granted by the European Commission.
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news