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Xarelto for the prevention of atherothrombotic events in patients after an acute coronary syndrome with elevated cardiac biomarkers


The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Xarelto ( Rivaroxaban ).

The CHMP 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.

For information, the full indication(s) for Xarelto will be as follows:

Xarelto 2.5mg

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.

Xarelto 10mg

Prevention of venous thromboembolism ( VTE ) in adult patients undergoing elective hip or knee replacement surgery.

Xarelto 15mg and 20mg

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age greater than or equal to 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
Treatment of deep vein thrombosis ( DVT ) and pulmonary embolism ( PE ), and prevention of recurrent DVT and PE in adults. ( Xagena )

Source: European Medicines Agency, 2013

XagenaMedicine_2013



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