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XARELTO 20 mg Film-coated tablet Ref [7444] Active ingredients: Rivaroxaban Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bayer AG, 51368 Leverkusen, GermanyXarelto® Indications __________ The below overview respresents the approval status of Xarelto in the European Union (as approved by EMA) Doctors should always refer to their local product information for further detail on approved indication in their country Oct 28, 2008 · The European Commission has granted marketing approval to the Bayer Group for Xarelto (rivaroxaban), an anticoagulant taken as one tablet, once-daily, to prevent venous thrombo-embolic events (VTE) in adults undergoing elective (planned) hip or knee replacement surgery The European Medicines Agency has waived the obligation to submit the results of studies with Xarelto in all subsets of the paediatric population in the prevention of thromboembolic events (see section 4 2 for information on paediatric use) XARELTO 20 mg Film-coated tablet Ref [7444] Active ingredients: Rivaroxaban Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bayer AG, 51368 Leverkusen, GermanyThis website contains information on Xarelto (rivaroxaban) which is based on the Summary of Product Characteristics (SPC) as approved by the European Commission Nov 20, 2012 · The latest approval gives Xarelto (rivaroxaban) an edge over its rival anticoagulant, Boehringer’s Pradaxa (dabigatran etexilate), which is only available in Europe for the latter two prevention indications