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This website contains information on Xarelto (rivaroxaban) which is based on the Summary of Product Characteristics (SPC) as approved by the European Commission XARELTO 2 5 mg Film-coated tablet Ref  [7073] Active ingredients: Rivaroxaban Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bayer AG, 51368 Leverkusen, GermanyXARELTO 20 mg Film-coated tablet Ref  [7444] Active ingredients: Rivaroxaban Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bayer AG, 51368 Leverkusen, GermanyDec 19, 2011 · The factor Xa oral anticoagulant rivaroxaban has been approved in the European Union for the prevention of nonvalvular AF-related stroke and systemic embolism and for the treatment of DVT Xarelto® 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 List of Marketing Authorisations (MA) containing Xarelto registered and approved in Europe on PharmaCompass comThe 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)
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