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Drug Safety Europe Regulation

EU Safety Review Starts For Oral Anticoagulants

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Executive Summary

The European Medicines Agency is conducting safety reviews of Eliquis, Pradaxa and Xarelto, and is looking at whether the marketing authorization for the anticancer medicine Lartruvo should be maintained. It has also asked manufacturers of angiotensin II receptor blockers to review their manufacturing processes to ensure they do not produce nitrosamine impurities. Meanwhile, manufacturers of omega 3 fatty acid medicines have requested a re-examination of a CHMP recommendation on their products. 

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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