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Saturday, August 31, 2019 4:51:20 PM
This means that these medicines should no longer be used in this way. However, they can still be used to reduce levels of certain types of blood fat called triglycerides.
Omega-3 fatty acid medicines have been authorised for use after a heart attack, in combination with other medicines, in several EU countries since 2000, at a dose of 1 g per day. At the time of their authorisation, available data showed some benefits in reducing serious problems with the heart and blood vessels.
EMA’s committee for human medicines, CHMP, re-assessed the evidence accumulated over the years on these medicines for this specific use and consulted additional experts in the field. It concluded that, although there are no new safety concerns, the effectiveness of these medicines in preventing recurrence of problems with the heart and blood vessels has not been confirmed.
EMA concluded that the marketing authorisations of these medicines should be updated to remove this use
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