Human medicines European public assessment report (EPAR): Dabigatran etexilate Teva , dabigatran etexilate, Status: Withdrawn application (after opinion)
Based on the review of the data and the company's response the Agency's questions, at the time of the withdrawal, concerns remained on the presence of nitrosamine impurities in the medicine and its provisional opinion was that Dabigatran etexilate Teva could not have been authorised for the requested indication.
Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of Dabigatran etexilate Teva did not outweigh its risks.
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