WORLD OSTEOPOROSIS DAY
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Approval of the marketing authorisation for Evenity (romosozumab)
Re-examination leads to recommendation to approve
After re-examining its initial opinion, the European Medicines Agency has recommended approving the marketing authorisation for the medicine Evenity for the treatment of severe osteoporosis.
The Agency had initially refused the application on 27 June 2019 for Evenity to treat osteoporosis. After re-examination, on 17 October 2019 the Agency recommended that marketing authorisation could be granted but for a restricted indication in postmenopausal women with severe osteoporosis at high risk of fracture.
The company that applied for authorisation was UCB Pharma S.A.