The Board of Directors

Approval of the marketing authorisation for Evenity (romosozumab)

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.

PRESIDENT	G.KAPETANOS Professor Emeritus of Orthopaedics Faculty of Medicine, Aristotle University of Thessaloniki
GEN.SECRETARY	C.ZAFEIRIS Orthopaedic Surgeon, Athens
TREASURER	A.KARPONIS Orthopaedic Surgeon, Thessaloniki
MEMBERS	Y.DIONYSSIOTIS Physician Consultant in Physical Medicine & Rehabilitation Clinic, University Hospital of Ioannina G.LYRITIS Professor Emeritus of Orthopaedics Faculty of Medicine, University of Athens M.POTOUPNIS Associate Professor of Orthopaedics Faculty of Medicine, Aristotle University of Thessaloniki G.TROVAS Endocrinologist- Diabetologist Research Associate at Laboratory for the Research of Musculoskeletal System (LRMS)

ΕΝΗΜΕΡΩΣΗ: ΣΥΜΒΟΥΛΕΥΤΙΚΟ ΙΑΤΡΕΙΟ ΣΤΟ LRMS

BMD After Transitioning From Denosumab to Alendronate

Approval of the marketing authorisation for Evenity (romosozumab)

ΔΕΛΤΙΟ ΤΥΠΟΥ ΓΙΑ ΤΗΝ ΠΑΓΚΟΣΜΙΑ ΗΜΕΡΑ ΟΣΤΕΟΠΟΡΩΣΗΣ

ΕΝΗΜΕΡΩΣΗ

FDA Approves Evenity

The Board of Directors