Evenity

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romosozumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Evenity is a medicine used to treat osteoporosis, a disease that makes bones fragile. It is for use in women who have been through the menopause and who have severe osteoporosis (low bone density and previous fracture), leading to a high risk of further fractures.

This EPAR was last updated on 24/02/2020

Authorisation details

Product details
Name
Evenity
Agency product number
EMEA/H/C/004465
Active substance
Romosozumab
International non-proprietary name (INN) or common name
romosozumab
Therapeutic area (MeSH)
Osteoporosis
Anatomical therapeutic chemical (ATC) code
M05BX
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
UCB Pharma S.A.
Date of issue of marketing authorisation valid throughout the European Union
09/12/2019
Contact address

Allée de la Recherche 60
B-1070 Bruxelles
Belgium

Product information

Evenity - EMEA/H/C/004465 -

Contents

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Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

Evenity is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

Assessment history

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