Evenity
romosozumab
Table of contents
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.
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List item
Evenity : EPAR - Medicine overview (PDF/123.21 KB)
First published: 24/02/2020
EMA/571266/2019 -
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List item
Evenity : EPAR - Risk-management-plan summary (PDF/221.95 KB)
First published: 24/02/2020
Last updated: 07/07/2022
Authorisation details
Product details | |
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Name |
Evenity
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Agency product number |
EMEA/H/C/004465
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Active substance |
Romosozumab
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International non-proprietary name (INN) or common name |
romosozumab
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Therapeutic area (MeSH) |
Osteoporosis
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Anatomical therapeutic chemical (ATC) code |
M05BX
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Additional 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 | |
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Marketing-authorisation holder |
UCB Pharma S.A.
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Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
09/12/2019
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Contact address |
Allée de la Recherche 60 |
Product information
07/08/2023 Evenity - EMEA/H/C/004465 - IB/0020
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 201918/10/2019
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26/07/2019
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28/06/2019