Eladynos
abaloparatide
Table of contents
Overview
Eladynos is a medicine used to treat osteoporosis (a disease that makes bones fragile) in women who have been through menopause and are at increased risk of bone fractures.
This medicine contains the active substance abaloparatide.
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List item
Eladynos : EPAR - Medicine overview (PDF/105.26 KB)
First published: 22/12/2022
EMA/852056/2022 -
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List item
Eladynos : EPAR - Risk-management-plan (PDF/1.17 MB)
First published: 22/12/2022
Authorisation details
Product details | |
---|---|
Name |
Eladynos
|
Agency product number |
EMEA/H/C/005928
|
Active substance |
abaloparatide
|
International non-proprietary name (INN) or common name |
abaloparatide
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
H05AA04
|
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 |
Theramex Ireland Limited
|
Revision |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
12/12/2022
|
Contact address |
3rd Floor, Kilmore House |
Product information
03/08/2023 Eladynos - EMEA/H/C/005928 - T/0003
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
Calcium homeostasis
Therapeutic indication
Treatment of osteoporosis in postmenopausal women at increased risk of fracture.