Eladynos

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abaloparatide

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

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.

This EPAR was last updated on 25/08/2023

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)
  • Osteoporosis, Postmenopausal
  • Osteoporosis
Anatomical therapeutic chemical (ATC) code
H05AA04
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
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
Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland

Product information

03/08/2023 Eladynos - EMEA/H/C/005928 - T/0003

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

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.

Assessment history

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