Table of contents
This is a summary of the European public assessment report (EPAR) for Terrosa. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Terrosa. For practical information about using Terrosa, patients should read the package leaflet or contact their doctor or pharmacist.
Terrosa : EPAR - Summary for the public (PDF/81.3 KB)
First published: 16/03/2017
Last updated: 16/03/2017
Terrosa : EPAR - Risk-management-plan summary (PDF/86.18 KB)
First published: 28/10/2020
Last updated: 03/11/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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.
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.
Gedeon Richter Plc.
|Date of issue of marketing authorisation valid throughout the European Union||
Gyomroi ut 19-21
10/11/2022 Terrosa - EMEA/H/C/003916 - II/0026/G
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.
Terrosa is indicated in adults.
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.
Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.