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
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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.
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23/02/2018 Terrosa - EMEA/H/C/003916 - IB/0004
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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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.