Terrosa

RSS

teriparatide

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

Overview

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.

This EPAR was last updated on 05/04/2018

Authorisation details

Product details
Name
Terrosa
Agency product number
EMEA/H/C/003916
Active substance
teriparatide
International non-proprietary name (INN) or common name
teriparatide
Therapeutic area (MeSH)
Osteoporosis
Anatomical therapeutic chemical (ATC) code
H05AA02
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.

Biosimilar

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.

Publication details
Marketing-authorisation holder
Gedeon Richter Plc.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
04/01/2017
Contact address
Gyomroi ut 19-21
1103 Budapest
Hungary

Product information

23/02/2018 Terrosa - EMEA/H/C/003916 - IB/0004

Contents

  • 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.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

CALCIUM HOMEOSTASIS

Therapeutic indication

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.

Assessment history

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