Livogiva

RSS

teriparatide

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

Overview

Livogiva is a medicine used for the treatment of osteoporosis (a disease that makes bones fragile) in:

  • women who have been through the menopause;
  • men who are at an increased risk of fractures;
  • men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid).

Livogiva is a ‘biosimilar medicine’. This means that Livogiva is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Livogiva is Forsteo.

Livogiva contains the active substance teriparatide.

This EPAR was last updated on 07/01/2021

Authorisation details

Product details
Name
Livogiva
Agency product number
EMEA/H/C/005087
Active substance
teriparatide
International non-proprietary name (INN) or common name
teriparatide
Therapeutic area (MeSH)
Osteoporosis
Anatomical therapeutic chemical (ATC) code
H05AA02
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.

BiosimilarBiosimilar

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
Theramex Ireland Limited
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
27/08/2020
Contact address

3rd Floor, Kilmore House
Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland

Product information

30/11/2020 Livogiva - EMEA/H/C/005087 - IB/0001

Contents

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Pharmacotherapeutic group

Calcium homeostasis

Therapeutic indication

Livogiva 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 have 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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