Basic Information
Livogiva
Regulatory Information
EMEA/H/C/005087
August 27, 2020
June 25, 2020
1
January 7, 2021
Company Information
Ireland
3rd Floor, Kilmore House Park Lane, Spencer Dock Dublin 1, D01 YE64
Theramex Ireland Ltd.
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.