Basic Information
Sondelbay
Regulatory Information
EMEA/H/C/005827
March 24, 2022
January 27, 2022
2
June 19, 2024
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Sondelbay 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
Sondelbay is a medicine used for the treatment of osteoporosis (a disease that makes the bones fragile) in: - women who have been through the menopause; - men who have an increased risk of fractures; - men and women who have an increased risk of fracture due to long-term treatment with glucocorticoids (a type of steroid). Sondelbay is a ‘biosimilar medicine’. This means that Sondelbay is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Sondelbay is Forsteo. For more information on biosimilar medicines, see [here](/en/biosimilar-medicines-overview). Sondelbay contains the active substance teriparatide.