Basic Information
Teriparatide Sun
Regulatory Information
EMEA/H/C/005793
November 18, 2022
September 15, 2022
3
September 13, 2024
Company Information
the netherlands
Polarisavenue 87 2132JH Hoofddorp
Sun Pharmaceutical Industries (Europe) B.V.
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Teriparatide SUN is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). 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 (see section 5.1).
Overview Summary
Teriparatide Sun is a medicine used to treat adults with osteoporosis (a disease that makes the bones fragile) in women who have been through menopause and in men who are at an increased risk of fractures. The medicine is also used to treat osteoporosis in men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid). Teriparatide Sun is a ‘hybrid medicine’, meaning that it is similar to a ‘reference medicine’ containing the same active substance, but there are certain differences between the two. The reference medicine for Teriparatide Sun is Forsteo, in which the active substance is of biological origin (produced using bacteria), whereas in Teriparatide Sun it is chemically synthesised. Teriparatide Sun contains the active substance teriparatide.