Basic Information
Stoboclo
Regulatory Information
EMEA/H/C/006156
February 14, 2025
December 12, 2024
1
May 5, 2025
Company Information
Hungary
1062 Budapest Váci út 1-3. WestEnd Office Building B torony
Celltrion Healthcare Hungary Kft
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
Overview Summary
Stoboclo is a medicine used to treat the following conditions: - osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fractures (broken bones). In women who have been through the menopause, Stoboclo reduces the risk of fractures in the spine and elsewhere in the body, including the hips; - bone loss in men receiving treatment for prostate cancer that increases their risk of fractures. Stoboclo reduces the risk of fractures in the spine; - bone loss in adults at increased risk of fractures due to long term treatment with corticosteroid medicines given by mouth or injection. Stoboclo is a biological medicine and contains the active substance denosumab. It is a ‘biosimilar medicine’; this means that Stoboclo is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Stoboclo is Prolia. For more information on biosimilar medicines, see [here](https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines).