OSENVELT (Celltrion Healthcare Australia Pty Ltd)

The approved indications for OSENVELT are:

Prevention of skeletal related events in patients with multiple myeloma and in patients with bone metastases from solid tumours.

Treatment of giant cell tumour of bone in adults or skeletally mature adolescents that is recurrent, or unresectable, or resectable but associated with severe morbidity.

Treatment of hypercalcaemia of malignancy that is refractory to intravenous bisphosphonate.

The approved indications for STOBOCLO are:

The treatment of osteoporosis in postmenopausal women. STOBOCLO significantly reduces the risk of vertebral, non-vertebral and hip fractures. Treatment to increase bone mass in men with osteopaenia receiving androgen deprivation therapy for non-metastatic prostate cancer (see section 5.1 Pharmacodynamic properties, Clinical trials).

Treatment to increase bone mass in men with osteoporosis at increased risk of fracture.

Treatment to increase bone mass in women and men at increased risk of fracture due to long-term systemic glucocorticoid therapy.