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DENOLIA (Accord Healthcare Pty Ltd)
Product name
DENOLIA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
236 (255 working days)
Active ingredients
Denosumab
Registration type
New biosimilar medicine
Indication
The treatment of osteoporosis in postmenopausal women. DENOLIA 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.