SONDELBAY (Accord Healthcare Pty Ltd)
Product name
SONDELBAY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
180 (255 working days)
Active ingredients
Teriparatide
Registration type
New biosimilar medicine
Indication
[TRADE NAME] is indicated for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures.
[TRADE NAME] is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.