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TERROSA (Gedeon Richter Australia Pty Ltd)
Product name
TERROSA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
195 working days (225)
Active ingredients
teriparatide
Registration type
New biosimilar medicine
Indication
TERROSA (solution for injection) 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.
TERROSA is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.