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EVENITY (Amgen Australia Pty Ltd)
Product name
EVENITY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
239 working days (255)
Active ingredients
romosozumab
Registration type
NCE/NBE
Indication
EVENITY (solution for injection) is indicated for:
- The treatment of osteoporosis in postmenopausal women at high risk of fracture (see Section 5.1 Pharmacodynamic properties, Clinical trials).
- Treatment to increase bone mass in men with osteoporosis at high risk of fracture.