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PROLIA (Amgen Australia Pty Ltd)
Product name
PROLIA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
221 working days (255)
Active ingredients
denosumab
Registration type
EOI
Indication
PROLIA (injection) is now also indicated for the treatment to increase bone mass in women and men at increased risk of fracture due to long-term systemic glucocorticoid therapy.