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TIBOLONE RMB, TIBOLONE SANDOZ, TIBOLONE SCP (Southern Cross Pharma Pty Ltd)
Product name
TIBOLONE RMB, TIBOLONE SANDOZ, TIBOLONE SCP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
175 working days (255)
Active ingredients
tibolone
Registration type
New generic medicine
Indication
TIBOLONE RMB, TIBOLONE SANDOZ, TIBOLONE SCP (tablets) is indicated for:
- Short-term treatment of symptoms resulting from the natural or surgical menopause in postmenopausal women.
- Second line of therapy for the prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss.