CIP TIOTROPIUM (Cipla Australia Pty Ltd)
Product name
CIP TIOTROPIUM
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
124 (255 working days)
Active ingredients
Tiotropium bromide monohydrate
Registration type
New generic medicine
Indication
CIP TIOTROPIUM,TIOVA,TIOCIP,TIOCORT is indicated for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD). CIP TIOTROPIUM,TIOVA,TIOCIP,TIOCORT is indicated for the prevention of COPD exacerbations.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine