BRALTUS (Teva Pharma Australia Pty Ltd)
Product name
BRALTUS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
224 working days (255)
Active ingredients
Tiotropium bromide
Registration type
New generic medicine
Indication
BRALTUS (powder for inhalation in hard capsule) is indicated for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD) BRALTUS 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