Posted by Michael Wonder on 29 Nov 2016
TGA publishes AusPAR for Spiriva Respimat
29 November 2015 - AusPAR published 18 months after registration.
The TGA approved tiotropium bromide monohydrate on 22 May 2015 for use as add-on maintenance bronchodilator treatment in adult patients who are currently treated with the maintenance combination of inhaled corticosteroids (≥ 800 μg budesonide/day or equivalent) and long acting β2 agonists and who experienced one or more severe exacerbations in the previous year.
The AusPAR is not clear on whether the approval relates to asthma or to COPD (page 8); one has to go the following page to determine the disease (asthma).
