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This is a summary of the European public assessment report (EPAR) for Onbrez Breezhaler. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Onbrez Breezhaler.

Onbrez Breezhaler is a medicine that contains the active substance indacaterol. It is available as capsules containing a powder for inhalation (150 and 300 micrograms).

A Phase III trial published in March 2010 examined the efficacy and safety of indacaterol in COPD patients. [5] This study, conducted in the U.S., New Zealand, and Belgium, compared indacaterol dry-powder inhaler to placebo in 416 COPD patients, mostly moderate to severe (mean FEV 1 of 1.5 L). Indacaterol produced statistically improved FEV 1 (both trough and AUC) and decreased use of rescue medication compared to placebo, but with safety and tolerability similar to those of placebo.

Transparent (uncoloured) capsules containing a white powder, with “IDL 150” printed in black above a black bar and company logo ( ) printed in black below the black bar.