ULTIBRO BREEZHALER

In patients with COPD :

- Substantial AB only in patients with moderate to very severe COPD whose symptoms are already controlled by the separately administered indacaterol and glycopyrronium combination ;

- Insufficient AB for reimbursement by National Health Insurance in the other cases.

ULTIBRO BREEZHALER fixed-dose indacaterol and glycopyrronium combination does not provide any improvement in actual benefit (IAB V, non-existent) compared with the free combination of its active ingredients administered separately in the population of patients with moderate to very severe COPD whose symptoms are already controlled by the separately administered indacaterol and glycopyrronium combination.