ULTIBRO BREEZHALER (indacaterol, glycopyrronium) long-acting bronchodilator

Opinions on drugs - Posted on Mar 29 2018

Reason for request

Re-assessment of the actual benefit and the improvement in actual benefit

Moderate clinical benefit in continuous bronchodilator treatment of chronic obstructive pulmonary disease


  • ULTIBRO BREEZHALER has Marketing Authorisation in continuous bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
  • The results of new data have led to the conclusion that this fixed combination of two long-acting bronchodilators has a moderate clinical benefit in this indication (and no longer substantial) in a population restricted to patients with moderate to very severe COPD whose symptoms are already controlled by the combination of indacaterol and glycopyrronium separately administered.
  • ULTIBRO BREEZHALER is more specifically for patients with moderate to very severe COPD who have associated persistent dyspnoea despite use of a long-acting bronchodilator in monotherapy.


Clinical Benefit



Clinical Added Value

no clinical added value


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