The CHMP has recommended the granting of a marketing authorisation for Bretaris Genuair 322 μg, inhalation powder, pre-dispensed, intended for maintenance bronchodilator treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD).
The applicant for this medicinal product is Almirall, S.A.
The active substance of Bretaris Genuair is aclidinium bromide, a long-acting, inhaled anticholinergic agent (ATC Code R03BB05) that inhibits acetylcholine-induced bronchoconstriction.
The benefits with Bretaris Genuair are its ability to relieve the symptoms experienced by patients with moderate to severe COPD in terms of lung function and quality of life (QoL).
The most common side effects are headache and nasopharyngitis.
A pharmacovigilance plan for Bretaris Genuair will be implemented as part of the marketing authorisation.
The approved indication is: “maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD).”
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been
granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Bretaris Genuair and therefore recommends the granting of the marketing authorisation.