The product was first approved in Denmark on December 18th, 2013 and Germany on January 13th, 2014. The new product offers the proven combination of salmeterol (a long-acting inhaled ?2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative inhalation device.

Sweden has approved the 50-500µg and 50-250µg dosage forms for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD in the same patient group. The product's safety, efficacy and equivalence have been proven in multiple clinical trials1,2.

The receipt of the marketing authorisations in Sweden, Germany and Denmark follows the successful completion of EU decentralised procedures also including Norway for the 50-500 µg and 50-250 µg dosage forms and for the 50-500 µg dosage form Germany, Belgium, Bulgaria, Hungary, Luxembourg and Romania. We will communicate as and when further market approvals are received.

Vectura initially developed the VR315 product and created the design of the innovative inhaler, before licensing the asset to Sandoz in 2006. It was subsequently developed in collaboration with Vectura as AirFluSal® Forspiro® by Aeropharm GmbH in Rudolstadt, Germany, Sandoz' global respiratory Center of Excellence. The innovative and intuitive to use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.

distributed by