First EU approvals for Bufomic Easyhaler for Asthma and COPD - Orion Pharma

Orion Corporation has received Irish and Hungarian marketing authorisation for Bufomix Easyhaler, an inhaled budesonide-formoterol combination product indicated for Asthma and Chronic Obstructive Pulmonary Disease (COPD). In this formulation, budesonide acts as an anti-inflammatory agent and formoterol acts as a long-acting bronchodilator. The marketing authorisation covers two strengths (budesonide 160 �g / formoterol 4.5 �g and budesonide 320 �g / formoterol 9 �g) for the treatment of asthma and COPD in patients above 12 years.

The Irish and Hungarian marketing authorisations are the first approvals of the EU decentralized procedures (DCP) for 22 EU countries, in which Sweden acted as a reference member state. National approval procedure of the marketing authorisation application is ongoing in following EU countries: Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden. In addition, national procedure is ongoing in Iceland, Norway and Switzerland. Orion will announce further information on approvals in these countries in its upcoming Interim Reports.