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).
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 160µg/formoterol 4.5µg and budesonide 320µg/formoterol 9µg) 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 decentralised 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 approval procedure is ongoing in Iceland, Norway and Switzerland. Orion will announce further information on approvals in these countries in its upcoming Interim Reports.
Orion’s Easyhaler is an in-house developed dry-powder inhaler. The company has developed Easyhaler-adapted dry powder formulations of several well-known generic active substances (salbutamol, beclometasone, budesonide, formoterol) used in the treatment of asthma and COPD. Currently under development is a new combined formulation of fluticasone-salmeterol for the treatment of asthma and COPD.
