Approved in 27 EU countries: AT, BE, BG, CY, CZ, DE, DK, EE, FI, FR, GR, HU, IE, IS, IT, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK

BREATH: 1Hellenic Thoracic Society Congress, 2010, PD AA016, ΑΝΑSA: 2European Respiratory Society Meeting 2012, Vienna, No P751, P758; 3Hellenic Thoracic Society Congress, 201, PD AA111; 4Hellenic Thoracic Society Congress, 201, PD AA18; 5http://clini-caltrials.gov, Identifier: NCT01475045, OPINION: 6European Respiratory Society Meeting 2013, Barcelona, No P3823, PAIR: 7Hellenic Thoracic Society Congress, 2014, accepted for presentation

Country Brand Name Launch Inhaled packs

Greece Rolenium Q4 2009 more than 1,500,000

Cyprus Rolenium Q4 2011 Elpenhaler® packs

Malta Rolenium Q1 2012 since launch

Germany Rolenium Q4 2012

Hungary Dimenio Q1 2013 Patient satisfaction

Sweden Relanio Q1 2013 demonstrated in post

Italy Rolenium Q4 2013 marketing trials

Netherlands

Salmeterol

Q4 2013

in more than 5,000 asthma

Fluticasonpropionaat

and COPD patients

Elpen

(BREATH1, ANASA2-5, OPINION6, PAIR7)Iceland Relanio Q1 2014

Elpenhaler® features

• Visual and Taste

Verification

• Simple and Robust

Construction

• Accurate Dosing

• Protection of Dose

• Patient Satisfaction

Presentations Budesonide + Formoterol fum. dihydr.

Pulmoton® 100 (100 mcg + 6 mcg) x 120

Pulmoton® 200 (200 mcg + 6 mcg) x 120

Pulmoton® 400 (400 mcg + 12 mcg) x 60

Indications Asthma, COPD

Registrations Europe, on-going

Launches Greece, Cyprus

Dossier e-CTD

CPP Available