BUFOMIX EASYHALER (Sun Pharma ANZ Pty Ltd)
Product name
BUFOMIX EASYHALER
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
205 (255 working days)
Active ingredients
Budesonide, formoterol (eformoterol) fumarate dihydrate
Registration type
New generic medicine
Indication
Asthma
BUFOMIX EASYHALER is indicated in adults and adolescents (12 years and older), for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see Section 4.2 Dose and method of administration).
Chronic obstructive pulmonary disease (COPD)
BUFOMIX EASYHALER is indicated for the symptomatic treatment of moderate to severe COPD (FEV1 ≤50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. BUFOMIX EASYHALER is not indicated for the initiation of bronchodilator therapy in COPD.