BIRESP SPIROMAX, DUORESP SPIROMAX (Teva Pharma Australia Pty Ltd)
Product name
BIRESP SPIROMAX, DUORESP SPIROMAX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
28 working days (45)
Active ingredients
budesonide; formoterol (eformoterol) fumarate dihydrate
Registration type
EOI
Indication
Generic medicine
Asthma
BIRESP SPIROMAX, DUORESP SPIROMAX (powder for inhalation) are now also indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk and exacerbations (see Section 4.2 Dose and method of administration).
BIRESP SPIROMAX, DUORESP SPIROMAX are not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.