| EMA number | EMEA/H/C/003952 |
| ATC code | R03AK07 |
| Authorisation | 19 November 2014 |
| Withdrawn | 9 January 2017 |
| Revision | 3 |
Vylaer Spiromax is indicated in adults 18 years of age and older only. AsthmaVylaer Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?2 adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?2 adrenoceptor agonists.or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?2 adrenoceptor agonists. COPDSymptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — TEVA PHARMS USA INC, approved 2026-04-23 (ANDA212212).
111,454 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.