Vylaer Spiromax (budesonide;formoterol)
- Region
- 🇪🇺 EU
- Active substance
- budesonide;formoterol
- Company
- Teva Pharma B.V.
- Status
- Withdrawn
- Therapeutic area
- Pulmonary Disease, Chronic Obstructive; Asthma
- EU approval
- Wed 19 Nov 2014
- Application
- EMEA/H/C/003952
- ATC
- R03AK07
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) Authorised · Teva Pharma B.V.
- 🇪🇺 DuoResp Spiromax Authorised · Teva Pharma B.V.
- 🇪🇺 BiResp Spiromax Authorised · Teva Pharma B.V.
- 🇪🇺 Budesonide/Formoterol Teva Pharma B.V. Withdrawn · Teva Pharma B.V.
- 🇪🇺 Budesonide/Formoterol Teva Withdrawn · Teva Pharma B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.