BiResp Spiromax (budesonide;formoterol)
- Region
- 🇪🇺 EU
- Active substance
- budesonide;formoterol
- Company
- Teva Pharma B.V.
- Status
- Authorised
- Therapeutic area
- Pulmonary Disease, Chronic Obstructive; Asthma
- EU approval
- Mon 28 Apr 2014
- Application
- EMEA/H/C/003890
- ATC
- R03AK07
- Official record
- www.ema.europa.eu
Indication
Asthma BiResp Spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?? adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?? adrenoceptor agonists. or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?? adrenoceptor agonists. COPDBiResp Spiromax is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV?) <70% predicted normal (post bronchodilator) 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.
- 🇪🇺 Budesonide/Formoterol Teva Pharma B.V. Withdrawn · Teva Pharma B.V.
- 🇪🇺 Budesonide/Formoterol Teva Withdrawn · Teva Pharma B.V.
- 🇪🇺 Vylaer Spiromax Withdrawn · Teva Pharma B.V.
Follow BiResp Spiromax
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.