GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) (budesonide;formoterol fumarate dihydrate)
- Region
- 🇪🇺 EU
- Active substance
- budesonide;formoterol fumarate dihydrate
- Company
- Teva Pharma B.V.
- Status
- Authorised
- Therapeutic area
- Asthma; Pulmonary Disease, Chronic Obstructive
- CHMP opinion
- Thu 30 Jan 2020
- EU approval
- Fri 03 Apr 2020
- Application
- EMEA/H/C/004882
- ATC
- R03AK07
- Official record
- www.ema.europa.eu
Indication
Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only. Asthma Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists. or -in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. COPD Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) < 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
- 🇪🇺 Budesonide/Formoterol Teva Pharma B.V. Withdrawn · Teva Pharma B.V.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.