Prognia
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🇪🇺EU · EMAAuthorisedATC: R03AK07

GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.)(Budesonide;formoterol fumarate dihydrate)

Asthma;Pulmonary Disease, Chronic Obstructive

Marketing Authorisation Holder: Teva Pharma B.V.

EMA Authorisation: 03/04/2020

INN: budesonide;formoterol fumarate dihydrate

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.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.