🇪🇺 Budesonide, Formoterol Fumarate Dihydrate in European Union

EMA authorised Budesonide, Formoterol Fumarate Dihydrate on 28 April 2014

Marketing authorisation

Application: EMEA/H/C/002348
Marketing authorisation holder: Teva Pharma B.V.
Local brand name: DuoResp Spiromax
Indication: Asthma DuoResp 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. COPDDuoResp Spiromax is indicated in adults, aged 18 years and older for the symptomatic treatment of patients with CO
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Budesonide, Formoterol Fumarate Dihydrate approved in European Union?

Yes. EMA authorised it on 28 April 2014.

Who is the marketing authorisation holder for Budesonide, Formoterol Fumarate Dihydrate in European Union?

Teva Pharma B.V. holds the EU marketing authorisation.