🇪🇺 Fluticasone/Salmeterol Diskus in European Union

EMA authorised Fluticasone/Salmeterol Diskus on 18 August 2016

Marketing authorisations

Application: EMEA/H/C/002752
Marketing authorisation holder: Teva B.V.
Local brand name: Aerivio Spiromax
Indication: Aerivio Spiromax is indicated for use in adults aged 18 years and older only. Asthma Aerivio Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting ?2 agonist) is appropriate: patients not adequately controlled on a lower strength corticosteroid combination product or patients already controlled on a high dose inhaled corticosteroid and long-acting ?2 agonist. Chronic Obstructive Pulmonary Disease (COPD) Aerivio Spiromax is indicated for the symptomatic treatment of patients with COPD, with a F
Status: withdrawn

Application: EMEA/H/C/004881
Marketing authorisation holder: Teva B.V.
Local brand name: Seffalair Spiromax
Indication: Seffalair Spiromax is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting ?? agonists.
Status: approved

Application: EMEA/H/C/005591
Marketing authorisation holder: Teva B.V.
Local brand name: BroPair Spiromax
Indication: BroPair Spiromax is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting ?? agonists.
Status: withdrawn

Is Fluticasone/Salmeterol Diskus approved in European Union?

Yes. EMA authorised it on 18 August 2016; EMA authorised it on 26 March 2021; EMA authorised it on 26 March 2021.

Who is the marketing authorisation holder for Fluticasone/Salmeterol Diskus in European Union?

Teva B.V. holds the EU marketing authorisation.