🇪🇺 FS MDPI in European Union

EMA authorised FS MDPI on 18 August 2016

Marketing authorisation

EMA — authorised 18 August 2016

  • Application: EMEA/H/C/004267
  • Marketing authorisation holder: Teva B.V.
  • Local brand name: Airexar Spiromax
  • Indication: Airexar Spiromax is indicated for use in adults aged 18 years and older only. AsthmaAirexar 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)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a F
  • Status: withdrawn

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Other Psychiatry/Neurology approved in European Union

Frequently asked questions

Is FS MDPI approved in European Union?

Yes. EMA authorised it on 18 August 2016.

Who is the marketing authorisation holder for FS MDPI in European Union?

Teva B.V. holds the EU marketing authorisation.