🇪🇺 Bronchodilator Agents in European Union

EMA authorised Bronchodilator Agents on 2 May 2014

Marketing authorisation

EMA — authorised 2 May 2014

  • Application: EMEA/H/C/002745
  • Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
  • Local brand name: Revinty Ellipta
  • Indication: Asthma Indication Revinty Ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2-agonists. COPD Indication Revinty Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite bronchodilator therapy.
  • Status: approved

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Other Respiratory approved in European Union

Frequently asked questions

Is Bronchodilator Agents approved in European Union?

Yes. EMA authorised it on 2 May 2014.

Who is the marketing authorisation holder for Bronchodilator Agents in European Union?

GlaxoSmithKline Trading Services Limited holds the EU marketing authorisation.