🇪🇺 fluticasone furoate & vilanterol in European Union

EMA authorised fluticasone furoate & vilanterol on 13 November 2013

Marketing authorisation

EMA — authorised 13 November 2013

  • Application: EMEA/H/C/002673
  • Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
  • Local brand name: Relvar Ellipta
  • Indication: Asthma indication: Relvar 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. patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist. COPD indication: Relvar Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bro
  • Status: approved

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fluticasone furoate & vilanterol in other countries

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

Frequently asked questions

Is fluticasone furoate & vilanterol approved in European Union?

Yes. EMA authorised it on 13 November 2013.

Who is the marketing authorisation holder for fluticasone furoate & vilanterol in European Union?

GlaxoSmithKline Trading Services Limited holds the EU marketing authorisation.