🇪🇺 Fluticasone Furoate (FF) in European Union

EMA authorised Fluticasone Furoate (FF) on 6 October 2008

Marketing authorisations

Application: EMEA/H/C/001019
Marketing authorisation holder: Glaxo Group Ltd.
Local brand name: Alisade
Indication: Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.
Status: withdrawn

Application: EMEA/H/C/004781
Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
Local brand name: Elebrato Ellipta
Indication: Elebrato Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting ?2-agonist.
Status: approved

Application: EMEA/H/C/005254
Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
Local brand name: Temybric Ellipta
Indication: Temybric Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting ?2-agonist or a combination of a long-acting ?2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).
Status: withdrawn

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

Is Fluticasone Furoate (FF) approved in European Union?

Yes. EMA authorised it on 6 October 2008; EMA authorised it on 15 November 2017; EMA authorised it on 12 June 2019.

Who is the marketing authorisation holder for Fluticasone Furoate (FF) in European Union?

Glaxo Group Ltd. holds the EU marketing authorisation.