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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Invented name:||Relvar Ellipta|
|Auth. number :||EU/1/13/886|
|INN :||fluticasone furoate/vilanterol trifenatate|
|ATC:||Anatomical main group: R - Respiratory system|
Therapeutic subgroup: R03 - Anti-asthmatics
Pharmacological subgroup: R03A - Adrenergics, inhalants
Chemical subgroup: R03AK - Adrenergics and other anti-asthmatics
Chemical substance: R03AK10 - Vilanterol and fluticasone furoate
(See WHO ATC Index)
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.
Relvar 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.
|Marketing Authorisation Holder:||Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".|
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|14/11/2013||Centralised - Authorisation||EMEA/H/C/2673||(2013)8089 of 13/11/2013|
|20/05/2014||Corrigendum||(2014)3419 of 16/05/2014|
|22/05/2014||Centralised - Variation||EMEA/H/C/2673/N/4|