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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Invented name:||Relvar Elllipta|
|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
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be 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|