Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Relvar Ellipta   
Auth. number : EU/1/13/886
Active substance : 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)
Indication: Asthma
Relvar Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal 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 (Chronic Obstructive Pulmonary Disease)

Relvar Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.
Marketing Authorisation Holder: Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
EPAR and active package presentations

Package presentations

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.

European Commission proceduresGoto top of the page

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 - Notification EMEA/H/C/2673/N/4
Updated with Decision(2015)7838 of 06/11/2015
20/11/2014 Centralised - Variation EMEA/H/C/2673/IG/496
Updated with Decision(2015)7838 of 06/11/2015
18/12/2014 Centralised - Variation EMEA/H/C/2673/WS/602
Updated with Decision(2015)7838 of 06/11/2015
23/04/2015 Centralised - Variation EMEA/H/C/2673/WS/713/G
Updated with Decision(2015)7838 of 06/11/2015
25/06/2015 Centralised - Variation EMEA/H/C/2673/WS/694
Updated with Decision(2015)7838 of 06/11/2015
24/09/2015 Centralised - Variation EMEA/H/C/2673/WS/772
Updated with Decision(2015)7838 of 06/11/2015
10/11/2015 Centralised - Yearly update (2015)7838 of 06/11/2015
17/12/2015 Centralised - Variation EMEA/H/C/2673/WS/850
Updated with Decision(2016)4085 of 24/06/2016
14/01/2016 Centralised - Variation EMEA/H/C/2673/WS/863/G
Updated with Decision(2016)4085 of 24/06/2016
28/06/2016 Referral EMEA/H/A-31/1415/C/2673/14 (2016)4085 of 24/06/2016