Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Revinty Ellipta   
Auth. number : EU/1/14/929
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
Revinty 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)
Revinty 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
06/05/2014 Centralised - Authorisation EMEA/H/C/2745 (2014)3040 of 02/05/2014
20/11/2014 Centralised - Variation EMEA/H/C/2745/IG/496
Updated with Decision(2015)8596 of 27/11/2015
18/12/2014 Centralised - Variation EMEA/H/C/2745/WS/602
Updated with Decision(2015)8596 of 27/11/2015
23/04/2015 Centralised - Variation EMEA/H/C/2745/WS/713/G
Updated with Decision(2015)8596 of 27/11/2015
25/06/2015 Centralised - Variation EMEA/H/C/2745/WS/694
Updated with Decision(2015)8596 of 27/11/2015
24/09/2015 Centralised - Variation EMEA/H/C/2745/WS/772
Updated with Decision(2015)8596 of 27/11/2015
01/12/2015 Centralised - Yearly update (2015)8596 of 27/11/2015
17/12/2015 Centralised - Variation EMEA/H/C/2745/WS/850
14/01/2016 Centralised - Variation EMEA/H/C/2745/WS/863/G