Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Anoro   
Auth. number : EU/1/14/898
Active substance : umeclidinium bromide / vilanterol trifenatate
ATC: Anatomical main group: R - Respiratory system
Therapeutic subgroup: R03 - Anti-asthmatics
Pharmacological subgroup: R03A - Adrenergics, inhalants
Chemical subgroup: R03AL - Adrenergics in combination with anticholinergics
Chemical substance: R03AL03 - vilanterol and umeclidinium bromide
(See WHO ATC Index)
Indication: Anoro is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)
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
13/05/2014 Centralised - Authorisation EMEA/H/C/2751 (2014)3178 of 08/05/2014
26/03/2015 Centralised - Variation EMEA/H/C/2751/IB/22
Updated with Decision(2016)1986 of 30/03/2016
01/10/2015 Centralised - Variation EMEA/H/C/2751/WS/823
Updated with Decision(2016)1986 of 30/03/2016
21/12/2015 Centralised - Notification EMEA/H/C/2751/N/8
Updated with Decision(2016)1986 of 30/03/2016
14/01/2016 Centralised - Variation EMEA/H/C/2751/WS/871/G
Updated with Decision(2016)1986 of 30/03/2016
01/04/2016 PSUSA - Modification EMEA/H/C/2751/PSUSA/10264/201506 (2016)1986 of 30/03/2016
26/09/2016 PSUSA - Modification EMEA/H/C/2751/PSUSA/10264/201512 (2016) 6242 of 22/09/2016
26/01/2017 Centralised - Variation EMEA/H/C/2751/WS/1031
Updated with Decision(2018) 1138 of 19/02/2018
21/04/2017 Centralised - Variation EMEA/H/C/2751/WS/1030
Updated with Decision(2018) 1138 of 19/02/2018
13/07/2017 Centralised - Variation EMEA/H/C/2751/WS/1189
Updated with Decision(2018) 1138 of 19/02/2018
21/02/2018 Centralised - Yearly update (2018) 1138 of 19/02/2018