Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Incruse   
Auth. number : EU/1/14/922
Active substance : umeclidinium bromide
ATC: Anatomical main group: R - Respiratory system
Therapeutic subgroup: R03 - Anti-asthmatics
Pharmacological subgroup: R03B - Other anti-asthmatics, inhalants
Chemical subgroup: R03BB - Anticholinergics
Chemical substance: R03BB07 - umeclidinium bromide
(See WHO ATC Index)
Indication: Incruse 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
30/04/2014 Centralised - Authorisation EMEA/H/C/2809 (2014)2919 of 28/04/2014
18/12/2014 Centralised - Variation EMEA/H/C/2809/II/1
Updated with Decision(2015)9546 of 14/12/2015
23/04/2015 Centralised - Variation EMEA/H/C/2809/II/2
Updated with Decision(2015)9546 of 14/12/2015
30/09/2015 Centralised - Variation EMEA/H/C/2809/IB/6
Updated with Decision(2015)9546 of 14/12/2015
12/11/2015 Centralised - Variation EMEA/H/C/2809/II/7
Updated with Decision(2016)7405 of 11/11/2016
16/12/2015 Centralised - Yearly update (2015)9546 of 14/12/2015
3/05/2016 Centralised - Variation EMEA/H/C/2809/IB/9
Updated with Decision(2016)7405 of 11/11/2016
15/11/2016 Centralised - Yearly update (2016)7405 of 11/11/2016
6/01/2017 PSUSA - Modification EMEA/H/C/PSUSA/10263/201604 (2017)41 of 4/01/2017
21/04/2017 Centralised - Variation EMEA/H/C/2809/II/13
Updated with Decision(2017)5088 of 13/07/2017
21/04/2017 Centralised - Variation EMEA/H/C/2809/WS/1030
Updated with Decision(2017)5088 of 13/07/2017
13/07/2017 Centralised - Variation EMEA/H/C/2809/WS/1191
17/07/2017 PSUSA - Modification EMEA/H/C/PSUSA/10263/201610 (2017)5088 of 13/07/2017