Navigation path

Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Xoterna Breezhaler   
Auth. number : EU/1/13/863
Active substance : indacaterol/glycopyrronium bromide
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: R03AL04 - indacaterol and glycopyrronium bromide
(See WHO ATC Index)
Indication: Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, 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
23/09/2013 Centralised - Authorisation EMEA/H/C/3755 (2013)6219 of 19/09/2013
23/01/2014 Centralised - Variation EMEA/H/C/3755/WS/482
Updated with Decision(2014)10073 of 16/12/2014
27/05/2014 Centralised - Notification EMEA/H/C/3755/N/3
Updated with Decision(2014)10073 of 16/12/2014
12/06/2014 Centralised - Notification EMEA/H/C/3755/N/4
Updated with Decision(2014)10073 of 16/12/2014
18/12/2014 PSUSA - Modification EMEA/H/C/3755/PSUV/5 (2014)10073 of 16/12/2014
21/01/2015 Centralised - Variation EMEA/H/C/3755/IG/518
Updated with Decision(2016)627 of 28/01/2016
09/10/2015 Centralised - Variation EMEA/H/C/3755/IB/12/G
Updated with Decision(2016)627 of 28/01/2016
01/02/2016 Centralised - Yearly update (2016)627 of 28/01/2016
27/10/2016 Centralised - Variation EMEA/H/C/3755/WS/1004
Updated with Decision(2017)6643 of 26/09/2017
10/11/2016 Centralised - Variation EMEA/H/C/3755/WS/1005
Updated with Decision(2017)6643 of 26/09/2017
02/08/2017 Centralised - Notification EMEA/H/C/3755/N/18
Updated with Decision(2017)6643 of 26/09/2017
28/09/2017 Centralised - Yearly update (2017)6643 of 26/09/2017
24/10/2017 Centralised - Variation EMEA/H/C/3755/IB/22/G