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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Ulunar Breezhaler   
Auth. number : EU/1/14/917
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: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)
Marketing Authorisation Holder: Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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
25/04/2014 Centralised - Authorisation EMEA/H/C/3875 (2014)2824 of 23/04/2014
19/12/2014 PSUSA - Modification EMEA/H/C/3875/PSUV/2 (2014)10109 of 16/12/2014
21/01/2015 Centralised - Variation EMEA/H/C/3875/IG/518
Updated with Decision(2016)408 of 22/01/2016
09/10/2015 Centralised - Variation EMEA/H/C/3875/IB/9/G
Updated with Decision(2016)408 of 22/01/2016
13/01/2016 Centralised - Notification EMEA/H/C/3875/N/11
Updated with Decision(2017)7025 of 13/10/2017
26/01/2016 Centralised - Yearly update (2016)408 of 22/01/2016
27/10/2016 Centralised - Variation EMEA/H/C/3875/WS/1004
Updated with Decision(2017)7025 of 13/10/2017
10/11/2016 Centralised - Variation EMEA/H/C/3875/WS/1005
Updated with Decision(2017)7025 of 13/10/2017
17/10/2017 Centralised - Yearly update (2017)7025 of 13/10/2017
24/10/2017 Centralised - Variation EMEA/H/C/3875/IB/19/G
Updated with Decision(2018)3058 of 08/05/2018
15/05/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/3875/T/24 (2018)3058 of 08/05/2018