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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Enurev Breezhaler   
Auth. number : EU/1/12/789
Active substance : glycopyrronium 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: R03BB06 - glycopyrronium bromide
(See WHO ATC Index)
Indication: Enurev 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
03/10/2012 Centralised - Authorisation EMEA/H/C/2691 (2012)6963 of 28/09/2012
30/07/2013 Centralised - Notification EMEA/H/C/2691/N/2
Updated with Decision(2014)4266 of 19/06/2014
18/12/2013 Centralised - Variation EMEA/H/C/2691/WS/456
Updated with Decision(2014)4266 of 19/06/2014
23/06/2014 PSUSA - Modification EMEA/H/C/2691/PSUV/4 (2014)4266 of 19/06/2014
19/05/2015 Centralised - Variation EMEA/H/C/2691/IB/10
Updated with Decision(2016)3000 of 12/05/2016
30/07/2015 Centralised - Variation EMEA/H/C/2691/WS/781
Updated with Decision(2016)3000 of 12/05/2016
30/07/2015 Centralised - Variation EMEA/H/C/2691/WS/782
Updated with Decision(2016)3000 of 12/05/2016
16/05/2016 Centralised - Yearly update (2016)3000 of 12/05/2016
15/09/2016 Centralised - Variation EMEA/H/C/2691/WS/1001
Updated with Decision(2017)5098 of 13/07/2017
17/07/2017 Centralised - Renewal EMEA/H/C/2691/R/20 (2017)5098 of 13/07/2017
11/10/2017 Corrigendum (2017)5098 of 13/07/2017
12/04/2018 Centralised - Variation EMEA/H/C/2691/WS/1299