Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Bretaris Genuair   
Auth. number : EU/1/12/781
Active substance : aclidinium 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: R03BB05 - Aclidinium bromide
(See WHO ATC Index)
Indication: Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Marketing Authorisation Holder: AstraZeneca AB
SE-151 85 Södertälje, Sverige
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
25/07/2012 Centralised - Authorisation EMEA/H/C/2706 (2012)5288 of 20/07/2012
03/12/2012 Centralised - Notification EMEA/H/C/2706/N/2
Updated with Decision(2013)8165 of 15/11/2013
22/02/2013 Centralised - Variation EMEA/H/C/2706/IB/5
Updated with Decision(2013)8165 of 15/11/2013
30/05/2013 Centralised - Variation EMEA/H/C/2706/II/4
Updated with Decision(2013)8165 of 15/11/2013
18/11/2013 PSUSA - Modification EMEA/H/C/2706/PSU/4 (2013)8165 of 15/11/2013
23/01/2014 Centralised - Variation EMEA/H/C/2706/II/9
Updated with Decision(2014)2825 of 23/04/2014
11/02/2014 Centralised - Variation EMEA/H/C/2706/IAin/13
Updated with Decision(2014)2825 of 23/04/2014
25/04/2014 PSUSA - Modification EMEA/H/C/2706/PSUR/8 (2014)2825 of 23/04/2014
22/05/2014 Centralised - Variation EMEA/H/C/2706/IAin/15
Updated with Decision(2014)8913 of 19/11/2014
21/11/2014 PSUSA - Modification EMEA/H/C/2706/PSUV/14 (2014)8913 of 19/11/2014
27/11/2014 Centralised - Notification EMEA/H/C/2706/N/19
Updated with Decision(2015)1567 of 05/03/2015
09/03/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2706/T/20 (2015)1567 of 05/03/2015
28/04/2015 PSUSA - Modification EMEA/H/C/2706/PSUSA/9005/201407 (2015)2927 of 24/04/2015