Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Eklira Genuair   
Auth. number : EU/1/12/778
INN : 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: Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Marketing Authorisation Holder: Almirall, S.A.
Ronda General Mitre, 151, E-08022 Barcelona, España

  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/2211 (2012)5287 of 20/07/2012
03/12/2012 Centralised - Variation EMEA/H/C/2211/N/2
Updated with Decision(2013)8166 of 15/11/2013
22/02/2013 Centralised - Variation EMEA/H/C/2211/IB/5
Updated with Decision(2013)8166 of 15/11/2013
30/05/2013 Centralised - Variation EMEA/H/C/2211/II/4
Updated with Decision(2013)8166 of 15/11/2013
18/11/2013 Centralised - Modification EMEA/H/C/2211/PSU/4 (2013)8166 of 15/11/2013
23/01/2014 Centralised - Variation EMEA/H/C/2211/II/9
Updated with Decision(2014)2826 of 23/04/2014
11/02/2014 Centralised - Variation EMEA/H/C/2211/IAIN/14
Updated with Decision(2014)2826 of 23/04/2014
25/04/2014 Centralised - Modification EMEA/H/C/2211/PSUR/8 (2014)2826 of 23/04/2014
22/05/2014 Centralised - Variation EMEA/H/C/2211/IAIN/16