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Community Register of medicinal products

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: R - Respiratory system
R03 - Anti-asthmatics
R03B - Other anti-asthmatics, inhalants
R03BB - Anticholinergics
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: Almirall, S.A.
Ronda General Mitre, 151, E-08022 Barcelona, España

  EPAR and active package presentations

Package presentations

The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be 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
22/02/2013 Centralised - Variation EMEA/H/C/2211/IB/5