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Community Register of medicinal products
Community register of medicinal products for human use
|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
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.
|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|