Daxas : EPAR - Medicine overview (PDF/75.74 KB)
First published: 28/07/2010
Last updated: 25/04/2018
Daxas : EPAR - Risk management plan summary (PDF/169.38 KB)
First published: 25/03/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Pulmonary Disease, Chronic Obstructive
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
SE-151 85 Södertälje
25/08/2022 Daxas - EMEA/H/C/001179 - N/0047
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Drugs for obstructive airway diseases
Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.