Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Daxas   
Auth. number : EU/1/10/636
INN : roflumilast
ATC: Anatomical main group: R - Respiratory system
Therapeutic subgroup: R03 - Anti-asthmatics
Pharmacological subgroup: R03D - Other anti-asthmatics for systemic use
Chemical subgroup: R03DX - Other anti-asthmatics for systemic use
Chemical substance: R03DX07 - Roflumilast
(See WHO ATC Index)
Indication: 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.
Marketing Authorisation Holder: Takeda GmbH
Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland

  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
07/07/2010 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1179 (2010)4784 of 05/07/2010
08/07/2010 Centralised - Authorisation EMEA/H/C/1179 (2010)4785 of 05/07/2010
08/09/2010 Centralised - Variation EMEA/H/C/1179/N/1
Updated with Decision(2011)7799 of 24/10/2011
15/10/2010 Corrigendum (2010)7220 corr of 14/10/2010
18/10/2010 Corrigendum (2010)7221 corr of 14/10/2010
02/05/2011 Centralised - Variation EMEA/H/C/1179/IB/2
Updated with Decision(2011)7799 of 24/10/2011
12/05/2011 Centralised - Variation EMEA/H/C/1179/IB/3/G
Updated with Decision(2011)7799 of 24/10/2011
26/10/2011 Centralised - Variation (2011)7799 of 24/10/2011
30/01/2012 Centralised - Variation EMEA/H/C/1179/N/7
Updated with Decision(2012)7648 of 24/10/2012
13/02/2012 Centralised - Variation EMEA/H/C/1179/N/9
Updated with Decision(2012)7648 of 24/10/2012
08/10/2012 Centralised - Variation EMEA/H/C/1179/X/4 (2012)7108 of 04/10/2012
26/10/2012 Centralised - Variation EMEA/H/C/1179/WS/231 (2012)7648 of 24/10/2012
25/01/2013 Centralised - Variation EMEA/H/C/1179/IG/262/G
Updated with Decision(2013)1895 of 26/03/2013
13/02/2013 Centralised - Variation EMEA/H/C/1179/N/14
Updated with Decision(2013)1895 of 26/03/2013
26/03/2013 Centralised - Modification EMEA/H/C/1179/PSUR/8 (2013)1842 of 22/03/2013
28/03/2013 Centralised - Variation EMEA/H/C/1179/WS/352 (2013)1895 of 26/03/2013
05/08/2013 Centralised - Variation EMEA/H/C/1179/N/16
23/09/2013 Centralised - Variation EMEA/H/C/1179/IG/353