Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Daliresp   
Auth. number : EU/1/11/668
Active substance : 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: Daliresp 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: AstraZeneca AB
SE-151 85 Södertälje, Sverige
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
01/03/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2398 (2011)1470 of 28/02/2011
02/03/2011 Centralised - Authorisation EMEA/H/C/2398 (2011)1467 of 28/02/2011
24/05/2011 Centralised - Variation EMEA/H/C/2398/IB/1
Updated with Decision(2012)1498 of 02/03/2012
06/03/2012 Centralised - Variation (2012)1498 of 02/03/2012
08/10/2012 Centralised - Variation EMEA/H/C/2398/X/2 (2012)7106 of 04/10/2012
26/10/2012 Centralised - Variation EMEA/H/C/2398/WS/231 (2012)7673 of 24/10/2012
25/01/2013 Centralised - Variation EMEA/H/C/2398/IG/268/G
Updated with Decision(2013)1899 of 26/03/2013
13/02/2013 Centralised - Notification EMEA/H/C/2398/N/10
Updated with Decision(2013)1899 of 26/03/2013
26/03/2013 PSUSA - Modification EMEA/H/C/2398/PSU/7 (2013)1843 of 22/03/2013
28/03/2013 Centralised - 2-Monthly update EMEA/H/C/2398/WS/352 (2013)1899 of 26/03/2013
05/08/2013 Centralised - Notification EMEA/H/C/2398/N/12
Updated with Decision(2014)6260 of 01/09/2014
20/09/2013 Centralised - Variation EMEA/H/C/2398/IAin/G/353
Updated with Decision(2014)6260 of 01/09/2014
03/09/2014 Centralised - Yearly update (2014)6260 of 01/09/2014
25/03/2015 PSUSA - Modification EMEA/H/C/PSUSA/2658/201407 (2015)2116 of 23/03/2015
28/04/2015 Centralised - Renewal EMEA/H/C/2398/R/20 (2015)2914 of 24/04/2015
30/10/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2398/T/23 (2015)7586 of 28/10/2015
17/12/2015 Centralised - Variation EMEA/H/C/2398/WS/768
Updated with Decision(2016)7190 of 03/11/2016
07/11/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2398/T/30 (2016)7190 of 03/11/2016