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Pharmaceuticals - Union Register
Union Register of not active medicinal products for human use |
WITHDRAWN |
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
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 Union Register. |
European Commission procedures |
Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
1/03/2011 | Centralised - Authorisation - Decision addressed to Member States | EMEA/H/C/2398 | (2011)1470 of 28/02/2011 | |||
2/03/2011 | 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 | ||||||
6/03/2012 | Centralised - Variation | (2012)1498 of 2/03/2012 | ||||
8/10/2012 | Centralised - Variation | EMEA/H/C/2398/X/2 | (2012)7106 of 4/10/2012 | |||
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 | |||
5/08/2013 | 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 | ||||||
3/09/2014 | Centralised - Yearly update | (2014)6260 of 1/09/2014 | ||||
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 | ||||||
7/11/2016 | Centralised - Transfer Marketing Authorisation Holder | EMEA/H/C/2398/T/30 | (2016)7190 of 3/11/2016 | |||
15/01/2018 | Centralised - Withdrawal | (2018)198 of 11/01/2018 |