- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 11 January 2018, the European Commission withdrew the marketing authorisation for Daliresp (roflumilast) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AstraZeneca AB, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Daliresp was granted marketing authorisation in the EU on 28 February 2011 for treatment of chronic obstructive pulmonary disease (COPD). The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period.
Daliresp was a duplicate of Daxas, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Daxas.
The European Public Assessment Report (EPAR) for Daliresp is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Daliresp : EPAR - Summary for the public
English (EN) (546.08 KB - PDF)
български (BG) (633.14 KB - PDF)
español (ES) (552.45 KB - PDF)
čeština (CS) (613.17 KB - PDF)
dansk (DA) (549.93 KB - PDF)
Deutsch (DE) (572.1 KB - PDF)
eesti keel (ET) (548.29 KB - PDF)
ελληνικά (EL) (636.5 KB - PDF)
français (FR) (549.53 KB - PDF)
hrvatski (HR) (570.52 KB - PDF)
italiano (IT) (550.18 KB - PDF)
latviešu valoda (LV) (611.23 KB - PDF)
lietuvių kalba (LT) (573.08 KB - PDF)
magyar (HU) (603.91 KB - PDF)
Malti (MT) (615.35 KB - PDF)
Nederlands (NL) (551.25 KB - PDF)
polski (PL) (613.23 KB - PDF)
português (PT) (551.5 KB - PDF)
română (RO) (571.82 KB - PDF)
slovenčina (SK) (612.85 KB - PDF)
slovenščina (SL) (605.35 KB - PDF)
Suomi (FI) (545.15 KB - PDF)
svenska (SV) (550.63 KB - PDF)
Product information
Daliresp : EPAR - Product Information
English (EN) (774.28 KB - PDF)
български (BG) (1.33 MB - PDF)
español (ES) (788.7 KB - PDF)
čeština (CS) (1.13 MB - PDF)
dansk (DA) (794.29 KB - PDF)
Deutsch (DE) (800.88 KB - PDF)
eesti keel (ET) (776.19 KB - PDF)
ελληνικά (EL) (1.42 MB - PDF)
français (FR) (804.59 KB - PDF)
hrvatski (HR) (794.74 KB - PDF)
íslenska (IS) (785.55 KB - PDF)
italiano (IT) (796.63 KB - PDF)
latviešu valoda (LV) (1.16 MB - PDF)
lietuvių kalba (LT) (780.52 KB - PDF)
magyar (HU) (1.14 MB - PDF)
Malti (MT) (1.19 MB - PDF)
Nederlands (NL) (798.54 KB - PDF)
norsk (NO) (774.52 KB - PDF)
polski (PL) (1.17 MB - PDF)
português (PT) (788.24 KB - PDF)
română (RO) (795.79 KB - PDF)
slovenčina (SK) (1.13 MB - PDF)
slovenščina (SL) (1.1 MB - PDF)
Suomi (FI) (777.71 KB - PDF)
svenska (SV) (787.97 KB - PDF)
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
Daliresp : EPAR - All Authorised presentations
English (EN) (486.93 KB - PDF)
български (BG) (538.13 KB - PDF)
español (ES) (487.32 KB - PDF)
čeština (CS) (505.6 KB - PDF)
dansk (DA) (480.29 KB - PDF)
Deutsch (DE) (487.21 KB - PDF)
eesti keel (ET) (480.16 KB - PDF)
ελληνικά (EL) (540.08 KB - PDF)
français (FR) (480.24 KB - PDF)
hrvatski (HR) (493.49 KB - PDF)
íslenska (IS) (489.44 KB - PDF)
italiano (IT) (486.97 KB - PDF)
latviešu valoda (LV) (529.57 KB - PDF)
lietuvių kalba (LT) (514.61 KB - PDF)
magyar (HU) (521.56 KB - PDF)
Malti (MT) (530.12 KB - PDF)
Nederlands (NL) (479.01 KB - PDF)
norsk (NO) (485.33 KB - PDF)
polski (PL) (506.02 KB - PDF)
português (PT) (487.73 KB - PDF)
română (RO) (515.38 KB - PDF)
slovenčina (SK) (522.74 KB - PDF)
slovenščina (SL) (491.74 KB - PDF)
Suomi (FI) (481.73 KB - PDF)
svenska (SV) (487.3 KB - PDF)
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
English (EN) (576.76 KB - PDF)
български (BG) (676.9 KB - PDF)
español (ES) (583.13 KB - PDF)
čeština (CS) (650.55 KB - PDF)
dansk (DA) (585.1 KB - PDF)
Deutsch (DE) (579.06 KB - PDF)
eesti keel (ET) (584.62 KB - PDF)
ελληνικά (EL) (682.29 KB - PDF)
français (FR) (582.02 KB - PDF)
íslenska (IS) (571.86 KB - PDF)
italiano (IT) (576 KB - PDF)
latviešu valoda (LV) (646.43 KB - PDF)
lietuvių kalba (LT) (606.07 KB - PDF)
magyar (HU) (634.99 KB - PDF)
Malti (MT) (627.75 KB - PDF)
Nederlands (NL) (575.84 KB - PDF)
norsk (NO) (583.22 KB - PDF)
polski (PL) (658.51 KB - PDF)
português (PT) (573.75 KB - PDF)
română (RO) (603.02 KB - PDF)
slovenčina (SK) (642.65 KB - PDF)
slovenščina (SL) (630.83 KB - PDF)
Suomi (FI) (580.37 KB - PDF)
svenska (SV) (583.1 KB - PDF)
Product details
- Name of medicine
- Daliresp
- Active substance
- roflumilast
- International non-proprietary name (INN) or common name
- roflumilast
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Anatomical therapeutic chemical (ATC) code
- R03DX07
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic 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.
Authorisation details
- EMA product number
- EMEA/H/C/002398
- Marketing authorisation holder
- AstraZeneca AB
151 85 Sodertalje
Sweden - Marketing authorisation issued
- 28/02/2011
- Withdrawal of marketing authorisation
- 11/01/2018
- Revision
- 9
Assessment history
Daliresp : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (625.79 KB - PDF)
Daliresp-H-C-PSUSA-00002658-201407 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (524.26 KB - PDF)