Daliresp
Withdrawn
This medicine's authorisation has been withdrawn
roflumilast
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Daliresp has been withdrawn at the request of the marketing authorisation holder.
Daliresp : EPAR - Summary for the public
Reference Number: EMA/CHMP/220794/2013
English (EN) (546.08 KB - PDF)
First published: Last updated:
български (BG) (633.14 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
español (ES) (552.45 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
čeština (CS) (613.17 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
dansk (DA) (549.93 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Deutsch (DE) (572.1 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
eesti keel (ET) (548.29 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
ελληνικά (EL) (636.5 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
français (FR) (549.53 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
hrvatski (HR) (570.52 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
italiano (IT) (550.18 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
latviešu valoda (LV) (611.23 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
lietuvių kalba (LT) (573.08 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
magyar (HU) (603.91 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Malti (MT) (615.35 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Nederlands (NL) (551.25 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
polski (PL) (613.23 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
português (PT) (551.5 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
română (RO) (571.82 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
slovenčina (SK) (612.85 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
slovenščina (SL) (605.35 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Suomi (FI) (545.15 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
svenska (SV) (550.63 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Product information
Daliresp : EPAR - Product Information
English (EN) (774.28 KB - PDF)
First published: Last updated:
български (BG) (1.33 MB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
español (ES) (788.7 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
čeština (CS) (1.13 MB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
dansk (DA) (794.29 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Deutsch (DE) (800.88 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
eesti keel (ET) (776.19 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
ελληνικά (EL) (1.42 MB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
français (FR) (804.59 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
hrvatski (HR) (794.74 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
íslenska (IS) (785.55 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
italiano (IT) (796.63 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
latviešu valoda (LV) (1.16 MB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
lietuvių kalba (LT) (780.52 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
magyar (HU) (1.14 MB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Malti (MT) (1.19 MB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Nederlands (NL) (798.54 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
norsk (NO) (774.52 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
polski (PL) (1.17 MB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
português (PT) (788.24 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
română (RO) (795.79 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
slovenčina (SK) (1.13 MB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
slovenščina (SL) (1.1 MB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Suomi (FI) (777.71 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
svenska (SV) (787.97 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Latest procedure affecting product information:
T/0030
03/11/2016
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)
First published: Last updated:
български (BG) (538.13 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
español (ES) (487.32 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
čeština (CS) (505.6 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
dansk (DA) (480.29 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Deutsch (DE) (487.21 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
eesti keel (ET) (480.16 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
ελληνικά (EL) (540.08 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
français (FR) (480.24 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
hrvatski (HR) (493.49 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
íslenska (IS) (489.44 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
italiano (IT) (486.97 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
latviešu valoda (LV) (529.57 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
lietuvių kalba (LT) (514.61 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
magyar (HU) (521.56 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Malti (MT) (530.12 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Nederlands (NL) (479.01 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
norsk (NO) (485.33 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
polski (PL) (506.02 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
português (PT) (487.73 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
română (RO) (515.38 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
slovenčina (SK) (522.74 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
slovenščina (SL) (491.74 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Suomi (FI) (481.73 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
svenska (SV) (487.3 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
English (EN) (576.76 KB - PDF)
First published: Last updated:
български (BG) (676.9 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
español (ES) (583.13 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
čeština (CS) (650.55 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
dansk (DA) (585.1 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Deutsch (DE) (579.06 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
eesti keel (ET) (584.62 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
ελληνικά (EL) (682.29 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
français (FR) (582.02 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
íslenska (IS) (571.86 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
italiano (IT) (576 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
latviešu valoda (LV) (646.43 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
lietuvių kalba (LT) (606.07 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
magyar (HU) (634.99 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Malti (MT) (627.75 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Nederlands (NL) (575.84 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
norsk (NO) (583.22 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
polski (PL) (658.51 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
português (PT) (573.75 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
română (RO) (603.02 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
slovenčina (SK) (642.65 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
slovenščina (SL) (630.83 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
Suomi (FI) (580.37 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
svenska (SV) (583.1 KB - PDF)
First published: 11/03/2011Last updated: 06/02/2018
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
- Revision
- 9
Assessment history
Daliresp : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (625.79 KB - PDF)
First published: Last updated:
Daliresp-H-C-PSUSA-00002658-201407 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/CHMP/117044/2015
English (EN) (524.26 KB - PDF)
First published: Last updated:
More information on Daliresp
Public statement on Daliresp: Withdrawal of the marketing authorisation in the European Union
AdoptedReference Number: EMA/58489/2018
English (EN) (82.13 KB - PDF)
First published: Last updated:
This page was last updated on