Daliresp

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Withdrawn

This medicine's authorisation has been withdrawn

roflumilast
MedicineHumanWithdrawn
  • 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Assessment Report (EPAR) for Daliresp is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: T/0030
03/11/2016
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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).

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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 diseases

Therapeutic 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

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