Daliresp

Withdrawn

This medicine's authorisation has been withdrawn

roflumilast

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Assessment Report (EPAR) for Daliresp is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.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

Reference Number: EMA/CHMP/220794/2013

Product information

Daliresp : EPAR - Product Information

Daliresp : EPAR - All Authorised presentations

Daliresp : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

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

Changes since initial authorisation of medicine

Daliresp : EPAR - Procedural steps taken and scientific information after authorisation

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

Initial marketing authorisation documents

Daliresp : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Daliresp

Adopted Reference Number: EMA/CHMP/825394/2010