Daxas

RSS

roflumilast

Authorised
This medicine is authorised for use in the European Union.

Overview

This EPAR was last updated on 25/04/2018

Authorisation details

Product details
Name
Daxas
Agency product number
EMEA/H/C/001179
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
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
05/07/2010
Contact address
SE-151 85 Södertälje
Sweden

Product information

23/04/2018 Daxas - EMEA/H/C/001179 - X/0035

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Daxas 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.

Assessment history

How useful was this page?

Add your rating
Average
1 rating