Libertek

RSS

roflumilast

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Libertek has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 08/02/2018

Authorisation details

Product details
Name
Libertek
Agency product number
EMEA/H/C/002399
Active substance
roflumilast
International non-proprietary name (INN) or common name
roflumilast
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03DX08
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
27/02/2011
Contact address
SE-151-85 Sodertalje
Sweden

Product information

11/01/2018 Libertek - EMEA/H/C/002399 - T/0031

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

Libertek 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

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