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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Libertek has been withdrawn at the request of the marketing-authorisation holder.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
28/02/2011
Contact address

151 85 Sodertalje
Sweden

Product information

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

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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