Libertek

roflumilast

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The marketing authorisation for Libertek has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Libertek : EPAR - Summary for the public BG = bălgarski 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public ES = español 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public CS = čeština 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public DA = dansk 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public DE = Deutsch 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public ET = eesti keel 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public EL = elliniká 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public EN = English 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public FR = français 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public IT = italiano 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public LV = latviešu valoda 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public LT = lietuvių kalba 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public HU = magyar 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public MT = Malti 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public NL = Nederlands 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public PL = polski 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public PT = português 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public RO = română 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public SK = slovenčina 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public SL = slovenščina 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public FI = suomi 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public SV = svenska 2011-03-11 2018-02-08
Libertek : EPAR - Summary for the public HR = Hrvatski 2011-03-11 2018-02-08

This EPAR was last updated on 08/02/2018 .

Authorisation details

Product details

Product details for Libertek
NameLibertek
Agency product numberEMEA/H/C/002399
Active substance

roflumilast

International non-proprietary name (INN) or common name

roflumilast

Therapeutic area Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03DX08

Publication details

Publication details for Libertek
Marketing-authorisation holder

AstraZeneca AB

Revision11
Date of issue of marketing authorisation valid throughout the European Union28/02/2011

Contact address:

AstraZeneca AB
SE-15185 Sodertalje
Sweden

Product information

Product information

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

Name Language First published Last updated
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Product Information HR = Hrvatski 2011-03-11 2018-02-08

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.


Name Language First published Last updated
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - All Authorised presentations HR = Hrvatski 2011-03-11 2018-02-08

Name Language First published Last updated
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08
Libertek : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-11 2018-02-08

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Libertek : EPAR - Public assessment report HR = Hrvatski 2011-03-11 2018-02-08
CHMP summary of positive opinion for Libertek HR = Hrvatski 2010-12-17 2018-02-08

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Libertek